WO2025189152A1 - Systems and methods for breathing entrainment - Google Patents
Systems and methods for breathing entrainmentInfo
- Publication number
- WO2025189152A1 WO2025189152A1 PCT/US2025/019027 US2025019027W WO2025189152A1 WO 2025189152 A1 WO2025189152 A1 WO 2025189152A1 US 2025019027 W US2025019027 W US 2025019027W WO 2025189152 A1 WO2025189152 A1 WO 2025189152A1
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- WIPO (PCT)
- Prior art keywords
- entrainment
- user
- stimulus
- waveform
- respiratory therapy
- Prior art date
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Definitions
- the present disclosure relates to systems and methods for pacing breathing of a user, and more particularly, to systems and methods for pacing breathing of a user via an entrainment stimulus.
- SDB Sleep-Disordered Breathing
- OSA Obstructive Sleep Apnea
- CSA Central Sleep Apnea
- RERA Respiratory Effort Related Arousal
- insomnia characterized by, for example, difficult in initiating sleep, frequent or prolonged awakenings after initially falling asleep, and/or an early awakening with an inability to return to sleep
- Periodic Limb Movement Disorder PLMD
- Restless Leg Syndrome RLS
- Cheyne-Stokes Respiration CSR
- respiratory insufficiency Obesity Hyperventilation Syndrome
- COPD Chronic Obstructive Pulmonary Disease
- NMD Neuromuscular Disease
- REM rapid eye movement
- DEB dream enactment behavior
- hypertension diabetes, stroke, and chest wall disorders.
- a respiratory therapy system e.g., a continuous positive airway pressure (CPAP) system
- CPAP continuous positive airway pressure
- some users have difficulty falling asleep, staying asleep, and/or waking up comfortably when using a respiration therapy device.
- CPAP continuous positive airway pressure
- the users may also elect to discontinue use of the respiratory therapy device, which may further exacerbate the user's sleep-related and/or respiratory-related disorders.
- the present disclosure is directed to solving these and other problems.
- a method comprises receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system.
- the method further comprises extracting first respiration information from the first data.
- the method further comprises presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating at least a first entrainment waveform and presenting at least a first entrainment stimulus based at least in part on the first entrainment waveform.
- the method further comprises generating at least one entrainment coherence score indicative of coherence between the first respiration information and the first entrainment waveform.
- the method further comprises receiving second data associated with a user engaging in a current sleep session.
- the method further comprises presenting a second entrainment program to the user during the current sleep session that is based at least in part on the second data, the at least one entrainment coherence score, or both.
- a method comprises receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system.
- the method further comprises extracting first respiration information from the first data.
- the method further comprises presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
- a method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session comprises receiving entrainment coherence data associated with one or more entrainment stimuli presented to the user during an acclimatization session prior to the sleep session.
- the method further comprises generating an entrainment waveform based at least in part on the entrainment coherence data.
- the method further comprises presenting an entrainment stimulus to the user based at least in part on the entrainment waveform, the entrainment coherence data, or both.
- FIG. 1 is a functional block diagram of a system for detecting rainout in a respiratory therapy system, according to some implementations of the present disclosure.
- FIG. 2 is a perspective view of the system of FIG. 1, a user of the system, and a bed partner of the user, according to some implementations of the present disclosure.
- FIG. 3 illustrates an exemplary timeline for a sleep session, according to some implementations of the present disclosure.
- FIG. 4 illustrates an exemplary hypnogram associated with the sleep session of FIG. 3, according to some implementations of the present disclosure.
- FIG. 5 is a process flow diagram of a method for presenting an entrainment program during an acclimatization session, according to some implementations of the present disclosure.
- FIG. 6 is a process flow diagram of a first method for presenting an entrainment program during a sleep session, according to some implementations of the present disclosure.
- FIG. 7 is a pressure curve illustrating the modulation of pressure in a respiratory therapy system to induce a user to breathe according to a target respiration pattern, according to some implementations of the present disclosure.
- FIG. 8A is plot showing a respiration rate trace and an entrainment stimulus trace used to induce a user to breathe according to a target respiration pattern, according to some implementations of the present disclosure.
- FIG. 8B is plot showing a respiration rate trace and an entrainment stimulus trace used to induce a user to breathe according to a target respiration pattern where the user falls asleep, according to some implementations of the present disclosure.
- FIG. 9 is a process flow diagram of a second method for presenting an entrainment program during a sleep session, according to some implementations of the present disclosure.
- FIG. 10 is a process flow diagram of a third method for presenting an entrainment program during a sleep session, according to some implementations of the present disclosure.
- FIG. 11 is a process flow diagram of a first method for presenting entrainment programs during an acclimatization session and a sleep session, according to some implementations of the present disclosure.
- FIG. 12 is a process flow diagram of a second method for presenting entrainment programs during an acclimatization session and a sleep session, according to some implementations of the present disclosure.
- FIG. 13A is a front view of a user device depicting a first view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
- FIG. 13B is a front view of the user device of FIG. 13 A depicting a second view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
- FIG. 13C is a front view of the user device of FIG. 13A depicting a third view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
- FIG. 13D is a front view of the user device of FIG. 13 A depicting a fourth view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
- FIG. 14A is a front view of a user device depicting a first view of a graphical user interface for entrainment using an alternate entrainment visual element, according to some implementations of the present disclosure.
- FIG. 14C is a front view of the user device of FIG. 13A depicting a third view of a graphical user interface for entrainment using an alternate entrainment visual element, according to some implementations of the present disclosure.
- sleep-related and/or respiratory disorders include Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), other types of apneas, Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders.
- PLMD Periodic Limb Movement Disorder
- RLS Restless Leg Syndrome
- SDB Sleep-Disordered Breathing
- OSA Obstructive Sleep Apnea
- CSA Central Sleep Apnea
- CSR Cheyne-Stokes Respiration
- OOS Obesity Hyperventilation Syndrome
- COPD Chronic Obstructive Pulmonary Disease
- NMD Neuromuscular Disease
- PLMD Periodic Limb Movement Disorder
- RLS Restless Leg Syndrome
- SDB Sleep-Disordered Breathing
- OSA Obstructive Sleep Apnea
- CSA Central Sleep Apnea
- RERA Respiratory Effort Related Arousal
- CSR Cheyne-Stokes Respiration
- OLS Obesity Hyperventilation Syndrome
- COPD Chronic Obstructive Pulmonary Disease
- NMD Neuromuscular Disease
- Obstructive Sleep Apnea a form of Sleep Disordered Breathing (SDB), is characterized by events including occlusion or obstruction of the upper air passage during sleep resulting from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate, and posterior oropharyngeal wall.
- Central Sleep Apnea CSA is another form of sleep disordered breathing. CSA results when the brain temporarily stops sending signals to the muscles that control breathing.
- Other types of apneas include hypopnea, hyperpnea, and hypercapnia. Hypopnea is generally characterized by slow or shallow breathing caused by a narrowed airway, as opposed to a blocked airway.
- Hyperpnea is generally characterized by an increase depth and/or rate of breathing. Hypercapnia is generally characterized by elevated or excessive carbon dioxide in the bloodstream, typically caused by inadequate respiration.
- a Respiratory Effort Related Arousal (RERA) event is typically characterized by an increased respiratory effort for ten seconds or longer leading to arousal from sleep and which does not fulfill the criteria for an apnea or hypopnea event.
- RERAs are defined as a sequence of breaths characterized by increasing respiratory effort leading to an arousal from sleep, but which does not meet criteria for an apnea or hypopnea.
- NMD encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology.
- Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage.
- Many of these disorders are characterized by particular events (e.g., snoring, an apnea, a hypopnea, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof) that can occur when the individual is sleeping.
- events e.g., snoring, an apnea, a hypopnea, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof.
- sleep-related and/or respiratory disorders or other disorders.
- the Apnea-Hypopnea Index is an index used to indicate the severity of sleep apnea during a sleep session.
- the AHI is calculated by dividing the number of apnea and/or hypopnea events experienced by the user during the sleep session by the total number of hours of sleep in the sleep session. The event can be, for example, a pause in breathing that lasts for at least 10 seconds.
- An AHI that is less than 5 is considered normal.
- An AHI that is greater than or equal to 5, but less than 15 is considered indicative of mild sleep apnea.
- An AHI that is greater than or equal to 15, but less than 30 is considered indicative of moderate sleep apnea.
- the system 10 can include any one or more of a respiratory therapy system 100, a control system 200, a memory device 204, an entrainment module 206, a stimulus device 208, one or more sensors 210.
- the system 10 may additionally or alternatively include a user device 260, an activity tracker 270, and a blood pressure device 280.
- the system 10 can be used to present an entrainment program that involves presenting entrainment stimuli to a user to guide the user's breathing pattern to a desired target breathing pattern.
- the system can monitor data associated with the user and leverage that data to adjust the entrainment stimuli as needed to guide the user towards the target breathing pattern.
- the respiratory therapy system 100 includes a respiratory pressure therapy (RPT) device 110 (referred to herein as respiratory therapy device 110), a user interface 120 (also referred to as a mask or a patient interface), a conduit 140 (also referred to as a tube or an air circuit), a display device 150, and a humidifier 160.
- Respiratory pressure therapy refers to the application of a supply of air to an entrance to a user’s airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the user’s breathing cycle (e.g., in contrast to negative pressure therapies such as the tank ventilator or cuirass).
- the respiratory therapy system 100 is generally used to treat individuals suffering from one or more sleep-related respiratory disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea).
- the respiratory therapy system 100 can be used, for example, as a ventilator or as a positive airway pressure (PAP) system, such as a continuous positive airway pressure (CPAP) system, an automatic positive airway pressure system (APAP), a bi-level or variable positive airway pressure system (BPAP or VPAP), or any combination thereof.
- PAP positive airway pressure
- CPAP continuous positive airway pressure
- APAP automatic positive airway pressure system
- BPAP or VPAP bi-level or variable positive airway pressure system
- the CPAP system delivers a predetermined air pressure (e.g., determined by a sleep physician) to the user.
- the APAP system automatically varies the air pressure delivered to the user based on, for example, respiration data associated with the user.
- the BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., an inspiratory positive airway pressure or IPAP) and a second predetermined pressure (e.g., an expiratory positive airway pressure or EPAP) that is lower than the first predetermined pressure.
- a first predetermined pressure e.g., an inspiratory positive airway pressure or IPAP
- a second predetermined pressure e.g., an expiratory positive airway pressure or EPAP
- the respiratory therapy system 100 can be used to treat a user 20.
- the user 20 of the respiratory therapy system 100 and a bed partner 30 are in a bed 40 and are laying on a mattress 42.
- the user interface 120 can be worn by the user 20 during a sleep session.
- the respiratory therapy system 100 generally aids in increasing the air pressure in the throat of the user 20 to aid in preventing the airway from closing and/or narrowing during sleep.
- the respiratory therapy device 110 can be positioned on a nightstand 44 that is directly adjacent to the bed 40 as shown in FIG. 2, or more generally, on any surface or structure that is generally adjacent to the bed 40 and/or the user 20.
- the respiratory therapy device 110 is generally used to generate pressurized air that is delivered to a user (e.g., using one or more motors that drive one or more compressors). In some implementations, the respiratory therapy device 110 generates continuous constant air pressure that is delivered to the user. In other implementations, the respiratory therapy device 110 generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In still other implementations, the respiratory therapy device 110 generates a variety of different air pressures within a predetermined range.
- the respiratory therapy device 110 can deliver at least about 6 cmFFO, at least about 10 cmFFO, at least about 20 cmFFO, between about 6 crnFFO and about 10 cmFFO, between about 7 cmFFO and about 12 cmFFO, etc.
- the respiratory therapy device 110 can also deliver pressurized air at a predetermined flow rate between, for example, about -20 L/min and about 150 L/min, while maintaining a positive pressure (relative to the ambient pressure).
- the control system 200 and/or the memory device 204 can be coupled to and/or positioned within a housing of the respiratory therapy device 110.
- the respiratory therapy device 110 includes a housing 112, a blower motor 114, an air inlet 116, and an air outlet 118.
- the blower motor 114 is at least partially disposed or integrated within the housing 112.
- the blower motor 114 draws air from outside the housing 112 (e.g., atmosphere) via the air inlet 116 and causes pressurized air to flow through the humidifier 160, and through the air outlet 118.
- the air inlet 116 and/or the air outlet 118 include a cover that is moveable between a closed position and an open position (e.g., to prevent or inhibit air from flowing through the air inlet 116 or the air outlet 118).
- the housing 112 can also include a vent to allow air to pass through the housing 112 to the air inlet 116.
- the conduit 140 is coupled to the air outlet 118 of the respiratory therapy device 110.
- the user interface 120 engages a portion of the user’s face and delivers pressurized air from the respiratory therapy device 110 to the user’s airway to aid in preventing the airway from narrowing and/or collapsing during sleep. This may also increase the user’s oxygen intake during sleep.
- the user interface 120 engages the user’s face such that the pressurized air is delivered to the user’s airway via the user’s mouth, the user’s nose, or both the user’s mouth and nose.
- the respiratory therapy system 100 forms an air pathway that extends between a motor of the respiratory therapy device 110 and the user and/or the user’s airway.
- the air pathway which is fluidly coupled to the user’s airway, generally includes at least the motor of the respiratory therapy device 110 and/or the respiratory therapy device 110 itself, the user interface 120, and the conduit 140.
- the pressurized air also increases the user’s oxygen intake during sleep.
- the user interface 120 may form a seal, for example, with a region or portion of the user’s face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, for example, at a positive pressure of about 10 cm H2O relative to ambient pressure.
- the user interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmFFO.
- the user interface 120 can include, for example, a cushion 122, a frame 124, a headgear 126, connector 128, and one or more vents 130.
- the cushion 122 and the frame 124 define a volume of space around the mouth and/or nose of the user. When the respiratory therapy system 100 is in use, this volume space receives pressurized air (e.g., from the respiratory therapy device 110 via the conduit 140) for passage into the airway(s) of the user.
- the headgear 126 is generally used to aid in positioning and/or stabilizing the user interface 120 on a portion of the user (e.g., the face), and along with the cushion 122 (which, for example, can comprise silicone, plastic, foam, etc.) aids in providing a substantially air-tight seal between the user interface 120 and the user 20.
- the headgear 126 includes one or more straps (e.g., including hook and loop fasteners).
- the connector 128 is generally used to couple (e.g., connect and fluidly couple) the conduit 140 to the cushion 122 and/or frame 124. Alternatively, the conduit 140 can be directly coupled to the cushion 122 and/or frame 124 without the connector 128.
- the one or more vents 130 can be used for permitting the escape of carbon dioxide and other gases exhaled by the user 20.
- the user interface 120 generally can include any suitable number of vents (e.g., one, two, five, ten, etc.).
- the user interface 120 is a facial mask (e.g., a full-face mask) that covers at least a portion of the nose and mouth of the user 20.
- the user interface 120 can be a nasal mask that provides air to the nose of the user or a nasal pillow mask that delivers air directly to the nostrils of the user 20.
- the user interface 120 includes a mouthpiece (e.g., a night guard mouthpiece molded to conform to the teeth of the user, a mandibular repositioning device, etc.).
- the conduit 140 (also referred to as an air circuit or tube) allows the flow of air between components of the respiratory therapy system 100, such as between the respiratory therapy device 110 and the user interface 120.
- the conduit 140 allows the flow of air between components of the respiratory therapy system 100, such as between the respiratory therapy device 110 and the user interface 120.
- a single limb conduit is used for both inhalation and exhalation.
- the conduit 140 includes a first end that is coupled to the air outlet 118 of the respiratory therapy device 110.
- the first end can be coupled to the air outlet 118 of the respiratory therapy device 110 using a variety of techniques (e.g., a press fit connection, a snap fit connection, a threaded connection, etc.).
- the conduit 140 includes one or more heating elements that heat the pressurized air flowing through the conduit 140 (e.g., heat the air to a predetermined temperature or within a range of predetermined temperatures). Such heating elements can be coupled to and/or imbedded in the conduit 140.
- the first end can include an electrical contact that is electrically coupled to the respiratory therapy device 110 to power the one or more heating elements of the conduit 140.
- the electrical contact can be electrically coupled to an electrical contact of the air outlet 118 of the respiratory therapy device 110.
- electrical contact of the conduit 140 can be a male connector and the electrical contact of the air outlet 118 can be female connector, or, alternatively, the opposite configuration can be used.
- the display device 150 is generally used to display image(s) including still images, video images, or both and/or information regarding the respiratory therapy device 110.
- the display device 150 can provide information regarding the status of the respiratory therapy device 110 (e.g., whether the respiratory therapy device 110 is on/off, the pressure of the air being delivered by the respiratory therapy device 110, the temperature of the air being delivered by the respiratory therapy device 110, etc.) and/or other information (e.g., a sleep score and/or a therapy score, also referred to as a my AirTM score, such as described in WO 2016/061629 and U.S. Patent Pub. No.
- the display device 150 acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) as an input interface.
- HMI human-machine interface
- GUI graphic user interface
- the display device 150 can be an LED display, an OLED display, an LCD display, or the like.
- the input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the respiratory therapy device 110.
- the humidifier 160 is coupled to or integrated in the respiratory therapy device 110 and includes a reservoir 162 for storing water that can be used to humidify the pressurized air delivered from the respiratory therapy device 110.
- the humidifier 160 includes a one or more heating elements 164 to heat the water in the reservoir to generate water vapor.
- the humidifier 160 can be fluidly coupled to a water vapor inlet of the air pathway between the blower motor 114 and the air outlet 118, or can be formed in-line with the air pathway between the blower motor 114 and the air outlet 118. For example, air flows from the air inlet 116 through the blower motor 114, and then through the humidifier 160 before exiting the respiratory therapy device 110 via the air outlet 118.
- a respiratory therapy system 100 has been described herein as including each of the respiratory therapy device 110, the user interface 120, the conduit 140, the display device 150, and the humidifier 160, more or fewer components can be included in a respiratory therapy system according to implementations of the present disclosure.
- a first alternative respiratory therapy system includes the respiratory therapy device 110, the user interface 120, and the conduit 140.
- a second alternative system includes the respiratory therapy device 110, the user interface 120, and the conduit 140, and the display device 150.
- various respiratory therapy systems can be formed using any portion or portions of the components shown and described herein and/or in combination with one or more other components.
- the control system 200 includes one or more processors 202 (hereinafter, processor 202).
- the control system 200 is generally used to control (e.g., actuate) the various components of the system 10 and/or analyze data obtained and/or generated by the components of the system 10.
- the processor 202 can be a general or special purpose processor or microprocessor. While one processor 202 is illustrated in FIG. 1, the control system 200 can include any number of processors (e.g., one processor, two processors, five processors, ten processors, etc.) that can be in a single housing, or located remotely from each other.
- the control system 200 (or any other control system) or a portion of the control system 200 such as the processor 202 (or any other processor(s) or portion(s) of any other control system), can be used to carry out one or more steps of any of the methods described and/or claimed herein.
- the control system 200 can be coupled to and/or positioned within, for example, a housing of the user device 260, a portion (e.g., the respiratory therapy device 110) of the respiratory therapy system 100, and/or within a housing of one or more of the sensors 210.
- the control system 200 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct).
- the housings can be located proximately and/or remotely from each other.
- the control system 200 (or one or more portions thereof) can be located in the respiratory therapy device 110, in the user device 260 (e.g., as part of a smartphone application), in the cloud (e.g., in a remote device or system connected various components of the system 10 such as the user device 260 and/or the respiratory therapy device 110), and/or in other locations.
- the memory device 204 stores machine-readable instructions that are executable by the processor 202 of the control system 200.
- the memory device 204 can be any suitable computer readable storage device or media, such as, for example, a random or serial access memory device, a hard drive, a solid-state drive, a flash memory device, etc. While one memory device 204 is shown in FIG. 1, the system 10 can include any suitable number of memory devices 204 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.).
- the memory device 204 can be coupled to and/or positioned within a housing of a respiratory therapy device 110 of the respiratory therapy system 100, within a housing of the user device 260, within a housing of one or more of the sensors 210, or any combination thereof. Like the control system 200, the memory device 204 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct).
- the memory device 204 stores a user profile associated with the user.
- the user profile can include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep- related parameters recorded from one or more earlier sleep sessions), or any combination thereof.
- the demographic information can include, for example, information indicative of an age of the user, a gender of the user, a race of the user, a geographic location of the user, a relationship status, a family history of insomnia or sleep apnea, an employment status of the user, an educational status of the user, a socioeconomic status of the user, or any combination thereof.
- the medical information can include, for example, information indicative of one or more medical conditions associated with the user, medication usage by the user, or both.
- the medical information data can further include a multiple sleep latency test (MSLT) result or score and/or a Pittsburgh Sleep Quality Index (PSQI) score or value.
- the self-reported user feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, a recent life event experienced by the user, or any combination thereof.
- the processor 202 and/or memory device 204 can receive data (e.g., physiological data and/or audio data) from the one or more sensors 210 such that the data for storage in the memory device 204 and/or for analysis by the processor 202.
- the processor 202 and/or memory device 204 can communicate with the one or more sensors 210 using a wired connection or a wireless connection (e.g., using an RF communication protocol, a Wi-Fi communication protocol, a Bluetooth communication protocol, over a cellular network, etc.).
- the system 10 can include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof.
- Such components can be coupled to or integrated a housing of the control system 200 (e.g., in the same housing as the processor 202 and/or memory device 204), or the user device 260.
- the entrainment module 206 determines and/or facilitates presentation of an entrainment program based at least in part on data (e.g., sensor data acquired from the one or more sensors 210 and/or other sensors, as disclosed in further detail herein). Some or all of the entrainment module 206 can be implemented by and/or make use of any other elements of system 10. For example, in some implementations, the entrainment module 206 may be implemented as a specific set of instructions stored in the memory device 204 and executed by the processors 202 of the control system 200.
- the entrainment module 206 can generate an entrainment waveform from the data in some cases.
- the entrainment waveform can include information indicative of a rhythm, a morphology, a rate, and/or other features of a desired respiration pattern.
- an entrainment waveform can be a sine wave at 0.333 Hz, which can be indicative of a respiration rate of at or approximately 20 breaths per minute (bpm).
- an entrainment waveform can be a non-sinusoidal wave that changes frequency over time, which can be indicative of a respiration morphology (e.g., timing and extent of inhalation and exhalation over time) and a changing respiration rate.
- the entrainment waveform can be used to present an entrainment stimulus to the user via one or more stimulus devices 208.
- Any suitable device that can present discernable input to the user can be used as a stimulus device 208.
- the one or more stimulus devices 208 can include (i) a tactile stimulus device (e.g., a vibrating motor); (ii) a visual stimulus device (e.g., a display device, such as the display device 262 of the user device 260 or the display device 150 of the respiratory therapy system 100); (iii) an audio stimulus device (e.g., a speaker, such as speaker 222); (iv) an airflow stimulus device (e.g., a respiratory therapy device, such as respiratory therapy device 110); or (v) any combination of (i)-(iv).
- a tactile stimulus device e.g., a vibrating motor
- a visual stimulus device e.g., a display device, such as the display device 262 of the user device 260 or the display device 150
- the entrainment signal can be used to present a single entrainment stimulus (e.g., a visual cue of an expanding and contracting circle) or multiple entrainment stimuli (e.g., a sound of lapping ocean waves and a visual cue of an expanding and contracting circle).
- a single entrainment stimulus e.g., a visual cue of an expanding and contracting circle
- multiple entrainment stimuli e.g., a sound of lapping ocean waves and a visual cue of an expanding and contracting circle.
- the one or more sensors 210 include a pressure sensor 212, a flow rate sensor 214, temperature sensor 216, a motion sensor 218, a microphone 220, a speaker 222, a radiofrequency (RF) receiver 226, a RF transmitter 228, a camera 232, an infrared (IR) sensor 234, a photoplethy smogram (PPG) sensor 236, an electrocardiogram (ECG) sensor 238, an electroencephalography (EEG) sensor 240, a capacitive sensor 242, a force sensor 244, a strain gauge sensor 246, an electromyography (EMG) sensor 248, an oxygen sensor 250, an analyte sensor 252, a moisture sensor 254, a Light Detection and Ranging (LiDAR) sensor 256, or any combination thereof.
- each of the one or more sensors 210 are configured to output sensor data that is received and stored in the memory device 204 or one or more other memory devices.
- the one or more sensors 210 are shown and described as including each of the pressure sensor 212, the flow rate sensor 214, the temperature sensor 216, the motion sensor 218, the microphone 220, the speaker 222, the RF receiver 226, the RF transmitter 228, the camera 232, the IR sensor 234, the PPG sensor 236, the ECG sensor 238, the EEG sensor 240, the capacitive sensor 242, the force sensor 244, the strain gauge sensor 246, the EMG sensor 248, the oxygen sensor 250, the analyte sensor 252, the moisture sensor 254, and the LiDAR sensor 256, more generally, the one or more sensors 210 can include any combination and any number of each of the sensors described and/or shown herein.
- the system 10 generally can be used to generate physiological data associated with a user (e.g., a user of the respiratory therapy system 100) during a sleep session.
- the physiological data can be analyzed to generate one or more sleep-related parameters, which can include any parameter, measurement, etc. related to the user during the sleep session.
- the one or more sleep-related parameters that can be determined for the user 20 during the sleep session include, for example, an Apnea-Hypopnea Index (AHI) score, a sleep score, a flow signal, a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a stage, pressure settings of the respiratory therapy device 110, a heart rate, a heart rate variability, movement of the user 20, temperature, EEG activity, EMG activity, arousal, snoring, choking, coughing, whistling, wheezing, or any combination thereof.
- AHI Apnea-Hypopnea Index
- the one or more sensors 210 can be used to generate, for example, physiological data, audio data, or both.
- Physiological data generated by one or more of the sensors 210 can be used by the control system 200 to determine a sleep-wake signal associated with the user 20 during the sleep session and one or more sleep-related parameters.
- the sleep-wake signal can be indicative of one or more sleep states, including wakefulness, relaxed wakefulness, micro- awakenings, or distinct sleep stages such as, for example, a rapid eye movement (REM) stage, a first non-REM stage (often referred to as “Nl”), a second non-REM stage (often referred to as “N2”), a third non-REM stage (often referred to as “N3”), or any combination thereof.
- REM rapid eye movement
- the sleep-wake signal described herein can be timestamped to indicate a time that the user enters the bed, a time that the user exits the bed, a time that the user attempts to fall asleep, etc.
- the sleep-wake signal can be measured by the one or more sensors 210 during the sleep session at a predetermined sampling rate, such as, for example, one sample per second, one sample per 30 seconds, one sample per minute, etc.
- the sleep-wake signal can also be indicative of a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, pressure settings of the respiratory therapy device 110, or any combination thereof during the sleep session.
- the event(s) can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak (e.g., from the user interface 120), a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof.
- a mask leak e.g., from the user interface 120
- a restless leg e.g., a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof.
- the one or more sleep-related parameters that can be determined for the user during the sleep session based on the sleep-wake signal include, for example, a total time in bed, a total sleep time, a sleep onset latency, a wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, or any combination thereof.
- the physiological data and/or the sleep-related parameters can be analyzed to determine one or more sleep-related scores.
- Physiological data and/or audio data generated by the one or more sensors 210 can also be used to determine a respiration signal associated with a user during a sleep session.
- the respiration signal is generally indicative of respiration or breathing of the user during the sleep session.
- the respiration signal can be indicative of and/or analyzed to determine (e.g., using the control system 200) one or more sleep-related parameters, such as, for example, a respiration rate, a respiration rate variability, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, a sleep state, a sleep stage, an apnea-hypopnea index (AHI), pressure settings of the respiratory therapy device 110, or any combination thereof.
- sleep-related parameters such as, for example, a respiration rate, a respiration rate variability, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, a sleep state, a sleep stage, an apnea-hypopnea index (AHI), pressure settings of the respiratory therapy device 110, or any combination thereof.
- the one or more events can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak (e.g., from the user interface 120), a cough, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, increased blood pressure, or any combination thereof.
- Many of the described sleep-related parameters are physiological parameters, although some of the sleep-related parameters can be considered to be non-physiological parameters. Other types of physiological and/or non-physiological parameters can also be determined, either from the data from the one or more sensors 210, or from other types of data.
- the pressure sensor 212 outputs pressure data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200.
- the pressure sensor 212 is an air pressure sensor (e.g., barometric pressure sensor) that generates sensor data indicative of the respiration (e.g., inhaling and/or exhaling) of the user of the respiratory therapy system 100 and/or ambient pressure.
- the pressure sensor 212 can be coupled to or integrated in the respiratory therapy device 110.
- the pressure sensor 212 can be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain-gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof.
- the flow rate sensor 214 outputs flow rate data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200. Examples of flow rate sensors (such as, for example, the flow rate sensor 214) are described in International Publication No. WO 2012/012835 and U.S. Patent No. 10,328,219, both of which are hereby incorporated by reference herein in their entireties.
- the flow rate sensor 214 is used to determine an air flow rate from the respiratory therapy device 110, an air flow rate through the conduit 140, an air flow rate through the user interface 120, or any combination thereof.
- the flow rate sensor 214 can be coupled to or integrated in the respiratory therapy device 110, the user interface 120, or the conduit 140.
- the flow rate sensor 214 can be a mass flow rate sensor such as, for example, a rotary flow meter (e.g., Hall effect flow meters), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or any combination thereof.
- the flow rate sensor 214 is configured to measure a vent flow (e.g., intentional “leak”), an unintentional leak (e.g., mouth leak and/or mask leak), a patient flow (e.g., air into and/or out of lungs), or any combination thereof.
- the flow rate data can be analyzed to determine cardiogenic oscillations of the user.
- the pressure sensor 212 can be used to determine a blood pressure of a user.
- the temperature sensor 216 outputs temperature data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200. In some implementations, the temperature sensor 216 generates temperatures data indicative of a core body temperature of the user 20, a skin temperature of the user 20, a temperature of the air flowing from the respiratory therapy device 110 and/or through the conduit 140, a temperature in the user interface 120, an ambient temperature, or any combination thereof.
- the temperature sensor 216 can be, for example, a thermocouple sensor, a thermistor sensor, a silicon band gap temperature sensor or semiconductor-based sensor, a resistance temperature detector, or any combination thereof.
- the motion sensor 218 outputs motion data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200.
- the motion sensor 218 can be used to detect movement of the user 20 during the sleep session, and/or detect movement of any of the components of the respiratory therapy system 100, such as the respiratory therapy device 110, the user interface 120, or the conduit 140.
- the motion sensor 218 can include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers.
- the motion sensor 218 can comprise an acoustic sensor (such as the acoustic sensor 224 discussed herein) and/or an RF sensor (such as the RF sensor 230 discussed herein), which can generate motion data as further discussed herein.
- the motion sensor 218, the acoustic sensor, and/or the RF sensor can be disposed in a portable device, such as the user device 260.
- FIG. 1 and FIG. 2 show the respiratory therapy device 110 as including its own display device 150, in some implementations the respiratory therapy device 110 may not include its own display device, as is discussed herein.
- the motion sensor 218 alternatively or additionally generates one or more signals representing bodily movement of the user, from which may be obtained a signal representing a sleep state of the user, for example, via a respiratory movement of the user.
- the motion data from the motion sensor 218 can be used in conjunction with additional data from another one of the sensors 210 to determine the sleep state of the user.
- the motion sensor 218 can be used to detect motion or acceleration associated with arterial pulses, such as pulses in or around the face of the user and proximal to the user interface 120, and configured to detect features of the pulse shape, speed, amplitude, or volume.
- the microphone 220 outputs sound and/or audio data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200.
- the audio data generated by the microphone 220 is reproducible as one or more sound(s) during a sleep session (e.g., sounds from the user 20).
- the audio data form the microphone 220 can also be used to identify (e.g., using the control system 200) an event experienced by the user during the sleep session, as described in further detail herein.
- the microphone 220 can be coupled to or integrated in the respiratory therapy device 110, the user interface 120, the conduit 140, or the user device 260.
- the microphone 220 can be coupled to or integrated in a wearable device, such as a smartwatch, smart glasses, earphones or ear buds, or other head wearable device.
- the system 10 includes a plurality of microphones (e.g., two or more microphones and/or an array of microphones with beamforming) such that sound data generated by each of the plurality of microphones can be used to discriminate the sound data generated by another of the plurality of microphones.
- the acoustic data from the microphone 220 is representative of noise associated with the respiratory therapy system 100.
- the acoustic data from the microphone 220 can be analyzed to detect the presence of liquid in the respiratory therapy system 100.
- the microphone 220 can be coupled to or integrated in the respiratory therapy system 100 (or the system 10) generally in any configuration.
- the microphone 220 can be disposed inside the respiratory therapy device 110, the user interface 120, the conduit 140, or other components.
- the microphone 220 can also be positioned adjacent to or coupled to the outside of the respiratory therapy device 110, the outside of the user interface 120, the outside of the conduit 140, or outside of any other components.
- the microphone 220 could also be a component of the user device 170 (e.g., the microphone 220 is a microphone of a smart phone).
- the microphone 220 can be integrated in the user interface 120, the conduit 140, the respiratory therapy device 110, or any combination thereof.
- the microphone 220 can be located at any point within or adjacent to the air pathway of the respiratory therapy system 100, which includes at least the motor of the respiratory therapy device 110, the user interface 120, and the conduit 140.
- the air pathway can also be referred to as the acoustic pathway.
- the speaker 222 outputs sound waves that are audible to a user of the system 10 (e.g., the user 20 of FIG. 2).
- the speaker 222 can be used, for example, as an alarm clock or to play an alert or message to the user 20 (e.g., in response to an event).
- the speaker 222 can be used to communicate the audio data generated by the microphone 220 to the user.
- the speaker 222 can be coupled to or integrated in the respiratory therapy device 110, the user interface 120, the conduit 140, or the user device 260, and/or can be coupled to or integrated in a wearable device, such as a smartwatch, smart glasses, earphones or ear buds, or other head wearable device.
- the microphone 220 and the speaker 222 can be used as separate devices.
- the microphone 220 and the speaker 222 can be combined into an acoustic sensor 224 (e.g., a sonar sensor), as described in, for example, WO 2018/050913, WO 2020/104465, U.S. Pat. App. Pub. No. 2022/0007965, each of which is hereby incorporated by reference herein in its entirety.
- the speaker 222 generates or emits sound waves at a predetermined interval and the microphone 220 detects the reflections of the emitted sound waves from the speaker 222.
- the sound waves generated or emitted by the speaker 222 have a frequency that is not audible to the human ear (e.g., below 20 Hz or above around 18 kHz) so as not to disturb the sleep of the user 20 or the bed partner 30.
- the control system 200 can determine a location of the user 20 and/or one or more of the sleep-related parameters described in herein such as, for example, a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a sleep state, a sleep stage, pressure settings of the respiratory therapy device 110, or any combination thereof.
- a sonar sensor may be understood to concern an active acoustic sensing, such as by generating and/or transmitting ultrasound and/or low frequency ultrasound sensing signals (e.g., in a frequency range of about 17-23 kHz, 18-22 kHz, or 17-18 kHz, for example), through the air.
- an active acoustic sensing such as by generating and/or transmitting ultrasound and/or low frequency ultrasound sensing signals (e.g., in a frequency range of about 17-23 kHz, 18-22 kHz, or 17-18 kHz, for example), through the air.
- the sensors 210 include (i) a first microphone that is the same as, or similar to, the microphone 220, and is integrated in the acoustic sensor 224 and (ii) a second microphone that is the same as, or similar to, the microphone 220, but is separate and distinct from the first microphone that is integrated in the acoustic sensor 224.
- the RF transmitter 228 generates and/or emits radio waves having a predetermined frequency and/or a predetermined amplitude (e.g., within a high frequency band, within a low frequency band, long wave signals, short wave signals, etc.).
- the RF receiver 226 detects the reflections of the radio waves emitted from the RF transmitter 228, and this data can be analyzed by the control system 200 to determine a location of the user and/or one or more of the sleep-related parameters described herein.
- An RF receiver (either the RF receiver 226 and the RF transmitter 228 or another RF pair) can also be used for wireless communication between the control system 200, the respiratory therapy device 110, the one or more sensors 210, the user device 260, or any combination thereof.
- the RF receiver 226 and RF transmitter 228 are shown as being separate and distinct elements in FIG. 1, in some implementations, the RF receiver 226 and RF transmitter 228 are combined as a part of an RF sensor 230 (e.g., a RADAR sensor). In some such implementations, the RF sensor 230 includes a control circuit.
- the format of the RF communication can be Wi-Fi, Bluetooth, or the like.
- the RF sensor 230 is a part of a mesh system.
- a mesh system is a Wi-Fi mesh system, which can include mesh nodes, mesh router(s), and mesh gateway(s), each of which can be mobile/movable or fixed.
- the Wi-Fi mesh system includes a Wi-Fi router and/or a Wi-Fi controller and one or more satellites (e.g., access points), each of which include an RF sensor that the is the same as, or similar to, the RF sensor 230.
- the Wi-Fi router and satellites continuously communicate with one another using Wi-Fi signals.
- the Wi-Fi mesh system can be used to generate motion data based on changes in the Wi-Fi signals (e.g., differences in received signal strength) between the router and the satellite(s) due to an object or person moving partially obstructing the signals.
- the motion data can be indicative of motion, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.
- the camera 232 outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or any combination thereof) that can be stored in the memory device 204.
- the image data from the camera 232 can be used by the control system 200 to determine one or more of the sleep-related parameters described herein, such as, for example, one or more events (e.g., periodic limb movement or restless leg syndrome), a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a sleep state, a sleep stage, or any combination thereof.
- events e.g., periodic limb movement or restless leg syndrome
- a respiration signal e.g., a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a sleep state, a sleep stage, or any combination thereof.
- the image data from the camera 232 can be used to, for example, identify a location of the user, to determine chest movement of the user, to determine air flow of the mouth and/or nose of the user, to determine a time when the user enters the bed, and to determine a time when the user exits the bed.
- the camera 232 includes a wide-angle lens or a fisheye lens. 230.
- the camera 232 can also be used to track eye movements, pupil dilation (if one or both of the user’s eyes are open), blink rate, or any changes during REM sleep.
- the camera 232 can also be used to track the position of the user, which can impact the duration and/or severity of apneic episodes in users with positional obstructive sleep apnea.
- the IR sensor 234 outputs infrared image data reproducible as one or more infrared images (e.g., still images, video images, or both) that can be stored in the memory device 204.
- the infrared data from the IR sensor 234 can be used to determine one or more sleep-related parameters during a sleep session, including a temperature of the user 20 and/or movement of the user 20.
- the IR sensor 234 can also be used in conjunction with the camera 232 when measuring the presence, location, and/or movement of the user 20.
- the IR sensor 234 can detect infrared light having a wavelength between about 700 nm and about 1 mm, for example, while the camera 232 can detect visible light having a wavelength between about 380 nm and about 740 nm.
- the PPG sensor 236 outputs physiological data associated with the user 20 that can be used to determine one or more sleep-related parameters, such as, for example, a heart rate, a heart rate variability, a cardiac cycle, respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, estimated blood pressure parameter(s), or any combination thereof.
- the PPG sensor 236 can be worn by the user 20, embedded in clothing and/or fabric that is worn by the user 20, embedded in and/or coupled to the user interface 120 and/or its associated headgear (e.g., straps, etc.), etc.
- the ECG sensor 238 outputs physiological data associated with electrical activity of the heart of the user 20.
- the ECG sensor 238 includes one or more electrodes that are positioned on or around a portion of the user 20 during the sleep session.
- the physiological data from the ECG sensor 238 can be used, for example, to determine one or more of the sleep-related parameters described herein.
- the EEG sensor 240 outputs physiological data associated with electrical activity of the brain of the user 20.
- the EEG sensor 240 includes one or more electrodes that are positioned on or around the scalp of the user 20 during the sleep session.
- the physiological data from the EEG sensor 240 can be used, for example, to determine a sleep state and/or a sleep stage of the user 20 at any given time during the sleep session.
- the EEG sensor 240 can be integrated into the user interface 120, into associated headgear (e.g., straps, etc.), into a head band or other head-worn sensor device, etc.
- the capacitive sensor 242, the force sensor 244, and the strain gauge sensor 246 output data that can be stored in the memory device 204 and used/analyzed by the control system 200 to determine, for example, one or more of the sleep-related parameters described herein.
- the EMG sensor 248 outputs physiological data associated with electrical activity produced by one or more muscles.
- the oxygen sensor 250 outputs oxygen data indicative of an oxygen concentration of gas (e.g., in the conduit 140 or at the user interface 120).
- the oxygen sensor 250 can be, for example, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, a pulse oximeter (e.g., SpCh sensor), or any combination thereof.
- the analyte sensor 252 can be used to detect the presence of an analyte in the exhaled breath of the user 20.
- the data output by the analyte sensor 252 can be stored in the memory device 204 and used by the control system 200 to determine the identity and concentration of any analytes in the breath of the user.
- the analyte sensor 252 is positioned near a mouth of the user to detect analytes in breath exhaled from the user’s mouth.
- the user interface 120 is a facial mask that covers the nose and mouth of the user
- the analyte sensor 252 can be positioned within the facial mask to monitor the user’s mouth breathing.
- the analyte sensor 252 can be positioned near the nose of the user to detect analytes in breath exhaled through the user’s nose.
- the analyte sensor 252 can be positioned near the user’s mouth when the user interface 120 is a nasal mask or a nasal pillow mask.
- the analyte sensor 252 can be used to detect whether any air is inadvertently leaking from the user’s mouth and/or the user interface 120.
- the analyte sensor 252 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds.
- VOC volatile organic compound
- the analyte sensor 252 can also be used to detect whether the user is breathing through their nose or mouth. For example, if the data output by an analyte sensor 252 positioned near the mouth of the user or within the facial mask (e.g., in implementations where the user interface 120 is a facial mask) detects the presence of an analyte, the control system 200 can use this data as an indication that the user is breathing through their mouth.
- the moisture sensor 254 outputs data that can be stored in the memory device 204 and used by the control system 200.
- the moisture sensor 254 can be used to detect moisture in various areas surrounding the user (e.g., inside the conduit 140 or the user interface 120, near the user’s face, near the connection between the conduit 140 and the user interface 120, near the connection between the conduit 140 and the respiratory therapy device 110, etc.).
- the moisture sensor 254 can be coupled to or integrated in the user interface 120 or in the conduit 140 to monitor the humidity of the pressurized air from the respiratory therapy device 110.
- the moisture sensor 254 is placed near any area where moisture levels need to be monitored.
- the moisture sensor 254 can also be used to monitor the humidity of the ambient environment surrounding the user, for example, the air inside the bedroom.
- the moisture sensor 176 can also be used to track the user’s biometric response to environmental changes.
- the LiDAR sensor 256 can be used for depth sensing. This type of optical sensor (e.g., laser sensor) can be used to detect objects and build three dimensional (3D) maps of the surroundings, such as of a living space. LiDAR can generally utilize a pulsed laser to make time of flight measurements. LiDAR is also referred to as 3D laser scanning. In an example of use of such a sensor, a fixed or mobile device (such as a smartphone) having a LiDAR sensor 256 can measure and map an area extending 5 meters or more away from the sensor. The LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor, for example.
- 3D laser scanning LiDAR is also referred to as 3D laser scanning.
- a fixed or mobile device such as a smartphone having a LiDAR sensor 256 can measure and map an area extending 5 meters or more away from the sensor.
- the LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor, for example.
- the LiDAR sensor(s) 256 can also use artificial intelligence (Al) to automatically geofence RADAR systems by detecting and classifying features in a space that might cause issues for RADAR systems, such a glass windows (which can be highly reflective to RADAR).
- LiDAR can also be used to provide an estimate of the height of a person, as well as changes in height when the person sits down or falls down, for example.
- LiDAR may be used to form a 3D mesh representation of an environment.
- the LiDAR may reflect off such surfaces, thus allowing a classification of different type of obstacles.
- the one or more sensors 210 also include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a sphygmomanometer sensor, an oximetry sensor, a sonar sensor, a RADAR sensor, a blood glucose sensor, a color sensor, a pH sensor, an air quality sensor, a tilt sensor, a rain sensor, a soil moisture sensor, a water flow sensor, an alcohol sensor, or any combination thereof.
- GSR galvanic skin response
- any combination of the one or more sensors 210 can be integrated in and/or coupled to any one or more of the components of the system 10, including the respiratory therapy device 110, the user interface 120, the conduit 140, the humidifier 160, the control system 200, the user device 260, the activity tracker 270, or any combination thereof.
- the microphone 220 and the speaker 222 can be integrated in and/or coupled to the user device 260 and the pressure sensor 212 and/or flow rate sensor 214 are integrated in and/or coupled to the respiratory therapy device 110.
- At least one of the one or more sensors 210 is not coupled to the respiratory therapy device 110, the control system 200, or the user device 260, and is positioned generally adjacent to the user 20 during the sleep session (e.g., positioned on or in contact with a portion of the user 20, worn by the user 20, coupled to or positioned on the nightstand, coupled to the mattress, coupled to the ceiling, etc.).
- One or more of the respiratory therapy device 110, the user interface 120, the conduit 140, the display device 150, and the humidifier 160 can contain one or more sensors (e.g., a pressure sensor, a flow rate sensor, or more generally any of the other sensors 210 described herein). These one or more sensors can be used, for example, to measure the air pressure and/or flow rate of pressurized air supplied by the respiratory therapy device 110. More generally, the one or more sensors 210 can be positioned at any suitable location relative to the user such that the one or more sensors 210 can generate physiological data associated with the user and/or the bed partner 30 during one or more sleep session.
- sensors e.g., a pressure sensor, a flow rate sensor, or more generally any of the other sensors 210 described herein. These one or more sensors can be used, for example, to measure the air pressure and/or flow rate of pressurized air supplied by the respiratory therapy device 110. More generally, the one or more sensors 210 can be positioned at any suitable location relative to the user such that the one or more sensors 210
- the data from the one or more sensors 210 can be analyzed (e.g., by the control system 200) to determine one or more sleep-related parameters, which can include a respiration signal, a respiration rate, a respiration pattern, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, an average duration of events, a range of event durations, a ration between the number of different events, a sleep state, a sleep stage, an apnea-hypopnea index (AHI), or any combination thereof.
- sleep-related parameters can include a respiration signal, a respiration rate, a respiration pattern, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, an average duration of events, a range of event durations, a ration between the number of different events
- the one or more events can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak, a cough, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, increased blood pressure, or any combination thereof.
- Many of these sleep- related parameters are physiological parameters, although some of the sleep-related parameters can be considered to be non-physiological parameters. Other types of physiological and non- physiological parameters can also be determined, either from the data from the one or more sensors 210, or from other types of data.
- the user device 260 includes a display device 262.
- the user device 260 can be, for example, a mobile device such as a smartphone, a tablet computer, a gaming console, a smartwatch, a laptop computer, or the like.
- the user device 260 is a portable device, such as a smart phone, a tablet computer, a smart watch, a laptop computer, etc.
- the user device 260 can be an external sensing system, a television (e.g., a smart television) or another smart home device (e.g., a smart speaker(s) such as Google Home®, Google Nest®, Amazon Echo®, Amazon Echo Show®, Alexa®-enable devices, etc.).
- the user device is a wearable device (e.g., a smart watch).
- the display device 262 is generally used to display image(s) including still images, video images, or both.
- the display device 262 acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) and an input interface.
- HMI human-machine interface
- GUI graphic user interface
- the display device 262 can be an LED display, an OLED display, an LCD display, or the like.
- the input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the user device 260.
- one or more user devices can be used by and/or included in the system 10.
- the user device 260 can include a smartphone that is received in a dock of the respiratory therapy device 110, as is discussed in more detail herein.
- the system 10 also includes the activity tracker 270.
- the activity tracker 270 is generally used to aid in generating physiological data associated with the user.
- the activity tracker 270 can include one or more of the sensors 210 described herein, such as, for example, the motion sensor 218 (e.g., one or more accelerometers and/or gyroscopes), the PPG sensor 236, and/or the ECG sensor 238.
- the physiological data from the activity tracker 270 can be used to determine, for example, a number of steps, a distance traveled, a number of steps climbed, a duration of physical activity, a type of physical activity, an intensity of physical activity, time spent standing, a respiration rate, an average respiration rate, a resting respiration rate, a maximum he respiration art rate, a respiration rate variability, a heart rate, an average heart rate, a resting heart rate, a maximum heart rate, a heart rate variability, a number of calories burned, blood oxygen saturation, electrodermal activity (also known as skin conductance or galvanic skin response), or any combination thereof.
- the activity tracker 270 is coupled (e.g., electronically or physically) to the user device 260.
- the activity tracker 270 is a wearable device that can be worn by the user, such as a smartwatch, a wristband, a ring, or a patch.
- the activity tracker 270 is worn on a wrist of the user 20.
- the activity tracker 270 can also be coupled to or integrated a garment or clothing that is worn by the user.
- the activity tracker 270 can also be coupled to or integrated in (e.g., within the same housing) the user device 260. More generally, the activity tracker 270 can be communicatively coupled with, or physically integrated in (e.g., within a housing), the control system 200, the memory device 204, the respiratory therapy system 100, and/or the user device 260.
- the system 10 also includes the blood pressure device 280.
- the blood pressure device 280 is generally used to aid in generating cardiovascular data for determining one or more blood pressure measurements associated with the user 20.
- the blood pressure device 280 can include at least one of the one or more sensors 210 to measure, for example, a systolic blood pressure component and/or a diastolic blood pressure component.
- the blood pressure device 280 is a sphygmomanometer including an inflatable cuff that can be worn by the user 20 and a pressure sensor (e.g., the pressure sensor 212 described herein).
- a pressure sensor e.g., the pressure sensor 212 described herein.
- the blood pressure device 280 can be worn on an upper arm of the user 20.
- the blood pressure device 280 also includes a pump (e.g., a manually operated bulb) for inflating the cuff.
- the blood pressure device 280 is coupled to the respiratory therapy device 110 of the respiratory therapy system 100, which in turn delivers pressurized air to inflate the cuff.
- the blood pressure device 280 can be communicatively coupled with, and/or physically integrated in (e.g., within a housing), the control system 200, the memory device 204, the respiratory therapy system 100, the user device 260, and/or the activity tracker 270.
- the blood pressure device 280 is an ambulatory blood pressure monitor communicatively coupled to the respiratory therapy system 100.
- An ambulatory blood pressure monitor includes a portable recording device attached to a belt or strap worn by the user 20 and an inflatable cuff attached to the portable recording device and worn around an arm of the user 20.
- the ambulatory blood pressure monitor is configured to measure blood pressure between about every fifteen minutes to about thirty minutes over a 24- hour or a 48-hour period.
- the ambulatory blood pressure monitor may measure heart rate of the user 20 at the same time. These multiple readings are averaged over the 24-hour period.
- the blood pressure device 280 maybe positioned external to the respiratory therapy system 100, coupled directly or indirectly to the user interface 120, coupled directly or indirectly to a headgear associated with the user interface 120, or inflatably coupled to or about a portion of the user 20.
- the blood pressure device 280 is generally used to aid in generating physiological data for determining one or more blood pressure measurements associated with a user, for example, a systolic blood pressure component and/or a diastolic blood pressure component.
- the blood pressure device 280 is a sphygmomanometer including an inflatable cuff that can be worn by a user and a pressure sensor (e.g., the pressure sensor 212 described herein).
- the blood pressure device 280 is an invasive device which can continuously monitor arterial blood pressure of the user 20 and take an arterial blood sample on demand for analyzing gas of the arterial blood.
- the blood pressure device 280 is a continuous blood pressure monitor, using a radio frequency sensor and capable of measuring blood pressure of the user 20 once very few seconds (e.g., every 3 seconds, every 5 seconds, every 7 seconds, etc.)
- the radio frequency sensor may use continuous wave, frequency-modulated continuous wave (FMCW with ramp chirp, triangle, sinewave), other schemes such as PSK, FSK etc., pulsed continuous wave, and/or spread in ultra-wideband ranges (which may include spreading, PRN codes or impulse systems).
- control system 200 or a portion thereof can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc., or any combination thereof.
- a cloud e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.
- servers e.g., remote servers, local servers, etc., or any combination thereof.
- control system 200 and the memory device 204 are described and shown in FIG. 1 as being a separate and distinct component of the system 10, in some implementations, the control system 200 and/or the memory device 204 are integrated in the user device 260 and/or the respiratory therapy device 110. Thus, the control system 200 and/or the memory device 204 can be disposed within the housing 112 of the respiratory therapy device 110.
- control system 200 or a portion thereof can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc., or any combination thereof.
- a cloud e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.
- servers e.g., remote servers, local servers, etc., or any combination thereof.
- a first alternative system includes the control system 200, the memory device 204, and at least one of the one or more sensors 210 and does not include the respiratory therapy system 100.
- a second alternative system includes the control system 200, the memory device 204, at least one of the one or more sensors 210, and the user device 260.
- a third alternative system includes the control system 200, the memory device 204, the respiratory therapy system 100, at least one of the one or more sensors 210, and the user device 260.
- a fourth alternative system includes the control system 200, the memory device 204, the respiratory therapy system 100, at least one of the one or more sensors 210, the user device 170, and the blood pressure device 180 and/or activity tracker 190.
- various systems for modifying pressure settings can be formed using any portion or portions of the components shown and described herein and/or in combination with one or more other components.
- the control system 200, the memory device 204, any of the one or more sensors 210, or a combination thereof can be located on and/or in any surface and/or structure that is generally adjacent to the bed 40 and/or the user 20.
- at least one of the one or more sensors 210 can be located at a first position on and/or in one or more components of the respiratory therapy system 100 adjacent to the bed 40 and/or the user 20.
- the one or more sensors 210 can be coupled to the respiratory therapy system 100, the user interface 120, the conduit 140, the display device 150, the humidification tank 129, or a combination thereof.
- At least one of the one or more sensors 210 can be located at a second position on and/or in the bed 40 (e.g., the one or more sensors 210 are coupled to and/or integrated in the bed 40). Further, alternatively or additionally, at least one of the one or more sensors 210 can be located at a third position on and/or in the mattress 42 that is adjacent to the bed 40 and/or the user 20 (e.g., the one or more sensors 210 are coupled to and/or integrated in the mattress 42). Alternatively, or additionally, at least one of the one or more sensors 210 can be located at a fourth position on and/or in a pillow that is generally adjacent to the bed 40 and/or the user 20.
- At least one of the one or more sensors 210 can be located at a fifth position on and/or in the nightstand 44 that is generally adjacent to the bed 40 and/or the user 20.
- at least one of the one or more sensors 210 can be located at a sixth position such that the at least one of the one or more sensors 210 are coupled to and/or positioned on the user 20 (e.g., the one or more sensors 210 are embedded in or coupled to fabric, clothing, and/or a smart device worn by the user 20). More generally, at least one of the one or more sensors 210 can be positioned at any suitable location relative to the user 20 such that the one or more sensors 210 can generate sensor data associated with the user 20.
- the microphone 220 is in fluid communication with the airflow pathway (e.g., an airflow pathway between the flow generator/motor and the distal end of the conduit).
- the airflow pathway e.g., an airflow pathway between the flow generator/motor and the distal end of the conduit.
- fluid communication it is intended to also include configurations wherein the microphone is in acoustic communication with the airflow pathway without being in direct or physical contact with the airflow.
- the microphone is positioned on a circuit board and in fluid communication, optionally via a duct sealed by a membrane, to the airflow pathway.
- one or more secondary sensors may be used in addition to the primary sensor to generate additional data.
- the one or more secondary sensors include: a microphone (e.g., the microphone 220 of the system 10), a flow rate sensor (e.g., the flow rate sensor 134 of the system 10), a pressure sensor (e.g., the pressure sensor 132 of the system 10), a temperature sensor (e.g., the temperature sensor 136 of the system 10), a camera (e.g., the camera 232 of the system 10), a vane sensor (VAF), a hot wire sensor (MAF), a cold wire sensor, a laminar flow sensor, an ultrasonic sensor, an inertial sensor, or a combination thereof.
- VAF vane sensor
- MAF hot wire sensor
- one or more microphones can be integrated in and/or coupled to a co-located smart device, such as the user device 170, a TV, a watch (e.g., a mechanical watch or another smart device worn by the user), a pendant, the mattress 42, the bed 40, beddings positioned on the bed 40, the pillow, a speaker (e.g., the speaker 142 of FIG. 1), a radio, a tablet device, a waterless humidifier, or a combination thereof.
- a co-located smart device can be any smart device that is within range for detecting sounds emitted by the user, the respiratory therapy system 100, and/or any portion of the system 10.
- the co-located smart device is a smart device that is in the same room as the user during the sleep session.
- one or more microphones can be remote from the system 10 (FIG. 1) and/or the user 20 (FIG. 2), so long as there is an air passage allowing acoustic signals to travel to the one or more microphones.
- the one or more microphones can be in a different room from the room containing the system 10.
- a sleep session can be defined multiple ways. For example, a sleep session can be defined by an initial start time and an end time.
- a sleep session is a duration where the user is asleep, that is, the sleep session has a start time and an end time, and during the sleep session, the user does not wake until the end time. That is, any period of the user being awake is not included in a sleep session. From this first definition of sleep session, if the user wakes ups and falls asleep multiple times in the same night, each of the sleep intervals separated by an awake interval is a sleep session.
- a sleep session has a start time and an end time, and during the sleep session, the user can wake up, without the sleep session ending, so long as a continuous duration that the user is awake is below an awake duration threshold.
- the awake duration threshold can be defined as a percentage of a sleep session.
- the awake duration threshold can be, for example, about twenty percent of the sleep session, about fifteen percent of the sleep session duration, about ten percent of the sleep session duration, about five percent of the sleep session duration, about two percent of the sleep session duration, etc., or any other threshold percentage.
- the awake duration threshold is defined as a fixed amount of time, such as, for example, about one hour, about thirty minutes, about fifteen minutes, about ten minutes, about five minutes, about two minutes, etc., or any other amount of time.
- a sleep session is defined as the entire time between the time in the evening at which the user first entered the bed, and the time the next morning when user last left the bed.
- a sleep session can be defined as a period of time that begins on a first date (e.g., Monday, January 6, 2020) at a first time (e.g., 10:00 PM), that can be referred to as the current evening, when the user first enters a bed with the intention of going to sleep (e.g., not if the user intends to first watch television or play with a smart phone before going to sleep, etc.), and ends on a second date (e.g., Tuesday, January 7, 2020) at a second time (e.g., 7:00 AM), that can be referred to as the next morning, when the user first exits the bed with the intention of not going back to sleep that next morning.
- a first date e.g., Monday, January 6, 2020
- a first time e.g., 10:00 PM
- a second date e.g.,
- the user can manually define the beginning of a sleep session and/or manually terminate a sleep session. For example, the user can select (e.g., by clicking or tapping) one or more user-selectable element that is displayed on the display device 262 of the user device 260 (FIG. 1) to manually initiate or terminate the sleep session.
- the user can select (e.g., by clicking or tapping) one or more user-selectable element that is displayed on the display device 262 of the user device 260 (FIG. 1) to manually initiate or terminate the sleep session.
- the sleep session includes any point in time after the user has laid or sat down in the bed (or another area or object on which they intend to sleep) and has turned on the respiratory therapy device 110 and donned the user interface 120.
- the sleep session can thus include time periods (i) when the user is using the respiratory therapy system 100, but before the user attempts to fall asleep (for example when the user lays in the bed reading a book); (ii) when the user begins trying to fall asleep but is still awake; (iii) when the user is in a light sleep (also referred to as stage 1 and stage 2 of non-rapid eye movement (NREM) sleep); (iv) when the user is in a deep sleep (also referred to as slow-wave sleep, SWS, or stage 3 of NREM sleep); (v) when the user is in rapid eye movement (REM) sleep; (vi) when the user is periodically awake between light sleep, deep sleep, or REM sleep; or (vii) when the user wakes up and does not fall back asleep.
- the sleep session may also be
- the sleep session is generally defined as ending once the user removes the user interface 120, turns off the respiratory therapy device 110, and gets out of bed.
- the sleep session can include additional periods of time, or can be limited to only some of the above-disclosed time periods.
- the sleep session can be defined to encompass a period of time beginning when the respiratory therapy device 110 begins supplying the pressurized air to the airway or the user, ending when the respiratory therapy device 110 stops supplying the pressurized air to the airway of the user, and including some or all of the time points in between, when the user is asleep or awake.
- FIG. 3 illustrates an exemplary timeline 300 for a sleep session.
- the timeline 300 includes an enter bed time (tbed), a go-to-sleep time (tors), an initial sleep time (t sieep ), a first micro-awakening MAi, a second micro-awakening MA2, an awakening A, a wake-up time (twake), and a rising time (tdse).
- the enter bed time tbed is associated with the time that the user initially enters the bed (e.g., bed 40 in FIG. 2) prior to falling asleep (e.g., when the user lies down or sits in the bed).
- the enter bed time tbed can be identified based at least in part on a bed threshold duration to distinguish between times when the user enters the bed for sleep and when the user enters the bed for other reasons (e.g., to watch TV).
- the bed threshold duration can be at least about 10 minutes, at least about 20 minutes, at least about 30 minutes, at least about 45 minutes, at least about 1 hour, at least about 2 hours, etc.
- the enter bed time tbed is described herein in reference to a bed, more generally, the enter time tbed can refer to the time the user initially enters any location for sleeping (e.g., a couch, a chair, a sleeping bag, etc.).
- the go-to-sleep time is associated with the time that the user initially attempts to fall asleep after entering the bed (tbed). For example, after entering the bed, the user may engage in one or more activities to wind down prior to trying to sleep (e.g., reading, watching TV, listening to music, using the user device 260, etc.).
- the initial sleep time is the time that the user initially falls asleep. For example, the initial sleep time (tsieep) can be the time that the user initially enters the first non-REM sleep stage.
- the wake-up time twake is the time associated with the time when the user wakes up without going back to sleep (e.g., as opposed to the user waking up in the middle of the night and going back to sleep).
- the user may experience one of more unconscious microawakenings (e.g., microawakenings MAi and MA2) having a short duration (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.) after initially falling asleep.
- the wake-up time twake the user goes back to sleep after each of the microawakenings MAi and MA2.
- the user may have one or more conscious awakenings (e.g., awakening A) after initially falling asleep (e.g., getting up to go to the bathroom, attending to children or pets, sleep walking, etc.). However, the user goes back to sleep after the awakening A.
- the wake-up time twake can be defined, for example, based at least in part on a wake threshold duration (e.g., the user is awake for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.).
- the rising time trise is associated with the time when the user exits the bed and stays out of the bed with the intent to end the sleep session (e.g., as opposed to the user getting up during the night to go to the bathroom, to attend to children or pets, sleep walking, etc.).
- the rising time trise is the time when the user last leaves the bed without returning to the bed until a next sleep session (e.g., the following evening).
- the rising time trise can be defined, for example, based at least in part on a rise threshold duration (e.g., the user has left the bed for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.).
- the enter bed time tbed time for a second, subsequent sleep session can also be defined based at least in part on a rise threshold duration (e.g., the user has left the bed for at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, etc.).
- a rise threshold duration e.g., the user has left the bed for at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, etc.
- the user may wake up and get out of bed one more times during the night between the initial tbed and the final trise.
- the final wake-up time twake and/or the final rising time trise that are identified or determined based at least in part on a predetermined threshold duration of time subsequent to an event (e.g., falling asleep or leaving the bed).
- a threshold duration can be customized for the user.
- any period between the user waking up (twake) or raising up (trise), and the user either going to bed (tbed), going to sleep (tors), or falling asleep (tsieep) of between about 12 and about 18 hours can be used.
- shorter threshold periods may be used (e.g., between about 8 hours and about 14 hours). The threshold period may be initially selected and/or later adjusted based at least in part on the system monitoring the user’s sleep behavior.
- the total time in bed (TIB) is the duration of time between the time enter bed time tbed and the rising time trise.
- the total sleep time (TST) is associated with the duration between the initial sleep time and the wake-up time, excluding any conscious or unconscious awakenings and/or micro-awakenings therebetween.
- the total sleep time (TST) will be shorter than the total time in bed (TIB) (e.g., one minute short, ten minutes shorter, one hour shorter, etc.).
- the total sleep time (TST) spans between the initial sleep time t sieep and the wake-up time twake, but excludes the duration of the first microawakening MAi, the second micro-awakening MA2, and the awakening A.
- the total sleep time (TST) is shorter than the total time in bed (TIB).
- the total sleep time can be defined as a persistent total sleep time (PTST).
- the persistent total sleep time excludes a predetermined initial portion or period of the first non-REM stage (e.g., light sleep stage).
- the predetermined initial portion can be between about 30 seconds and about 20 minutes, between about 1 minute and about 10 minutes, between about 3 minutes and about 5 minutes, etc.
- the persistent total sleep time is a measure of sustained sleep and smooths the sleep-wake hypnogram.
- the user when the user is initially falling asleep, the user may be in the first non-REM stage for a very short time (e.g., about 30 seconds), then back into the wakefulness stage for a short period (e.g., one minute), and then goes back to the first non- REM stage.
- the persistent total sleep time excludes the first instance (e.g., about 30 seconds) of the first non-REM stage.
- the sleep session is defined as starting at the enter bed time (tbed) and ending at the rising time (trise), i.e., the sleep session is defined as the total time in bed (TIB).
- a sleep session is defined as starting at the initial sleep time (tsieep) and ending at the wake-up time (twake).
- the sleep session is defined as the total sleep time (TST).
- a sleep session is defined as starting at the go-to-sleep time (tors) and ending at the wake-up time (twake).
- a sleep session is defined as starting at the go-to-sleep time (tors) and ending at the rising time (trise).
- a sleep session is defined as starting at the enter bed time (tbed) and ending at the wake-up time (twake). In some implementations, a sleep session is defined as starting at the initial sleep time (tsieep) and ending at the rising time (trise). [0120] Referring to FIG. 4, an exemplary hypnogram 400 corresponding to the timeline 300 of FIG. 3, according to some implementations, is illustrated. As shown, the hypnogram 400 includes a sleep-wake signal 401, a wakefulness stage axis 410, a REM stage axis 420, a light sleep stage axis 430, and a deep sleep stage axis 440. The intersection between the sleep-wake signal 401 and one of the axes 410-440 is indicative of the sleep stage at any given time during the sleep session.
- the sleep-wake signal 401 can be generated based at least in part on physiological data associated with the user (e.g., generated by one or more of the sensors 210 described herein).
- the sleep-wake signal can be indicative of one or more sleep stages, including wakefulness, relaxed wakefulness, microawakenings, a REM stage, a first non-REM stage, a second non- REM stage, a third non-REM stage, or any combination thereof.
- one or more of the first non-REM stage, the second non-REM stage, and the third non-REM stage can be grouped together and categorized as a light sleep stage or a deep sleep stage.
- the light sleep stage can include the first non-REM stage and the deep sleep stage can include the second non-REM stage and the third non-REM stage.
- the hypnogram 400 is shown in FIG. 4 as including the light sleep stage axis 430 and the deep sleep stage axis 440, in some implementations, the hypnogram 400 can include an axis for each of the first non- REM stage, the second non-REM stage, and the third non-REM stage.
- the sleep-wake signal can also be indicative of a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration amplitude ratio, an inspiration-expiration duration ratio, a number of events per hour, a pattern of events, or any combination thereof.
- Information describing the sleep-wake signal can be stored in the memory device 204.
- the hypnogram 400 can be used to determine one or more sleep-related parameters, such as, for example, a sleep onset latency (SOL), wake-after-sleep onset (WASO), a sleep efficiency (SE), a sleep fragmentation index, sleep blocks, or any combination thereof.
- SOL sleep onset latency
- WASO wake-after-sleep onset
- SE sleep efficiency
- sleep fragmentation index sleep blocks, or any combination thereof.
- the sleep onset latency is defined as the time between the go-to-sleep time (tors) and the initial sleep time (t sieep ). In other words, the sleep onset latency is indicative of the time that it took the user to actually fall asleep after initially attempting to fall asleep.
- the sleep onset latency is defined as a persistent sleep onset latency (PSOL).
- PSOL persistent sleep onset latency
- the persistent sleep onset latency differs from the sleep onset latency in that the persistent sleep onset latency is defined as the duration time between the go-to-sleep time and a predetermined amount of sustained sleep.
- the predetermined amount of sustained sleep can include, for example, at least 10 minutes of sleep within the second non-REM stage, the third non-REM stage, and/or the REM stage with no more than 2 minutes of wakefulness, the first non-REM stage, and/or movement therebetween.
- the persistent sleep onset latency requires up to, for example, 8 minutes of sustained sleep within the second non- REM stage, the third non-REM stage, and/or the REM stage.
- the predetermined amount of sustained sleep can include at least 10 minutes of sleep within the first non-REM stage, the second non-REM stage, the third non-REM stage, and/or the REM stage subsequent to the initial sleep time.
- the predetermined amount of sustained sleep can exclude any micro-awakenings (e.g., a ten second micro-awakening does not restart the 10-minute period).
- the wake-after-sleep onset is associated with the total duration of time that the user is awake between the initial sleep time and the wake-up time.
- the wake-after- sleep onset includes short and micro-awakenings during the sleep session (e.g., the microawakenings MAi and MA2 shown in FIG. 4), whether conscious or unconscious.
- the wake-after-sleep onset (WASO) is defined as a persistent wake-after- sleep onset (PWASO) that only includes the total durations of awakenings having a predetermined length (e.g., greater than 10 seconds, greater than 30 seconds, greater than 60 seconds, greater than about 5 minutes, greater than about 10 minutes, etc.)
- the sleep efficiency (SE) is determined as a ratio of the total time in bed (TIB) and the total sleep time (TST). For example, if the total time in bed is 8 hours and the total sleep time is 7.5 hours, the sleep efficiency for that sleep session is 93.75%.
- the sleep efficiency is indicative of the sleep hygiene of the user. For example, if the user enters the bed and spends time engaged in other activities (e.g., watching TV) before sleep, the sleep efficiency will be reduced (e.g., the user is penalized).
- the sleep efficiency (SE) can be calculated based at least in part on the total time in bed (TIB) and the total time that the user is attempting to sleep.
- the total time that the user is attempting to sleep is defined as the duration between the go-to-sleep (GTS) time and the rising time described herein. For example, if the total sleep time is 8 hours (e.g., between 11 PM and 7 AM), the go- to-sleep time is 10:45 PM, and the rising time is 7: 15 AM, in such implementations, the sleep efficiency parameter is calculated as about 94%.
- the fragmentation index is determined based at least in part on the number of awakenings during the sleep session. For example, if the user had two micro-awakenings (e.g., micro-awakening MAi and micro-awakening MA2 shown in FIG. 4), the fragmentation index can be expressed as 2. In some implementations, the fragmentation index is scaled between a predetermined range of integers (e.g., between 0 and 10).
- the sleep blocks are associated with a transition between any stage of sleep (e.g., the first non-REM stage, the second non-REM stage, the third non-REM stage, and/or the REM) and the wakefulness stage.
- the sleep blocks can be calculated at a resolution of, for example, 30 seconds.
- the systems and methods described herein can include generating or analyzing a hypnogram including a sleep-wake signal to determine or identify the enter bed time (tbed), the go-to-sleep time (tors), the initial sleep time (tsieep), one or more first micro-awakenings (e.g., MAi and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof based at least in part on the sleep-wake signal of a hypnogram.
- a sleep-wake signal to determine or identify the enter bed time (tbed), the go-to-sleep time (tors), the initial sleep time (tsieep), one or more first micro-awakenings (e.g., MAi and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof based at least in part on the sleep-wake signal of a hypnogram.
- one or more of the sensors 210 can be used to determine or identify the enter bed time (tbed), the go-to-sleep time (tors), the initial sleep time (tsieep), one or more first micro-awakenings (e.g., MAi and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof, which in turn define the sleep session.
- the enter bed time tbed can be determined based at least in part on, for example, data generated by the motion sensor 218, the microphone 220, the camera 232, or any combination thereof.
- the go- to-sleep time can be determined based at least in part on, for example, data from the motion sensor 218 (e.g., data indicative of no movement by the user), data from the camera 232 (e.g., data indicative of no movement by the user and/or that the user has turned off the lights), data from the microphone 220 (e.g., data indicative of the using turning off a TV), data from the user device 260 (e.g., data indicative of the user no longer using the user device 260), data from the pressure sensor 212 and/or the flow rate sensor 214 (e.g., data indicative of the user turning on the respiratory therapy device 110, data indicative of the user donning the user interface 120, etc.), or any combination thereof.
- data from the motion sensor 218 e.g., data indicative of no movement by the user
- data from the camera 232 e.g., data indicative of no movement by the user and/or that the user has turned off the lights
- data from the microphone 220 e.g., data
- presenting breathing entrainment to a user can promote a relaxed state in advance of and/or after beginning the respiratory therapy.
- the breathing patterns encouraged and facilitated by the entrainment programs and stimuli described herein may promote parasympathetic nervous activity and conversely decrease sympathetic nervous system activity.
- the parasympathetic nervous system predominates in quiet “rest and digest” conditions while the sympathetic nervous system drives the “fight or flight” response in stressful situations.
- the system 10 can present the entrainment program to a user making use of the respiratory therapy system 100, but without the user engaging in a sleep session.
- the user can be sitting or laying in bed while wearing the user interface 120, as the respiratory therapy device 110 causes pressurized air to flow through the conduit 140 to the user interface 120, but not be actually attempting to fall asleep.
- This type of use case can allow a user to become familiar with the entrainment stimuli and overall entrainment process while the user is making use of the respiratory therapy device 110 that they will use when engaging in a sleep session (e.g., when attempting to fall asleep).
- This type of acclimatization can allow the user to become familiar both with different types of entrainment stimuli, and with the respiratory therapy device 110 itself.
- This acclimatization also allows for various parameters associated with the entrainment stimulus to be determined, and allows the collection of important information from the user (e.g., how the user responded to different entrainment stimuli, how susceptible the user was to entrainment, how successful the user was in implementing the entrainment to their breathing pattern, and the like), all before the user attempts to actually engage in a sleep session.
- a session where the user is undergoing this type of acclimatization can be referred to as an “acclimatization session” or an “on-device acclimatization session,” where the “device” is referring to a respiratory therapy device.
- Such a session could be especially useful for users with a respiratory therapy device who have some anxiety or difficulty getting used to the respiratory therapy device and/or respiratory therapy in general.
- FIG. 5 is a flowchart of a method 500 for presenting an entrainment program while the user is using a respiratory therapy system (such as the respiratory therapy system 100), while not actually engaging in a sleep session.
- a control system having one or more processors (such as control system 200 of system 10) is configured to carry out the steps of method 500.
- a memory device (such as memory device 204 of system 10) can be used to store machine-readable instructions that are executed by the control system to carry out the steps of method 500.
- the memory device can also store any type of data utilized in the steps of method 500.
- method 500 can be implemented using a system (such as system 10) that includes the respiratory therapy system, the control system, and the memory device.
- Step 510 of method 500 includes receiving data associated with the user while engaging in the acclimatization session.
- the data can include a variety of different types of data.
- the data can include sensor data from any suitable type of sensor, such as pressure data from the pressure sensor 212, flow rate data from the flow rate sensor 214, motion data from the motion sensor 218 (which can be indicative of movement of the user’s chest during breathing), image data from the camera 232 (which can be indicative of movement of the user’ s chest during breathing), PPG data from the PPG sensor 236, ECG data from the ECG sensor 238, EEG data from the EEG sensor 240, and/or any sensor or combination of sensors.
- sensor data from any suitable type of sensor, such as pressure data from the pressure sensor 212, flow rate data from the flow rate sensor 214, motion data from the motion sensor 218 (which can be indicative of movement of the user’s chest during breathing), image data from the camera 232 (which can be indicative of movement of the user’ s chest during breathing), PPG data from the PPG sensor
- the sensor data can include any combination of physiological data associated with physiological parameters, and airflow data associated with air flowing in the respiratory therapy system.
- the physiological data may additionally or alternatively be derived from the airflow data (e.g., respiratory information that is derived from pressure and flow rate data).
- the data includes environmental data associated with the location of the user and/or the respiratory therapy device.
- the environmental data can include data from any of the sensors 210 (e.g., temperature from the temperature sensor 216, humidity from the moisture sensor 254, etc.).
- the environmental can also include data from sources other than any of the sensors 210.
- the data includes health/demographic data associated with the user.
- the health/demographic data can include, for example, data associated with an age of the user, a gender of the user, a race of the user, a geographic location of the user, an employment status of the user, an educational status of the user, a socioeconomic status of the user, a BMI of the user, the presence of other co-morbidities (e.g., COPD), a lung compliance parameter, etc.
- the health/demographic data can in some cases include physiological data and/or airflow data, similar to the sensor data.
- the data can include at least sensor data generated by one or more sensors (which may include physiological data and/or airflow data), environmental data associated with the location of the user and/or the respiratory therapy system, health/demographic data associated with the user, other types of data, and any combinations thereof.
- sensors which may include physiological data and/or airflow data
- environmental data associated with the location of the user and/or the respiratory therapy system
- health/demographic data associated with the user other types of data, and any combinations thereof.
- method 500 can first include prompting the user to perform specific actions to generate desired data. For example, the user could be prompted (using the respiratory therapy device, their smartphone, etc.) to breath deeply to, for example, win a game (e.g., gamify the breathing exercise) or copy a certain breathing pattern, which can be used to generate data that may be used to, for example, inform the selection of an entrainment program and/or generated an entrainment waveform.
- a game e.g., gamify the breathing exercise
- copy a certain breathing pattern which can be used to generate data that may be used to, for example, inform the selection of an entrainment program and/or generated an entrainment waveform.
- Step 520 includes extracting respiration information from the data.
- the respiration information can include any suitable information that may be used to analyze the user’s respiration.
- the respiratory information can include a respiration rate, an inspiration (or inhalation) amplitude, an expiration (or exhalation) amplitude, an inspiration- expiration ratio, a respiration signal representing the user’s respiration, a lung capacity parameter (such as total lung capacity (TLC), forced expiratory volume (FEV1), forced vital capacity (FVC), vital capacity (VC), residual lung volume (RV), and maximum voluntary minute ventilation (MMV)), and/or any other suitable type of respiratory information.
- TLC total lung capacity
- FEV1 forced expiratory volume
- FVC forced vital capacity
- VC vital capacity
- RV residual lung volume
- MMV maximum voluntary minute ventilation
- Steps 530 and 540 of method 500 encompass the presentation of an entrainment program to the user during the acclimatization session.
- Step 530 includes generating an entrainment waveform.
- the entrainment waveform can generally be any type of waveform or pattern that is desired to be presented to the user, and can be used to entrain the user’s respiration toward desired respiration.
- the entrainment waveform can take any of a number of different forms so as to represent a target respiration pattern (e.g., a specific inspiration and/or expiration pattern) for the user.
- the shape of the entrainment waveform e.g., amplitude, frequency, other characteristics
- the entrainment waveform could represent the target respiration pattern in other manners as well.
- the frequency of the entrainment waveform could represent the target respiration rate, but with no correlation between the amplitude of the entrainment waveform and a desired respiration amplitude.
- the target respiration pattern represented by a given entrainment waveform is the final target respiration pattern for the acclimatization session.
- This final target respiration represents the ultimate desired respiration pattern that the user is trying to be entrained to.
- the final target respiration pattern may be a pattern with a respiration rate of 6 breaths per minute, and no entrainment waveforms will be generated during the acclimatization session representing a respiration rate less than that.
- the target respiration pattern represented by a given entrainment waveform is only an intermediate target respiration pattern.
- intermediate target respiration patterns represent respiration patterns where once the user reaches such a pattern, the entrainment waveform can be updated to represent a new (e.g., updated) target respiration pattern, which itself may be the final target respiration pattern or an additional intermediate respiration pattern.
- the use of intermediate target respiration patterns allows for the user’s respiration pattern to be changed in a step-wise manner. In some cases, this step-wise change will include reducing the user’s respiration rate in a step-wise manner.
- target respiration pattern simply refers to the respiration pattern represented by a given entrainment waveform, and generally encompasses both final target respiration patterns and intermediate target respiration patterns.
- the entrainment waveform may have portions corresponding to inspiration, and portions corresponding to expiration (e.g., the entrainment waveform may be a sine wave with the positive portion representing inspiration and the negative portion representing expiration, or with the positive slope portion representing inspiration and the negative slope portion representing expiration).
- the entrainment waveform can include a sine wave, a square wave, a triangle wave, a sawtooth wave, symmetric waves, asymmetric waves, other types of waves, or any combinations thereof.
- the entrainment waveform for the acclimatization session is a predetermined waveform that is not based on the data or the respiration information.
- the entrainment waveform could represent a stock target respiration pattern that is generally suitable for a large number of typical users, or for a cohort of typical users to which the user belongs, where the cohort can be defined by one or more parameters, such as demographic parameters.
- the entrainment waveform (and thus the target respiration pattern) for the acclimatization session can be based at least in part on the data and/or the respiration information.
- the entrainment waveform may be newly generated for the acclimatization session based on the data and/or the respiration information.
- generating the entrainment waveform includes generated a predetermined entrainment waveform, and then modifying the predetermined entrainment waveform based on the data and/or the respiration information.
- the respiration information can include the current respiration pattern of the user, and the entrainment waveform represents the target respiration pattern.
- the received data and/or the respiration information can be used to adjust the entrainment waveform based on the user’s specific needs. For example, if the data and/or the respiration information indicates that the user has a diminished lung capacity, an entrainment waveform with a relatively smaller amplitude (representing a smaller inspiration and/or expiration volume) can be generated. In another example, if the data and/or the respiration information indicates that the user has a relatively high current respiration rate, an entrainment waveform representing a higher than typical respiration rate can be generated.
- Step 540 includes presenting an entrainment stimulus to the user based at least in part on the entrainment waveform.
- the entrainment stimulus will generally be presented using a stimulus device (such as the stimulus device 208), which may include a speaker (such as speaker 222), a display device (such as display device 150, display device 262 of the user device 260, a projector from which a visual stimulus may be projected onto a surface such as a wall or ceiling, etc.), a haptic device, the respiratory therapy device, or any other suitable stimulus device.
- the entrainment stimulus will match the entrainment waveform. In other implementations, the entrainment stimulus will be based on but not match the entrainment waveform.
- the stimulus device could receive the entrainment waveform as input, such that the entrainment waveform is used to modulate or otherwise modify a standard output of the stimulus device.
- the stimulus device is a speaker that can play a sound representative of a base waveform.
- the entrainment waveform is used to modify the base waveform, and the speaker can play a sound representative of the modified base waveform.
- the base waveform effectively functions as a carrier signal, with the entrainment waveform functioning as a modulation signal.
- the output of the speaker does not match the entrainment waveform, but is based on the entrainment waveform.
- the entrainment stimulus is an audio stimulus.
- presenting the entrainment stimulus can include generating an audio stimulus and/or modulating an existing audio stimulus.
- a speaker could play a tone that with a changing pitch and/or volume that matches the entrainment stimulus.
- a speaker could modulate some existing audio source (e.g., a song or video being played) to match the entrainment stimulus.
- method 500 can include presenting acclimatization sounds during the acclimatization session. These acclimatization sounds can be changing sounds that are presented as the entrainment stimulus. These acclimatization sounds could also be constant background noise that is then modulated when the entrainment stimulus is presented. These acclimatization sounds could also be presented during acclimatization sounds where is not wearing the user interface.
- the entrainment stimulus is a visual stimulus.
- presenting the entrainment stimulus can include generating a visual stimulus and/or modulating an existing visual stimulus.
- a display device could display an animation that changes in color, size, shape, etc. to match the entrainment stimulus.
- the display device could display a circle that grows larger during the portion of the entrainment waveform representing inspiration, and grows smaller during the portion of the entrainment waveform representing expiration (e.g., matching the volume of the user’s lungs during breathing).
- the display device could show a waveform being traced out, or a marker moving along a waveform.
- the display device could modulate some existing visual that is being displayed on a display device, such as by increasing and decreasing the brightness of the visual.
- the entrainment stimulus is a haptic stimulus.
- presenting the entrainment stimulus can include generating a visual stimulus or modifying an existing haptic stimulus.
- the haptic stimulus can include generally any stimulus or action that the user may be able to physically feel, such as movement of the user’s bed; vibration of a user device (e.g., the user’s smartphone); pulsing of a blower motor of the respiratory therapy device to generate vibrations in the conduit, in the user interface, in the air passing through the conduit and the user interface to the user’s airways, or any combination thereof; and others.
- a user device e.g., the user’s smartphone
- pulsing of a blower motor of the respiratory therapy device to generate vibrations in the conduit, in the user interface, in the air passing through the conduit and the user interface to the user’s airways, or any combination thereof; and others.
- the inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP) settings of a respiratory therapy device may be adjusted based on the entrainment waveform to encourage the user’ s breathing to align with entrainment waveform.
- the duration of increased pressure during a desired inspiration period and decreased pressure during a desired expiration period can be extended, to promote extended (slower) inspiration during the desired inspiration period and extended (slower) expiration during the desired expiration period.
- the pressure can be increased during the desired inspiration period and decreased during the desired expiration period, to promote inspiration during the desired inspiration period and expiration during the desired expiration period.
- the pressure of the air could be increased during the inspiration portion of the entrainment waveform and/or decreased during the expiration portion of the entrainment waveform.
- the Expiratory Pressure Relief (EPR) settings of the respiratory therapy device may be adjusted to adapt to the user’s breathing modulated in accordance with the entrainment stimulus.
- the respiratory therapy device may not actively promote alignment of the user’s breathing with the entrainment waveform, but does facilitate such alignment. Other parameters associated with the air flow can also be modulated.
- the modulation of the air flow can cause vibration to occur in the conduit and/or in the user interface, such that a haptic stimulus is also presented.
- a blower motor of the respiratory therapy device can be pulsed to generate vibrations in the conduit and/or in the user interface.
- Method 500 thus allows the user to become acclimatized (or begin to acclimatize) to using the respiratory therapy system (e.g., wearing the user interface while the respiratory therapy device causes pressurized air to flow to the user interface) while encouraging the user to breath according to a target respiration pattern (which as noted, could be a final target respiration pattern or an intermediate target respiration).
- a target respiration pattern which as noted, could be a final target respiration pattern or an intermediate target respiration.
- the target respiration pattern includes a target inspirationexpiration ratio of about 35% inspiration/65% expiration, about 40% inspiration/60% expiration, about 45% inspired on/55% expiration, or other ratios.
- the target respiration pattern includes a target respiration rate of about 5-7 breaths per minute, or about 6 breaths per minute.
- the target respiration pattern includes both a target inspiration-expiration ratio (e.g., 35%/65%, 40%/60%, 45%/55%, etc.) and a target respiration rate (e.g., 5-7 breaths per minute, 6 breaths per minute, etc.).
- the paced breathing induced to achieve a target respiration pattern could embody the concept of box breathing, which generally involves breathing in for a specific amount of time, holding the breath in for a specific amount of time, breathing out for a specific amount of time, holding the breath out for a specific amount of time, or any combination thereof.
- the paced breathing induced to achieve a target respiration pattern may implement the 4-7-8 breathing technique, where the user breathes in for 4 seconds, holds their breath for 7 seconds, and breathes out for 8 seconds.
- one or more intermediate target respiration patterns can be applied in a step-wise manner until the final target respiration pattern is achieved.
- the entrainment program may move to a next intermediate (or final) target respiration pattern only if the preceding target respiration pattern is achieved by the user and/or is maintained for a predetermined period (which may include a predetermined amount of time and/or a predetermined number of breaths).
- the final target respiration pattern may not be achieved by the user, but the user may reach one or more intermediate targets, and which may result in reduced anxiety, improved familiarity with breathing on pressurized air, etc. Additional information related to entraining a respiration pattern of the user toward a target respiration pattern using different stimuli can be found in WO 2023/031802, which is hereby incorporated by reference herein in its entirety.
- the presentation of the entrainment program also includes displaying, on a display device, both a current waveform that represents the user’s current respiration pattern, and the entrainment waveform that represents the target respiration pattern.
- This allows the user to be able to visually track how close their breathing is to the target respiration pattern (which thus may encourage the user to achieve the target respiration pattern), while also receiving the entrainment stimulus that represents the target respiration pattern.
- the entrainment waveform could be overlaid on the current waveform and/or adjacent to the current waveform.
- the current waveform and the entrainment waveform can be represented on the display using lines, circles, bubbles, or generally any suitable shape and/or format.
- method 500 further includes determining an entrainment coherence score that represents the coherence between the respiration information and the entrainment waveform (e.g., between the user’s current respiration pattern and the target respiration pattern).
- This entrainment coherence score can indicate how close the user’s breathing is to the target.
- the entrainment coherence score can be based at least partially on a phase difference between the entrainment waveform and a waveform representing the user’s current respiration pattern, and/or if a phase difference that is changing over time (e.g., if the user’s respiration pattern is coming into alignment with the target respiration pattern).
- the entrainment coherence score could be the actual phase difference, could be derived from the phase difference, or could have other forms.
- the entrainment coherence score can be based at least partially on the difference in the volumes (e.g., amplitude) of inspiration and/or expiration between the entrainment waveform and the waveform representing the user’s current respiration pattern (e.g., amplitude differences between the two waveforms).
- the entrainment coherence score could be the ratio of the inspiration volume to the target inspiration volume, the ratio of the expiration volume to the target expiration volume, the ratio of the current inspiration/expiration ratio to the target inspiration/expiration ratio, etc.
- the entrainment coherence score can additionally or alternatively be based on the user’s stress level.
- a physiological parameter representing stress experienced by the user e.g., galvanic skin response, heart rate variability, heart rate, blood pressure, EEG parameters, etc.
- the entrainment coherence score could be the difference between the current value of the physiological parameter and a desired value of the physiological parameter.
- the entrainment coherence score can include any type of information learned about the relationship between a specific entrainment waveform and/or entrainment stimulus, and the user’ s breathing in response to being presented with the entrainment stimulus corresponding to that entrainment waveform.
- the entrainment coherence score can be displayed to the user so as to represent another visual indication that the user can track while receiving the entrainment stimulus.
- the entrainment coherence score is only displayed once the entrainment coherence score satisfies a predetermined threshold.
- the entrainment coherence score can be displayed as soon as it is determined.
- the entrainment coherence score may dynamically adjust depending on how closely the user’s breathing corresponds to the entrainment waveform at different times within the acclimatization session (or sleep session, as discussed further herein).
- the entrainment coherence score is only displayed to the user after the acclimatization session ends.
- the entrainment coherence score is presented to the user as a numerical value. In other implementations, the entrainment coherence score is presented to the user as a series of traces that compare the user’s respiration pattern to the target respiration pattern represented by the entrainment waveform. For example, a first trace can be generated based at least in part on the respiration information that shows the user’s breathing, and a second trace can be generated at least in part on the entrainment waveform. The second trace may just be a visual reproduction of the entrainment waveform. The first trace and the second trace can be presented overlaid on each other or next to each other, to provide the user an indication of the entrainment coherence score.
- the entrainment coherence score is presented as both a numerical value and a series of traces. Further, it will be understood that “traces” can be implemented as any form of visual representation suitable to illustrate the relative relationship (e.g., quantitative, semi -quantitative, etc.) between the respiration information and entrainment waveform. [0157] In some implementations, the entrainment waveform may be updated if the user’s current respiration rate differs from (e.g., is too high relative to) the target respiration rate by a predetermined threshold amount.
- a respiration rate may be too fast if it is faster than the user’s current respiration rate (also referred to as the user’s spontaneous respiration rate) at the point of commencing the entrainment program/stimulus.
- a suitable initial entrainment waveform can comprise a respiration rate that is between the user’s current respiration rate (such as the user’s respiration rate in a current body position, such as prone, supine, left, right) and 1-4 breaths/minute less than the current respiration rate. Also, it should be no more than around 4 breaths/minute less than the current respiration rate since this could create a discomfort or difficulty for the user by having to reduce current respiration rate to such an extent.
- the user’s current respiration rate is therefore calculated over a window of time (which may be, about 15- 20 seconds, about 30 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, etc.), to ensure accuracy and to avoid skewing due to perturbations in their breathing rate, and typically requires a median of preceding breaths or a trimmed mean to reduce outliers.
- a window of time which may be, about 15- 20 seconds, about 30 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, etc.
- the entrainment waveform can be updated so that it represents an updated target respiration rate that is higher than the actual target respiration rate (but still lower than the current respiration rate).
- the entrainment stimulus can then be presented based at least in part on the updated entrainment waveform.
- the entrainment waveform could be updated to again represent the actual target respiration rate, and the entrainment stimulus can be presented based at least on the updated entrainment waveform.
- the entrainment coherence score can also be utilized to aid in bringing down the user’s respiration rate in a step-wise manner if needed.
- the entrainment waveform can be updated if the entrainment coherence score satisfies a threshold value, and/or satisfies a threshold value for at least a predetermined amount of time. For example, if the entrainment coherence score indicates that the current respiration rate is sufficiently higher than the target respiration rate, the entrainment waveform can be updated, and the entrainment stimulus re-presented.
- the entrainment waveform can be updated, and the entrainment stimulus represented.
- method 500 can be implemented while the user is awake and is wearing the user interface.
- method 500 is implemented while the respiratory therapy system is fully connected and operating, e.g., the user interface is fluidly coupled to the respiratory therapy device via the conduit, and the respiratory therapy device is causing air to flow through the conduit and to the user interface.
- the user interface can be fluidly coupled to the respiratory therapy device via the conduit, but with no air flowing.
- the user interface may be fluidly coupled to the respiratory therapy device via the conduit with one or more valves of the user interface open to the atmosphere (and with or without air flowing from the respiratory therapy device to the user interface).
- method 500 is implemented while the user is wearing the user interface, but the user interface is not fluidly coupled to the respiratory therapy device (e.g., not directly fluidly coupled to the conduit or an elbow connector; fluidly coupled to the elbow connector with either the elbow connector not fluidly coupled to the conduit, or the elbow connector fluidly coupled to the conduit and the conduit not fluidly coupled to the respiratory therapy device; fluidly coupled to the conduit with the conduit not fluidly coupled to the respiratory therapy device; etc.).
- method 500 can be implemented while the user is not wearing the user interface at all.
- methods 500 can further include the use of tests to assess the fit of the user interface, including user interface seal. Leak can be determined (e.g., estimated) by the respiratory therapy device using any suitable technique.
- the user may also be prompted to input feedback information, such as the sensation of air blowing into their eyes, the location of a leak, etc. Based on the leak determination (such as amount and/or nature of leak), the user can be prompted to adjust the user interface fit, use a different user interface (such as different cushion size), use a difference type of user interface (such as a full face mask rather than a nasal mask), etc.
- the entrainment coherence score may include a plurality of sub-scores, where each sub-score represents a different aspect or portion of the acclimatization session.
- the respiratory therapy system can provide air at different pressures.
- An entrainment coherence sub-score can be generated for each distinct pressure with a given entrainment waveform and/or entrainment stimulus, so that the coherence between the user’s respiration pattern and the target respiration pattern can be measured at each of the different pressures.
- each of the sub-scores corresponds to a different amount of elapsed time since the initial presentation of the entrainment stimulus based on the entrainment waveform, so that the coherence between the user’s respiration pattern and the target respiration pattern can be measured over time.
- the system 10 can present the entrainment program to a user making use of a respiratory therapy system 100 and engaging in a sleep session.
- the user will generally be lying in bed attempting to fall asleep at the beginning of or during the use of the respiratory therapy system .
- the entrainment program can attempt to guide the user's breathing pattern to a target breathing pattern that is designed to improve the user's sleep (e.g., reduce sleep onset latency, or otherwise improve the user's sleep session by reducing anxiety, feelings of claustrophobia, etc.).
- a session where the user is undergoing this type of entrainment can be referred to as a “sleep session with respiratory entrainment” or a “on-device sleep session with respiratory entrainment,” wherein the “device” is referring to a respiratory therapy device.
- a session can be useful to all users, especially those who have previously undergone an off-device or on- device acclimatization session.
- FIG. 6 is a flowchart of a method 600 for presenting an entrainment program while the user is using a respiratory therapy system (such as the respiratory therapy system 100) and engaging in a sleep session.
- a control system having one or more processors (such as control system 200 of system 10) is configured to carry out the steps of method 600.
- a memory device (such as memory device 204 of system 10) can be used to store machine- readable instructions that are executed by the control system to carry out the steps of method 600.
- the memory device can also store any type of data utilized in the steps of method 600.
- method 600 can be implemented using a system (such as system 10) that includes the respiratory therapy system, the control system, and the memory device.
- Step 610 of method 600 includes receiving data associated with the user while engaging in the sleep session.
- the data can include data from any suitable type of sensor, such as pressure data from the pressure sensor 212, flow rate data from the flow rate sensor 214, motion data from the motion sensor 218 (which can be indicative of movement of the user and/or a portion of the user’s body, such as the user’s chest during breathing), image data from the camera 232 (which can be indicative of movement of the user and/or a portion of the user, such as the user’ s chest during breathing), PPG data from the PPG sensor 236, ECG data from the ECG sensor 238, EEG data from the EEG sensor 240, and/or any sensor or combination of sensors.
- Steps 620 and 630 of method 600 encompass the generation and presentation of an entrainment program to the user during the sleep session.
- Step 620 includes generating an entrainment waveform
- step 630 includes presenting an entrainment stimulus based at least in part on the entrainment waveform.
- the entrainment waveform can generally be any type of waveform or pattern that is desired to be presented to the user, and can be used to entrain the user’s respiration toward desired respiration.
- the entrainment waveform represents a target respiration pattern (e.g., a specific inspiration and/or expiration pattern) for the user.
- the entrainment waveform may have portions corresponding to inspiration, and portions corresponding to expiration (e.g., the entrainment waveform may be a sine wave with the positive portion representing inspiration and the negative portion representing expiration, or with the positive slope portion representing inspiration and the negative slope portion representing expiration).
- the target respiration pattern during the sleep session can be the ultimate desired respiration pattern during the sleep session, or may be an intermediate respiration pattern between the user’s initial respiration pattern and the final target respiration pattern.
- the entrainment stimulus presented in step 630 can be the same as or similar to the entrainment stimulus presented in step 540 of method 500.
- the entrainment waveform presented during the sleep session is intended to entrain the user toward a target respiration pattern that will encourage the user to fall asleep (e.g., will reduce the user’s sleep onset latency).
- An entrainment waveform such as this will typically encourage paced breathing involving slow, diaphragmatic breathing that aims to reduce initial respiration rate from, for example, 15 breaths/minute to 6 breaths/minute. It has been widely demonstrated that this type of breathing causes respiratory sinus arrhythmia (RSA), which is heart rate variability (HRV) in synchrony with respiration. Increased HRV initiates physiological changes associated with system wide health benefits, promoting a relaxed state. System wide health benefits include overall decreased heart rate, lower blood pressure, etc.
- RSA comprises fluctuation in heart rate corresponding to breathing, with heart rate increasing with inhalation and decreasing with exhalation.
- HRV is a measure of the variation in time between each heartbeat, controlled by the autonomic nervous system (ANS).
- the ANS operates in a delicate balance between parasympathetic activity and sympathetic activity. Inducing RSA or HRV with respiration is indicative of parasympathetic activation. Sympathetic nervous system activation results in more regular, and more consistent intervals between, heartbeats.
- FIG. 7 shows an example pressure curve 700 used to modulate the airflow of the respiratory therapy system as the entrainment stimulus, to reduce the user’s respiration rate in a step-wise fashion at the beginning of a sleep session and aid the user in falling asleep.
- a single breath is divided into an inspiration period 702A (when the user is breathing in), an inspiration hold period 702B (when the user is momentarily holding their breath after breathing in and before breathing out), an expiration period 702C (when the user is breathing out), and an expiration hold period 702D (when the user is holding their breath after breathing out and before breathing in).
- inspiration period 702A the pressure gradually increases from an EPAP pressure 704 to an IPAP pressure 706.
- the inspiration hold period 702B the pressure remains at the IPAP pressure 706.
- the expiration period 702C the pressure gradually decreases from the IPAP pressure 706 to the EPAP pressure 704.
- the expiration hold period 702D the pressure remains at the EPAP pressure 704.
- the pressure changes linearly during the inspiration period 702A and the expiration period 702C.
- the pressure curve 700 may be designed so that the pressure changes in other manners during these periods, such as based on curved lines during the inspiration period 702A and the expiration period 702C.
- the pressure curve 700 can be modified to represent a new (intermediate or final) target respiration rate, which will generally the less than the prior (e.g., intermediate) target respiration rate. This step-wise reduction can continue until (i) the user’s respiration rate reaches the final target respiration rate, (ii) the user’s respiration rate reaches a minimum respiration rate above the final target respiration rate but will not decrease any further, or (iii) the user falls asleep.
- the entrainment waveform generated at step 620 can take the form of the pressure curve 700, which is then used to present the entrainment stimulus as a modulation of the airflow.
- additional or alternative entrainment stimuli can also be based on the pressure curve 700.
- Information about the pressure curve 700 can be transmitted to the stimulus device (which may be a smartphone) in any suitable manner, such as via BluetoothTM, Wi-Fi, etc., through which audio, visual, and/or haptic stimuli may be produced.
- the entrainment stimulus includes circle displayed on the user’s smartphone increases and decreases in size, the circle can grow bigger during the intended respiration period, and the grow smaller during the intended expiration period.
- the entrainment stimulus includes a modulated tone played through a speaker, the volume and/or pitch of the tone can increase during the inspiration period, and decrease during the expiration period.
- the pressure curve 700 is discussed herein with respect to reducing the user’s respiration rate during a sleep session, the pressure curve 700 (and/or similar pressure curves) can be used during any of the methods discussed herein.
- the pressure curve 700 could be used to modulate the airflow during an acclimatization session. This entrainment stimulus can be used during the acclimatization session to aid the user in getting used to the same type of modulation of the airflow during the sleep session.
- FIGS. 8A and 8B are respiration rate vs. time plots that illustrate the use of entrainment stimuli to reduce the user’s respiration rate in a step-wise manner during a sleep session, to aid the user in falling asleep.
- FIGS. 8A and 8B are applicable to implementations where the entrainment stimulus comprises a modulation of the air flowing from the respiratory therapy device to the user interface (e.g., the implementation illustrated in FIG. 7), but are also applicable to generally any type of entrainment stimulus that is presented to the user during the sleep session.
- Plot 800 in FIG. 8A includes a respiration rate trace 802 that shows the respiration rate of the user in breaths per minute (bpm), and an entrainment stimulus trace 804 that shows the target respiration rate represented by the current entrainment waveform and entrainment stimulus.
- the entrainment stimulus trace 804 is initially at a rate of 15 bpm, while the respiration rate trace 802 varies between about 15 bpm and greater than 17.5 bpm. Between 75 and 100 seconds, once the respiration rate trace 802 remains at about 15 bpm for a threshold period of time (and/or number of breaths), the entrainment stimulus trace 804 drops down to about 12 bpm.
- the respiration rate trace 802 then begins to decrease toward the entrainment stimulus trace 804 as a result of the user being induced to breath at the lower respiration rate by the corresponding entrainment stimulus. This cycle can continue until the respiration rate trace 802 reaches the final target respiration rate, which in this case is about 5-6 bpm.
- Plot 810 in FIG. 8B is similar to plot 800 of FIG. 8A, and includes a respiration rate trace 812 and an entrainment stimulus trace 814.
- the respiration rate trace 812 shows the respiration rate of the user in bpm (breaths per minute), and the entrainment stimulus trace 814 shows the target respiration rate represented by the current entrainment waveform and entrainment stimulus.
- the respiration rate trace 812 follows the entrainment stimulus trace 814 downward to around 9 bpm. However, at a time of about 60 seconds, it is detected that the user has fallen asleep.
- plots 800 and 810 demonstrate the efficacy of the entrainment waveform and the entrainment stimulus in reducing the user’s respiration rate in a step-wise fashion to reach the final target respiration through one or more intermediate target respiration rates, inducing the user to fall asleep, and then allowing the user to sleep normally.
- the generation of the entrainment waveform and the presentation of the entrainment stimulus can be based on the data generated in step 610.
- step 620 could include determining the user’s current respiration rate, and then generating the entrainment waveform so that the entrainment waveform represents a target respiration rate that is between 1-4 breaths per minute less than the user’s current respiration rate.
- This target respiration rate may be the final target respiration rate (if the user’s current respiration rate is close to final target respiration rate for the user), or may be an intermediate target respiration rate that is higher than the desired respiration rate.
- the data can be used to determine when to begin the generation of the entrainment waveform and the presentation of the entrainment stimulus.
- the entrainment waveform can be generated, and the entrainment stimulus presented.
- the entrainment waveform and the entrainment stimulus can be triggered to begin by the use of the respiratory therapy system, such as via user device (e.g., a smartphone having an app optionally in communication with the respiratory therapy device).
- the entrainment waveform and the entrainment stimulus are based on the current pressure of the air provided by the respiratory therapy system.
- method 600 can include sub-step 615 after step 610.
- Sub-step 615 includes determining the current pressure of the air flowing from the respiratory therapy device to the user interface.
- generating the entrainment waveform at step 620 comprises step 622, which includes generating the entrainment waveform based at least in part on the current pressure.
- Method 600 then proceeds to step 630, where the entrainment stimulus is presented. Because the entrainment waveform was generated based on the current pressure, the entrainment waveform presented in step 630 will thus also be based on the current pressure.
- This example of method 600 may be used if it is determined that different entrainment waveforms (e.g., different target respiration patterns) are desirable for different pressures of air flowing to the user interface.
- this example of method 600 can include providing air at a first pressure during the sleep session, generating a first entrainment waveform based on the first pressure, and then presenting a first entrainment waveform based on the first entrainment waveform.
- air may be provided at a second pressure (e.g., during a ramp up in the pressure at an early portion of the sleep session), a second entrainment waveform is generated, and a second entrainment stimulus is presented based on the second entrainment waveform.
- This example of method 600 may also include altering the type of entrainment stimulus that is used.
- FIG. 9 is a flowchart of a method 900 for presenting an entrainment program during the sleep session where the entrainment stimulus presented to the user changes based at least in part on the time within the sleep session, instead of or in addition to the pressure of the air.
- a control system having one or more processors (such as control system 200 of system 10) is configured to carry out the steps of method 900.
- a memory device (such as memory device 204 of system 10) can be used to store machine-readable instructions that are executed by the control system to carry out the steps of method 900.
- the memory device can also store any type of data utilized in the steps of method 900.
- method 900 can be implemented using a system (such as system 10) that includes the respiratory therapy system, the control system, and the memory device.
- Step 910 includes generating a first entrainment waveform during the sleep session.
- Step 910 is generally the same as or similar to step 620 of method 600.
- Step 920 includes, at a first time during the sleep session, presenting a first entrainment waveform to the user based on the first entrainment waveform.
- Step 920 is generally the same as or similar to step 630 of method 600.
- Step 930 of method 900 includes generating a second entrainment waveform.
- Step 940 includes, at a second time during the sleep session that is after the first time, presenting a second entrainment stimulus to the user based on the second entrainment waveform.
- the second entrainment waveform generated at step 930 is different than the first entrainment waveform generated at step 910, and is more suitable for a later time within the sleep session, and thus may be dependent on the time within the sleep session and/or the time elapsed since the beginning of the sleep session with respiratory entrainment.
- the first entrainment waveform could represent one respiration rate while the second entrainment waveform represents a slightly slower respiration rate, which thus causes the first and second entrainment stimuli to aid in decreasing the user’s respiration rate in multiple smaller steps, rather than one larger step.
- the first entrainment stimulus may include a visual stimulus (and optionally one or more other entrainment stimuli such as an audio stimulus) whereas the second entrainment stimulus may not include, or may gradually discontinue, a visual stimulus since it would be expected that the user would close their eyes as they attempt or begin to fall asleep.
- the second entrainment stimulus may therefore include an audio stimulus (and optionally one or more other entrainment stimuli such as a haptic stimulus).
- Biometric data may be used to determine the sleep state (and/or sleep stage) of the user, which information can be used to determine a suitable entrainment waveform and entrainment stimulus based on the user’s sleep state/stage.
- biometric data may be used to monitor changes in physiological parameters which indicate sleepiness, as a user approaches a sleep state/stage.
- physiological parameters include a reduction in respiration rate, heart rate, bodily movement, or any combination thereof.
- the second entrainment stimulus is a different type of entrainment stimulus than the first entrainment stimulus, and is more suitable for a later time within the sleep session as compared to the first entrainment stimulus presented earlier during the sleep session.
- the first entrainment stimulus could be a visual stimulus that is suitable for the beginning of the sleep session
- the second entrainment stimulus could be an audio stimulus that is suitable for later on during the sleep session as the user begins to fall asleep.
- the second entrainment waveform is different than the first entrainment waveform. For example, it may be determined that a slightly different entrainment waveform is more suitable for the type of entrainment stimulus that is used for second entrainment stimulus as compared to the type of entrainment stimulus used for the first entrainment stimulus.
- the second entrainment stimulus is based on the same entrainment waveform as the first entrainment stimulus.
- there is no generation of another entrainment waveform and instead the second entrainment stimulus is based on the first entrainment waveform.
- the generation of the second entrainment waveform and/or the presentation of the second entrainment stimulus can occur if it is determined that the user has awakened at some point during the sleep session. For example, after the first entrainment stimulus is presented, is the data indicates that the user has fallen asleep, the presentation of the first entrainment stimulus can end. Then, if the data later indicates that the user as awoken, the second entrainment waveform can be generated and/or the second entrainment stimulus can be presented.
- the second entrainment stimulus only includes a modulation of the air flowing from the respiratory therapy device to the user interface (and/or any other airflow-based stimulus as described herein), which will aid the user in falling back asleep without having to look at a smartphone and/or turn the lights on to receive the entrainment stimulus.
- FIG. 10 is a flowchart of a method 1000 for presenting an entrainment program during the sleep session where the entrainment stimulus presented to the user changes based at least in part on the time within the sleep session, instead of or in addition to the pressure of the air.
- a control system having one or more processors (such as control system 200 of system 10) is configured to carry out the steps of method 1000.
- a memory device (such as memory device 204 of system 10) can be used to store machine-readable instructions that are executed by the control system to carry out the steps of method 1000.
- the memory device can also store any type of data utilized in the steps of method 1000.
- method 1000 can be implemented using a system (such as system 10) that includes the respiratory therapy system, the control system, and the memory device.
- Step 1010 of methods 1000 includes receiving entrainment coherence data associated with one or more entrainment stimuli presented to the user during a prior acclimatization session.
- the entrainment coherence data can include one or more entrainment coherence scores as discussed herein, where each entrainment coherence score indicates the coherence between the user’s breathing during the acclimatization session and the entrainment stimuli presented to the user.
- the entrainment coherence data can include any suitable information for each respective entrainment coherence score, such as the entrainment waveform used to generate the entrainment stimulus to which the entrainment coherence score applies, the type of the entrainment stimulus (e.g., audio stimulus, visual stimulus, etc.) to which the entrainment coherence score applies, the pressure of the air being provided when the respective entrainment coherence score was determined (e.g., the pressure of the air when the respective entrainment waveform was generated and/or when the corresponding entrainment stimulus was presented), or any combination thereof.
- the entrainment waveform used to generate the entrainment stimulus to which the entrainment coherence score applies
- the type of the entrainment stimulus e.g., audio stimulus, visual stimulus, etc.
- the pressure of the air being provided when the respective entrainment coherence score was determined e.g., the pressure of the air when the respective entrainment waveform was
- Step 1020 includes generating an entrainment waveform based at least in part on the entrainment coherence data
- step 1030 includes presenting an entrainment stimulus based at least in part on the entrainment waveform, the entrainment coherence data, or both.
- the entrainment coherence data indicates that a particular target respiration rate (final or intermediate) and/or a particular type of entrainment stimulus may be useful in improving the user’s experience during the sleep session (e.g., by reducing the user’s sleep onset latency)
- a specific entrainment waveform and/or a specific type of entrainment stimulus can be used.
- entrainment coherence scores can be used to determine when to update the entrainment waveform to represent a lower target respiration rate (e.g., updating from a higher intermediate target respiration rate to a lower intermediate target respiration rate, or updating from the lowest intermediate target respiration rate to the final target respiration rate).
- the entrainment waveform can be updated to represent a lower target respiration rate.
- the entrainment coherence score can then again be determined between the user’s current respiration rate and the lower target respiration rate. This process can continue until any desired stopping point is reached, such as the user’s respiration rate reaching the final target respiration rate, the user’s respiration rate not decreasing below a respiration rate higher than the final target respiration rate, the user falling asleep, etc.
- the entrainment coherence score can additionally or alternatively be based on the user’s stress levels.
- One or more physiological parameters representing stress experienced by the user e.g., galvanic skin response, heart rate variability, heart rate, blood pressure, EEG parameters, etc.
- the entrainment waveform can be updated to represent a lower target respiration rate.
- the new entrainment stimulus could be the same type of entrainment stimulus (e.g., still an audio stimulus, still a visual stimulus, etc.) with a new entrainment waveform, or a new type of entrainment stimulus with the same entrainment waveform, a new type of entrainment stimulus with a new entrainment waveform.
- the new stimulus presented to the user could be brought about by adding an additional entrainment stimulus of a different type.
- an audio entrainment stimulus could be newly presented to the user while the existing visual entrainment stimulus continues to be presented to the user, where the new audio entrainment stimulus has the same entrainment waveform as the existing visual entrainment stimulus, or a different entrainment waveform.
- the system 10 can present the entrainment program to a user making use of a respiratory therapy system 100 and engaging in a sleep session, while utilizing information gained from presenting the entrainment program to the user during the acclimatization session.
- FIG. 11 is a flowchart of a method 1100 for presenting an entrainment program that combines aspects of methods 500, 600, 900, and 1000.
- Steps 1110, 1120, 1130, and 1140 are generally identical to steps 510, 520, 530, and 540 of method 500
- Step 1110 includes receiving data associated with the user while engaging in the acclimatization session (referred to as first data)
- step 1120 includes extracting respiration information from the sensor data
- step 1130 includes generating a first entrainment waveform
- step 1140 includes presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
- Step 1150 of method 1100 includes generating an entrainment coherence score indicative of the coherence between the first respiration information and the first entrainment waveform.
- the generation of the entrainment coherence score is generally the same as or similar to the generation of the entrainment coherence score described herein with respect to method 500.
- Step 1160 of method 1100 includes receiving second data associated with the user while the user is engaging in a sleep session, and is generally the same as or similar to step 610 of method 600.
- Step 1170 of method 1100 includes generating a second entrainment waveform based at least in part on the entrainment coherence score, and step 1180 includes presenting a second entrainment stimulus based at least in part on the second entrainment waveform.
- Method 1100 thus allows for certain features or characteristics of the user and their response to entrainment stimuli to be learned during the acclimatization session, which can then be used to generate the entrainment waveform during the actual sleep session. For example, if the entrainment coherence score indicates low coherence between the user’s respiration pattern during the acclimatization session and a given target respiration pattern (e.g., the first entrainment waveform), then a different target respiration pattern (and accompanying entrainment waveform) can be used during the sleep session. This can be useful if the first entrainment waveform represents a predetermined starting target respiration pattern that tends to be useful for a general population of users.
- a target respiration pattern e.g., the first entrainment waveform
- a different target respiration pattern and entrainment waveform can be used during the actual sleep session.
- the entrainment coherence score can generally include any information that is learned during the acclimatization session that can be applied during a later sleep session.
- step 1170 includes generating a temporary entrainment waveform, and then modifying the temporary entrainment waveform based at least in part on the entrainment coherence score to generate the second entrainment waveform.
- the temporary entrainment waveform may represent a starting target respiration pattern (e.g., a predetermined target respiration pattern typically suitable for many users). Updating the temporary entrainment waveform can then include determining a subsequent target respiration pattern for the user based at least in part on the starting target respiration pattern and the entrainment coherence score, and then updating the temporary entrainment waveform so that the second entrainment waveform represents the subsequent target respiration pattern.
- the determination of the subsequent target respiration pattern may be based only on the entrainment coherence score, but additionally or alternatively is based on the second data. For example, if the entrainment coherence score indicates poor coherence at a certain air pressure, then the second data can be analyzed to determine the current air pressure, and determine the subsequent target respiration pattern on that current air pressure.
- the subsequent target respiration pattern could be the final target respiration pattern for the sleep session, or could be an intermediate target respiration pattern.
- the entrainment stimulus presented to the user during the acclimatization session is different from the entrainment stimulus presented during the sleep session.
- the first entrainment stimulus can include a visual stimulus.
- a visual stimulus might not be appropriate during the sleep session since the user is attempting to fall asleep.
- an audio stimulus, a haptic stimulus, a modulation of the airflow, or any combinations thereof can be used for the second entrainment stimulus.
- both the first entrainment stimulus and the second entrainment stimulus are the same type of stimulus or comprise the same type of stimuli.
- generating the second entrainment waveform may be based on more than just the entrainment coherence score from the acclimatization session.
- historical acclimatization information associated with a plurality of prior acclimatization sessions can be obtained.
- This historical acclimatization information can include historical respiration information for each of these prior acclimatization sessions and a historical entrainment coherence score for each of these prior acclimatization sessions.
- Such longitudinal data can be used to determine a more suitable second entrainment waveform based on a richer data set of historical respiration information and historical entrainment coherence scores.
- the entrainment coherence score determined at step 1150 includes generating a plurality of entrainment coherence sub-scores, where each sub-score is associated with a different pressure of the air flowing from the respiratory therapy device to the user interface during the acclimatization session.
- Step 1160 can then first include determining the current pressure of the air during the sleep session based at least in part on the second data, and then generating the second entrainment waveform based on the current pressure of the air and the entrainment coherence sub-score associated with the current pressure.
- the second entrainment waveform that is generated may represent a higher target respiration rate than if the entrainment coherence sub-score was higher, to make it less difficult for the user to match their respiration pattern to the second entrainment stimulus.
- second respiration information is generated from the second data.
- An additional entrainment coherence score can then be determined that is indicative of the coherence between the second respiration information (e.g., the user’s respiration pattern during the sleep session) and the second entrainment waveform. If the additional entrainment coherence score satisfies a threshold (e.g., satisfies a threshold value once or for at least a threshold amount of time), a notification can be generated and/or transmitted to the user and/or a caretaker of the user or other third party. This notification can indicative a need to adjust the respiratory therapy system.
- a threshold e.g., satisfies a threshold value once or for at least a threshold amount of time
- FIG. 12 is a flowchart of another method 1200 for presenting an entrainment program that combines aspects of methods 500, 600, 900, and 1000.
- Step 1210 includes, during an acclimatization session, cycling through (i) a plurality of different pressures of the air provided to the user interface and (ii) a plurality of different entrainment waveforms for each pressure.
- Step 1220 includes determining an entrainment coherence score for distinct combination of one of the plurality of pressures and one of the plurality of entrainment waveforms.
- Step 1230 includes, during a sleep session, receiving data and determining the current pressure of the air flowing to the user interface based on the second data.
- Step 1240 includes generating an entrainment waveform based on the current pressure of the air and the plurality of entrainment coherence scores associated with the current pressure.
- the entrainment waveform that is generated is the one entrainment waveform of the plurality of entrainment waveforms with the highest entrainment coherence score for the current pressure.
- Step 1250 includes presenting an entrainment stimulus to the user based on the entrainment waveform.
- the system 10 can present the entrainment program without use of the respiratory therapy device 110.
- a system 10 can present the entrainment program to a user not receiving respiratory therapy to demonstrate how the entrainment stimuli would otherwise be presented to the user if they were receiving respiratory therapy from a respiratory therapy device 110 while being entrained.
- This type of acclimatization can allow a user to become familiar with the entrainment program, allows the user to pre-set various parameters associated with the entrainment program, and allows the entrainment system to collect important information from the user (e.g., how the user responded to different entrainment stimuli, how susceptible the user was to entrainment, and the like), all without the user needing to make use of a respiratory therapy device 110.
- information can include, or be based upon, the respiration pattern changes induced by the entrainment programs and the entrainment stimuli, including respiration rate reduction, inspiration/expiration ratio, etc.
- the acclimatization session can also provide information respiratory therapy and the respiratory therapy system itself to the user, which can be particularly helpful if the user has never used a respiratory therapy system before.
- the user can be presented with a variety of tutorials associated with operation of the respiratory therapy system, such as how to don the user interface, how to connect the user interface to the conduit, how to connect the conduit to the respiratory therapy device, how to operate the respiratory therapy device, how to fill the humidifier, and others.
- this type of acclimatization can be performed while the user is not engaging in a sleep session (e.g., while the user is not lying in bed attempting to fall asleep), although that need not always be the case.
- a session where a user is undergoing this type of acclimatization can be referred to as an “off-device acclimatization session," where the “device” is referring to a respiratory therapy device (e.g., a CPAP device).
- a respiratory therapy device e.g., a CPAP device
- a single acclimatization session could comprise periods where the user is not wearing the user interface, and periods where the user is wearing the user interface while air is flowing from the respiratory therapy device to the user interface.
- a single acclimatization session may include at least one portion where the user is not wearing the user interface and is receiving entrainment stimuli and/or other types of information, and at least one portion where the user is wearing the user interface and receiving therapy from the respiratory therapy device while receiving entrainment stimuli.
- a first entrainment stimulus can be presented to the user, and subsequently a second entrainment stimulus can be presented to the user.
- the two entrainment stimuli may be different types of stimuli.
- one entrainment stimulus could be a visual stimulus while the other is an audio stimulus
- one entrainment stimulus could be a visual stimulus while the other is a haptic stimulus
- one entrainment stimulus could be an audio stimulus while the other is a haptic stimulus
- the two entrainment stimuli are based on entrainment waveforms that represent two different target respiration patterns. In these implementations, the two entrainment stimuli may be the same type of stimuli or different.
- various aspects of any of the methods disclosed herein can be performed with and/or using a machine learning model.
- the data and/or the respiration information can be input into a machine learning model which has been trained to output the entrainment waveform based at least on those inputs.
- machine learning model can be trained to generate the entrainment coherence scores in response to receiving an entrainment waveform and the corresponding respiration information of the user.
- a large language model can be used, and can be fine tuned with domain specific parameters or use retrieval augmented generation.
- the machine learning model can be trained on a database of historical sleep onset and/or sleep maintenance data, which may include respiration patterns, sleep onset data, and other types of data.
- training data can be generated where each set of training data include (i) respiration patterns of the user and (ii) an indication of whether a low sleep onset latency was achieved.
- the machine learning model can be trained on this data to learn what specific types of respiration patterns are best for achieving a low sleep onset latency for the user.
- the machine learning model is also trained on types of entrainment stimuli used (e.g., audio vs. visual vs. haptic vs. airflow modulation, etc.), user demographic data (e.g. age, gender, health conditions, BMI, etc.) so that the machine learning model can provide a more tailored entrainment program to the user.
- types of entrainment stimuli used e.g., audio vs. visual vs. haptic vs. airflow modulation, etc.
- user demographic data e.g. age, gender, health conditions, BMI, etc.
- FIG. 13 A is a front view of a user device 260 depicting a first view of a graphical user interface (GUI) 1300 for entrainment, according to some implementations of the present disclosure.
- the GUI 1300 can include various elements, such as instruction text 1302 and an entrainment visual element 1304A.
- the entrainment visual element 1304A can be animated to change in a fashion that intuitively shows how a user is currently breathing and/or how the user should be breathing to achieve entrainment, as discussed in further detail herein.
- the entrainment visual element 1304A is depicted as a set of concentric circles that increase and decrease in diameter to indicate inspiration and expiration, respectively.
- An outer circle 1306A can have a largest diameter
- the inner circle 1310A can have the smallest diameter
- the middle circle 1308 A can have a middle diameter that falls between the largest diameter of the outer circle 1306A and the smallest diameter of the inner circle 1310A.
- visual elements other than mere size can be used to intuitively signal inspiration and expiration, such as color, transparency, motion other than increasing or decreasing size, and the like.
- FIG. 13B is a front view of the user device 260 of FIG. 13 A depicting a second view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
- the size of the entrainment visual element 1304B can be slightly larger than that of the entrainment visual element 1304A of FIG. 13A, thus depicting an inhalation animation from the first view to the second view.
- the outer circle 1306B, middle circle 1308B, and inner circle 1310B each has a larger diameter than that of the outer circle 1306A, middle circle 1308A, and inner circle 1310A of FIG. 13 A, respectively.
- the relative visible surface area of any of the outer circle 1306B, middle circle 1308B, and inner circle 1310B can be controlled to provide additional intuitive cues to a user.
- the relative visible surface area of the outer circle 1306B and middle circle 1308B can be relatively smaller than that of the outer circle 1306A and middle circle 1308A of FIG. 13 A, respectively.
- Such a visual cue can indicate a given point within the user’s breath cycle or desired breath cycle, or can indicate a speed of inhalation/expiration.
- the entrainment visual element 1304B of the second view may show a middle point in a desired breath cycle, which may be a point when the user is inhaling or exhaling relatively fast.
- visual cues can be used to show a point in the breath cycle where the user is inhaling or exhaling relatively slowly.
- FIG. 13C is a front view of the user device 260 of FIG. 13 A depicting a third view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
- the size of the entrainment visual element 1304C can be slightly larger than that of the entrainment visual element 1304B of FIG. 13B, thus depicting a further inhalation animation from the second view to the third view.
- the outer circle 1306C, middle circle 1308C, and inner circle 1310C each has a larger diameter than that of the outer circle 1306B, middle circle 1308B, and inner circle 1310B of FIG. 13B, respectively.
- the relative visible surface area of any of the outer circle 1306C, middle circle 1308C, and inner circle 1310C can be controlled to provide additional intuitive cues to a user.
- the relative visible surface area of the outer circle 1306C and middle circle 1308C can be relatively larger than that of the outer circle 1306B and middle circle 1308B of FIG. 13B, respectively.
- Such a visual cue can indicate that the depicted breath cycle is nearing a maximum inhalation.
- FIG. 13D is a front view of the user device 260 of FIG. 13 A depicting a fourth view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
- the size of the entrainment visual element 1304D can be smaller than that of the entrainment visual element 1304C of FIG. 13C, thus depicting an expiration animation from the third view to the fourth view.
- the outer circle 1306D, middle circle 1308D, and inner circle 1310D each has a smaller diameter than that of the outer circle 1306C, middle circle 1308C, and inner circle 1310C of FIG. 13C, respectively.
- FIG. 14A is a front view of a user device 260 depicting a first view of a graphical user interface for entrainment using an alternate entrainment visual element 1404A, according to some implementations of the present disclosure.
- the user device 260 can be showing a graphical user interface that is similar to that of GUI 1300, but with a different style of animating its entrainment visual element 1404A. More specifically, the style of animation of the entrainment visual element 1404A in FIG. 14A is to have various parts of the entrainment visual element 1404A appear and disappear to represent inhalation and exhalation.
- the entrainment visual element 1404A can show an outer circle 1406A, a middle circle 1408A, and an inner circle 1410A, each having a smaller diameter than the previous. As depicted in the first view in FIG. 14A, each of the outer circle 1406A, middle circle 1408A, and inner circle 1410A are visible. Having these three circles all visible can represent a time of maximum inhalation.
- FIG. 14B is a front view of the user device of FIG. 13 A depicting a second view of a graphical user interface for entrainment using an alternate entrainment visual element 1404B, according to some implementations of the present disclosure.
- the entrainment visual element 1404B can show a middle circle 1408B and an inner circle 1410B.
- the outer circle 1406B is de-emphasized, such as by decreasing its transparency or by simply not displaying it. Having the outer circle 1406B be de-emphasized (e.g., hidden) can represent a time between maximum inhalation and maximum expiration.
- FIG. 14C is a front view of the user device of FIG. 13A depicting a third view of a graphical user interface for entrainment using an alternate entrainment visual element 1304C, according to some implementations of the present disclosure.
- the entrainment visual element 1404C can show an inner circle 1410C.
- the outer circle 1406C and the middle circle 1408C are both de-emphasized, such as by decreasing their transparencies or by simply not displaying them. Having the outer circle 1406C and middle circle 1408C be de-emphasized (e.g., hidden) can represent maximum expiration.
- the GUI can move between the first view (e.g., maximum inhalation) and the third view (e.g., maximum exhalation), passing through the second view.
- the circles being de-emphasized can gradually fade away or otherwise become de-emphasized, thus representing the process of expiration.
- the circles no longer being de-emphasized can be reemphasized gradually, such as by gradually fading in or otherwise becoming re-emphasized.
- the speed of inhalation or expiration can be intuitively indicated by changing the speed by which a circle becomes de-emphasized or re-emphasized.
- an entrainment visual element can be animated using a combination on animations, such as a combination of those discussed with reference to FIGs. 13A - 14C (e.g., a combination of animating the diameter of concentric circles while also animating the visibility of at least some of those circles).
- FIGs. 13A-13D and FIGs. 14A-14C depict how an entrainment visual element may appear at different points in a breath cycle. While the examples in these figures describe a certain respiratory orientation to the animation (e.g., increases in diameter or appearance of larger-diameter circles equates to inspiration), opposite or other respiratory orientations can be used (e.g., increases in diameter or appearance of larger-diameter circles equates to expiration). Additionally, while circles are depicted in these examples, in some cases, other shapes, images, or visual elements can be used. For example, instead of the growing and shrinking concentric circles of FIGs. 13 A- 13D, a growing and shrinking set of overlapping curves or a growing and shrinking image can be used.
- portions of an image e.g., a top 1/3 and middle 1/3 of a diagram of a pair of lungs
- an image e.g., a top 1/3 and middle 1/3 of a diagram of a pair of lungs
- any of the methods disclosed herein can be implemented using a system having a control system with one or more processors, and a memory device storing machine- readable instructions.
- the control system can be coupled to the memory device, and methods can be implemented when the machine-readable instructions are executed by at least one of the processors of the control system.
- the methods can also be implemented using a computer program product (such as a non-transitory computer readable medium) comprising instructions that when executed by a computer, cause the computer to carry out the steps of the methods.
- a method comprising: receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extracting first respiration information from the first data; presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating at least a first entrainment waveform and presenting at least a first entrainment stimulus based at least in part on the first entrainment waveform; generating at least one entrainment coherence score indicative of coherence between the first respiration information and the first entrainment waveform; receiving second data associated with a user engaging in a current sleep session; and presenting a second entrainment program to the user during the current sleep session that is based at least in part on the second data, the at least one entrainment coherence score, or both.
- Alternative Implementation 2 The method of Alternative Implementation 1, wherein the first entrainment waveform is predetermined and not based on either the first data or the first respiration information.
- Alternative Implementation 3 The method of Alternative Implementation 1, wherein the first entrainment waveform is based at least in part on the first data, the first respiration information, or both.
- Alternative Implementation 5 The method of any one of Alternative Implementations 1 to 4, wherein the first respiration information includes a current respiration pattern of the user, and wherein the first entrainment waveform represents a target respiration pattern.
- Alternative Implementation 6 The method of Alternative Implementation 5, wherein the target respiration pattern includes a target inspiration/expiration ratio.
- Alternative Implementation 7 The method of Alternative Implementation 5, wherein the target respiration pattern includes a target inspiration duration, a target inspiration hold duration, a target expiration duration, and a target expiration hold duration.
- Alternative Implementation 8 The method of any one of Alternative Implementations 5 to 7, wherein presenting the first entrainment program includes displaying on a display device (i) a current waveform representing the current respiration pattern of the user, and (ii) the first entrainment waveform representing the target respiration pattern.
- Alternative Implementation 10 The method of any one of Alternative Implementations 1 to 9, wherein the first respiration information includes a current respiration rate of the user, and wherein the first entrainment waveform represents a target respiration rate.
- Alternative Implementation 11 The method of Alternative Implementation 10, further comprising: updating the first entrainment waveform to represent an updated target respiration rate that is different than the target respiration rate; and presenting the first entrainment stimulus based at least in part on the updated first entrainment waveform.
- Alternative Implementation 13 The method of Alternative Implementation 12, wherein the first entrainment waveform is updated in response to the entrainment coherence score satisfying the threshold value for at least a predetermined amount of time.
- Alternative Implementation 14 The method of any one of Alternative Implementations 10 to 13, wherein the target respiration rate is less than the current respiration rate.
- Alternative Implementation 15 The method of any one of Alternative Implementations 1 to 14, wherein presenting the first entrainment stimulus includes (i) generating an audio stimulus; (ii) modulating an existing audio stimulus; (iii) generating a visual stimulus; (iv) modulating an existing visual stimulus; (v) generating a haptic stimulus; (vi) modulating an existing haptic stimulus; (vii) modulating a flow of air generated by the respiratory therapy system; or (viii) any combination of (i)-(vii).
- Alternative Implementation 16 The method of any one of Alternative Implementations 1 to 15, wherein generating the first entrainment waveform includes inputting into a machine learning algorithm the first data, the first respiration information, or both, the machine learning algorithm being trained to output the first entrainment waveform.
- Alternative Implementation 17 The method of any one of Alternative Implementations 1 to 16, wherein the second entrainment program is based at least in part on both the second data and the entrainment coherence score.
- Alternative Implementation 18 The method of any one of Alternative Implementations 1 to 17, wherein presenting the second entrainment program to the user during the current sleep session includes: generating a second entrainment waveform; and presenting a second entrainment stimulus based at least in part on the second entrainment waveform.
- Alternative Implementation 22 The method of Alternative Implementation 18 or 21, wherein the first entrainment stimulus and the second entrainment stimulus both include an audio stimulus, a visual stimulus, a haptic stimulus, a modulation of a flow of air generated by the respiratory therapy system, or any combination thereof.
- Alternative Implementation 23 The method of any one of Alternative Implementations 18 to 22, wherein presenting the second entrainment stimulus includes (i) generating an audio stimulus; (ii) modulating an existing audio stimulus; (iii) generating a visual stimulus; (iv) modulating an existing visual stimulus; (v) generating a haptic stimulus; (vi) modulating an existing haptic stimulus; (vii) modulating a flow of air generated by the respiratory therapy system; or (viii) any combination of (i)-(vii).
- Alternative Implementation 24 The method of Alternative Implementation 23, wherein modulating the flow of air includes modulating a pressure of the air.
- Alternative Implementation 25 The method of Alternative Implementation 24, wherein modulating the flow of air includes modulating the pressure of the air in accordance with a target respiration pattern.
- presenting the second entrainment program includes: generating a temporary entrainment waveform; and updating the temporary entrainment waveform based at least in part on the coherence score to generate the second entrainment waveform.
- Alternative Implementation 27 The method of Alternative Implementation 26, wherein updating the temporary entrainment waveform is further based on the second data.
- Alternative Implementation 28 The method of Alternative Implementation 26 or 27, wherein the temporary entrainment waveform represents an initial target respiration pattern, and wherein updating the temporary entrainment waveform includes: determining an updated target respiration pattern based at least in part on the initial target respiration pattern and the coherence score; and updating the temporary entrainment waveform so that the second entrainment waveform represents the updated target respiration pattern.
- Alternative Implementation 29 The method of Alternative Implementation 27, wherein determining the updated target respiration pattern is further based on the second data.
- generating the second entrainment waveform includes inputting into a machine learning algorithm the second data, the coherence score, or both, the machine learning algorithm being trained to output the second entrainment waveform.
- Alternative Implementation 32 The method of any one of Alternative Implementations 1 to 31 , wherein the respiratory therapy system includes a user interface configured to be fluidly coupled to a respiratory therapy device via a conduit, the respiratory therapy device being operable to cause air to flow through the conduit and to the user interface.
- Alternative Implementation 33 The method of Alternative Implementation 32, wherein the acclimatization session occurs while the user is awake and is wearing the user interface.
- Alternative Implementation 34 The method of Alternative Implementation 33, wherein the acclimatization session occurs while the user interface is fluidly coupled to the respiratory therapy device via the conduit.
- Alternative Implementation 35 The method of Alternative Implementation 34, wherein the acclimatization session occurs while the respiratory therapy device is causing air to flow through the conduit and to the user interface.
- Alternative Implementation 36 The method of Alternative Implementation 34, wherein the acclimatization session occurs while the respiratory therapy device is not causing air to flow through the conduit and to the user interface.
- Alternative Implementation 37 The method of Alternative Implementation 33, wherein the acclimatization session occurs while the user interface is not fluidly coupled to the respiratory therapy devices via the conduit.
- Alternative Implementation 39 The method of Alternative Implementation 32, wherein the acclimatization session occurs while the user is not wearing the user interface of a respiratory therapy system.
- Alternative Implementation 40 The method of any one of Alternative Implementations 1 to 39, further comprising presenting acclimatization sounds during the acclimatization session, the acclimatization sounds presented to simulate to the use of a respiratory therapy system by the user.
- Alternative Implementation 41 The method of Alternative Implementation 40, wherein presenting the first entrainment stimulus includes modulating the acclimatization sounds based at least in part on the first entrainment waveform.
- Alternative Implementation 42 The method of any one of Alternative Implementations 1 to 41, wherein the entrainment coherence score includes a plurality of entrainment coherence sub-scores, and wherein each entrainment coherence sub-score of the plurality of entrainment coherence sub-scores is indicative of entrainment coherence at a respective time during the acclimatization session.
- Alternative Implementation 43 The method of Alternative Implementation 42, wherein the acclimatization session occurs while a respiratory therapy device of the respiratory therapy system is causing air to flow to a user interface that is worn by the user, and wherein each subscore of the plurality of sub-scores corresponds to a respective pressure of the air flowing to the user interface.
- Alternative Implementation 44 The method of Alternative Implementation 42, wherein presenting the second entrainment program to the user during the current sleep session includes: determining, based at least in part on the second data, a current pressure of air provided to the user via a respiratory therapy system during the current sleep session; generating a second entrainment waveform based on (i) the current pressure of the air and (ii) the one of the plurality of entrainment coherence sub-scores that is associated with the current pressure; and presenting a second entrainment stimulus based on the second entrainment waveform.
- Alternative Implementation 45 The method of any one of Alternative Implementations 1 to 43, further comprising: extracting second respiration information from the second data, wherein presenting the second entrainment program includes generating a second entrainment waveform; determining an additional entrainment coherence score indicative of coherence between the second respiration information and the second entrainment waveform; and in response to determining that the additional entrainment coherence score satisfies a threshold, transmitting a notification signal indicative of a need for an adjustment in the respiratory therapy system.
- Alternative Implementation 46 The method of any one of Alternative Implementations 1 to 45, further comprising presenting the entrainment coherence score using a display device.
- Alternative Implementation 47 The method of Alternative Implementation 46, wherein presenting the entrainment coherence score occurs during the acclimatization session.
- Alternative Implementation 48 The method of Alternative Implementation 46 or 47, wherein presenting the entrainment coherence score includes: generating a first trace based at least in part on the first respiration information; generating a second trace at least in part on the first entrainment waveform; presenting the first trace; and presenting the second trace adjacent to or overlying the first trace.
- Alternative Implementation 50 The method of any one of Alternative Implementations 1 to 49, wherein the first data, the second data, or both, include: pressure data associated with a pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user, flow rate data associated with a flow rate of the air, motion data associated with movement of the user, image data reproducible as one or more images of the user, PPG data, ECG data, EEG data, or any combination thereof.
- Alternative Implementation 51 The method of any one of Alternative Implementations 1 to 50, wherein presenting the first entrainment program and generating the entrainment coherence score comprises: during the acclimatization session where the user is awake and wearing the user interface, causing air to flow from the respiratory therapy device to the user interface at a plurality of different pressure values; for each of the plurality of pressure values, presenting a plurality of entrainment stimuli to the user, each of the plurality of entrainment stimuli being based on one of a plurality of entrainment waveforms; and determining, for each distinct combination of one of the plurality of pressure values and one of the plurality of entrainment waveforms, an entrainment coherence score indicative of coherence between a respiration pattern of the user and the one entrainment waveform.
- Alternative Implementation 52 The method of Alternative Implementation 51, wherein presenting the second entrainment program comprises: during the current sleep session where the user is wearing the user interface and air is flowing from the respiratory therapy device to the user interface, determining a pressure value of the air; generating a sleep session entrainment waveform based on the pressure value of the air flowing during the sleep session and the entrainment coherence scores associated with the corresponding pressure value of the air flowing during the acclimatization session; and presenting a sleep session entrainment stimulus to the user based on the sleep session entrainment waveform.
- Alternative Implementation 53 The method of Alternative Implementation 52, wherein the sleep session entrainment waveform is the one of the plurality of entrainment waveforms having a maximum entrainment coherence score among all entrainment coherence scores for the corresponding pressure value of the air flowing during the acclimatization session.
- Alternative Implementation 54 The method of any one of Alternative Implementations 1 to 53, wherein presenting the first entrainment program or the second entrainment program to the user comprises: determining a current pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generating an entrainment waveform based at least in part on the current pressure of the air; and presenting an entrainment stimulus to the user based at least in part on the entrainment waveform.
- Alternative Implementation 55 The method of Alternative Implementation 54, wherein in response to the current pressure of the air changing to a new pressure, the method further comprises: generating a new entrainment waveform based at least in part on the new pressure of the air; and presenting a new entrainment stimulus to the user based at least in part on the new entrainment waveform.
- Alternative Implementation 56 The method of Alternative Implementation 54, wherein the generation of the entrainment waveform is further based at least in part on the entrainment coherence score determined during use of the respiratory therapy system by the user during the acclimatization session.
- Alternative Implementation 57 The method of any one of Alternative Implementations 1 to 56, wherein presenting the first entrainment program or the second entrainment program comprises: causing air having a first pressure to flow from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generating an initial entrainment waveform based at least in part on the first pressure of the air; presenting an initial entrainment stimulus to the user based at least in part on the initial entrainment waveform; subsequently causing air having a second pressure to flow from the respiratory therapy device to the user interface, the second pressure being different than the first pressure; and presenting a subsequent entrainment stimulus to the user that is different than the initial entrainment stimulus.
- Alternative Implementation 58 The method of Alternative Implementation 57, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, and is based on the initial entrainment waveform.
- Alternative Implementation 59 The method of Alternative Implementation 57, further comprising generating a subsequent entrainment waveform based at least in part on the second pressure of the air that is different than the initial entrainment waveform, wherein the subsequent entrainment stimulus is based on the subsequent entrainment waveform.
- Alternative Implementation 60 The method of Alternative Implementation 59, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, or is an identical type of stimulus as the initial entrainment stimulus.
- Alternative Implementation 61 The method of any one of Alternative Implementations 1 to 60, wherein presenting the second entrainment program to the user during the sleep session comprises: generating an initial entrainment waveform; at a first time during the sleep session, presenting an initial entrainment stimulus to the user based at least in part on the initial entrainment waveform; and at a second time after the first time during the sleep session, presenting a subsequent entrainment stimulus to the user that is different than the initial entrainment stimulus.
- Alternative Implementation 62 The method of Alternative Implementation 61, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, and is based on the initial entrainment waveform.
- Alternative Implementation 63 The method of Alternative Implementation 61, further comprising generating a subsequent entrainment waveform, wherein the subsequent entrainment stimulus is based on the subsequent entrainment waveform.
- Alternative Implementation 64 The method of Alternative Implementation 63, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, or is an identical type of stimulus as the initial entrainment stimulus.
- Alternative Implementation 65 The method of any one of Alternative Implementations 1 to 64, wherein presenting the second entrainment program to the user during the current sleep session comprises: determining a first current respiration rate of the user; generating an initial entrainment waveform representing a first target respiration rate that is less than the first current respiration rate of the user; presenting an initial entrainment stimulus to the user based on the initial entrainment waveform; determining, after the initial entrainment stimulus has been presented to the user, a second current respiration rate of the user; and in response to determining that a difference between the second current respiration rate of the user and the first target respiration rate satisfies a threshold difference, (i) generating a first subsequent entrainment waveform representing a second target respiration rate that is less than the first target respiration rate and (ii) presenting a first subsequent entrainment stimulus to the user based on the first subsequent entrainment waveform.
- Alternative Implementation 66 The method of Alternative Implementation 65, wherein the subsequent entrainment stimulus is an identical type of stimulus as the initial entrainment stimulus.
- Alternative Implementation 67 The method of Alternative Implementation 65, further comprising: determining, after the subsequent entrainment stimulus has been presented to the user, a third current respiration rate of the user; and in response to determining that a difference between the third current respiration rate of the user and the second target respiration rate satisfies the threshold difference, (i) generating a second subsequent entrainment waveform representing a third target respiration rate that is less than the second target respiration rate and (ii) presenting a second subsequent entrainment stimulus to the user based on the third entrainment waveform.
- Alternative Implementation 68 The method of Alternative Implementation 65, further comprising determining an elapsed time since a beginning of the sleep session, and wherein in response to the elapsed time being greater than or equal to a threshold time, the second subsequent entrainment stimulus is a different type of stimulus than the first subsequent entrainment stimulus.
- Alternative Implementation 69 The method of Alternative Implementation 68, wherein the second subsequent entrainment stimulus is an identical type of stimulus as the first subsequent entrainment stimulus in response to the elapsed time being less than the threshold time.
- Alternative Implementation 70 The method of Alternative Implementation 65, further comprising: determining, after the first subsequent entrainment stimulus has been presented to the user, a third current respiration rate of the user; and in response to determining that a difference between the third current respiration rate of the user and the second current respiration rate satisfies the threshold difference, continuing to present the first entrainment stimulus.
- Alternative Implementation 71 The method of any one of Alternative Implementations 1 to 70, wherein the at least one entrainment coherence score includes a plurality of entrainment coherence scores, each entrainment coherence score being associated with a respective entrainment waveform generated during the acclimatization session, a type of entrainment stimulus presented to the user based on the respective entrainment waveform, a pressure of air flowing in the respiratory therapy system when the respective entrainment waveform was generated, or any combination thereof.
- Alternative Implementation 72 The method of any one of Alternative Implementations 1 to 71, wherein presenting the first entrainment program to the user during the acclimatization session comprises: while the user is awake and not wearing a user interface to which air is provided by a respiratory therapy device of the respiratory therapy system, presenting the first entrainment stimulus to the user; and while the user is awake and not wearing the user interface, subsequently presenting a second entrainment stimulus to the user.
- Alternative Implementation 74 The method of Alternative Implementation 73, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
- Alternative Implementation 75 The method of Alternative Implementation 73, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
- Alternative Implementation 76 The method of Alternative Implementation 73, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
- Alternative Implementation 77 The method of Alternative Implementation 72, wherein the first entrainment stimulus is based on a first entrainment waveform representing a first target respiration pattern, and wherein the second entrainment stimulus is based on a second entrainment waveform representing a second target respiration pattern that is different than the first target respiration pattern.
- Alternative Implementation 79 The method of Alternative Implementation 77, wherein both the first entrainment stimulus and the second entrainment stimulus comprise audio stimuli.
- Alternative Implementation 80 The method of Alternative Implementation 77, wherein both the first entrainment stimulus and the second entrainment stimulus comprise haptic stimuli.
- Alternative Implementation 81 The method of Alternative Implementation 77, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
- Alternative Implementation 82 The method of Alternative Implementation 77, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
- Alternative Implementation 83 The method of Alternative Implementation 77, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
- a method comprising: receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extracting first respiration information from the first data; and presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
- Alternative Implementation 85 The method of Alternative Implementation 84, wherein the first entrainment waveform is predetermined and not based on either the first data or the first respiration information.
- Alternative Implementation 86 The method of Alternative Implementation 84, wherein the first entrainment waveform is based at least in part on the first data, the first respiration information, or both.
- Alternative Implementation 88 The method of any one of Alternative Implementations 84 to 87, wherein the first respiration information includes a current respiration pattern of the user, and wherein the first entrainment waveform represents a target respiration pattern.
- Alternative Implementation 89 The method of Alternative Implementation 88, wherein presenting the first entrainment program includes displaying on a display device (i) a current waveform representing the current respiration pattern of the user, and (ii) the first entrainment waveform representing the target respiration pattern.
- Alternative Implementation 90 The method of Alternative Implementation 89, wherein, on the display device, the first entrainment waveform is overlaid on the current waveform.
- Alternative Implementation 91 The method of any one of Alternative Implementations 84 to 90, wherein the first respiration information includes a current respiration rate of the user, and wherein the first entrainment waveform represents a target respiration rate.
- Alternative Implementation 92 The method of Alternative Implementation 91, further comprising: updating the first entrainment waveform to represent an updated target respiration rate that is different than the target respiration rate; and presenting the first entrainment stimulus based at least in part on the updated first entrainment waveform.
- Alternative Implementation 93 The method of Alternative Implementation 92, wherein the first entrainment waveform is updated in response to an entrainment coherence score satisfying a threshold value, the entrainment coherence score being indicative of coherence between the current respiration rate of the user and the first entrainment waveform.
- Alternative Implementation 94 The method of Alternative Implementation 93, wherein the first entrainment waveform is updated in response to the entrainment coherence score satisfying the threshold value for at least a predetermined amount of time.
- Alternative Implementation 95 The method of any one of Alternative Implementations 91 to 94, wherein the target respiration rate is less than the current respiration rate.
- Alternative Implementation 96 The method of any one of Alternative Implementations 84 to 95, wherein presenting the first entrainment stimulus includes (i) generating an audio stimulus; (ii) modulating an existing audio stimulus; (iii) generating a visual stimulus; (iv) modulating an existing visual stimulus; (v) generating a haptic stimulus; (vi) modulating an existing haptic stimulus; (vii) modulating a flow of air generated by the respiratory therapy system; or (viii) any combination of (i)-(vii).
- Alternative Implementation 97 The method of any one of Alternative Implementations 84 to 96, wherein generating the first entrainment waveform includes inputting into a machine learning algorithm the first data, the first respiration information, or both, the machine learning algorithm being trained to output the first entrainment waveform.
- Alternative Implementation 98 The method of any one of Alternative Implementations 84 to 97, wherein the respiratory therapy system includes a user interface configured to be fluidly coupled to a respiratory therapy device via a conduit, the respiratory therapy device being operable to cause air to flow through the conduit and to the user interface.
- Alternative Implementation 99 The method of Alternative Implementation 98, wherein the acclimatization session occurs while the user is awake and is wearing the user interface.
- Alternative Implementation 100 The method of Alternative Implementation 99, wherein the acclimatization session occurs while the user interface is fluidly coupled to the respiratory therapy device via the conduit.
- Alternative Implementation 101 The method of Alternative Implementation 100, wherein the acclimatization session occurs while the respiratory therapy device is causing air to flow through the conduit and to the user interface.
- Alternative Implementation 102 The method of Alternative Implementation 100, wherein the acclimatization session occurs while the respiratory therapy device is not causing air to flow through the conduit and to the user interface.
- Alternative Implementation 103 The method of Alternative Implementation 99, wherein the acclimatization session occurs while the user interface is not fluidly coupled to the respiratory therapy devices via the conduit.
- Alternative Implementation 104 The method of any one of Alternative Implementations 99 to 103, wherein the acclimatization session occurs when one or more valves of the user interface are open to surrounding air.
- Alternative Implementation 105 The method of Alternative Implementation 98, wherein the acclimatization session occurs while the user is not wearing the user interface of a respiratory therapy system.
- Alternative Implementation 106 The method of any one of Alternative Implementations 84 to 105, further comprising presenting acclimatization sounds during the acclimatization session, the acclimatization sounds presented to simulate to the user use of a respiratory therapy system by the user.
- Alternative Implementation 107 The method of Alternative Implementation 106, wherein presenting the first entrainment stimulus includes modulating the acclimatization sounds based at least in part on the first entrainment waveform.
- Alternative Implementation 108 The method of any one of Alternative Implementations 84 to 107, further comprising generating an entrainment coherence score indicative of coherence between the first respiration information and the first entrainment waveform, wherein the entrainment coherence score includes a plurality of sub-scores, and wherein each sub-score of the plurality of sub-scores is indicative of entrainment coherence at a respective time during the acclimatization session.
- Alternative Implementation 109 The method of Alternative Implementation 108, wherein the acclimatization session occurs while a respiratory therapy device of the respiratory therapy system is causing air to flow to a user interface that is worn by the user, and wherein each sub-score of the plurality of sub-scores corresponds to a respective pressure of the air flowing to the user interface.
- Alternative Implementation 110 The method of Alternative Implementation 108 or Alternative Implementation 109, further comprising presenting the entrainment coherence score using a display device.
- Alternative Implementation 111 The method of Alternative Implementation 110, wherein presenting the entrainment coherence score occurs during the acclimatization session.
- Alternative Implementation 113 The method of any one of Alternative Implementations 110 to 112, wherein presenting the entrainment coherence score occurs when the entrainment coherence score satisfies a threshold value.
- a method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session comprising: receiving entrainment coherence data associated with one or more entrainment stimuli presented to the user during an acclimatization session prior to the sleep session; generating an entrainment waveform based at least in part on the entrainment coherence data; and presenting an entrainment stimulus to the user based at least in part on the entrainment waveform, the entrainment coherence data, or both.
- Alternative Implementation 115 The method of Alternative Implementation 114, wherein the entrainment coherence data includes a plurality of entrainment coherence scores, each entrainment coherence score being associated with a respective entrainment waveform generated during the acclimatization session, a type of entrainment stimulus presented to the user based on the respective entrainment waveform, a pressure of air flowing in the respiratory therapy system when the respective entrainment waveform was generated, or any combination thereof.
- a method of presenting an entrainment program during use of a respiratory therapy system by a user the respiratory therapy system including a respiratory therapy device configured to cause pressurized air to flow to a user interface worn by the user, the method comprising: during an acclimatization session where the user is awake and wearing the user interface, causing air to flow from the respiratory therapy device to the user interface at a plurality of different pressure values; for each of the plurality of pressure values, presenting a plurality of entrainment stimuli to the user, each of the plurality of entrainment stimuli being based on one of a plurality of entrainment waveforms; determining, for each distinct combination of one of the plurality of pressure values and one of the plurality of entrainment waveforms, an entrainment coherence score indicative of coherence between a respiration pattern of the user and the one entrainment waveform; during a sleep session where the user is wearing the user interface and air is flowing from the respiratory therapy device
- Alternative Implementation 117 The method of Alternative Implementation 116, wherein the sleep session entrainment waveform is the one of the plurality of entrainment waveforms having a maximum entrainment coherence score among all entrainment coherence scores for the corresponding pressure value of the air flowing during the acclimatization session.
- Alternative Implementation 118 Alternative Implementation 118.
- a method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session comprising: determining a current pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generating an entrainment waveform based at least in part on the current pressure of the air; and presenting an entrainment stimulus to the user based at least in part on the entrainment waveform.
- Alternative Implementation 119 The method of Alternative Implementation 118, wherein in response to the current pressure of the air changing to a new pressure, the method further comprises: generating a new entrainment waveform based at least in part on the new pressure of the air; and presenting a new entrainment stimulus to the user based at least in part on the new entrainment waveform.
- Alternative Implementation 120 The method of Alternative Implementation 118, wherein the generation of the entrainment waveform is further based at least in part on an entrainment coherence score determined during use of the respiratory therapy system by the user during an acclimatization session.
- a method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session comprising: causing air having a first pressure to flow from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generating a first entrainment waveform based at least in part on the first pressure of the air; presenting a first entrainment stimulus to the user based at least in part on the first entrainment waveform; subsequently causing air having a second pressure to flow from the respiratory therapy device to the user interface, the second pressure being different than the first pressure; and presenting a second entrainment stimulus to the user that is different than the first entrainment stimulus.
- Alternative Implementation 122 The method of Alternative Implementation 121, wherein the second entrainment stimulus is a different type of stimulus than the first entrainment stimulus, and is based on the first entrainment waveform.
- Alternative Implementation 123 The method of Alternative Implementation 121, further comprising generating a second entrainment waveform based at least in part on the second pressure of the air that is different than the first entrainment waveform, wherein the second entrainment stimulus is based on the second entrainment waveform.
- Alternative Implementation 124 The method of Alternative Implementation 123, wherein the second entrainment stimulus is a different type of stimulus than the first entrainment stimulus, or is an identical type of stimulus as the first entrainment stimulus.
- Alternative Implementation 125 Alternative Implementation 125.
- a method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session comprising: generating a first entrainment waveform; at a first time during the sleep session, presenting a first entrainment stimulus to the user based at least in part on the first entrainment waveform; and at a second time after the first time during the sleep session, presenting a second entrainment stimulus to the user that is different than the first entrainment stimulus.
- Alternative Implementation 126 The method of Alternative Implementation 125, wherein the second entrainment stimulus is a different type of stimulus than the first entrainment stimulus, and is based on the first entrainment waveform.
- Alternative Implementation 127 The method of Alternative Implementation 125, further comprising generating a second entrainment waveform, wherein the second entrainment stimulus is based on the second entrainment waveform.
- Alternative Implementation 128 The method of Alternative Implementation 127, wherein the second entrainment stimulus is a different type of stimulus than the first entrainment stimulus, or is an identical type of stimulus as the first entrainment stimulus.
- a method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session comprising: determining a first respiration rate of the user; generating a first entrainment waveform representing a first target respiration rate that is less than the current respiration rate of the user; presenting a first entrainment stimulus to the user based on the first entrainment waveform; determining, after the first entrainment stimulus has been presented to the user, a second respiration rate of the user; and in response to determining that a difference between the second respiration rate of the user and the first target respiration rate satisfies a threshold difference, (i) generating a second entrainment waveform representing a second target respiration rate that is less than the first target respiration rate and (ii) presenting a second entrainment stimulus to the user based on the second entrainment waveform.
- Alternative Implementation 130 The method of Alternative Implementation 129, wherein the second entrainment stimulus is an identical type of stimulus as the first entrainment stimulus.
- Alternative Implementation 131 The method of Alternative Implementation 129, further comprising: determining, after the second entrainment stimulus has been presented to the user, a third respiration rate of the user; and in response to determining that a difference between the third respiration rate of the user and the second respiration rate satisfies the threshold difference, (i) generating a third entrainment waveform representing a third target respiration rate that is less than the second target respiration rate and (ii) presenting a third entrainment stimulus to the user based on the third entrainment waveform.
- Alternative Implementation 132 The method of Alternative Implementation 131, further comprising determining an elapsed time since a beginning of the sleep session, and wherein in response to the elapsed time being greater than or equal to a threshold time, the third entrainment stimulus is a different type of stimulus than the second entrainment stimulus.
- Alternative Implementation 133 The method of Alternative Implementation 132, wherein the third entrainment stimulus is an identical type of stimulus as the second entrainment stimulus in response to the elapsed time being less than the threshold time.
- Alternative Implementation 134 The method of Alternative Implementation 129, further comprising: determining, after the second entrainment stimulus has been presented to the user, a third respiration rate of the user; and in response to determining that a difference between the third respiration rate of the user and the second respiration rate satisfies the threshold difference, continuing to present the second entrainment stimulus.
- a method of presenting stimuli during an acclimatization session to a user who uses a respiratory therapy system during a sleep session the respiratory therapy system including a respiratory therapy device configured to provide air to a user interface worn by the user during the sleep session, the method comprising: while the user is awake and not wearing the user interface, presenting a first entrainment stimulus to the user; and while the user is awake and not wearing the user interface, subsequently presenting a second entrainment stimulus to the user.
- Alternative Implementation 136 The method of Alternative Implementation 135, wherein the first entrainment stimulus is different than the second entrainment stimulus.
- Alternative Implementation 137 The method of Alternative Implementation 136, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
- Alternative Implementation 138 The method of Alternative Implementation 136, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
- Alternative Implementation 139 The method of Alternative Implementation 136, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
- Alternative Implementation 140 The method of Alternative Implementation 135, wherein the first entrainment stimulus is based on a first entrainment waveform representing a first target respiration pattern, and wherein the second entrainment stimulus is based on a second entrainment waveform representing a second target respiration pattern that is different than the first target respiration pattern.
- Alternative Implementation 144 The method of Alternative Implementation 140, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
- Alternative Implementation 145 The method of Alternative Implementation 140, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
- Alternative Implementation 146 The method of Alternative Implementation 140, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
- a system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extract first respiration information from the first data; present a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating at least a first entrainment waveform and presenting at least a first entrainment stimulus based at least in part on the first entrainment waveform; generate at least one entrainment coherence score indicative of coherence between the first respiration information
- Alternative Implementation 148 The system of Alternative Implementation 147, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of any one of Alternative Implementations 2-83.
- a system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extract first respiration information from the first data; and present a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
- Alternative Implementation 150 The system of Alternative Implementation 149, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of any one of Alternative Implementations 85 to 113.
- a system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive entrainment coherence data associated with one or more entrainment stimuli presented to the user during an acclimatization session prior to a sleep session; generate an entrainment waveform based at least in part on the entrainment coherence data; and present an entrainment stimulus to the user based at least in part on the entrainment waveform, the entrainment coherence data, or both.
- a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user
- Alternative Implementation 152 The system of Alternative Implementation 151, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of Alternative Implementation 115.
- a system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: during an acclimatization session where the user is awake and wearing the user interface, cause air to flow from the respiratory therapy device to the user interface at a plurality of different pressure values; for each of the plurality of pressure values, present a plurality of entrainment stimuli to the user, each of the plurality of entrainment stimuli being based on one of a plurality of entrainment waveforms; determine, for each distinct combination of one of the plurality of pressure values and one of the plurality of entrainment waveforms, an entrainment
- Alternative Implementation 154 The system of Alternative Implementation 153, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of Alternative Implementation 117
- Alternative Implementation 155 A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: determine a current pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generate an entrainment waveform based at least in part on the current pressure of the air; and present an entrainment stimulus to the user based at least in part on the entrainment waveform.
- Alternative Implementation 156 The system of Alternative Implementation 155, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of Alternative Implementation 84 or Alternative Implementation 120.
- a system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: cause air having a first pressure to flow from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generate a first entrainment waveform based at least in part on the first pressure of the air; present a first entrainment stimulus to the user based at least in part on the first entrainment waveform; subsequently cause air having a second pressure to flow from the respiratory therapy device to the user interface, the second pressure being different than the first pressure; and present a second entrainment stimulus to the user that is different than the first en
- Alternative Implementation 158 The system of Alternative Implementation 157, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of any one of Alternative Implementations 122 to 124.
- a system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: generate a first entrainment waveform; at a first time during the sleep session, present a first entrainment stimulus to the user based at least in part on the first entrainment waveform; and at a second time after the first time during the sleep session, present a second entrainment stimulus to the user that is different than the first entrainment stimulus.
- Alternative Implementation 160 The system of Alternative Implementation 159, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of any one of Alternative Implementations 116 to 128.
- a system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: determine a first respiration rate of the user; generate a first entrainment waveform representing a first target respiration rate that is less than the current respiration rate of the user; present a first entrainment stimulus to the user based on the first entrainment waveform; determine, after the first entrainment stimulus has been presented to the user, a second respiration rate of the user; and in response to determining that a difference between the second respiration rate of the user and the first target respiration rate satisfies a threshold difference, (i) generate a
- Alternative Implementation 162 The system of Alternative Implementation 161, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of any one of Alternative Implementations 130 to 134.
- a system comprising: a control system including one or more processors; and a memory having stored thereon machine readable instructions; wherein the control system is coupled to the memory, and the method of any one of Alternative Implementations 1-146 is implemented when the machine-readable instructions in the memory are executed by at least one of the one or more processors of the control system.
- Alternative Implementation 166 A system for personalized entrainment, the system including a control system configured to implement the method of any one of Alternative Implementations 1-146.
- Alternative Implementation 167 A computer program product comprising instructions which, when executed by a computer, cause the computer to carry out the method of any one of Alternative Implementations 1-146.
- Alternative Implementation 168 The computer program product of Alternative Implementation 167, wherein the computer program product is a non-transitory computer readable medium.
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Abstract
A method comprises receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extracting first respiration information from the first data; presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform; generating an entrainment coherence score indicative of coherence between the first respiration information and the first entrainment waveform; receiving second data associated with a user engaging in a current sleep session; and presenting a second entrainment program to the user during the current sleep session that is based at least in part on the second data, the entrainment coherence score, or both.
Description
SYSTEMS AND METHODS FOR BREATHING ENTRAINMENT
CROSS-REFERENCE TO REPLATED APPLICATIONS
[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent Application No. 63/657,399 filed on June 7, 2024, and U.S. Provisional Patent Application No. 63/563,205 filed on March 8, 2024, each of which is hereby incorporated by reference herein in its entirety.
TECHNICAL FIELD
[0002] The present disclosure relates to systems and methods for pacing breathing of a user, and more particularly, to systems and methods for pacing breathing of a user via an entrainment stimulus.
BACKGROUND
[0003] Many individuals suffer from sleep-related and/or respiratory disorders such as, for example, Sleep-Disordered Breathing (SDB), which can include Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), other types of apneas such as mixed apneas and hypopneas, and Respiratory Effort Related Arousal (RERA). These individuals may also suffer from other health conditions (which may be referred to as comorbidities), such as insomnia (characterized by, for example, difficult in initiating sleep, frequent or prolonged awakenings after initially falling asleep, and/or an early awakening with an inability to return to sleep), Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), rapid eye movement (REM) behavior disorder (also referred to as RBD), dream enactment behavior (DEB), hypertension, diabetes, stroke, and chest wall disorders.
[0004] These disorders are often treated using a respiratory therapy system (e.g., a continuous positive airway pressure (CPAP) system), which delivers pressurized air to aid in preventing the individual’s airway from narrowing or collapsing during sleep. However, some users have difficulty falling asleep, staying asleep, and/or waking up comfortably when using a respiration therapy device. As a result, not only do these users experience the negative impact of troublesome sleep, but the users may also elect to discontinue use of the respiratory therapy device, which may further exacerbate the user's sleep-related and/or respiratory-related disorders. The present disclosure is directed to solving these and other problems.
SUMMARY
[0005] According to some implementations of the present disclosure, a method comprises receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system. The method further comprises extracting first respiration information from the first data. The method further comprises presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating at least a first entrainment waveform and presenting at least a first entrainment stimulus based at least in part on the first entrainment waveform. The method further comprises generating at least one entrainment coherence score indicative of coherence between the first respiration information and the first entrainment waveform. The method further comprises receiving second data associated with a user engaging in a current sleep session. The method further comprises presenting a second entrainment program to the user during the current sleep session that is based at least in part on the second data, the at least one entrainment coherence score, or both.
[0006] According to some implementations of the present disclosure, a method comprises receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system. The method further comprises extracting first respiration information from the first data. The method further comprises presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
[0007] According to some implementations of the present disclosure, a method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session comprises receiving entrainment coherence data associated with one or more entrainment stimuli presented to the user during an acclimatization session prior to the sleep session. The method further comprises generating an entrainment waveform based at least in part on the entrainment coherence data. The method further comprises presenting an entrainment stimulus to the user based at least in part on the entrainment waveform, the entrainment coherence data, or both.
[0008] The above summary is not intended to represent each embodiment or every aspect of the present invention. Additional features and benefits of the present invention are apparent from the detailed description and figures set forth below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a functional block diagram of a system for detecting rainout in a respiratory therapy system, according to some implementations of the present disclosure.
[0010] FIG. 2 is a perspective view of the system of FIG. 1, a user of the system, and a bed partner of the user, according to some implementations of the present disclosure.
[0011] FIG. 3 illustrates an exemplary timeline for a sleep session, according to some implementations of the present disclosure.
[0012] FIG. 4 illustrates an exemplary hypnogram associated with the sleep session of FIG. 3, according to some implementations of the present disclosure.
[0013] FIG. 5 is a process flow diagram of a method for presenting an entrainment program during an acclimatization session, according to some implementations of the present disclosure. [0014] FIG. 6 is a process flow diagram of a first method for presenting an entrainment program during a sleep session, according to some implementations of the present disclosure.
[0015] FIG. 7 is a pressure curve illustrating the modulation of pressure in a respiratory therapy system to induce a user to breathe according to a target respiration pattern, according to some implementations of the present disclosure.
[0016] FIG. 8A is plot showing a respiration rate trace and an entrainment stimulus trace used to induce a user to breathe according to a target respiration pattern, according to some implementations of the present disclosure.
[0017] FIG. 8B is plot showing a respiration rate trace and an entrainment stimulus trace used to induce a user to breathe according to a target respiration pattern where the user falls asleep, according to some implementations of the present disclosure.
[0018] FIG. 9 is a process flow diagram of a second method for presenting an entrainment program during a sleep session, according to some implementations of the present disclosure.
[0019] FIG. 10 is a process flow diagram of a third method for presenting an entrainment program during a sleep session, according to some implementations of the present disclosure.
[0020] FIG. 11 is a process flow diagram of a first method for presenting entrainment programs during an acclimatization session and a sleep session, according to some implementations of the present disclosure.
[0021] FIG. 12 is a process flow diagram of a second method for presenting entrainment programs during an acclimatization session and a sleep session, according to some implementations of the present disclosure.
[0022] FIG. 13A is a front view of a user device depicting a first view of a graphical user
interface for entrainment, according to some implementations of the present disclosure.
[0023] FIG. 13B is a front view of the user device of FIG. 13 A depicting a second view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
[0024] FIG. 13C is a front view of the user device of FIG. 13A depicting a third view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
[0025] FIG. 13D is a front view of the user device of FIG. 13 A depicting a fourth view of a graphical user interface for entrainment, according to some implementations of the present disclosure.
[0026] FIG. 14A is a front view of a user device depicting a first view of a graphical user interface for entrainment using an alternate entrainment visual element, according to some implementations of the present disclosure.
[0027] FIG. 14B is a front view of the user device of FIG. 13 A depicting a second view of a graphical user interface for entrainment using an alternate entrainment visual element, according to some implementations of the present disclosure.
[0028] FIG. 14C is a front view of the user device of FIG. 13A depicting a third view of a graphical user interface for entrainment using an alternate entrainment visual element, according to some implementations of the present disclosure.
[0029] While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that it is not intended to limit the present disclosure to the particular forms disclosed, but on the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
DETAILED DESCRIPTION
[0030] The present disclosure is described with reference to the attached figures, where like reference numerals are used throughout the figures to designate similar or equivalent elements. The figures are not drawn to scale, and are provided merely to illustrate the instant disclosure. Several aspects of the disclosure are described below with reference to example applications for illustration.
[0031] Many individuals suffer from sleep-related and/or respiratory disorders. Examples of sleep-related and/or respiratory disorders include Periodic Limb Movement Disorder (PLMD),
Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), other types of apneas, Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders.
[0032] Many individuals suffer from sleep-related and/or respiratory disorders, such as Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Sleep-Disordered Breathing (SDB) such as Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA) and other types of apneas, Respiratory Effort Related Arousal (RERA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders. Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterized by events including occlusion or obstruction of the upper air passage during sleep resulting from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate, and posterior oropharyngeal wall. Central Sleep Apnea (CSA) is another form of sleep disordered breathing. CSA results when the brain temporarily stops sending signals to the muscles that control breathing. Other types of apneas include hypopnea, hyperpnea, and hypercapnia. Hypopnea is generally characterized by slow or shallow breathing caused by a narrowed airway, as opposed to a blocked airway. Hyperpnea is generally characterized by an increase depth and/or rate of breathing. Hypercapnia is generally characterized by elevated or excessive carbon dioxide in the bloodstream, typically caused by inadequate respiration. A Respiratory Effort Related Arousal (RERA) event is typically characterized by an increased respiratory effort for ten seconds or longer leading to arousal from sleep and which does not fulfill the criteria for an apnea or hypopnea event. RERAs are defined as a sequence of breaths characterized by increasing respiratory effort leading to an arousal from sleep, but which does not meet criteria for an apnea or hypopnea. These events must fulfil both of the following criteria: (1) a pattern of progressively more negative esophageal pressure, terminated by a sudden change in pressure to a less negative level and an arousal, and (2) the event lasts ten seconds or longer. In some implementations, a Nasal Cannula/Pressure Transducer System is adequate and reliable in the detection of RERAs. A RERA detector may be based on a real flow signal derived from a respiratory therapy device. For example, a flow limitation measure may be determined based on a flow signal. A measure of arousal may then be derived as a function of the flow limitation measure and a measure of sudden increase in ventilation. One such method is described in WO 2008/138040 and U.S.
Patent No. 9,358,353, assigned to ResMed Ltd., the disclosure of each of which is hereby incorporated by reference herein in their entireties.
[0033] Cheyne- Stokes Respiration (CSR) is a further form of SDB. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive de-oxygenation and re-oxygenation of the arterial blood. OHS is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness. COPD encompasses any of a group of lower airway diseases that have certain characteristics in common, such as increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. NMD encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage.
[0034] Many of these disorders are characterized by particular events (e.g., snoring, an apnea, a hypopnea, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof) that can occur when the individual is sleeping. A wide variety of types of data can be used to monitor the health of individuals having any of the above types of sleep-related and/or respiratory disorders (or other disorders).
[0035] The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea during a sleep session. The AHI is calculated by dividing the number of apnea and/or hypopnea events experienced by the user during the sleep session by the total number of hours of sleep in the sleep session. The event can be, for example, a pause in breathing that lasts for at least 10 seconds. An AHI that is less than 5 is considered normal. An AHI that is greater than or equal to 5, but less than 15 is considered indicative of mild sleep apnea. An AHI that is greater than or equal to 15, but less than 30 is considered indicative of moderate sleep apnea. An AHI that is greater than or equal to 30 is considered indicative of severe sleep apnea. In children, an AHI that is greater than 1 is considered abnormal. Sleep apnea can be considered “controlled” when the AHI is normal, or when the AHI is normal or mild. The AHI can also be used in combination with oxygen desaturation levels to indicate the severity of Obstructive Sleep Apnea.
[0036] Referring to FIG. 1, a system 10, according to some implementations of the present disclosure, is illustrated. The system 10 can include any one or more of a respiratory therapy system 100, a control system 200, a memory device 204, an entrainment module 206, a stimulus device 208, one or more sensors 210. The system 10 may additionally or alternatively include a user device 260, an activity tracker 270, and a blood pressure device 280. The system 10 can be used to present an entrainment program that involves presenting entrainment stimuli to a user to guide the user's breathing pattern to a desired target breathing pattern. The system can monitor data associated with the user and leverage that data to adjust the entrainment stimuli as needed to guide the user towards the target breathing pattern.
[0037] The respiratory therapy system 100 includes a respiratory pressure therapy (RPT) device 110 (referred to herein as respiratory therapy device 110), a user interface 120 (also referred to as a mask or a patient interface), a conduit 140 (also referred to as a tube or an air circuit), a display device 150, and a humidifier 160. Respiratory pressure therapy refers to the application of a supply of air to an entrance to a user’s airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the user’s breathing cycle (e.g., in contrast to negative pressure therapies such as the tank ventilator or cuirass). The respiratory therapy system 100 is generally used to treat individuals suffering from one or more sleep-related respiratory disorders (e.g., obstructive sleep apnea, central sleep apnea, or mixed sleep apnea).
[0038] The respiratory therapy system 100 can be used, for example, as a ventilator or as a positive airway pressure (PAP) system, such as a continuous positive airway pressure (CPAP) system, an automatic positive airway pressure system (APAP), a bi-level or variable positive airway pressure system (BPAP or VPAP), or any combination thereof. The CPAP system delivers a predetermined air pressure (e.g., determined by a sleep physician) to the user. The APAP system automatically varies the air pressure delivered to the user based on, for example, respiration data associated with the user. The BPAP or VPAP system is configured to deliver a first predetermined pressure (e.g., an inspiratory positive airway pressure or IPAP) and a second predetermined pressure (e.g., an expiratory positive airway pressure or EPAP) that is lower than the first predetermined pressure.
[0039] As shown in FIG. 2, the respiratory therapy system 100 can be used to treat a user 20. In this example, the user 20 of the respiratory therapy system 100 and a bed partner 30 are in a bed 40 and are laying on a mattress 42. The user interface 120 can be worn by the user 20 during a sleep session. The respiratory therapy system 100 generally aids in increasing the air pressure in the throat of the user 20 to aid in preventing the airway from closing and/or
narrowing during sleep. The respiratory therapy device 110 can be positioned on a nightstand 44 that is directly adjacent to the bed 40 as shown in FIG. 2, or more generally, on any surface or structure that is generally adjacent to the bed 40 and/or the user 20.
[0040] Referring back to FIG. 1, the respiratory therapy device 110 is generally used to generate pressurized air that is delivered to a user (e.g., using one or more motors that drive one or more compressors). In some implementations, the respiratory therapy device 110 generates continuous constant air pressure that is delivered to the user. In other implementations, the respiratory therapy device 110 generates two or more predetermined pressures (e.g., a first predetermined air pressure and a second predetermined air pressure). In still other implementations, the respiratory therapy device 110 generates a variety of different air pressures within a predetermined range. For example, the respiratory therapy device 110 can deliver at least about 6 cmFFO, at least about 10 cmFFO, at least about 20 cmFFO, between about 6 crnFFO and about 10 cmFFO, between about 7 cmFFO and about 12 cmFFO, etc. The respiratory therapy device 110 can also deliver pressurized air at a predetermined flow rate between, for example, about -20 L/min and about 150 L/min, while maintaining a positive pressure (relative to the ambient pressure). In some implementations, the control system 200 and/or the memory device 204 can be coupled to and/or positioned within a housing of the respiratory therapy device 110.
[0041] The respiratory therapy device 110 includes a housing 112, a blower motor 114, an air inlet 116, and an air outlet 118. The blower motor 114 is at least partially disposed or integrated within the housing 112. The blower motor 114 draws air from outside the housing 112 (e.g., atmosphere) via the air inlet 116 and causes pressurized air to flow through the humidifier 160, and through the air outlet 118. In some implementations, the air inlet 116 and/or the air outlet 118 include a cover that is moveable between a closed position and an open position (e.g., to prevent or inhibit air from flowing through the air inlet 116 or the air outlet 118). The housing 112 can also include a vent to allow air to pass through the housing 112 to the air inlet 116. As described below, the conduit 140 is coupled to the air outlet 118 of the respiratory therapy device 110.
[0042] The user interface 120 engages a portion of the user’s face and delivers pressurized air from the respiratory therapy device 110 to the user’s airway to aid in preventing the airway from narrowing and/or collapsing during sleep. This may also increase the user’s oxygen intake during sleep. Generally, the user interface 120 engages the user’s face such that the pressurized air is delivered to the user’s airway via the user’s mouth, the user’s nose, or both the user’s mouth and nose. Generally, the respiratory therapy system 100 forms an air pathway that
extends between a motor of the respiratory therapy device 110 and the user and/or the user’s airway. Thus, the air pathway, which is fluidly coupled to the user’s airway, generally includes at least the motor of the respiratory therapy device 110 and/or the respiratory therapy device 110 itself, the user interface 120, and the conduit 140. The pressurized air also increases the user’s oxygen intake during sleep. Depending upon the therapy to be applied, the user interface 120 may form a seal, for example, with a region or portion of the user’s face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, for example, at a positive pressure of about 10 cm H2O relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the user interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmFFO.
[0043] The user interface 120 can include, for example, a cushion 122, a frame 124, a headgear 126, connector 128, and one or more vents 130. The cushion 122 and the frame 124 define a volume of space around the mouth and/or nose of the user. When the respiratory therapy system 100 is in use, this volume space receives pressurized air (e.g., from the respiratory therapy device 110 via the conduit 140) for passage into the airway(s) of the user. The headgear 126 is generally used to aid in positioning and/or stabilizing the user interface 120 on a portion of the user (e.g., the face), and along with the cushion 122 (which, for example, can comprise silicone, plastic, foam, etc.) aids in providing a substantially air-tight seal between the user interface 120 and the user 20. In some implementations the headgear 126 includes one or more straps (e.g., including hook and loop fasteners). The connector 128 is generally used to couple (e.g., connect and fluidly couple) the conduit 140 to the cushion 122 and/or frame 124. Alternatively, the conduit 140 can be directly coupled to the cushion 122 and/or frame 124 without the connector 128. The one or more vents 130 can be used for permitting the escape of carbon dioxide and other gases exhaled by the user 20. The user interface 120 generally can include any suitable number of vents (e.g., one, two, five, ten, etc.).
[0044] As shown in FIG. 2, in some implementations, the user interface 120 is a facial mask (e.g., a full-face mask) that covers at least a portion of the nose and mouth of the user 20. Alternatively, the user interface 120 can be a nasal mask that provides air to the nose of the user or a nasal pillow mask that delivers air directly to the nostrils of the user 20. In other implementations, the user interface 120 includes a mouthpiece (e.g., a night guard mouthpiece molded to conform to the teeth of the user, a mandibular repositioning device, etc.).
[0045] Referring back to FIG. 1, the conduit 140 (also referred to as an air circuit or tube) allows the flow of air between components of the respiratory therapy system 100, such as
between the respiratory therapy device 110 and the user interface 120. In some implementations, there can be separate limbs of the conduit for inhalation and exhalation. In other implementations, a single limb conduit is used for both inhalation and exhalation.
[0046] The conduit 140 includes a first end that is coupled to the air outlet 118 of the respiratory therapy device 110. The first end can be coupled to the air outlet 118 of the respiratory therapy device 110 using a variety of techniques (e.g., a press fit connection, a snap fit connection, a threaded connection, etc.). In some implementations, the conduit 140 includes one or more heating elements that heat the pressurized air flowing through the conduit 140 (e.g., heat the air to a predetermined temperature or within a range of predetermined temperatures). Such heating elements can be coupled to and/or imbedded in the conduit 140. In such implementations, the first end can include an electrical contact that is electrically coupled to the respiratory therapy device 110 to power the one or more heating elements of the conduit 140. For example, the electrical contact can be electrically coupled to an electrical contact of the air outlet 118 of the respiratory therapy device 110. In this example, electrical contact of the conduit 140 can be a male connector and the electrical contact of the air outlet 118 can be female connector, or, alternatively, the opposite configuration can be used.
[0047] The display device 150 is generally used to display image(s) including still images, video images, or both and/or information regarding the respiratory therapy device 110. For example, the display device 150 can provide information regarding the status of the respiratory therapy device 110 (e.g., whether the respiratory therapy device 110 is on/off, the pressure of the air being delivered by the respiratory therapy device 110, the temperature of the air being delivered by the respiratory therapy device 110, etc.) and/or other information (e.g., a sleep score and/or a therapy score, also referred to as a my Air™ score, such as described in WO 2016/061629 and U.S. Patent Pub. No. 2017/0311879, which are hereby incorporated by reference herein in their entireties, the current date/time, personal information for the user 20, etc.). In some implementations, the display device 150 acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) as an input interface. The display device 150 can be an LED display, an OLED display, an LCD display, or the like. The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the respiratory therapy device 110.
[0048] The humidifier 160 is coupled to or integrated in the respiratory therapy device 110 and includes a reservoir 162 for storing water that can be used to humidify the pressurized air delivered from the respiratory therapy device 110. The humidifier 160 includes a one or more
heating elements 164 to heat the water in the reservoir to generate water vapor. The humidifier 160 can be fluidly coupled to a water vapor inlet of the air pathway between the blower motor 114 and the air outlet 118, or can be formed in-line with the air pathway between the blower motor 114 and the air outlet 118. For example, air flows from the air inlet 116 through the blower motor 114, and then through the humidifier 160 before exiting the respiratory therapy device 110 via the air outlet 118.
[0049] While the respiratory therapy system 100 has been described herein as including each of the respiratory therapy device 110, the user interface 120, the conduit 140, the display device 150, and the humidifier 160, more or fewer components can be included in a respiratory therapy system according to implementations of the present disclosure. For example, a first alternative respiratory therapy system includes the respiratory therapy device 110, the user interface 120, and the conduit 140. As another example, a second alternative system includes the respiratory therapy device 110, the user interface 120, and the conduit 140, and the display device 150. Thus, various respiratory therapy systems can be formed using any portion or portions of the components shown and described herein and/or in combination with one or more other components.
[0050] The control system 200 includes one or more processors 202 (hereinafter, processor 202). The control system 200 is generally used to control (e.g., actuate) the various components of the system 10 and/or analyze data obtained and/or generated by the components of the system 10. The processor 202 can be a general or special purpose processor or microprocessor. While one processor 202 is illustrated in FIG. 1, the control system 200 can include any number of processors (e.g., one processor, two processors, five processors, ten processors, etc.) that can be in a single housing, or located remotely from each other. The control system 200 (or any other control system) or a portion of the control system 200 such as the processor 202 (or any other processor(s) or portion(s) of any other control system), can be used to carry out one or more steps of any of the methods described and/or claimed herein. The control system 200 can be coupled to and/or positioned within, for example, a housing of the user device 260, a portion (e.g., the respiratory therapy device 110) of the respiratory therapy system 100, and/or within a housing of one or more of the sensors 210. The control system 200 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct). In such implementations including two or more housings containing the control system 200, the housings can be located proximately and/or remotely from each other. The control system 200 (or one or more portions thereof) can be located in the respiratory therapy device 110, in the user device 260 (e.g., as part of a smartphone application), in the cloud (e.g.,
in a remote device or system connected various components of the system 10 such as the user device 260 and/or the respiratory therapy device 110), and/or in other locations.
[0051] The memory device 204 stores machine-readable instructions that are executable by the processor 202 of the control system 200. The memory device 204 can be any suitable computer readable storage device or media, such as, for example, a random or serial access memory device, a hard drive, a solid-state drive, a flash memory device, etc. While one memory device 204 is shown in FIG. 1, the system 10 can include any suitable number of memory devices 204 (e.g., one memory device, two memory devices, five memory devices, ten memory devices, etc.). The memory device 204 can be coupled to and/or positioned within a housing of a respiratory therapy device 110 of the respiratory therapy system 100, within a housing of the user device 260, within a housing of one or more of the sensors 210, or any combination thereof. Like the control system 200, the memory device 204 can be centralized (within one such housing) or decentralized (within two or more of such housings, which are physically distinct).
[0052] In some implementations, the memory device 204 stores a user profile associated with the user. The user profile can include, for example, demographic information associated with the user, biometric information associated with the user, medical information associated with the user, self-reported user feedback, sleep parameters associated with the user (e.g., sleep- related parameters recorded from one or more earlier sleep sessions), or any combination thereof. The demographic information can include, for example, information indicative of an age of the user, a gender of the user, a race of the user, a geographic location of the user, a relationship status, a family history of insomnia or sleep apnea, an employment status of the user, an educational status of the user, a socioeconomic status of the user, or any combination thereof. The medical information can include, for example, information indicative of one or more medical conditions associated with the user, medication usage by the user, or both. The medical information data can further include a multiple sleep latency test (MSLT) result or score and/or a Pittsburgh Sleep Quality Index (PSQI) score or value. The self-reported user feedback can include information indicative of a self-reported subjective sleep score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, a recent life event experienced by the user, or any combination thereof.
[0053] As described herein, the processor 202 and/or memory device 204 can receive data (e.g., physiological data and/or audio data) from the one or more sensors 210 such that the data for storage in the memory device 204 and/or for analysis by the processor 202. The processor 202
and/or memory device 204 can communicate with the one or more sensors 210 using a wired connection or a wireless connection (e.g., using an RF communication protocol, a Wi-Fi communication protocol, a Bluetooth communication protocol, over a cellular network, etc.). In some implementations, the system 10 can include an antenna, a receiver (e.g., an RF receiver), a transmitter (e.g., an RF transmitter), a transceiver, or any combination thereof. Such components can be coupled to or integrated a housing of the control system 200 (e.g., in the same housing as the processor 202 and/or memory device 204), or the user device 260.
[0054] The entrainment module 206 determines and/or facilitates presentation of an entrainment program based at least in part on data (e.g., sensor data acquired from the one or more sensors 210 and/or other sensors, as disclosed in further detail herein). Some or all of the entrainment module 206 can be implemented by and/or make use of any other elements of system 10. For example, in some implementations, the entrainment module 206 may be implemented as a specific set of instructions stored in the memory device 204 and executed by the processors 202 of the control system 200.
[0055] The entrainment module 206 can generate an entrainment waveform from the data in some cases. The entrainment waveform can include information indicative of a rhythm, a morphology, a rate, and/or other features of a desired respiration pattern. For example, an entrainment waveform can be a sine wave at 0.333 Hz, which can be indicative of a respiration rate of at or approximately 20 breaths per minute (bpm). In another example, an entrainment waveform can be a non-sinusoidal wave that changes frequency over time, which can be indicative of a respiration morphology (e.g., timing and extent of inhalation and exhalation over time) and a changing respiration rate.
[0056] The entrainment waveform can be used to present an entrainment stimulus to the user via one or more stimulus devices 208. Any suitable device that can present discernable input to the user can be used as a stimulus device 208. In some cases, the one or more stimulus devices 208 can include (i) a tactile stimulus device (e.g., a vibrating motor); (ii) a visual stimulus device (e.g., a display device, such as the display device 262 of the user device 260 or the display device 150 of the respiratory therapy system 100); (iii) an audio stimulus device (e.g., a speaker, such as speaker 222); (iv) an airflow stimulus device (e.g., a respiratory therapy device, such as respiratory therapy device 110); or (v) any combination of (i)-(iv). The entrainment signal can be used to present a single entrainment stimulus (e.g., a visual cue of an expanding and contracting circle) or multiple entrainment stimuli (e.g., a sound of lapping ocean waves and a visual cue of an expanding and contracting circle).
[0057] The one or more sensors 210 include a pressure sensor 212, a flow rate sensor 214, temperature sensor 216, a motion sensor 218, a microphone 220, a speaker 222, a radiofrequency (RF) receiver 226, a RF transmitter 228, a camera 232, an infrared (IR) sensor 234, a photoplethy smogram (PPG) sensor 236, an electrocardiogram (ECG) sensor 238, an electroencephalography (EEG) sensor 240, a capacitive sensor 242, a force sensor 244, a strain gauge sensor 246, an electromyography (EMG) sensor 248, an oxygen sensor 250, an analyte sensor 252, a moisture sensor 254, a Light Detection and Ranging (LiDAR) sensor 256, or any combination thereof. Generally, each of the one or more sensors 210 are configured to output sensor data that is received and stored in the memory device 204 or one or more other memory devices.
[0058] While the one or more sensors 210 are shown and described as including each of the pressure sensor 212, the flow rate sensor 214, the temperature sensor 216, the motion sensor 218, the microphone 220, the speaker 222, the RF receiver 226, the RF transmitter 228, the camera 232, the IR sensor 234, the PPG sensor 236, the ECG sensor 238, the EEG sensor 240, the capacitive sensor 242, the force sensor 244, the strain gauge sensor 246, the EMG sensor 248, the oxygen sensor 250, the analyte sensor 252, the moisture sensor 254, and the LiDAR sensor 256, more generally, the one or more sensors 210 can include any combination and any number of each of the sensors described and/or shown herein.
[0059] As described herein, the system 10 generally can be used to generate physiological data associated with a user (e.g., a user of the respiratory therapy system 100) during a sleep session. The physiological data can be analyzed to generate one or more sleep-related parameters, which can include any parameter, measurement, etc. related to the user during the sleep session. The one or more sleep-related parameters that can be determined for the user 20 during the sleep session include, for example, an Apnea-Hypopnea Index (AHI) score, a sleep score, a flow signal, a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a stage, pressure settings of the respiratory therapy device 110, a heart rate, a heart rate variability, movement of the user 20, temperature, EEG activity, EMG activity, arousal, snoring, choking, coughing, whistling, wheezing, or any combination thereof.
[0060] The one or more sensors 210 can be used to generate, for example, physiological data, audio data, or both. Physiological data generated by one or more of the sensors 210 can be used by the control system 200 to determine a sleep-wake signal associated with the user 20 during the sleep session and one or more sleep-related parameters. The sleep-wake signal can be indicative of one or more sleep states, including wakefulness, relaxed wakefulness, micro-
awakenings, or distinct sleep stages such as, for example, a rapid eye movement (REM) stage, a first non-REM stage (often referred to as “Nl”), a second non-REM stage (often referred to as “N2”), a third non-REM stage (often referred to as “N3”), or any combination thereof. Methods for determining sleep states and/or sleep stages from physiological data generated by one or more sensors, such as the one or more sensors 210, are described in, for example, WO 2014/047310, U.S. Patent Pub. No. 2014/0088373, WO 2017/132726, WO 2019/122413, WO 2019/122414, U.S. Patent Pub. No. 2020/0383580, and WO 2022/249013, each of which is hereby incorporated by reference herein in its entirety.
[0061] In some implementations, the sleep-wake signal described herein can be timestamped to indicate a time that the user enters the bed, a time that the user exits the bed, a time that the user attempts to fall asleep, etc. The sleep-wake signal can be measured by the one or more sensors 210 during the sleep session at a predetermined sampling rate, such as, for example, one sample per second, one sample per 30 seconds, one sample per minute, etc. In some implementations, the sleep-wake signal can also be indicative of a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, pressure settings of the respiratory therapy device 110, or any combination thereof during the sleep session. The event(s) can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak (e.g., from the user interface 120), a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof. The one or more sleep-related parameters that can be determined for the user during the sleep session based on the sleep-wake signal include, for example, a total time in bed, a total sleep time, a sleep onset latency, a wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, or any combination thereof. As described in further detail herein, the physiological data and/or the sleep-related parameters can be analyzed to determine one or more sleep-related scores.
[0062] Physiological data and/or audio data generated by the one or more sensors 210 can also be used to determine a respiration signal associated with a user during a sleep session. The respiration signal is generally indicative of respiration or breathing of the user during the sleep session. The respiration signal can be indicative of and/or analyzed to determine (e.g., using the control system 200) one or more sleep-related parameters, such as, for example, a respiration rate, a respiration rate variability, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, a sleep state, a sleep stage, an apnea-hypopnea index (AHI), pressure
settings of the respiratory therapy device 110, or any combination thereof. The one or more events can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak (e.g., from the user interface 120), a cough, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, increased blood pressure, or any combination thereof. Many of the described sleep-related parameters are physiological parameters, although some of the sleep-related parameters can be considered to be non-physiological parameters. Other types of physiological and/or non-physiological parameters can also be determined, either from the data from the one or more sensors 210, or from other types of data.
[0063] The pressure sensor 212 outputs pressure data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200. In some implementations, the pressure sensor 212 is an air pressure sensor (e.g., barometric pressure sensor) that generates sensor data indicative of the respiration (e.g., inhaling and/or exhaling) of the user of the respiratory therapy system 100 and/or ambient pressure. In such implementations, the pressure sensor 212 can be coupled to or integrated in the respiratory therapy device 110. The pressure sensor 212 can be, for example, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, a strain-gauge sensor, an optical sensor, a potentiometric sensor, or any combination thereof.
[0064] The flow rate sensor 214 outputs flow rate data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200. Examples of flow rate sensors (such as, for example, the flow rate sensor 214) are described in International Publication No. WO 2012/012835 and U.S. Patent No. 10,328,219, both of which are hereby incorporated by reference herein in their entireties. In some implementations, the flow rate sensor 214 is used to determine an air flow rate from the respiratory therapy device 110, an air flow rate through the conduit 140, an air flow rate through the user interface 120, or any combination thereof. In such implementations, the flow rate sensor 214 can be coupled to or integrated in the respiratory therapy device 110, the user interface 120, or the conduit 140. The flow rate sensor 214 can be a mass flow rate sensor such as, for example, a rotary flow meter (e.g., Hall effect flow meters), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or any combination thereof. In some implementations, the flow rate sensor 214 is configured to measure a vent flow (e.g., intentional “leak”), an unintentional leak (e.g., mouth leak and/or mask leak), a patient flow (e.g., air into and/or out of lungs), or any combination thereof. In some implementations, the
flow rate data can be analyzed to determine cardiogenic oscillations of the user. In some examples, the pressure sensor 212 can be used to determine a blood pressure of a user.
[0065] The temperature sensor 216 outputs temperature data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200. In some implementations, the temperature sensor 216 generates temperatures data indicative of a core body temperature of the user 20, a skin temperature of the user 20, a temperature of the air flowing from the respiratory therapy device 110 and/or through the conduit 140, a temperature in the user interface 120, an ambient temperature, or any combination thereof. The temperature sensor 216 can be, for example, a thermocouple sensor, a thermistor sensor, a silicon band gap temperature sensor or semiconductor-based sensor, a resistance temperature detector, or any combination thereof.
[0066] The motion sensor 218 outputs motion data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200. The motion sensor 218 can be used to detect movement of the user 20 during the sleep session, and/or detect movement of any of the components of the respiratory therapy system 100, such as the respiratory therapy device 110, the user interface 120, or the conduit 140. The motion sensor 218 can include one or more inertial sensors, such as accelerometers, gyroscopes, and magnetometers. In some implementations, the motion sensor 218 can comprise an acoustic sensor (such as the acoustic sensor 224 discussed herein) and/or an RF sensor (such as the RF sensor 230 discussed herein), which can generate motion data as further discussed herein. In such implementations, the motion sensor 218, the acoustic sensor, and/or the RF sensor can be disposed in a portable device, such as the user device 260. Further, while FIG. 1 and FIG. 2 show the respiratory therapy device 110 as including its own display device 150, in some implementations the respiratory therapy device 110 may not include its own display device, as is discussed herein. In some implementations, the motion sensor 218 alternatively or additionally generates one or more signals representing bodily movement of the user, from which may be obtained a signal representing a sleep state of the user, for example, via a respiratory movement of the user. In some implementations, the motion data from the motion sensor 218 can be used in conjunction with additional data from another one of the sensors 210 to determine the sleep state of the user. In some implementation, the motion sensor 218 can be used to detect motion or acceleration associated with arterial pulses, such as pulses in or around the face of the user and proximal to the user interface 120, and configured to detect features of the pulse shape, speed, amplitude, or volume.
[0067] The microphone 220 outputs sound and/or audio data that can be stored in the memory device 204 and/or analyzed by the processor 202 of the control system 200. The audio data generated by the microphone 220 is reproducible as one or more sound(s) during a sleep session (e.g., sounds from the user 20). The audio data form the microphone 220 can also be used to identify (e.g., using the control system 200) an event experienced by the user during the sleep session, as described in further detail herein. The microphone 220 can be coupled to or integrated in the respiratory therapy device 110, the user interface 120, the conduit 140, or the user device 260. The microphone 220 can be coupled to or integrated in a wearable device, such as a smartwatch, smart glasses, earphones or ear buds, or other head wearable device. In some implementations, the system 10 includes a plurality of microphones (e.g., two or more microphones and/or an array of microphones with beamforming) such that sound data generated by each of the plurality of microphones can be used to discriminate the sound data generated by another of the plurality of microphones. In some implementations, the acoustic data from the microphone 220 is representative of noise associated with the respiratory therapy system 100. In some implementations, the acoustic data from the microphone 220 can be analyzed to detect the presence of liquid in the respiratory therapy system 100.
[0068] The microphone 220 can be coupled to or integrated in the respiratory therapy system 100 (or the system 10) generally in any configuration. For example, the microphone 220 can be disposed inside the respiratory therapy device 110, the user interface 120, the conduit 140, or other components. The microphone 220 can also be positioned adjacent to or coupled to the outside of the respiratory therapy device 110, the outside of the user interface 120, the outside of the conduit 140, or outside of any other components. The microphone 220 could also be a component of the user device 170 (e.g., the microphone 220 is a microphone of a smart phone). The microphone 220 can be integrated in the user interface 120, the conduit 140, the respiratory therapy device 110, or any combination thereof. In general, the microphone 220 can be located at any point within or adjacent to the air pathway of the respiratory therapy system 100, which includes at least the motor of the respiratory therapy device 110, the user interface 120, and the conduit 140. Thus, the air pathway can also be referred to as the acoustic pathway.
[0069] The speaker 222 outputs sound waves that are audible to a user of the system 10 (e.g., the user 20 of FIG. 2). The speaker 222 can be used, for example, as an alarm clock or to play an alert or message to the user 20 (e.g., in response to an event). In some implementations, the speaker 222 can be used to communicate the audio data generated by the microphone 220 to the user. The speaker 222 can be coupled to or integrated in the respiratory therapy device 110, the user interface 120, the conduit 140, or the user device 260, and/or can be coupled to or
integrated in a wearable device, such as a smartwatch, smart glasses, earphones or ear buds, or other head wearable device.
[0070] The microphone 220 and the speaker 222 can be used as separate devices. In some implementations, the microphone 220 and the speaker 222 can be combined into an acoustic sensor 224 (e.g., a sonar sensor), as described in, for example, WO 2018/050913, WO 2020/104465, U.S. Pat. App. Pub. No. 2022/0007965, each of which is hereby incorporated by reference herein in its entirety. In such implementations, the speaker 222 generates or emits sound waves at a predetermined interval and the microphone 220 detects the reflections of the emitted sound waves from the speaker 222. The sound waves generated or emitted by the speaker 222 have a frequency that is not audible to the human ear (e.g., below 20 Hz or above around 18 kHz) so as not to disturb the sleep of the user 20 or the bed partner 30. Based at least in part on the data from the microphone 220 and/or the speaker 222, the control system 200 can determine a location of the user 20 and/or one or more of the sleep-related parameters described in herein such as, for example, a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a sleep state, a sleep stage, pressure settings of the respiratory therapy device 110, or any combination thereof. In such a context, a sonar sensor may be understood to concern an active acoustic sensing, such as by generating and/or transmitting ultrasound and/or low frequency ultrasound sensing signals (e.g., in a frequency range of about 17-23 kHz, 18-22 kHz, or 17-18 kHz, for example), through the air.
[0071] In some implementations, the sensors 210 include (i) a first microphone that is the same as, or similar to, the microphone 220, and is integrated in the acoustic sensor 224 and (ii) a second microphone that is the same as, or similar to, the microphone 220, but is separate and distinct from the first microphone that is integrated in the acoustic sensor 224.
[0072] The RF transmitter 228 generates and/or emits radio waves having a predetermined frequency and/or a predetermined amplitude (e.g., within a high frequency band, within a low frequency band, long wave signals, short wave signals, etc.). The RF receiver 226 detects the reflections of the radio waves emitted from the RF transmitter 228, and this data can be analyzed by the control system 200 to determine a location of the user and/or one or more of the sleep-related parameters described herein. An RF receiver (either the RF receiver 226 and the RF transmitter 228 or another RF pair) can also be used for wireless communication between the control system 200, the respiratory therapy device 110, the one or more sensors 210, the user device 260, or any combination thereof. While the RF receiver 226 and RF transmitter 228 are shown as being separate and distinct elements in FIG. 1, in some
implementations, the RF receiver 226 and RF transmitter 228 are combined as a part of an RF sensor 230 (e.g., a RADAR sensor). In some such implementations, the RF sensor 230 includes a control circuit. The format of the RF communication can be Wi-Fi, Bluetooth, or the like.
[0073] In some implementations, the RF sensor 230 is a part of a mesh system. One example of a mesh system is a Wi-Fi mesh system, which can include mesh nodes, mesh router(s), and mesh gateway(s), each of which can be mobile/movable or fixed. In such implementations, the Wi-Fi mesh system includes a Wi-Fi router and/or a Wi-Fi controller and one or more satellites (e.g., access points), each of which include an RF sensor that the is the same as, or similar to, the RF sensor 230. The Wi-Fi router and satellites continuously communicate with one another using Wi-Fi signals. The Wi-Fi mesh system can be used to generate motion data based on changes in the Wi-Fi signals (e.g., differences in received signal strength) between the router and the satellite(s) due to an object or person moving partially obstructing the signals. The motion data can be indicative of motion, breathing, heart rate, gait, falls, behavior, etc., or any combination thereof.
[0074] The camera 232 outputs image data reproducible as one or more images (e.g., still images, video images, thermal images, or any combination thereof) that can be stored in the memory device 204. The image data from the camera 232 can be used by the control system 200 to determine one or more of the sleep-related parameters described herein, such as, for example, one or more events (e.g., periodic limb movement or restless leg syndrome), a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, a number of events per hour, a pattern of events, a sleep state, a sleep stage, or any combination thereof. Further, the image data from the camera 232 can be used to, for example, identify a location of the user, to determine chest movement of the user, to determine air flow of the mouth and/or nose of the user, to determine a time when the user enters the bed, and to determine a time when the user exits the bed. In some implementations, the camera 232 includes a wide-angle lens or a fisheye lens. 230. The camera 232 can also be used to track eye movements, pupil dilation (if one or both of the user’s eyes are open), blink rate, or any changes during REM sleep. The camera 232 can also be used to track the position of the user, which can impact the duration and/or severity of apneic episodes in users with positional obstructive sleep apnea.
[0075] The IR sensor 234 outputs infrared image data reproducible as one or more infrared images (e.g., still images, video images, or both) that can be stored in the memory device 204. The infrared data from the IR sensor 234 can be used to determine one or more sleep-related parameters during a sleep session, including a temperature of the user 20 and/or movement of
the user 20. The IR sensor 234 can also be used in conjunction with the camera 232 when measuring the presence, location, and/or movement of the user 20. The IR sensor 234 can detect infrared light having a wavelength between about 700 nm and about 1 mm, for example, while the camera 232 can detect visible light having a wavelength between about 380 nm and about 740 nm.
[0076] The PPG sensor 236 outputs physiological data associated with the user 20 that can be used to determine one or more sleep-related parameters, such as, for example, a heart rate, a heart rate variability, a cardiac cycle, respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, estimated blood pressure parameter(s), or any combination thereof. The PPG sensor 236 can be worn by the user 20, embedded in clothing and/or fabric that is worn by the user 20, embedded in and/or coupled to the user interface 120 and/or its associated headgear (e.g., straps, etc.), etc.
[0077] The ECG sensor 238 outputs physiological data associated with electrical activity of the heart of the user 20. In some implementations, the ECG sensor 238 includes one or more electrodes that are positioned on or around a portion of the user 20 during the sleep session. The physiological data from the ECG sensor 238 can be used, for example, to determine one or more of the sleep-related parameters described herein.
[0078] The EEG sensor 240 outputs physiological data associated with electrical activity of the brain of the user 20. In some implementations, the EEG sensor 240 includes one or more electrodes that are positioned on or around the scalp of the user 20 during the sleep session. The physiological data from the EEG sensor 240 can be used, for example, to determine a sleep state and/or a sleep stage of the user 20 at any given time during the sleep session. In some implementations, the EEG sensor 240 can be integrated into the user interface 120, into associated headgear (e.g., straps, etc.), into a head band or other head-worn sensor device, etc. [0079] The capacitive sensor 242, the force sensor 244, and the strain gauge sensor 246 output data that can be stored in the memory device 204 and used/analyzed by the control system 200 to determine, for example, one or more of the sleep-related parameters described herein. The EMG sensor 248 outputs physiological data associated with electrical activity produced by one or more muscles. The oxygen sensor 250 outputs oxygen data indicative of an oxygen concentration of gas (e.g., in the conduit 140 or at the user interface 120). The oxygen sensor 250 can be, for example, an ultrasonic oxygen sensor, an electrical oxygen sensor, a chemical oxygen sensor, an optical oxygen sensor, a pulse oximeter (e.g., SpCh sensor), or any combination thereof.
[0080] The analyte sensor 252 can be used to detect the presence of an analyte in the exhaled breath of the user 20. The data output by the analyte sensor 252 can be stored in the memory device 204 and used by the control system 200 to determine the identity and concentration of any analytes in the breath of the user. In some implementations, the analyte sensor 252 is positioned near a mouth of the user to detect analytes in breath exhaled from the user’s mouth. For example, when the user interface 120 is a facial mask that covers the nose and mouth of the user, the analyte sensor 252 can be positioned within the facial mask to monitor the user’s mouth breathing. In other implementations, such as when the user interface 120 is a nasal mask or a nasal pillow mask, the analyte sensor 252 can be positioned near the nose of the user to detect analytes in breath exhaled through the user’s nose. In still other implementations, the analyte sensor 252 can be positioned near the user’s mouth when the user interface 120 is a nasal mask or a nasal pillow mask. In this implementation, the analyte sensor 252 can be used to detect whether any air is inadvertently leaking from the user’s mouth and/or the user interface 120. In some implementations, the analyte sensor 252 is a volatile organic compound (VOC) sensor that can be used to detect carbon-based chemicals or compounds. In some implementations, the analyte sensor 252 can also be used to detect whether the user is breathing through their nose or mouth. For example, if the data output by an analyte sensor 252 positioned near the mouth of the user or within the facial mask (e.g., in implementations where the user interface 120 is a facial mask) detects the presence of an analyte, the control system 200 can use this data as an indication that the user is breathing through their mouth.
[0081] The moisture sensor 254 outputs data that can be stored in the memory device 204 and used by the control system 200. The moisture sensor 254 can be used to detect moisture in various areas surrounding the user (e.g., inside the conduit 140 or the user interface 120, near the user’s face, near the connection between the conduit 140 and the user interface 120, near the connection between the conduit 140 and the respiratory therapy device 110, etc.). Thus, in some implementations, the moisture sensor 254 can be coupled to or integrated in the user interface 120 or in the conduit 140 to monitor the humidity of the pressurized air from the respiratory therapy device 110. In other implementations, the moisture sensor 254 is placed near any area where moisture levels need to be monitored. The moisture sensor 254 can also be used to monitor the humidity of the ambient environment surrounding the user, for example, the air inside the bedroom. The moisture sensor 176 can also be used to track the user’s biometric response to environmental changes.
[0082] The LiDAR sensor 256 can be used for depth sensing. This type of optical sensor (e.g., laser sensor) can be used to detect objects and build three dimensional (3D) maps of the
surroundings, such as of a living space. LiDAR can generally utilize a pulsed laser to make time of flight measurements. LiDAR is also referred to as 3D laser scanning. In an example of use of such a sensor, a fixed or mobile device (such as a smartphone) having a LiDAR sensor 256 can measure and map an area extending 5 meters or more away from the sensor. The LiDAR data can be fused with point cloud data estimated by an electromagnetic RADAR sensor, for example. The LiDAR sensor(s) 256 can also use artificial intelligence (Al) to automatically geofence RADAR systems by detecting and classifying features in a space that might cause issues for RADAR systems, such a glass windows (which can be highly reflective to RADAR). LiDAR can also be used to provide an estimate of the height of a person, as well as changes in height when the person sits down or falls down, for example. LiDAR may be used to form a 3D mesh representation of an environment. In a further use, for solid surfaces through which radio waves pass (e.g., radio-translucent materials), the LiDAR may reflect off such surfaces, thus allowing a classification of different type of obstacles.
[0083] In some implementations, the one or more sensors 210 also include a galvanic skin response (GSR) sensor, a blood flow sensor, a respiration sensor, a pulse sensor, a sphygmomanometer sensor, an oximetry sensor, a sonar sensor, a RADAR sensor, a blood glucose sensor, a color sensor, a pH sensor, an air quality sensor, a tilt sensor, a rain sensor, a soil moisture sensor, a water flow sensor, an alcohol sensor, or any combination thereof.
[0084] While shown separately in FIG. 1, any combination of the one or more sensors 210 can be integrated in and/or coupled to any one or more of the components of the system 10, including the respiratory therapy device 110, the user interface 120, the conduit 140, the humidifier 160, the control system 200, the user device 260, the activity tracker 270, or any combination thereof. For example, the microphone 220 and the speaker 222 can be integrated in and/or coupled to the user device 260 and the pressure sensor 212 and/or flow rate sensor 214 are integrated in and/or coupled to the respiratory therapy device 110. In some implementations, at least one of the one or more sensors 210 is not coupled to the respiratory therapy device 110, the control system 200, or the user device 260, and is positioned generally adjacent to the user 20 during the sleep session (e.g., positioned on or in contact with a portion of the user 20, worn by the user 20, coupled to or positioned on the nightstand, coupled to the mattress, coupled to the ceiling, etc.).
[0085] One or more of the respiratory therapy device 110, the user interface 120, the conduit 140, the display device 150, and the humidifier 160 can contain one or more sensors (e.g., a pressure sensor, a flow rate sensor, or more generally any of the other sensors 210 described herein). These one or more sensors can be used, for example, to measure the air pressure and/or
flow rate of pressurized air supplied by the respiratory therapy device 110. More generally, the one or more sensors 210 can be positioned at any suitable location relative to the user such that the one or more sensors 210 can generate physiological data associated with the user and/or the bed partner 30 during one or more sleep session.
[0086] The data from the one or more sensors 210 can be analyzed (e.g., by the control system 200) to determine one or more sleep-related parameters, which can include a respiration signal, a respiration rate, a respiration pattern, an inspiration amplitude, an expiration amplitude, an inspiration-expiration ratio, an occurrence of one or more events, a number of events per hour, a pattern of events, an average duration of events, a range of event durations, a ration between the number of different events, a sleep state, a sleep stage, an apnea-hypopnea index (AHI), or any combination thereof. The one or more events can include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak, a cough, a restless leg, a sleeping disorder, choking, an increased heart rate, labored breathing, an asthma attack, an epileptic episode, a seizure, increased blood pressure, or any combination thereof. Many of these sleep- related parameters are physiological parameters, although some of the sleep-related parameters can be considered to be non-physiological parameters. Other types of physiological and non- physiological parameters can also be determined, either from the data from the one or more sensors 210, or from other types of data.
[0087] The user device 260 includes a display device 262. The user device 260 can be, for example, a mobile device such as a smartphone, a tablet computer, a gaming console, a smartwatch, a laptop computer, or the like. In some implementations, the user device 260 is a portable device, such as a smart phone, a tablet computer, a smart watch, a laptop computer, etc. Alternatively, the user device 260 can be an external sensing system, a television (e.g., a smart television) or another smart home device (e.g., a smart speaker(s) such as Google Home®, Google Nest®, Amazon Echo®, Amazon Echo Show®, Alexa®-enable devices, etc.). In some implementations, the user device is a wearable device (e.g., a smart watch). The display device 262 is generally used to display image(s) including still images, video images, or both. In some implementations, the display device 262 acts as a human-machine interface (HMI) that includes a graphic user interface (GUI) configured to display the image(s) and an input interface. The display device 262 can be an LED display, an OLED display, an LCD display, or the like. The input interface can be, for example, a touchscreen or touch-sensitive substrate, a mouse, a keyboard, or any sensor system configured to sense inputs made by a human user interacting with the user device 260. In some implementations, one or more user devices can be used by and/or included in the system 10. As shown in FIG. 2, the user device
260 can include a smartphone that is received in a dock of the respiratory therapy device 110, as is discussed in more detail herein.
[0088] In some implementations, the system 10 also includes the activity tracker 270. The activity tracker 270 is generally used to aid in generating physiological data associated with the user. The activity tracker 270 can include one or more of the sensors 210 described herein, such as, for example, the motion sensor 218 (e.g., one or more accelerometers and/or gyroscopes), the PPG sensor 236, and/or the ECG sensor 238. The physiological data from the activity tracker 270 can be used to determine, for example, a number of steps, a distance traveled, a number of steps climbed, a duration of physical activity, a type of physical activity, an intensity of physical activity, time spent standing, a respiration rate, an average respiration rate, a resting respiration rate, a maximum he respiration art rate, a respiration rate variability, a heart rate, an average heart rate, a resting heart rate, a maximum heart rate, a heart rate variability, a number of calories burned, blood oxygen saturation, electrodermal activity (also known as skin conductance or galvanic skin response), or any combination thereof. In some implementations, the activity tracker 270 is coupled (e.g., electronically or physically) to the user device 260.
[0089] In some implementations, the activity tracker 270 is a wearable device that can be worn by the user, such as a smartwatch, a wristband, a ring, or a patch. For example, referring to FIG. 2, the activity tracker 270 is worn on a wrist of the user 20. The activity tracker 270 can also be coupled to or integrated a garment or clothing that is worn by the user. Alternatively still, the activity tracker 270 can also be coupled to or integrated in (e.g., within the same housing) the user device 260. More generally, the activity tracker 270 can be communicatively coupled with, or physically integrated in (e.g., within a housing), the control system 200, the memory device 204, the respiratory therapy system 100, and/or the user device 260.
[0090] In some implementations, the system 10 also includes the blood pressure device 280. The blood pressure device 280 is generally used to aid in generating cardiovascular data for determining one or more blood pressure measurements associated with the user 20. The blood pressure device 280 can include at least one of the one or more sensors 210 to measure, for example, a systolic blood pressure component and/or a diastolic blood pressure component.
[0091] In some implementations, the blood pressure device 280 is a sphygmomanometer including an inflatable cuff that can be worn by the user 20 and a pressure sensor (e.g., the pressure sensor 212 described herein). For example, in the example of FIG. 2, the blood pressure device 280 can be worn on an upper arm of the user 20. In such implementations where the blood pressure device 280 is a sphygmomanometer, the blood pressure device 280
also includes a pump (e.g., a manually operated bulb) for inflating the cuff. In some implementations, the blood pressure device 280 is coupled to the respiratory therapy device 110 of the respiratory therapy system 100, which in turn delivers pressurized air to inflate the cuff. More generally, the blood pressure device 280 can be communicatively coupled with, and/or physically integrated in (e.g., within a housing), the control system 200, the memory device 204, the respiratory therapy system 100, the user device 260, and/or the activity tracker 270.
[0092] In other implementations, the blood pressure device 280 is an ambulatory blood pressure monitor communicatively coupled to the respiratory therapy system 100. An ambulatory blood pressure monitor includes a portable recording device attached to a belt or strap worn by the user 20 and an inflatable cuff attached to the portable recording device and worn around an arm of the user 20. The ambulatory blood pressure monitor is configured to measure blood pressure between about every fifteen minutes to about thirty minutes over a 24- hour or a 48-hour period. The ambulatory blood pressure monitor may measure heart rate of the user 20 at the same time. These multiple readings are averaged over the 24-hour period. The ambulatory blood pressure monitor determines any changes in the measured blood pressure and heart rate of the user 20, as well as any distribution and/or trending patterns of the blood pressure and heart rate data during a sleeping period and an awakened period of the user 20. The measured data and statistics may then be communicated to the respiratory therapy system 100.
[0093] The blood pressure device 280 maybe positioned external to the respiratory therapy system 100, coupled directly or indirectly to the user interface 120, coupled directly or indirectly to a headgear associated with the user interface 120, or inflatably coupled to or about a portion of the user 20. The blood pressure device 280 is generally used to aid in generating physiological data for determining one or more blood pressure measurements associated with a user, for example, a systolic blood pressure component and/or a diastolic blood pressure component. In some implementations, the blood pressure device 280 is a sphygmomanometer including an inflatable cuff that can be worn by a user and a pressure sensor (e.g., the pressure sensor 212 described herein).
[0094] In some implementations, the blood pressure device 280 is an invasive device which can continuously monitor arterial blood pressure of the user 20 and take an arterial blood sample on demand for analyzing gas of the arterial blood. In some other implementations, the blood pressure device 280 is a continuous blood pressure monitor, using a radio frequency sensor and capable of measuring blood pressure of the user 20 once very few seconds (e.g.,
every 3 seconds, every 5 seconds, every 7 seconds, etc.) The radio frequency sensor may use continuous wave, frequency-modulated continuous wave (FMCW with ramp chirp, triangle, sinewave), other schemes such as PSK, FSK etc., pulsed continuous wave, and/or spread in ultra-wideband ranges (which may include spreading, PRN codes or impulse systems).
[0095] While the control system 200 and the memory device 204 are described and shown in FIG. 1 as being a separate and distinct component of the system 10, in some implementations, the control system 200 and/or the memory device 204 are integrated in the user device 260 and/or the respiratory therapy device 110. Thus, the control system 200 and/or the memory device 204 can be disposed within the housing 112 of the respiratory therapy device 110. Alternatively, in some implementations, the control system 200 or a portion thereof (e.g., the processor 202) can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc., or any combination thereof.
[0096] While the control system 200 and the memory device 204 are described and shown in FIG. 1 as being a separate and distinct component of the system 10, in some implementations, the control system 200 and/or the memory device 204 are integrated in the user device 260 and/or the respiratory therapy device 110. Thus, the control system 200 and/or the memory device 204 can be disposed within the housing 112 of the respiratory therapy device 110. Alternatively, in some implementations, the control system 200 or a portion thereof (e.g., the processor 202) can be located in a cloud (e.g., integrated in a server, integrated in an Internet of Things (loT) device, connected to the cloud, be subject to edge cloud processing, etc.), located in one or more servers (e.g., remote servers, local servers, etc., or any combination thereof.
[0097] While system 10 is shown as including all of the components described above, more or fewer components can be included in a system for presenting an entrainment program, according to implementations of the present disclosure. For example, a first alternative system includes the control system 200, the memory device 204, and at least one of the one or more sensors 210 and does not include the respiratory therapy system 100. As another example, a second alternative system includes the control system 200, the memory device 204, at least one of the one or more sensors 210, and the user device 260. As yet another example, a third alternative system includes the control system 200, the memory device 204, the respiratory therapy system 100, at least one of the one or more sensors 210, and the user device 260. As a further example, a fourth alternative system includes the control system 200, the memory
device 204, the respiratory therapy system 100, at least one of the one or more sensors 210, the user device 170, and the blood pressure device 180 and/or activity tracker 190. Thus, various systems for modifying pressure settings can be formed using any portion or portions of the components shown and described herein and/or in combination with one or more other components.
[0098] Referring again to FIG. 2, in some implementations, the control system 200, the memory device 204, any of the one or more sensors 210, or a combination thereof can be located on and/or in any surface and/or structure that is generally adjacent to the bed 40 and/or the user 20. For example, in some implementations, at least one of the one or more sensors 210 can be located at a first position on and/or in one or more components of the respiratory therapy system 100 adjacent to the bed 40 and/or the user 20. The one or more sensors 210 can be coupled to the respiratory therapy system 100, the user interface 120, the conduit 140, the display device 150, the humidification tank 129, or a combination thereof.
[0099] Alternatively, or additionally, at least one of the one or more sensors 210 can be located at a second position on and/or in the bed 40 (e.g., the one or more sensors 210 are coupled to and/or integrated in the bed 40). Further, alternatively or additionally, at least one of the one or more sensors 210 can be located at a third position on and/or in the mattress 42 that is adjacent to the bed 40 and/or the user 20 (e.g., the one or more sensors 210 are coupled to and/or integrated in the mattress 42). Alternatively, or additionally, at least one of the one or more sensors 210 can be located at a fourth position on and/or in a pillow that is generally adjacent to the bed 40 and/or the user 20.
[0100] Alternatively, or additionally, at least one of the one or more sensors 210 can be located at a fifth position on and/or in the nightstand 44 that is generally adjacent to the bed 40 and/or the user 20. Alternatively, or additionally, at least one of the one or more sensors 210 can be located at a sixth position such that the at least one of the one or more sensors 210 are coupled to and/or positioned on the user 20 (e.g., the one or more sensors 210 are embedded in or coupled to fabric, clothing, and/or a smart device worn by the user 20). More generally, at least one of the one or more sensors 210 can be positioned at any suitable location relative to the user 20 such that the one or more sensors 210 can generate sensor data associated with the user 20.
[0101] In some implementations, a primary sensor, such as the microphone 220, is configured to generate acoustic data associated with the user 20 during a sleep session. The acoustic data can be based on, for example, acoustic signals in the conduit 140 of the respiratory therapy system 100. For example, one or more microphones (the same as, or similar to, the microphone
220 of FIG. 1) can be integrated in and/or coupled to (i) a circuit board of the respiratory therapy device 110, (ii) the conduit 140, (iii) a connector between components of the respiratory therapy system 100, (iv) the user interface 120, (v) a headgear (e.g., straps) associated with the user interface, or (vi) a combination thereof. In some implementations, the microphone 220 is in fluid communication with the airflow pathway (e.g., an airflow pathway between the flow generator/motor and the distal end of the conduit). By fluid communication, it is intended to also include configurations wherein the microphone is in acoustic communication with the airflow pathway without being in direct or physical contact with the airflow. For example, in some implementations, the microphone is positioned on a circuit board and in fluid communication, optionally via a duct sealed by a membrane, to the airflow pathway.
[0102] In some implementations, one or more secondary sensors may be used in addition to the primary sensor to generate additional data. In some such implementations, the one or more secondary sensors include: a microphone (e.g., the microphone 220 of the system 10), a flow rate sensor (e.g., the flow rate sensor 134 of the system 10), a pressure sensor (e.g., the pressure sensor 132 of the system 10), a temperature sensor (e.g., the temperature sensor 136 of the system 10), a camera (e.g., the camera 232 of the system 10), a vane sensor (VAF), a hot wire sensor (MAF), a cold wire sensor, a laminar flow sensor, an ultrasonic sensor, an inertial sensor, or a combination thereof.
[0103] Additionally, or alternatively, one or more microphones (the same as, or similar to, the microphone 220 of FIG. 1) can be integrated in and/or coupled to a co-located smart device, such as the user device 170, a TV, a watch (e.g., a mechanical watch or another smart device worn by the user), a pendant, the mattress 42, the bed 40, beddings positioned on the bed 40, the pillow, a speaker (e.g., the speaker 142 of FIG. 1), a radio, a tablet device, a waterless humidifier, or a combination thereof. A co-located smart device can be any smart device that is within range for detecting sounds emitted by the user, the respiratory therapy system 100, and/or any portion of the system 10. In some implementations, the co-located smart device is a smart device that is in the same room as the user during the sleep session.
[0104] Additionally, or alternatively, in some implementations, one or more microphones (the same as, or similar to, the microphone 220 of FIG. 1) can be remote from the system 10 (FIG. 1) and/or the user 20 (FIG. 2), so long as there is an air passage allowing acoustic signals to travel to the one or more microphones. For example, the one or more microphones can be in a different room from the room containing the system 10.
[0105] Referring now to FIG. 3, as used herein, a sleep session can be defined multiple ways. For example, a sleep session can be defined by an initial start time and an end time. In some implementations, a sleep session is a duration where the user is asleep, that is, the sleep session has a start time and an end time, and during the sleep session, the user does not wake until the end time. That is, any period of the user being awake is not included in a sleep session. From this first definition of sleep session, if the user wakes ups and falls asleep multiple times in the same night, each of the sleep intervals separated by an awake interval is a sleep session.
[0106] Alternatively, in some implementations, a sleep session has a start time and an end time, and during the sleep session, the user can wake up, without the sleep session ending, so long as a continuous duration that the user is awake is below an awake duration threshold. The awake duration threshold can be defined as a percentage of a sleep session. The awake duration threshold can be, for example, about twenty percent of the sleep session, about fifteen percent of the sleep session duration, about ten percent of the sleep session duration, about five percent of the sleep session duration, about two percent of the sleep session duration, etc., or any other threshold percentage. In some implementations, the awake duration threshold is defined as a fixed amount of time, such as, for example, about one hour, about thirty minutes, about fifteen minutes, about ten minutes, about five minutes, about two minutes, etc., or any other amount of time.
[0107] In some implementations, a sleep session is defined as the entire time between the time in the evening at which the user first entered the bed, and the time the next morning when user last left the bed. Put another way, a sleep session can be defined as a period of time that begins on a first date (e.g., Monday, January 6, 2020) at a first time (e.g., 10:00 PM), that can be referred to as the current evening, when the user first enters a bed with the intention of going to sleep (e.g., not if the user intends to first watch television or play with a smart phone before going to sleep, etc.), and ends on a second date (e.g., Tuesday, January 7, 2020) at a second time (e.g., 7:00 AM), that can be referred to as the next morning, when the user first exits the bed with the intention of not going back to sleep that next morning.
[0108] In some implementations, the user can manually define the beginning of a sleep session and/or manually terminate a sleep session. For example, the user can select (e.g., by clicking or tapping) one or more user-selectable element that is displayed on the display device 262 of the user device 260 (FIG. 1) to manually initiate or terminate the sleep session.
[0109] Generally, the sleep session includes any point in time after the user has laid or sat down in the bed (or another area or object on which they intend to sleep) and has turned on the respiratory therapy device 110 and donned the user interface 120. The sleep session can thus
include time periods (i) when the user is using the respiratory therapy system 100, but before the user attempts to fall asleep (for example when the user lays in the bed reading a book); (ii) when the user begins trying to fall asleep but is still awake; (iii) when the user is in a light sleep (also referred to as stage 1 and stage 2 of non-rapid eye movement (NREM) sleep); (iv) when the user is in a deep sleep (also referred to as slow-wave sleep, SWS, or stage 3 of NREM sleep); (v) when the user is in rapid eye movement (REM) sleep; (vi) when the user is periodically awake between light sleep, deep sleep, or REM sleep; or (vii) when the user wakes up and does not fall back asleep. The sleep session may also be referred to as a therapy session, or may comprise a therapy session, which can be understood to be the period of time within the sleep session during which the individual is engaged in respiratory therapy (e.g., the use of a respiratory therapy system).
[0110] The sleep session is generally defined as ending once the user removes the user interface 120, turns off the respiratory therapy device 110, and gets out of bed. In some implementations, the sleep session can include additional periods of time, or can be limited to only some of the above-disclosed time periods. For example, the sleep session can be defined to encompass a period of time beginning when the respiratory therapy device 110 begins supplying the pressurized air to the airway or the user, ending when the respiratory therapy device 110 stops supplying the pressurized air to the airway of the user, and including some or all of the time points in between, when the user is asleep or awake.
[OHl] FIG. 3 illustrates an exemplary timeline 300 for a sleep session. The timeline 300 includes an enter bed time (tbed), a go-to-sleep time (tors), an initial sleep time (tsieep), a first micro-awakening MAi, a second micro-awakening MA2, an awakening A, a wake-up time (twake), and a rising time (tdse).
[0112] The enter bed time tbed is associated with the time that the user initially enters the bed (e.g., bed 40 in FIG. 2) prior to falling asleep (e.g., when the user lies down or sits in the bed). The enter bed time tbed can be identified based at least in part on a bed threshold duration to distinguish between times when the user enters the bed for sleep and when the user enters the bed for other reasons (e.g., to watch TV). For example, the bed threshold duration can be at least about 10 minutes, at least about 20 minutes, at least about 30 minutes, at least about 45 minutes, at least about 1 hour, at least about 2 hours, etc. While the enter bed time tbed is described herein in reference to a bed, more generally, the enter time tbed can refer to the time the user initially enters any location for sleeping (e.g., a couch, a chair, a sleeping bag, etc.).
[0113] The go-to-sleep time (GTS) is associated with the time that the user initially attempts to fall asleep after entering the bed (tbed). For example, after entering the bed, the user may
engage in one or more activities to wind down prior to trying to sleep (e.g., reading, watching TV, listening to music, using the user device 260, etc.). The initial sleep time (tsieep) is the time that the user initially falls asleep. For example, the initial sleep time (tsieep) can be the time that the user initially enters the first non-REM sleep stage.
[0114] The wake-up time twake is the time associated with the time when the user wakes up without going back to sleep (e.g., as opposed to the user waking up in the middle of the night and going back to sleep). The user may experience one of more unconscious microawakenings (e.g., microawakenings MAi and MA2) having a short duration (e.g., 5 seconds, 10 seconds, 30 seconds, 1 minute, etc.) after initially falling asleep. In contrast to the wake-up time twake, the user goes back to sleep after each of the microawakenings MAi and MA2. Similarly, the user may have one or more conscious awakenings (e.g., awakening A) after initially falling asleep (e.g., getting up to go to the bathroom, attending to children or pets, sleep walking, etc.). However, the user goes back to sleep after the awakening A. Thus, the wake-up time twake can be defined, for example, based at least in part on a wake threshold duration (e.g., the user is awake for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.).
[0115] Similarly, the rising time trise is associated with the time when the user exits the bed and stays out of the bed with the intent to end the sleep session (e.g., as opposed to the user getting up during the night to go to the bathroom, to attend to children or pets, sleep walking, etc.). In other words, the rising time trise is the time when the user last leaves the bed without returning to the bed until a next sleep session (e.g., the following evening). Thus, the rising time trise can be defined, for example, based at least in part on a rise threshold duration (e.g., the user has left the bed for at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 1 hour, etc.). The enter bed time tbed time for a second, subsequent sleep session can also be defined based at least in part on a rise threshold duration (e.g., the user has left the bed for at least 4 hours, at least 6 hours, at least 8 hours, at least 12 hours, etc.).
[0116] As described above, the user may wake up and get out of bed one more times during the night between the initial tbed and the final trise. In some implementations, the final wake-up time twake and/or the final rising time trise that are identified or determined based at least in part on a predetermined threshold duration of time subsequent to an event (e.g., falling asleep or leaving the bed). Such a threshold duration can be customized for the user. For a standard user which goes to bed in the evening, then wakes up and goes out of bed in the morning any period (between the user waking up (twake) or raising up (trise), and the user either going to bed (tbed), going to sleep (tors), or falling asleep (tsieep) of between about 12 and about 18 hours can be used. For users that spend longer periods of time in bed, shorter threshold periods may be used
(e.g., between about 8 hours and about 14 hours). The threshold period may be initially selected and/or later adjusted based at least in part on the system monitoring the user’s sleep behavior. [0117] The total time in bed (TIB) is the duration of time between the time enter bed time tbed and the rising time trise. The total sleep time (TST) is associated with the duration between the initial sleep time and the wake-up time, excluding any conscious or unconscious awakenings and/or micro-awakenings therebetween. Generally, the total sleep time (TST) will be shorter than the total time in bed (TIB) (e.g., one minute short, ten minutes shorter, one hour shorter, etc.). For example, as shown in the timeline 300, the total sleep time (TST) spans between the initial sleep time tsieep and the wake-up time twake, but excludes the duration of the first microawakening MAi, the second micro-awakening MA2, and the awakening A. As shown, in this example, the total sleep time (TST) is shorter than the total time in bed (TIB).
[0118] In some implementations, the total sleep time (TST) can be defined as a persistent total sleep time (PTST). In such implementations, the persistent total sleep time excludes a predetermined initial portion or period of the first non-REM stage (e.g., light sleep stage). For example, the predetermined initial portion can be between about 30 seconds and about 20 minutes, between about 1 minute and about 10 minutes, between about 3 minutes and about 5 minutes, etc. The persistent total sleep time is a measure of sustained sleep and smooths the sleep-wake hypnogram. For example, when the user is initially falling asleep, the user may be in the first non-REM stage for a very short time (e.g., about 30 seconds), then back into the wakefulness stage for a short period (e.g., one minute), and then goes back to the first non- REM stage. In this example, the persistent total sleep time excludes the first instance (e.g., about 30 seconds) of the first non-REM stage.
[0119] In some implementations, the sleep session is defined as starting at the enter bed time (tbed) and ending at the rising time (trise), i.e., the sleep session is defined as the total time in bed (TIB). In some implementations, a sleep session is defined as starting at the initial sleep time (tsieep) and ending at the wake-up time (twake). In some implementations, the sleep session is defined as the total sleep time (TST). In some implementations, a sleep session is defined as starting at the go-to-sleep time (tors) and ending at the wake-up time (twake). In some implementations, a sleep session is defined as starting at the go-to-sleep time (tors) and ending at the rising time (trise). In some implementations, a sleep session is defined as starting at the enter bed time (tbed) and ending at the wake-up time (twake). In some implementations, a sleep session is defined as starting at the initial sleep time (tsieep) and ending at the rising time (trise). [0120] Referring to FIG. 4, an exemplary hypnogram 400 corresponding to the timeline 300 of FIG. 3, according to some implementations, is illustrated. As shown, the hypnogram 400
includes a sleep-wake signal 401, a wakefulness stage axis 410, a REM stage axis 420, a light sleep stage axis 430, and a deep sleep stage axis 440. The intersection between the sleep-wake signal 401 and one of the axes 410-440 is indicative of the sleep stage at any given time during the sleep session.
[0121] The sleep-wake signal 401 can be generated based at least in part on physiological data associated with the user (e.g., generated by one or more of the sensors 210 described herein). The sleep-wake signal can be indicative of one or more sleep stages, including wakefulness, relaxed wakefulness, microawakenings, a REM stage, a first non-REM stage, a second non- REM stage, a third non-REM stage, or any combination thereof. In some implementations, one or more of the first non-REM stage, the second non-REM stage, and the third non-REM stage can be grouped together and categorized as a light sleep stage or a deep sleep stage. For example, the light sleep stage can include the first non-REM stage and the deep sleep stage can include the second non-REM stage and the third non-REM stage. While the hypnogram 400 is shown in FIG. 4 as including the light sleep stage axis 430 and the deep sleep stage axis 440, in some implementations, the hypnogram 400 can include an axis for each of the first non- REM stage, the second non-REM stage, and the third non-REM stage. In other implementations, the sleep-wake signal can also be indicative of a respiration signal, a respiration rate, an inspiration amplitude, an expiration amplitude, an inspiration-expiration amplitude ratio, an inspiration-expiration duration ratio, a number of events per hour, a pattern of events, or any combination thereof. Information describing the sleep-wake signal can be stored in the memory device 204.
[0122] The hypnogram 400 can be used to determine one or more sleep-related parameters, such as, for example, a sleep onset latency (SOL), wake-after-sleep onset (WASO), a sleep efficiency (SE), a sleep fragmentation index, sleep blocks, or any combination thereof.
[0123] The sleep onset latency (SOL) is defined as the time between the go-to-sleep time (tors) and the initial sleep time (tsieep). In other words, the sleep onset latency is indicative of the time that it took the user to actually fall asleep after initially attempting to fall asleep. In some implementations, the sleep onset latency is defined as a persistent sleep onset latency (PSOL). The persistent sleep onset latency differs from the sleep onset latency in that the persistent sleep onset latency is defined as the duration time between the go-to-sleep time and a predetermined amount of sustained sleep. In some implementations, the predetermined amount of sustained sleep can include, for example, at least 10 minutes of sleep within the second non-REM stage, the third non-REM stage, and/or the REM stage with no more than 2 minutes of wakefulness, the first non-REM stage, and/or movement therebetween. In other words, the persistent sleep
onset latency requires up to, for example, 8 minutes of sustained sleep within the second non- REM stage, the third non-REM stage, and/or the REM stage. In other implementations, the predetermined amount of sustained sleep can include at least 10 minutes of sleep within the first non-REM stage, the second non-REM stage, the third non-REM stage, and/or the REM stage subsequent to the initial sleep time. In such implementations, the predetermined amount of sustained sleep can exclude any micro-awakenings (e.g., a ten second micro-awakening does not restart the 10-minute period).
[0124] The wake-after-sleep onset (WASO) is associated with the total duration of time that the user is awake between the initial sleep time and the wake-up time. Thus, the wake-after- sleep onset includes short and micro-awakenings during the sleep session (e.g., the microawakenings MAi and MA2 shown in FIG. 4), whether conscious or unconscious. In some implementations, the wake-after-sleep onset (WASO) is defined as a persistent wake-after- sleep onset (PWASO) that only includes the total durations of awakenings having a predetermined length (e.g., greater than 10 seconds, greater than 30 seconds, greater than 60 seconds, greater than about 5 minutes, greater than about 10 minutes, etc.)
[0125] The sleep efficiency (SE) is determined as a ratio of the total time in bed (TIB) and the total sleep time (TST). For example, if the total time in bed is 8 hours and the total sleep time is 7.5 hours, the sleep efficiency for that sleep session is 93.75%. The sleep efficiency is indicative of the sleep hygiene of the user. For example, if the user enters the bed and spends time engaged in other activities (e.g., watching TV) before sleep, the sleep efficiency will be reduced (e.g., the user is penalized). In some implementations, the sleep efficiency (SE) can be calculated based at least in part on the total time in bed (TIB) and the total time that the user is attempting to sleep. In such implementations, the total time that the user is attempting to sleep is defined as the duration between the go-to-sleep (GTS) time and the rising time described herein. For example, if the total sleep time is 8 hours (e.g., between 11 PM and 7 AM), the go- to-sleep time is 10:45 PM, and the rising time is 7: 15 AM, in such implementations, the sleep efficiency parameter is calculated as about 94%.
[0126] The fragmentation index is determined based at least in part on the number of awakenings during the sleep session. For example, if the user had two micro-awakenings (e.g., micro-awakening MAi and micro-awakening MA2 shown in FIG. 4), the fragmentation index can be expressed as 2. In some implementations, the fragmentation index is scaled between a predetermined range of integers (e.g., between 0 and 10).
[0127] The sleep blocks are associated with a transition between any stage of sleep (e.g., the first non-REM stage, the second non-REM stage, the third non-REM stage, and/or the REM)
and the wakefulness stage. The sleep blocks can be calculated at a resolution of, for example, 30 seconds.
[0128] In some implementations, the systems and methods described herein can include generating or analyzing a hypnogram including a sleep-wake signal to determine or identify the enter bed time (tbed), the go-to-sleep time (tors), the initial sleep time (tsieep), one or more first micro-awakenings (e.g., MAi and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof based at least in part on the sleep-wake signal of a hypnogram.
[0129] In other implementations, one or more of the sensors 210 can be used to determine or identify the enter bed time (tbed), the go-to-sleep time (tors), the initial sleep time (tsieep), one or more first micro-awakenings (e.g., MAi and MA2), the wake-up time (twake), the rising time (trise), or any combination thereof, which in turn define the sleep session. For example, the enter bed time tbed can be determined based at least in part on, for example, data generated by the motion sensor 218, the microphone 220, the camera 232, or any combination thereof. The go- to-sleep time can be determined based at least in part on, for example, data from the motion sensor 218 (e.g., data indicative of no movement by the user), data from the camera 232 (e.g., data indicative of no movement by the user and/or that the user has turned off the lights), data from the microphone 220 (e.g., data indicative of the using turning off a TV), data from the user device 260 (e.g., data indicative of the user no longer using the user device 260), data from the pressure sensor 212 and/or the flow rate sensor 214 (e.g., data indicative of the user turning on the respiratory therapy device 110, data indicative of the user donning the user interface 120, etc.), or any combination thereof.
[0130] Disclosed herein are systems and methods for presenting breathing entrainment to a user. Presenting breathing entrainment prior to and/or during respiratory therapy can promote a relaxed state in advance of and/or after beginning the respiratory therapy. In particular, the breathing patterns encouraged and facilitated by the entrainment programs and stimuli described herein may promote parasympathetic nervous activity and conversely decrease sympathetic nervous system activity. The parasympathetic nervous system predominates in quiet “rest and digest” conditions while the sympathetic nervous system drives the “fight or flight” response in stressful situations. Therefore, promotion of parasympathetic nervous activity by the entrainment programs and stimuli described herein can improve relaxation and reduce anxiety of the user, help the user to fall asleep faster, and result in an improved respiratory therapy experience, which in turn results in improved adherence to therapy. Breathing entrainment can be presented to the user in a variety of different scenarios.
[0131] Referring now to FIG. 5, in some cases, the system 10 can present the entrainment program to a user making use of the respiratory therapy system 100, but without the user engaging in a sleep session. For example, the user can be sitting or laying in bed while wearing the user interface 120, as the respiratory therapy device 110 causes pressurized air to flow through the conduit 140 to the user interface 120, but not be actually attempting to fall asleep. This type of use case can allow a user to become familiar with the entrainment stimuli and overall entrainment process while the user is making use of the respiratory therapy device 110 that they will use when engaging in a sleep session (e.g., when attempting to fall asleep). This type of acclimatization can allow the user to become familiar both with different types of entrainment stimuli, and with the respiratory therapy device 110 itself. This acclimatization also allows for various parameters associated with the entrainment stimulus to be determined, and allows the collection of important information from the user (e.g., how the user responded to different entrainment stimuli, how susceptible the user was to entrainment, how successful the user was in implementing the entrainment to their breathing pattern, and the like), all before the user attempts to actually engage in a sleep session. A session where the user is undergoing this type of acclimatization can be referred to as an “acclimatization session” or an “on-device acclimatization session,” where the “device” is referring to a respiratory therapy device. Such a session could be especially useful for users with a respiratory therapy device who have some anxiety or difficulty getting used to the respiratory therapy device and/or respiratory therapy in general.
[0132] FIG. 5 is a flowchart of a method 500 for presenting an entrainment program while the user is using a respiratory therapy system (such as the respiratory therapy system 100), while not actually engaging in a sleep session. Generally, a control system having one or more processors (such as control system 200 of system 10) is configured to carry out the steps of method 500. A memory device (such as memory device 204 of system 10) can be used to store machine-readable instructions that are executed by the control system to carry out the steps of method 500. The memory device can also store any type of data utilized in the steps of method 500. Generally, method 500 can be implemented using a system (such as system 10) that includes the respiratory therapy system, the control system, and the memory device.
[0133] Step 510 of method 500 includes receiving data associated with the user while engaging in the acclimatization session. The data can include a variety of different types of data. In some implementations, the data can include sensor data from any suitable type of sensor, such as pressure data from the pressure sensor 212, flow rate data from the flow rate sensor 214, motion data from the motion sensor 218 (which can be indicative of movement of the user’s chest
during breathing), image data from the camera 232 (which can be indicative of movement of the user’ s chest during breathing), PPG data from the PPG sensor 236, ECG data from the ECG sensor 238, EEG data from the EEG sensor 240, and/or any sensor or combination of sensors. Thus, in some cases, the sensor data can include any combination of physiological data associated with physiological parameters, and airflow data associated with air flowing in the respiratory therapy system. In some cases, the physiological data may additionally or alternatively be derived from the airflow data (e.g., respiratory information that is derived from pressure and flow rate data).
[0134] In some implementations, the data includes environmental data associated with the location of the user and/or the respiratory therapy device. The environmental data can include data from any of the sensors 210 (e.g., temperature from the temperature sensor 216, humidity from the moisture sensor 254, etc.). The environmental can also include data from sources other than any of the sensors 210.
[0135] In some implementations, the data includes health/demographic data associated with the user. The health/demographic data can include, for example, data associated with an age of the user, a gender of the user, a race of the user, a geographic location of the user, an employment status of the user, an educational status of the user, a socioeconomic status of the user, a BMI of the user, the presence of other co-morbidities (e.g., COPD), a lung compliance parameter, etc. The health/demographic data can in some cases include physiological data and/or airflow data, similar to the sensor data.
[0136] Thus, the data can include at least sensor data generated by one or more sensors (which may include physiological data and/or airflow data), environmental data associated with the location of the user and/or the respiratory therapy system, health/demographic data associated with the user, other types of data, and any combinations thereof.
[0137] In some implementations, method 500 can first include prompting the user to perform specific actions to generate desired data. For example, the user could be prompted (using the respiratory therapy device, their smartphone, etc.) to breath deeply to, for example, win a game (e.g., gamify the breathing exercise) or copy a certain breathing pattern, which can be used to generate data that may be used to, for example, inform the selection of an entrainment program and/or generated an entrainment waveform.
[0138] Step 520 includes extracting respiration information from the data. The respiration information can include any suitable information that may be used to analyze the user’s respiration. For example, the respiratory information can include a respiration rate, an inspiration (or inhalation) amplitude, an expiration (or exhalation) amplitude, an inspiration-
expiration ratio, a respiration signal representing the user’s respiration, a lung capacity parameter (such as total lung capacity (TLC), forced expiratory volume (FEV1), forced vital capacity (FVC), vital capacity (VC), residual lung volume (RV), and maximum voluntary minute ventilation (MMV)), and/or any other suitable type of respiratory information.
[0139] Steps 530 and 540 of method 500 encompass the presentation of an entrainment program to the user during the acclimatization session. Step 530 includes generating an entrainment waveform. The entrainment waveform can generally be any type of waveform or pattern that is desired to be presented to the user, and can be used to entrain the user’s respiration toward desired respiration. In general, the entrainment waveform can take any of a number of different forms so as to represent a target respiration pattern (e.g., a specific inspiration and/or expiration pattern) for the user. Generally, the shape of the entrainment waveform (e.g., amplitude, frequency, other characteristics) will match the shape of the target respiration pattern. However, the entrainment waveform could represent the target respiration pattern in other manners as well. For example, in some cases the frequency of the entrainment waveform could represent the target respiration rate, but with no correlation between the amplitude of the entrainment waveform and a desired respiration amplitude.
[0140] In some cases, the target respiration pattern represented by a given entrainment waveform is the final target respiration pattern for the acclimatization session. This final target respiration represents the ultimate desired respiration pattern that the user is trying to be entrained to. For example, the final target respiration pattern may be a pattern with a respiration rate of 6 breaths per minute, and no entrainment waveforms will be generated during the acclimatization session representing a respiration rate less than that. In other cases however, the target respiration pattern represented by a given entrainment waveform is only an intermediate target respiration pattern. These intermediate target respiration patterns represent respiration patterns where once the user reaches such a pattern, the entrainment waveform can be updated to represent a new (e.g., updated) target respiration pattern, which itself may be the final target respiration pattern or an additional intermediate respiration pattern. As discussed in more detail herein, the use of intermediate target respiration patterns allows for the user’s respiration pattern to be changed in a step-wise manner. In some cases, this step-wise change will include reducing the user’s respiration rate in a step-wise manner. As used herein, the term “target respiration pattern” simply refers to the respiration pattern represented by a given entrainment waveform, and generally encompasses both final target respiration patterns and intermediate target respiration patterns.
[0141] The entrainment waveform may have portions corresponding to inspiration, and portions corresponding to expiration (e.g., the entrainment waveform may be a sine wave with the positive portion representing inspiration and the negative portion representing expiration, or with the positive slope portion representing inspiration and the negative slope portion representing expiration). The entrainment waveform can include a sine wave, a square wave, a triangle wave, a sawtooth wave, symmetric waves, asymmetric waves, other types of waves, or any combinations thereof.
[0142] In some implementations, the entrainment waveform for the acclimatization session is a predetermined waveform that is not based on the data or the respiration information. For example, the entrainment waveform could represent a stock target respiration pattern that is generally suitable for a large number of typical users, or for a cohort of typical users to which the user belongs, where the cohort can be defined by one or more parameters, such as demographic parameters. In other implementations, the entrainment waveform (and thus the target respiration pattern) for the acclimatization session can be based at least in part on the data and/or the respiration information. In some of these implementations, the entrainment waveform may be newly generated for the acclimatization session based on the data and/or the respiration information. In others of these implementations, generating the entrainment waveform includes generated a predetermined entrainment waveform, and then modifying the predetermined entrainment waveform based on the data and/or the respiration information. In any of these implementations, the respiration information can include the current respiration pattern of the user, and the entrainment waveform represents the target respiration pattern.
[0143] The received data and/or the respiration information can be used to adjust the entrainment waveform based on the user’s specific needs. For example, if the data and/or the respiration information indicates that the user has a diminished lung capacity, an entrainment waveform with a relatively smaller amplitude (representing a smaller inspiration and/or expiration volume) can be generated. In another example, if the data and/or the respiration information indicates that the user has a relatively high current respiration rate, an entrainment waveform representing a higher than typical respiration rate can be generated.
[0144] Step 540 includes presenting an entrainment stimulus to the user based at least in part on the entrainment waveform. The entrainment stimulus will generally be presented using a stimulus device (such as the stimulus device 208), which may include a speaker (such as speaker 222), a display device (such as display device 150, display device 262 of the user device 260, a projector from which a visual stimulus may be projected onto a surface such as a wall or ceiling, etc.), a haptic device, the respiratory therapy device, or any other suitable
stimulus device. In some implementations, the entrainment stimulus will match the entrainment waveform. In other implementations, the entrainment stimulus will be based on but not match the entrainment waveform. For example, the stimulus device could receive the entrainment waveform as input, such that the entrainment waveform is used to modulate or otherwise modify a standard output of the stimulus device. In one specific example, the stimulus device is a speaker that can play a sound representative of a base waveform. The entrainment waveform is used to modify the base waveform, and the speaker can play a sound representative of the modified base waveform. The base waveform effectively functions as a carrier signal, with the entrainment waveform functioning as a modulation signal. In this case, the output of the speaker does not match the entrainment waveform, but is based on the entrainment waveform.
[0145] In some implementations, the entrainment stimulus is an audio stimulus. In these implementations, presenting the entrainment stimulus can include generating an audio stimulus and/or modulating an existing audio stimulus. For example, a speaker could play a tone that with a changing pitch and/or volume that matches the entrainment stimulus. In another example, a speaker could modulate some existing audio source (e.g., a song or video being played) to match the entrainment stimulus. In some implementations, method 500 can include presenting acclimatization sounds during the acclimatization session. These acclimatization sounds can be changing sounds that are presented as the entrainment stimulus. These acclimatization sounds could also be constant background noise that is then modulated when the entrainment stimulus is presented. These acclimatization sounds could also be presented during acclimatization sounds where is not wearing the user interface.
[0146] In other implementations, the entrainment stimulus is a visual stimulus. In these implementations, presenting the entrainment stimulus can include generating a visual stimulus and/or modulating an existing visual stimulus. For example, a display device could display an animation that changes in color, size, shape, etc. to match the entrainment stimulus. In a specific example, the display device could display a circle that grows larger during the portion of the entrainment waveform representing inspiration, and grows smaller during the portion of the entrainment waveform representing expiration (e.g., matching the volume of the user’s lungs during breathing). In another specific example, the display device could show a waveform being traced out, or a marker moving along a waveform. In a further example, the display device could modulate some existing visual that is being displayed on a display device, such as by increasing and decreasing the brightness of the visual.
[0147] In further implementations, the entrainment stimulus is a haptic stimulus. In these implementations, presenting the entrainment stimulus can include generating a visual stimulus or modifying an existing haptic stimulus. The haptic stimulus can include generally any stimulus or action that the user may be able to physically feel, such as movement of the user’s bed; vibration of a user device (e.g., the user’s smartphone); pulsing of a blower motor of the respiratory therapy device to generate vibrations in the conduit, in the user interface, in the air passing through the conduit and the user interface to the user’s airways, or any combination thereof; and others.
[0148] In additional implementations, the entrainment stimulus includes a modulation of the flow of the air that is being generated by the respiratory therapy system. For example, if the respiratory therapy device is causing air to flow to the user interface being worn by the user during the acclimatization session, the pressure of the air can be modulated to match the entrainment waveform and/or to adapt to the user’s breathing which itself may be modulated via a separate entrainment stimulus — such as a visual stimulus and/or audio stimulus — corresponding to the entrainment waveform. In implementations wherein the pressure of the air is modulated to match the entrainment waveform, the inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP) settings of a respiratory therapy device may be adjusted based on the entrainment waveform to encourage the user’ s breathing to align with entrainment waveform. For example, the duration of increased pressure during a desired inspiration period and decreased pressure during a desired expiration period can be extended, to promote extended (slower) inspiration during the desired inspiration period and extended (slower) expiration during the desired expiration period. Additionally or alternatively, the pressure can be increased during the desired inspiration period and decreased during the desired expiration period, to promote inspiration during the desired inspiration period and expiration during the desired expiration period.
[0149] In implementations wherein the pressure of the air is modulated to adapt to the user’s breathing which itself is modulated via the separate entrainment stimulus, the pressure of the air could be increased during the inspiration portion of the entrainment waveform and/or decreased during the expiration portion of the entrainment waveform. In a specific example, the Expiratory Pressure Relief (EPR) settings of the respiratory therapy device may be adjusted to adapt to the user’s breathing modulated in accordance with the entrainment stimulus. In such examples, the respiratory therapy device may not actively promote alignment of the user’s breathing with the entrainment waveform, but does facilitate such alignment. Other parameters associated with the air flow can also be modulated. In some implementations, the modulation
of the air flow can cause vibration to occur in the conduit and/or in the user interface, such that a haptic stimulus is also presented. For example, a blower motor of the respiratory therapy device can be pulsed to generate vibrations in the conduit and/or in the user interface.
[0150] Method 500 thus allows the user to become acclimatized (or begin to acclimatize) to using the respiratory therapy system (e.g., wearing the user interface while the respiratory therapy device causes pressurized air to flow to the user interface) while encouraging the user to breath according to a target respiration pattern (which as noted, could be a final target respiration pattern or an intermediate target respiration). This can aid the user in getting used to the feeling of the pressurized air while not breathing too rapidly and/or too irregularly, so that once the user uses the respiratory therapy system during a sleep session, the user has reduced anxiety and less difficulty in breathing normally. As used herein, a “respiration pattern” will generally refer to any group of one or more characteristics indicative of the pattern of the user’s respiration, including respiration rate (e.g., how frequently the user inhales and exhales), inspiration amplitude and duration, expiration amplitude and duration, inspirationexpiration ratio, etc. Thus, the target respiration pattern could refer to a target respiration rate, a target inspiration-expiration ratio, a target inspiration and/or expiration amplitude, a target inspiration duration, a target inspiration hold duration, a target expiration duration, a target expiration hold duration, a target breath shape, other parameters, or any combination thereof.
[0151] In some implementations, the target respiration pattern includes a target inspirationexpiration ratio of about 35% inspiration/65% expiration, about 40% inspiration/60% expiration, about 45% inspired on/55% expiration, or other ratios. In some implementations, the target respiration pattern includes a target respiration rate of about 5-7 breaths per minute, or about 6 breaths per minute. In some implementations, the target respiration pattern includes both a target inspiration-expiration ratio (e.g., 35%/65%, 40%/60%, 45%/55%, etc.) and a target respiration rate (e.g., 5-7 breaths per minute, 6 breaths per minute, etc.). In other implementations, the paced breathing induced to achieve a target respiration pattern could embody the concept of box breathing, which generally involves breathing in for a specific amount of time, holding the breath in for a specific amount of time, breathing out for a specific amount of time, holding the breath out for a specific amount of time, or any combination thereof. Also, for example, the paced breathing induced to achieve a target respiration pattern may implement the 4-7-8 breathing technique, where the user breathes in for 4 seconds, holds their breath for 7 seconds, and breathes out for 8 seconds.
[0152] As discussed herein, one or more intermediate target respiration patterns can be applied in a step-wise manner until the final target respiration pattern is achieved. In an example, the
entrainment program may move to a next intermediate (or final) target respiration pattern only if the preceding target respiration pattern is achieved by the user and/or is maintained for a predetermined period (which may include a predetermined amount of time and/or a predetermined number of breaths). Further, the final target respiration pattern may not be achieved by the user, but the user may reach one or more intermediate targets, and which may result in reduced anxiety, improved familiarity with breathing on pressurized air, etc. Additional information related to entraining a respiration pattern of the user toward a target respiration pattern using different stimuli can be found in WO 2023/031802, which is hereby incorporated by reference herein in its entirety.
[0153] In some implementations, the presentation of the entrainment program also includes displaying, on a display device, both a current waveform that represents the user’s current respiration pattern, and the entrainment waveform that represents the target respiration pattern. This allows the user to be able to visually track how close their breathing is to the target respiration pattern (which thus may encourage the user to achieve the target respiration pattern), while also receiving the entrainment stimulus that represents the target respiration pattern. On the display device, the entrainment waveform could be overlaid on the current waveform and/or adjacent to the current waveform. The current waveform and the entrainment waveform can be represented on the display using lines, circles, bubbles, or generally any suitable shape and/or format.
[0154] In some implementations, method 500 further includes determining an entrainment coherence score that represents the coherence between the respiration information and the entrainment waveform (e.g., between the user’s current respiration pattern and the target respiration pattern). This entrainment coherence score can indicate how close the user’s breathing is to the target. For example, the entrainment coherence score can be based at least partially on a phase difference between the entrainment waveform and a waveform representing the user’s current respiration pattern, and/or if a phase difference that is changing over time (e.g., if the user’s respiration pattern is coming into alignment with the target respiration pattern). In these examples, the entrainment coherence score could be the actual phase difference, could be derived from the phase difference, or could have other forms. In another example, the entrainment coherence score can be based at least partially on the difference in the volumes (e.g., amplitude) of inspiration and/or expiration between the entrainment waveform and the waveform representing the user’s current respiration pattern (e.g., amplitude differences between the two waveforms). In these examples, the entrainment coherence score could be the ratio of the inspiration volume to the target inspiration volume,
the ratio of the expiration volume to the target expiration volume, the ratio of the current inspiration/expiration ratio to the target inspiration/expiration ratio, etc. The entrainment coherence score can additionally or alternatively be based on the user’s stress level. For example, a physiological parameter representing stress experienced by the user (e.g., galvanic skin response, heart rate variability, heart rate, blood pressure, EEG parameters, etc.) can be measured, and used to determine the entrainment coherence score. In some of these examples, the entrainment coherence score could be the difference between the current value of the physiological parameter and a desired value of the physiological parameter. In general, the entrainment coherence score can include any type of information learned about the relationship between a specific entrainment waveform and/or entrainment stimulus, and the user’ s breathing in response to being presented with the entrainment stimulus corresponding to that entrainment waveform.
[0155] In some implementations, the entrainment coherence score can be displayed to the user so as to represent another visual indication that the user can track while receiving the entrainment stimulus. In some cases, the entrainment coherence score is only displayed once the entrainment coherence score satisfies a predetermined threshold. In other cases, the entrainment coherence score can be displayed as soon as it is determined. In these cases, the entrainment coherence score may dynamically adjust depending on how closely the user’s breathing corresponds to the entrainment waveform at different times within the acclimatization session (or sleep session, as discussed further herein). In further cases, the entrainment coherence score is only displayed to the user after the acclimatization session ends. [0156] In some implementations, the entrainment coherence score is presented to the user as a numerical value. In other implementations, the entrainment coherence score is presented to the user as a series of traces that compare the user’s respiration pattern to the target respiration pattern represented by the entrainment waveform. For example, a first trace can be generated based at least in part on the respiration information that shows the user’s breathing, and a second trace can be generated at least in part on the entrainment waveform. The second trace may just be a visual reproduction of the entrainment waveform. The first trace and the second trace can be presented overlaid on each other or next to each other, to provide the user an indication of the entrainment coherence score. In further implementations, the entrainment coherence score is presented as both a numerical value and a series of traces. Further, it will be understood that “traces” can be implemented as any form of visual representation suitable to illustrate the relative relationship (e.g., quantitative, semi -quantitative, etc.) between the respiration information and entrainment waveform.
[0157] In some implementations, the entrainment waveform may be updated if the user’s current respiration rate differs from (e.g., is too high relative to) the target respiration rate by a predetermined threshold amount. It is generally undesirable for the user to breathe at a rate that is too fast or uncomfortable for the user (and/or to induce a user to breath at such a rate), as this could result in the opposite of the desired relaxation effect of the entrainment program, and in fact make the user more anxious, for example as a result of the sympathetic nervous system’s “fight or flight” response. A respiration rate may be too fast if it is faster than the user’s current respiration rate (also referred to as the user’s spontaneous respiration rate) at the point of commencing the entrainment program/stimulus. A suitable initial entrainment waveform can comprise a respiration rate that is between the user’s current respiration rate (such as the user’s respiration rate in a current body position, such as prone, supine, left, right) and 1-4 breaths/minute less than the current respiration rate. Also, it should be no more than around 4 breaths/minute less than the current respiration rate since this could create a discomfort or difficulty for the user by having to reduce current respiration rate to such an extent. The user’s current respiration rate is therefore calculated over a window of time (which may be, about 15- 20 seconds, about 30 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, etc.), to ensure accuracy and to avoid skewing due to perturbations in their breathing rate, and typically requires a median of preceding breaths or a trimmed mean to reduce outliers.
[0158] Therefore, in some examples, if the entrainment coherence score indicates that the user’s current respiration rate is too high for the entrainment stimulus to be effective (such as by inducing anxiety or the sympathetic nervous system’s “fight or flight” response), the entrainment waveform can be updated so that it represents an updated target respiration rate that is higher than the actual target respiration rate (but still lower than the current respiration rate). The entrainment stimulus can then be presented based at least in part on the updated entrainment waveform. Once the user’s current respiration rate slows down to match the updated target respiration rate, the entrainment waveform could be updated to again represent the actual target respiration rate, and the entrainment stimulus can be presented based at least on the updated entrainment waveform. Thus, the entrainment coherence score can also be utilized to aid in bringing down the user’s respiration rate in a step-wise manner if needed.
[0159] In some implementations, the entrainment waveform can be updated if the entrainment coherence score satisfies a threshold value, and/or satisfies a threshold value for at least a predetermined amount of time. For example, if the entrainment coherence score indicates that the current respiration rate is sufficiently higher than the target respiration rate, the entrainment
waveform can be updated, and the entrainment stimulus re-presented. In another example, if the entrainment coherence score indicates that the current respiration rate has been higher than the target respiration rate for a threshold period of time (e.g., the current entrainment stimulus does not appear to be reducing the user’s respiration rate or reducing the user’s respiration rate at a desired rate), the entrainment waveform can be updated, and the entrainment stimulus represented.
[0160] In general, method 500 can be implemented while the user is awake and is wearing the user interface. In many implementations, method 500 is implemented while the respiratory therapy system is fully connected and operating, e.g., the user interface is fluidly coupled to the respiratory therapy device via the conduit, and the respiratory therapy device is causing air to flow through the conduit and to the user interface. In other implementations, the user interface can be fluidly coupled to the respiratory therapy device via the conduit, but with no air flowing. In further implementations, the user interface may be fluidly coupled to the respiratory therapy device via the conduit with one or more valves of the user interface open to the atmosphere (and with or without air flowing from the respiratory therapy device to the user interface). In additional implementations, method 500 is implemented while the user is wearing the user interface, but the user interface is not fluidly coupled to the respiratory therapy device (e.g., not directly fluidly coupled to the conduit or an elbow connector; fluidly coupled to the elbow connector with either the elbow connector not fluidly coupled to the conduit, or the elbow connector fluidly coupled to the conduit and the conduit not fluidly coupled to the respiratory therapy device; fluidly coupled to the conduit with the conduit not fluidly coupled to the respiratory therapy device; etc.). In still further implementations, method 500 can be implemented while the user is not wearing the user interface at all. In some implementations, methods 500 can further include the use of tests to assess the fit of the user interface, including user interface seal. Leak can be determined (e.g., estimated) by the respiratory therapy device using any suitable technique. The user may also be prompted to input feedback information, such as the sensation of air blowing into their eyes, the location of a leak, etc. Based on the leak determination (such as amount and/or nature of leak), the user can be prompted to adjust the user interface fit, use a different user interface (such as different cushion size), use a difference type of user interface (such as a full face mask rather than a nasal mask), etc.
[0161] In some implementations, the entrainment coherence score may include a plurality of sub-scores, where each sub-score represents a different aspect or portion of the acclimatization session. For example, in some implementations, the respiratory therapy system can provide air at different pressures. An entrainment coherence sub-score can be generated
for each distinct pressure with a given entrainment waveform and/or entrainment stimulus, so that the coherence between the user’s respiration pattern and the target respiration pattern can be measured at each of the different pressures. In other cases, each of the sub-scores corresponds to a different amount of elapsed time since the initial presentation of the entrainment stimulus based on the entrainment waveform, so that the coherence between the user’s respiration pattern and the target respiration pattern can be measured over time.
[0162] Referring now to FIGS. 6-10, in some cases, the system 10 can present the entrainment program to a user making use of a respiratory therapy system 100 and engaging in a sleep session. For example, the user will generally be lying in bed attempting to fall asleep at the beginning of or during the use of the respiratory therapy system . In this use case, the entrainment program can attempt to guide the user's breathing pattern to a target breathing pattern that is designed to improve the user's sleep (e.g., reduce sleep onset latency, or otherwise improve the user's sleep session by reducing anxiety, feelings of claustrophobia, etc.). A session where the user is undergoing this type of entrainment can be referred to as a “sleep session with respiratory entrainment” or a “on-device sleep session with respiratory entrainment,” wherein the “device” is referring to a respiratory therapy device. Such a session can be useful to all users, especially those who have previously undergone an off-device or on- device acclimatization session.
[0163] FIG. 6 is a flowchart of a method 600 for presenting an entrainment program while the user is using a respiratory therapy system (such as the respiratory therapy system 100) and engaging in a sleep session. Generally, a control system having one or more processors (such as control system 200 of system 10) is configured to carry out the steps of method 600. A memory device (such as memory device 204 of system 10) can be used to store machine- readable instructions that are executed by the control system to carry out the steps of method 600. The memory device can also store any type of data utilized in the steps of method 600. Generally, method 600 can be implemented using a system (such as system 10) that includes the respiratory therapy system, the control system, and the memory device.
[0164] Step 610 of method 600 includes receiving data associated with the user while engaging in the sleep session. The data can include data from any suitable type of sensor, such as pressure data from the pressure sensor 212, flow rate data from the flow rate sensor 214, motion data from the motion sensor 218 (which can be indicative of movement of the user and/or a portion of the user’s body, such as the user’s chest during breathing), image data from the camera 232 (which can be indicative of movement of the user and/or a portion of the user, such as the user’ s
chest during breathing), PPG data from the PPG sensor 236, ECG data from the ECG sensor 238, EEG data from the EEG sensor 240, and/or any sensor or combination of sensors.
[0165] Steps 620 and 630 of method 600 encompass the generation and presentation of an entrainment program to the user during the sleep session. Step 620 includes generating an entrainment waveform, and step 630 includes presenting an entrainment stimulus based at least in part on the entrainment waveform.
[0166] Similar to method 500, the entrainment waveform can generally be any type of waveform or pattern that is desired to be presented to the user, and can be used to entrain the user’s respiration toward desired respiration. In general, the entrainment waveform represents a target respiration pattern (e.g., a specific inspiration and/or expiration pattern) for the user. Thus, the entrainment waveform may have portions corresponding to inspiration, and portions corresponding to expiration (e.g., the entrainment waveform may be a sine wave with the positive portion representing inspiration and the negative portion representing expiration, or with the positive slope portion representing inspiration and the negative slope portion representing expiration). Similar to method 500, the target respiration pattern during the sleep session can be the ultimate desired respiration pattern during the sleep session, or may be an intermediate respiration pattern between the user’s initial respiration pattern and the final target respiration pattern. The entrainment stimulus presented in step 630 can be the same as or similar to the entrainment stimulus presented in step 540 of method 500.
[0167] In some implementations, the entrainment waveform presented during the sleep session is intended to entrain the user toward a target respiration pattern that will encourage the user to fall asleep (e.g., will reduce the user’s sleep onset latency). An entrainment waveform such as this will typically encourage paced breathing involving slow, diaphragmatic breathing that aims to reduce initial respiration rate from, for example, 15 breaths/minute to 6 breaths/minute. It has been widely demonstrated that this type of breathing causes respiratory sinus arrhythmia (RSA), which is heart rate variability (HRV) in synchrony with respiration. Increased HRV initiates physiological changes associated with system wide health benefits, promoting a relaxed state. System wide health benefits include overall decreased heart rate, lower blood pressure, etc. RSA comprises fluctuation in heart rate corresponding to breathing, with heart rate increasing with inhalation and decreasing with exhalation. HRV is a measure of the variation in time between each heartbeat, controlled by the autonomic nervous system (ANS). The ANS operates in a delicate balance between parasympathetic activity and sympathetic activity. Inducing RSA or HRV with respiration is indicative of parasympathetic activation.
Sympathetic nervous system activation results in more regular, and more consistent intervals between, heartbeats.
[0168] FIG. 7 shows an example pressure curve 700 used to modulate the airflow of the respiratory therapy system as the entrainment stimulus, to reduce the user’s respiration rate in a step-wise fashion at the beginning of a sleep session and aid the user in falling asleep. The pressure curve 700 plots the pressure P on the vertical axis and the time t on the horizontal axis, with time t=to marking the beginning of the inspiratory portion of a breath. As shown, a single breath is divided into an inspiration period 702A (when the user is breathing in), an inspiration hold period 702B (when the user is momentarily holding their breath after breathing in and before breathing out), an expiration period 702C (when the user is breathing out), and an expiration hold period 702D (when the user is holding their breath after breathing out and before breathing in). During the inspiration period 702A, the pressure gradually increases from an EPAP pressure 704 to an IPAP pressure 706. During the inspiration hold period 702B, the pressure remains at the IPAP pressure 706. During the expiration period 702C, the pressure gradually decreases from the IPAP pressure 706 to the EPAP pressure 704. During the expiration hold period 702D, the pressure remains at the EPAP pressure 704. In the illustrated implementation, the pressure changes linearly during the inspiration period 702A and the expiration period 702C. However, the pressure curve 700 may be designed so that the pressure changes in other manners during these periods, such as based on curved lines during the inspiration period 702A and the expiration period 702C.
[0169] Once the user’s actual respiration reaches the target respiration rate represented by the pressure curve 700 (or if the difference between the actual respiration rate and the target respiration rate is within a predetermined threshold difference), the pressure curve 700 can be modified to represent a new (intermediate or final) target respiration rate, which will generally the less than the prior (e.g., intermediate) target respiration rate. This step-wise reduction can continue until (i) the user’s respiration rate reaches the final target respiration rate, (ii) the user’s respiration rate reaches a minimum respiration rate above the final target respiration rate but will not decrease any further, or (iii) the user falls asleep.
[0170] Thus, the entrainment waveform generated at step 620 can take the form of the pressure curve 700, which is then used to present the entrainment stimulus as a modulation of the airflow. In some implementations, additional or alternative entrainment stimuli can also be based on the pressure curve 700. Information about the pressure curve 700 can be transmitted to the stimulus device (which may be a smartphone) in any suitable manner, such as via Bluetooth™, Wi-Fi, etc., through which audio, visual, and/or haptic stimuli may be produced.
For example, if the entrainment stimulus includes circle displayed on the user’s smartphone increases and decreases in size, the circle can grow bigger during the intended respiration period, and the grow smaller during the intended expiration period. In another example, if the entrainment stimulus includes a modulated tone played through a speaker, the volume and/or pitch of the tone can increase during the inspiration period, and decrease during the expiration period.
[0171] Moreover, while the pressure curve 700 is discussed herein with respect to reducing the user’s respiration rate during a sleep session, the pressure curve 700 (and/or similar pressure curves) can be used during any of the methods discussed herein. For example, the pressure curve 700 could be used to modulate the airflow during an acclimatization session. This entrainment stimulus can be used during the acclimatization session to aid the user in getting used to the same type of modulation of the airflow during the sleep session.
[0172] FIGS. 8A and 8B are respiration rate vs. time plots that illustrate the use of entrainment stimuli to reduce the user’s respiration rate in a step-wise manner during a sleep session, to aid the user in falling asleep. FIGS. 8A and 8B are applicable to implementations where the entrainment stimulus comprises a modulation of the air flowing from the respiratory therapy device to the user interface (e.g., the implementation illustrated in FIG. 7), but are also applicable to generally any type of entrainment stimulus that is presented to the user during the sleep session.
[0173] Plot 800 in FIG. 8A includes a respiration rate trace 802 that shows the respiration rate of the user in breaths per minute (bpm), and an entrainment stimulus trace 804 that shows the target respiration rate represented by the current entrainment waveform and entrainment stimulus. As shown, the entrainment stimulus trace 804 is initially at a rate of 15 bpm, while the respiration rate trace 802 varies between about 15 bpm and greater than 17.5 bpm. Between 75 and 100 seconds, once the respiration rate trace 802 remains at about 15 bpm for a threshold period of time (and/or number of breaths), the entrainment stimulus trace 804 drops down to about 12 bpm. The respiration rate trace 802 then begins to decrease toward the entrainment stimulus trace 804 as a result of the user being induced to breath at the lower respiration rate by the corresponding entrainment stimulus. This cycle can continue until the respiration rate trace 802 reaches the final target respiration rate, which in this case is about 5-6 bpm.
[0174] Plot 810 in FIG. 8B is similar to plot 800 of FIG. 8A, and includes a respiration rate trace 812 and an entrainment stimulus trace 814. The respiration rate trace 812 shows the respiration rate of the user in bpm (breaths per minute), and the entrainment stimulus trace 814 shows the target respiration rate represented by the current entrainment waveform and
entrainment stimulus. As shown, the respiration rate trace 812 follows the entrainment stimulus trace 814 downward to around 9 bpm. However, at a time of about 60 seconds, it is detected that the user has fallen asleep. At this point, while the entrainment stimulus trace 814 can continue to decrease, the respiration rate trace 812 no longer follows the entrainment stimulus trace 814, since the user is asleep. Thus, plots 800 and 810 demonstrate the efficacy of the entrainment waveform and the entrainment stimulus in reducing the user’s respiration rate in a step-wise fashion to reach the final target respiration through one or more intermediate target respiration rates, inducing the user to fall asleep, and then allowing the user to sleep normally. [0175] Referring back to FIG. 6, in some implementations, the generation of the entrainment waveform and the presentation of the entrainment stimulus can be based on the data generated in step 610. For example, step 620 could include determining the user’s current respiration rate, and then generating the entrainment waveform so that the entrainment waveform represents a target respiration rate that is between 1-4 breaths per minute less than the user’s current respiration rate. This target respiration rate may be the final target respiration rate (if the user’s current respiration rate is close to final target respiration rate for the user), or may be an intermediate target respiration rate that is higher than the desired respiration rate. In other examples, the data can be used to determine when to begin the generation of the entrainment waveform and the presentation of the entrainment stimulus. For example, if the data indicates that the user has begun the sleep session (e.g., data indicating that the user is wearing a user interface and/or is breathing pressurized air, data indicating reduced or no motion by the user other than chest movement, data indicating that the user is in a lying (e.g., supine) position, etc.), then the entrainment waveform can be generated, and the entrainment stimulus presented. In another example, the entrainment waveform and the entrainment stimulus can be triggered to begin by the use of the respiratory therapy system, such as via user device (e.g., a smartphone having an app optionally in communication with the respiratory therapy device).
[0176] In another example, the entrainment waveform and the entrainment stimulus are based on the current pressure of the air provided by the respiratory therapy system. In this example, method 600 can include sub-step 615 after step 610. Sub-step 615 includes determining the current pressure of the air flowing from the respiratory therapy device to the user interface. Once the current pressure is determined, generating the entrainment waveform at step 620 comprises step 622, which includes generating the entrainment waveform based at least in part on the current pressure. Method 600 then proceeds to step 630, where the entrainment stimulus is presented. Because the entrainment waveform was generated based on the current pressure, the entrainment waveform presented in step 630 will thus also be based on the current pressure.
[0177] This example of method 600 may be used if it is determined that different entrainment waveforms (e.g., different target respiration patterns) are desirable for different pressures of air flowing to the user interface. In general, this example of method 600 can include providing air at a first pressure during the sleep session, generating a first entrainment waveform based on the first pressure, and then presenting a first entrainment waveform based on the first entrainment waveform. At a later time during the sleep session, air may be provided at a second pressure (e.g., during a ramp up in the pressure at an early portion of the sleep session), a second entrainment waveform is generated, and a second entrainment stimulus is presented based on the second entrainment waveform. This example of method 600 may also include altering the type of entrainment stimulus that is used.
[0178] FIG. 9 is a flowchart of a method 900 for presenting an entrainment program during the sleep session where the entrainment stimulus presented to the user changes based at least in part on the time within the sleep session, instead of or in addition to the pressure of the air. Generally, a control system having one or more processors (such as control system 200 of system 10) is configured to carry out the steps of method 900. A memory device (such as memory device 204 of system 10) can be used to store machine-readable instructions that are executed by the control system to carry out the steps of method 900. The memory device can also store any type of data utilized in the steps of method 900. Generally, method 900 can be implemented using a system (such as system 10) that includes the respiratory therapy system, the control system, and the memory device.
[0179] Step 910 includes generating a first entrainment waveform during the sleep session. Step 910 is generally the same as or similar to step 620 of method 600. Step 920 includes, at a first time during the sleep session, presenting a first entrainment waveform to the user based on the first entrainment waveform. Step 920 is generally the same as or similar to step 630 of method 600. Step 930 of method 900 includes generating a second entrainment waveform. Step 940 includes, at a second time during the sleep session that is after the first time, presenting a second entrainment stimulus to the user based on the second entrainment waveform.
[0180] In some implementations of method 900, the second entrainment waveform generated at step 930 is different than the first entrainment waveform generated at step 910, and is more suitable for a later time within the sleep session, and thus may be dependent on the time within the sleep session and/or the time elapsed since the beginning of the sleep session with respiratory entrainment. For example, the first entrainment waveform could represent one respiration rate while the second entrainment waveform represents a slightly slower respiration rate, which thus causes the first and second entrainment stimuli to aid in decreasing the user’s
respiration rate in multiple smaller steps, rather than one larger step. In further examples, the first entrainment stimulus may include a visual stimulus (and optionally one or more other entrainment stimuli such as an audio stimulus) whereas the second entrainment stimulus may not include, or may gradually discontinue, a visual stimulus since it would be expected that the user would close their eyes as they attempt or begin to fall asleep. The second entrainment stimulus may therefore include an audio stimulus (and optionally one or more other entrainment stimuli such as a haptic stimulus). Biometric data may be used to determine the sleep state (and/or sleep stage) of the user, which information can be used to determine a suitable entrainment waveform and entrainment stimulus based on the user’s sleep state/stage. Similarly, biometric data may be used to monitor changes in physiological parameters which indicate sleepiness, as a user approaches a sleep state/stage. Such physiological parameters include a reduction in respiration rate, heart rate, bodily movement, or any combination thereof. [0181] In other implementations of method 900, the second entrainment stimulus is a different type of entrainment stimulus than the first entrainment stimulus, and is more suitable for a later time within the sleep session as compared to the first entrainment stimulus presented earlier during the sleep session. For example, the first entrainment stimulus could be a visual stimulus that is suitable for the beginning of the sleep session, and the second entrainment stimulus could be an audio stimulus that is suitable for later on during the sleep session as the user begins to fall asleep. In some examples of these implementations, the second entrainment waveform is different than the first entrainment waveform. For example, it may be determined that a slightly different entrainment waveform is more suitable for the type of entrainment stimulus that is used for second entrainment stimulus as compared to the type of entrainment stimulus used for the first entrainment stimulus. However, in other examples of these implementations, the second entrainment stimulus is based on the same entrainment waveform as the first entrainment stimulus. Thus, in these examples, there is no generation of another entrainment waveform, and instead the second entrainment stimulus is based on the first entrainment waveform.
[0182] In some implementations, the generation of the second entrainment waveform and/or the presentation of the second entrainment stimulus can occur if it is determined that the user has awakened at some point during the sleep session. For example, after the first entrainment stimulus is presented, is the data indicates that the user has fallen asleep, the presentation of the first entrainment stimulus can end. Then, if the data later indicates that the user as awoken, the second entrainment waveform can be generated and/or the second entrainment stimulus can be presented. In some implementations, the second entrainment stimulus only includes a
modulation of the air flowing from the respiratory therapy device to the user interface (and/or any other airflow-based stimulus as described herein), which will aid the user in falling back asleep without having to look at a smartphone and/or turn the lights on to receive the entrainment stimulus.
[0183] FIG. 10 is a flowchart of a method 1000 for presenting an entrainment program during the sleep session where the entrainment stimulus presented to the user changes based at least in part on the time within the sleep session, instead of or in addition to the pressure of the air. Generally, a control system having one or more processors (such as control system 200 of system 10) is configured to carry out the steps of method 1000. A memory device (such as memory device 204 of system 10) can be used to store machine-readable instructions that are executed by the control system to carry out the steps of method 1000. The memory device can also store any type of data utilized in the steps of method 1000. Generally, method 1000 can be implemented using a system (such as system 10) that includes the respiratory therapy system, the control system, and the memory device.
[0184] Step 1010 of methods 1000 includes receiving entrainment coherence data associated with one or more entrainment stimuli presented to the user during a prior acclimatization session. The entrainment coherence data can include one or more entrainment coherence scores as discussed herein, where each entrainment coherence score indicates the coherence between the user’s breathing during the acclimatization session and the entrainment stimuli presented to the user. The entrainment coherence data can include any suitable information for each respective entrainment coherence score, such as the entrainment waveform used to generate the entrainment stimulus to which the entrainment coherence score applies, the type of the entrainment stimulus (e.g., audio stimulus, visual stimulus, etc.) to which the entrainment coherence score applies, the pressure of the air being provided when the respective entrainment coherence score was determined (e.g., the pressure of the air when the respective entrainment waveform was generated and/or when the corresponding entrainment stimulus was presented), or any combination thereof.
[0185] Step 1020 includes generating an entrainment waveform based at least in part on the entrainment coherence data, and step 1030 includes presenting an entrainment stimulus based at least in part on the entrainment waveform, the entrainment coherence data, or both. For example, if the entrainment coherence data indicates that a particular target respiration rate (final or intermediate) and/or a particular type of entrainment stimulus may be useful in improving the user’s experience during the sleep session (e.g., by reducing the user’s sleep
onset latency), then a specific entrainment waveform and/or a specific type of entrainment stimulus can be used.
[0186] In any of the implementations herein where an entrainment stimulus is presented to the user during the sleep session to aid in reducing the user’s respiration rate in a step-wise manner (in an acclimatization session or a sleep session), entrainment coherence scores can be used to determine when to update the entrainment waveform to represent a lower target respiration rate (e.g., updating from a higher intermediate target respiration rate to a lower intermediate target respiration rate, or updating from the lowest intermediate target respiration rate to the final target respiration rate). For example, if the entrainment coherence score measuring the coherence between the user’s current respiration rate and the current target respiration rate reaches a threshold value or remains at a threshold value for at least a threshold amount of time, the entrainment waveform can be updated to represent a lower target respiration rate. The entrainment coherence score can then again be determined between the user’s current respiration rate and the lower target respiration rate. This process can continue until any desired stopping point is reached, such as the user’s respiration rate reaching the final target respiration rate, the user’s respiration rate not decreasing below a respiration rate higher than the final target respiration rate, the user falling asleep, etc.
[0187] As discussed herein, the entrainment coherence score can additionally or alternatively be based on the user’s stress levels. One or more physiological parameters representing stress experienced by the user (e.g., galvanic skin response, heart rate variability, heart rate, blood pressure, EEG parameters, etc.) can be measured and used to determine the entrainment coherence score. If the entrainment coherence score indicates that the user’s stress has been reduced to an acceptable amount, the entrainment waveform can be updated to represent a lower target respiration rate.
[0188] In any of the implementations herein where a new (or second) entrainment stimulus is presented to the user (e.g., after the air pressure changes, after time passes during the acclimatization/sleep session, after the entrainment coherence score indicates that a new entrainment stimulus is needed), the new entrainment stimulus could be the same type of entrainment stimulus (e.g., still an audio stimulus, still a visual stimulus, etc.) with a new entrainment waveform, or a new type of entrainment stimulus with the same entrainment waveform, a new type of entrainment stimulus with a new entrainment waveform. The new stimulus presented to the user could be brought about by adding an additional entrainment stimulus of a different type. For example, an audio entrainment stimulus could be newly presented to the user while the existing visual entrainment stimulus continues to be presented
to the user, where the new audio entrainment stimulus has the same entrainment waveform as the existing visual entrainment stimulus, or a different entrainment waveform.
[0189] Referring now to FIGS. 11 and 12, the system 10 can present the entrainment program to a user making use of a respiratory therapy system 100 and engaging in a sleep session, while utilizing information gained from presenting the entrainment program to the user during the acclimatization session.
[0190] FIG. 11 is a flowchart of a method 1100 for presenting an entrainment program that combines aspects of methods 500, 600, 900, and 1000. Steps 1110, 1120, 1130, and 1140 are generally identical to steps 510, 520, 530, and 540 of method 500 Step 1110 includes receiving data associated with the user while engaging in the acclimatization session (referred to as first data), step 1120 includes extracting respiration information from the sensor data, step 1130 includes generating a first entrainment waveform, and step 1140 includes presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
[0191] Step 1150 of method 1100 includes generating an entrainment coherence score indicative of the coherence between the first respiration information and the first entrainment waveform. The generation of the entrainment coherence score is generally the same as or similar to the generation of the entrainment coherence score described herein with respect to method 500. Step 1160 of method 1100 includes receiving second data associated with the user while the user is engaging in a sleep session, and is generally the same as or similar to step 610 of method 600. Step 1170 of method 1100 includes generating a second entrainment waveform based at least in part on the entrainment coherence score, and step 1180 includes presenting a second entrainment stimulus based at least in part on the second entrainment waveform.
[0192] Method 1100 thus allows for certain features or characteristics of the user and their response to entrainment stimuli to be learned during the acclimatization session, which can then be used to generate the entrainment waveform during the actual sleep session. For example, if the entrainment coherence score indicates low coherence between the user’s respiration pattern during the acclimatization session and a given target respiration pattern (e.g., the first entrainment waveform), then a different target respiration pattern (and accompanying entrainment waveform) can be used during the sleep session. This can be useful if the first entrainment waveform represents a predetermined starting target respiration pattern that tends to be useful for a general population of users. Once it is learned in step 1150 that the user has, for example, difficulty in reaching this target respiration pattern, a different target respiration pattern and entrainment waveform can be used during the actual sleep session. The entrainment
coherence score can generally include any information that is learned during the acclimatization session that can be applied during a later sleep session.
[0193] In some implementations, step 1170 includes generating a temporary entrainment waveform, and then modifying the temporary entrainment waveform based at least in part on the entrainment coherence score to generate the second entrainment waveform. In some cases, the temporary entrainment waveform may represent a starting target respiration pattern (e.g., a predetermined target respiration pattern typically suitable for many users). Updating the temporary entrainment waveform can then include determining a subsequent target respiration pattern for the user based at least in part on the starting target respiration pattern and the entrainment coherence score, and then updating the temporary entrainment waveform so that the second entrainment waveform represents the subsequent target respiration pattern. The determination of the subsequent target respiration pattern may be based only on the entrainment coherence score, but additionally or alternatively is based on the second data. For example, if the entrainment coherence score indicates poor coherence at a certain air pressure, then the second data can be analyzed to determine the current air pressure, and determine the subsequent target respiration pattern on that current air pressure. The subsequent target respiration pattern could be the final target respiration pattern for the sleep session, or could be an intermediate target respiration pattern.
[0194] In some implementations, the entrainment stimulus presented to the user during the acclimatization session is different from the entrainment stimulus presented during the sleep session. For example, since the user is awake during the acclimatization session, the first entrainment stimulus can include a visual stimulus. However, a visual stimulus might not be appropriate during the sleep session since the user is attempting to fall asleep. Thus, an audio stimulus, a haptic stimulus, a modulation of the airflow, or any combinations thereof can be used for the second entrainment stimulus. In other implementations however, both the first entrainment stimulus and the second entrainment stimulus are the same type of stimulus or comprise the same type of stimuli.
[0195] In some cases, generating the second entrainment waveform may be based on more than just the entrainment coherence score from the acclimatization session. For example, in some cases historical acclimatization information associated with a plurality of prior acclimatization sessions can be obtained. This historical acclimatization information can include historical respiration information for each of these prior acclimatization sessions and a historical entrainment coherence score for each of these prior acclimatization sessions. Such longitudinal
data can be used to determine a more suitable second entrainment waveform based on a richer data set of historical respiration information and historical entrainment coherence scores.
[0196] In some implementations, the entrainment coherence score determined at step 1150 includes generating a plurality of entrainment coherence sub-scores, where each sub-score is associated with a different pressure of the air flowing from the respiratory therapy device to the user interface during the acclimatization session. Step 1160 can then first include determining the current pressure of the air during the sleep session based at least in part on the second data, and then generating the second entrainment waveform based on the current pressure of the air and the entrainment coherence sub-score associated with the current pressure. For example, if the entrainment coherence sub-score associated with the current pressure is low, then the second entrainment waveform that is generated may represent a higher target respiration rate than if the entrainment coherence sub-score was higher, to make it less difficult for the user to match their respiration pattern to the second entrainment stimulus.
[0197] In some implementations, once the second entrainment waveform is generated and the second entrainment stimulus is presented to the user, second respiration information is generated from the second data. An additional entrainment coherence score can then be determined that is indicative of the coherence between the second respiration information (e.g., the user’s respiration pattern during the sleep session) and the second entrainment waveform. If the additional entrainment coherence score satisfies a threshold (e.g., satisfies a threshold value once or for at least a threshold amount of time), a notification can be generated and/or transmitted to the user and/or a caretaker of the user or other third party. This notification can indicative a need to adjust the respiratory therapy system.
[0198] FIG. 12 is a flowchart of another method 1200 for presenting an entrainment program that combines aspects of methods 500, 600, 900, and 1000. Step 1210 includes, during an acclimatization session, cycling through (i) a plurality of different pressures of the air provided to the user interface and (ii) a plurality of different entrainment waveforms for each pressure. Step 1220 includes determining an entrainment coherence score for distinct combination of one of the plurality of pressures and one of the plurality of entrainment waveforms. Step 1230 includes, during a sleep session, receiving data and determining the current pressure of the air flowing to the user interface based on the second data. Step 1240 includes generating an entrainment waveform based on the current pressure of the air and the plurality of entrainment coherence scores associated with the current pressure. In general, the entrainment waveform that is generated is the one entrainment waveform of the plurality of entrainment waveforms
with the highest entrainment coherence score for the current pressure. Step 1250 includes presenting an entrainment stimulus to the user based on the entrainment waveform.
[0199] In some implementations, the system 10 can present the entrainment program without use of the respiratory therapy device 110. For example, a system 10 can present the entrainment program to a user not receiving respiratory therapy to demonstrate how the entrainment stimuli would otherwise be presented to the user if they were receiving respiratory therapy from a respiratory therapy device 110 while being entrained. This type of acclimatization can allow a user to become familiar with the entrainment program, allows the user to pre-set various parameters associated with the entrainment program, and allows the entrainment system to collect important information from the user (e.g., how the user responded to different entrainment stimuli, how susceptible the user was to entrainment, and the like), all without the user needing to make use of a respiratory therapy device 110. Such information can include, or be based upon, the respiration pattern changes induced by the entrainment programs and the entrainment stimuli, including respiration rate reduction, inspiration/expiration ratio, etc. The acclimatization session can also provide information respiratory therapy and the respiratory therapy system itself to the user, which can be particularly helpful if the user has never used a respiratory therapy system before. For example, the user can be presented with a variety of tutorials associated with operation of the respiratory therapy system, such as how to don the user interface, how to connect the user interface to the conduit, how to connect the conduit to the respiratory therapy device, how to operate the respiratory therapy device, how to fill the humidifier, and others.
[0200] As will be understood, this type of acclimatization can be performed while the user is not engaging in a sleep session (e.g., while the user is not lying in bed attempting to fall asleep), although that need not always be the case. A session where a user is undergoing this type of acclimatization can be referred to as an “off-device acclimatization session," where the “device” is referring to a respiratory therapy device (e.g., a CPAP device). Such a session could be especially useful for new users that are new to respiratory therapy, even users who have not yet received their respiratory therapy device. Moreover, in some implementations, a single acclimatization session could comprise periods where the user is not wearing the user interface, and periods where the user is wearing the user interface while air is flowing from the respiratory therapy device to the user interface. Thus, a single acclimatization session may include at least one portion where the user is not wearing the user interface and is receiving entrainment stimuli and/or other types of information, and at least one portion where the user is wearing the user
interface and receiving therapy from the respiratory therapy device while receiving entrainment stimuli.
[0201] During the off-device acclimatization session, while the user is awake and not wearing the user interface, a first entrainment stimulus can be presented to the user, and subsequently a second entrainment stimulus can be presented to the user. In some implementations, the two entrainment stimuli may be different types of stimuli. For example, one entrainment stimulus could be a visual stimulus while the other is an audio stimulus, one entrainment stimulus could be a visual stimulus while the other is a haptic stimulus, one entrainment stimulus could be an audio stimulus while the other is a haptic stimulus, etc. In other implementations, the two entrainment stimuli are based on entrainment waveforms that represent two different target respiration patterns. In these implementations, the two entrainment stimuli may be the same type of stimuli or different.
[0202] In some implementations, various aspects of any of the methods disclosed herein can be performed with and/or using a machine learning model. For example, the data and/or the respiration information can be input into a machine learning model which has been trained to output the entrainment waveform based at least on those inputs. In another example, machine learning model can be trained to generate the entrainment coherence scores in response to receiving an entrainment waveform and the corresponding respiration information of the user. In some implementations, a large language model can be used, and can be fine tuned with domain specific parameters or use retrieval augmented generation. The machine learning model can be trained on a database of historical sleep onset and/or sleep maintenance data, which may include respiration patterns, sleep onset data, and other types of data. For example, training data can be generated where each set of training data include (i) respiration patterns of the user and (ii) an indication of whether a low sleep onset latency was achieved. The machine learning model can be trained on this data to learn what specific types of respiration patterns are best for achieving a low sleep onset latency for the user. In some cases, the machine learning model is also trained on types of entrainment stimuli used (e.g., audio vs. visual vs. haptic vs. airflow modulation, etc.), user demographic data (e.g. age, gender, health conditions, BMI, etc.) so that the machine learning model can provide a more tailored entrainment program to the user.
[0203] FIG. 13 A is a front view of a user device 260 depicting a first view of a graphical user interface (GUI) 1300 for entrainment, according to some implementations of the present disclosure. The GUI 1300 can include various elements, such as instruction text 1302 and an entrainment visual element 1304A. The entrainment visual element 1304A can be animated to
change in a fashion that intuitively shows how a user is currently breathing and/or how the user should be breathing to achieve entrainment, as discussed in further detail herein.
[0204] In the example depicted in Fig. 13A, the entrainment visual element 1304A is depicted as a set of concentric circles that increase and decrease in diameter to indicate inspiration and expiration, respectively. An outer circle 1306A can have a largest diameter, the inner circle 1310A can have the smallest diameter, and the middle circle 1308 A can have a middle diameter that falls between the largest diameter of the outer circle 1306A and the smallest diameter of the inner circle 1310A.
[0205] In some cases, visual elements other than mere size can be used to intuitively signal inspiration and expiration, such as color, transparency, motion other than increasing or decreasing size, and the like.
[0206] FIG. 13B is a front view of the user device 260 of FIG. 13 A depicting a second view of a graphical user interface for entrainment, according to some implementations of the present disclosure. In this second view, the size of the entrainment visual element 1304B can be slightly larger than that of the entrainment visual element 1304A of FIG. 13A, thus depicting an inhalation animation from the first view to the second view.
[0207] The outer circle 1306B, middle circle 1308B, and inner circle 1310B each has a larger diameter than that of the outer circle 1306A, middle circle 1308A, and inner circle 1310A of FIG. 13 A, respectively.
[0208] In some cases, the relative visible surface area of any of the outer circle 1306B, middle circle 1308B, and inner circle 1310B can be controlled to provide additional intuitive cues to a user. For example, in this second view, the relative visible surface area of the outer circle 1306B and middle circle 1308B can be relatively smaller than that of the outer circle 1306A and middle circle 1308A of FIG. 13 A, respectively. Such a visual cue can indicate a given point within the user’s breath cycle or desired breath cycle, or can indicate a speed of inhalation/expiration. For example, the entrainment visual element 1304B of the second view may show a middle point in a desired breath cycle, which may be a point when the user is inhaling or exhaling relatively fast. By contrast, at maximum inhalation or maximum exhalation, visual cues can be used to show a point in the breath cycle where the user is inhaling or exhaling relatively slowly.
[0209] FIG. 13C is a front view of the user device 260 of FIG. 13 A depicting a third view of a graphical user interface for entrainment, according to some implementations of the present disclosure. In this third view, the size of the entrainment visual element 1304C can be slightly larger than that of the entrainment visual element 1304B of FIG. 13B, thus depicting a further
inhalation animation from the second view to the third view.
[0210] The outer circle 1306C, middle circle 1308C, and inner circle 1310C each has a larger diameter than that of the outer circle 1306B, middle circle 1308B, and inner circle 1310B of FIG. 13B, respectively.
[0211] In some cases, the relative visible surface area of any of the outer circle 1306C, middle circle 1308C, and inner circle 1310C can be controlled to provide additional intuitive cues to a user. For example, in this third view, the relative visible surface area of the outer circle 1306C and middle circle 1308C can be relatively larger than that of the outer circle 1306B and middle circle 1308B of FIG. 13B, respectively. Such a visual cue can indicate that the depicted breath cycle is nearing a maximum inhalation.
[0212] FIG. 13D is a front view of the user device 260 of FIG. 13 A depicting a fourth view of a graphical user interface for entrainment, according to some implementations of the present disclosure. In this fourth view, the size of the entrainment visual element 1304D can be smaller than that of the entrainment visual element 1304C of FIG. 13C, thus depicting an expiration animation from the third view to the fourth view.
[0213] The outer circle 1306D, middle circle 1308D, and inner circle 1310D each has a smaller diameter than that of the outer circle 1306C, middle circle 1308C, and inner circle 1310C of FIG. 13C, respectively.
[0214] In an example use case, the GUI can move between the third view (e.g., maximum inhalation) and the fourth view (e.g., maximum exhalation), passing through the second view. [0215] FIG. 14A is a front view of a user device 260 depicting a first view of a graphical user interface for entrainment using an alternate entrainment visual element 1404A, according to some implementations of the present disclosure. The user device 260 can be showing a graphical user interface that is similar to that of GUI 1300, but with a different style of animating its entrainment visual element 1404A. More specifically, the style of animation of the entrainment visual element 1404A in FIG. 14A is to have various parts of the entrainment visual element 1404A appear and disappear to represent inhalation and exhalation.
[0216] The entrainment visual element 1404A can show an outer circle 1406A, a middle circle 1408A, and an inner circle 1410A, each having a smaller diameter than the previous. As depicted in the first view in FIG. 14A, each of the outer circle 1406A, middle circle 1408A, and inner circle 1410A are visible. Having these three circles all visible can represent a time of maximum inhalation.
[0217] FIG. 14B is a front view of the user device of FIG. 13 A depicting a second view of a graphical user interface for entrainment using an alternate entrainment visual element 1404B,
according to some implementations of the present disclosure.
[0218] The entrainment visual element 1404B can show a middle circle 1408B and an inner circle 1410B. However, the outer circle 1406B is de-emphasized, such as by decreasing its transparency or by simply not displaying it. Having the outer circle 1406B be de-emphasized (e.g., hidden) can represent a time between maximum inhalation and maximum expiration.
[0219] FIG. 14C is a front view of the user device of FIG. 13A depicting a third view of a graphical user interface for entrainment using an alternate entrainment visual element 1304C, according to some implementations of the present disclosure.
[0220] The entrainment visual element 1404C can show an inner circle 1410C. However, the outer circle 1406C and the middle circle 1408C are both de-emphasized, such as by decreasing their transparencies or by simply not displaying them. Having the outer circle 1406C and middle circle 1408C be de-emphasized (e.g., hidden) can represent maximum expiration.
[0221] In an example use case, the GUI can move between the first view (e.g., maximum inhalation) and the third view (e.g., maximum exhalation), passing through the second view. When moving from the first view to the second view and second view to the third view, the circles being de-emphasized can gradually fade away or otherwise become de-emphasized, thus representing the process of expiration. When moving from a third view to the second view and the second view to the first view, the circles no longer being de-emphasized can be reemphasized gradually, such as by gradually fading in or otherwise becoming re-emphasized. The speed of inhalation or expiration can be intuitively indicated by changing the speed by which a circle becomes de-emphasized or re-emphasized.
[0222] In some cases, an entrainment visual element can be animated using a combination on animations, such as a combination of those discussed with reference to FIGs. 13A - 14C (e.g., a combination of animating the diameter of concentric circles while also animating the visibility of at least some of those circles).
[0223] FIGs. 13A-13D and FIGs. 14A-14C depict how an entrainment visual element may appear at different points in a breath cycle. While the examples in these figures describe a certain respiratory orientation to the animation (e.g., increases in diameter or appearance of larger-diameter circles equates to inspiration), opposite or other respiratory orientations can be used (e.g., increases in diameter or appearance of larger-diameter circles equates to expiration). Additionally, while circles are depicted in these examples, in some cases, other shapes, images, or visual elements can be used. For example, instead of the growing and shrinking concentric circles of FIGs. 13 A- 13D, a growing and shrinking set of overlapping curves or a growing and shrinking image can be used. Likewise, instead of the de-emphasized and re-emphasized
concentric circles of FIGs. 14A-14C, portions of an image (e.g., a top 1/3 and middle 1/3 of a diagram of a pair of lungs) can be de-emphasized and re-emphasized progressively.
[0224] Generally, any of the methods disclosed herein can be implemented using a system having a control system with one or more processors, and a memory device storing machine- readable instructions. The control system can be coupled to the memory device, and methods can be implemented when the machine-readable instructions are executed by at least one of the processors of the control system. The methods can also be implemented using a computer program product (such as a non-transitory computer readable medium) comprising instructions that when executed by a computer, cause the computer to carry out the steps of the methods.
[0225] One or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of claims and/or Alternative Implementations below can be combined with one or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the other claims and/or Alternative Implementations and/or combinations thereof, to form one or more additional implementations and/or claims of the present disclosure.
[0226] ALTERNATIVE IMPLEMENTATIONS
[0227] Alternative Implementation 1. A method comprising: receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extracting first respiration information from the first data; presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating at least a first entrainment waveform and presenting at least a first entrainment stimulus based at least in part on the first entrainment waveform; generating at least one entrainment coherence score indicative of coherence between the first respiration information and the first entrainment waveform; receiving second data associated with a user engaging in a current sleep session; and presenting a second entrainment program to the user during the current sleep session that is based at least in part on the second data, the at least one entrainment coherence score, or both.
[0228] Alternative Implementation 2. The method of Alternative Implementation 1, wherein the first entrainment waveform is predetermined and not based on either the first data or the first respiration information.
[0229] Alternative Implementation 3. The method of Alternative Implementation 1, wherein the first entrainment waveform is based at least in part on the first data, the first respiration information, or both.
[0230] Alternative Implementation 4. The method of Alternative Implementation 3, wherein generating the first entrainment waveform includes:
[0231] generating a predetermined entrainment waveform; and
[0232] modifying the predetermined entrainment waveform based on the first data, the first respiration information, or both.
[0233] Alternative Implementation 5. The method of any one of Alternative Implementations 1 to 4, wherein the first respiration information includes a current respiration pattern of the user, and wherein the first entrainment waveform represents a target respiration pattern.
[0234] Alternative Implementation 6. The method of Alternative Implementation 5, wherein the target respiration pattern includes a target inspiration/expiration ratio.
[0235] Alternative Implementation 7. The method of Alternative Implementation 5, wherein the target respiration pattern includes a target inspiration duration, a target inspiration hold duration, a target expiration duration, and a target expiration hold duration.
[0236] Alternative Implementation 8. The method of any one of Alternative Implementations 5 to 7, wherein presenting the first entrainment program includes displaying on a display device (i) a current waveform representing the current respiration pattern of the user, and (ii) the first entrainment waveform representing the target respiration pattern.
[0237] Alternative Implementation 9. The method of Alternative Implementation 8, wherein, on the display device, the first entrainment waveform is overlaid on the current waveform.
[0238] Alternative Implementation 10. The method of any one of Alternative Implementations 1 to 9, wherein the first respiration information includes a current respiration rate of the user, and wherein the first entrainment waveform represents a target respiration rate.
[0239] Alternative Implementation 11. The method of Alternative Implementation 10, further comprising: updating the first entrainment waveform to represent an updated target respiration rate that is different than the target respiration rate; and presenting the first entrainment stimulus based at least in part on the updated first entrainment waveform.
[0240] Alternative Implementation 12. The method of Alternative Implementation 11, wherein the first entrainment waveform is updated in response to the entrainment coherence score satisfying a threshold value.
[0241] Alternative Implementation 13. The method of Alternative Implementation 12, wherein the first entrainment waveform is updated in response to the entrainment coherence score satisfying the threshold value for at least a predetermined amount of time.
[0242] Alternative Implementation 14. The method of any one of Alternative Implementations 10 to 13, wherein the target respiration rate is less than the current respiration rate.
[0243] Alternative Implementation 15. The method of any one of Alternative Implementations 1 to 14, wherein presenting the first entrainment stimulus includes (i) generating an audio
stimulus; (ii) modulating an existing audio stimulus; (iii) generating a visual stimulus; (iv) modulating an existing visual stimulus; (v) generating a haptic stimulus; (vi) modulating an existing haptic stimulus; (vii) modulating a flow of air generated by the respiratory therapy system; or (viii) any combination of (i)-(vii).
[0244] Alternative Implementation 16. The method of any one of Alternative Implementations 1 to 15, wherein generating the first entrainment waveform includes inputting into a machine learning algorithm the first data, the first respiration information, or both, the machine learning algorithm being trained to output the first entrainment waveform.
[0245] Alternative Implementation 17. The method of any one of Alternative Implementations 1 to 16, wherein the second entrainment program is based at least in part on both the second data and the entrainment coherence score.
[0246] Alternative Implementation 18. The method of any one of Alternative Implementations 1 to 17, wherein presenting the second entrainment program to the user during the current sleep session includes: generating a second entrainment waveform; and presenting a second entrainment stimulus based at least in part on the second entrainment waveform.
[0247] Alternative Implementation 19. The method of Alternative Implementation 18, wherein the second entrainment stimulus is different than the first entrainment stimulus.
[0248] Alternative Implementation 20. The method of Alternative Implementation 18 or 19, wherein the first entrainment stimulus includes a visual stimulus, and wherein the second entrainment stimulus includes an audio stimulus, a haptic stimulus, a modulation of a flow of air generated by the respiratory therapy system, or any combination thereof.
[0249] Alternative Implementation 21. The method of Alternative Implementation 18, wherein the second entrainment stimulus is identical to the first entrainment stimulus.
[0250] Alternative Implementation 22. The method of Alternative Implementation 18 or 21, wherein the first entrainment stimulus and the second entrainment stimulus both include an audio stimulus, a visual stimulus, a haptic stimulus, a modulation of a flow of air generated by the respiratory therapy system, or any combination thereof.
[0251] Alternative Implementation 23. The method of any one of Alternative Implementations 18 to 22, wherein presenting the second entrainment stimulus includes (i) generating an audio stimulus; (ii) modulating an existing audio stimulus; (iii) generating a visual stimulus; (iv) modulating an existing visual stimulus; (v) generating a haptic stimulus; (vi) modulating an existing haptic stimulus; (vii) modulating a flow of air generated by the respiratory therapy system; or (viii) any combination of (i)-(vii).
[0252] Alternative Implementation 24. The method of Alternative Implementation 23, wherein modulating the flow of air includes modulating a pressure of the air.
[0253] Alternative Implementation 25. The method of Alternative Implementation 24, wherein modulating the flow of air includes modulating the pressure of the air in accordance with a target respiration pattern.
[0254] Alternative Implementation 26. The method of any one of Alternative Implementations
17 to 23, wherein presenting the second entrainment program includes: generating a temporary entrainment waveform; and updating the temporary entrainment waveform based at least in part on the coherence score to generate the second entrainment waveform.
[0255] Alternative Implementation 27. The method of Alternative Implementation 26, wherein updating the temporary entrainment waveform is further based on the second data.
[0256] Alternative Implementation 28. The method of Alternative Implementation 26 or 27, wherein the temporary entrainment waveform represents an initial target respiration pattern, and wherein updating the temporary entrainment waveform includes: determining an updated target respiration pattern based at least in part on the initial target respiration pattern and the coherence score; and updating the temporary entrainment waveform so that the second entrainment waveform represents the updated target respiration pattern.
[0257] Alternative Implementation 29. The method of Alternative Implementation 27, wherein determining the updated target respiration pattern is further based on the second data.
[0258] Alternative Implementation 30. The method of any one of Alternative Implementations
18 to 23, wherein generating the second entrainment waveform includes inputting into a machine learning algorithm the second data, the coherence score, or both, the machine learning algorithm being trained to output the second entrainment waveform.
[0259] Alternative Implementation 31. The method of any one of Alternative Implementations 18 to 30, further comprising accessing historical acclimatization information associated with one or more prior acclimatization sessions, the historical acclimatization information including historical respiration information and a historical entrainment coherence score for each session of the one or more prior acclimatization sessions, wherein generating the second entrainment waveform is based at least in part on the historical acclimatization information.
[0260] Alternative Implementation 32. The method of any one of Alternative Implementations 1 to 31 , wherein the respiratory therapy system includes a user interface configured to be fluidly coupled to a respiratory therapy device via a conduit, the respiratory therapy device being operable to cause air to flow through the conduit and to the user interface.
[0261] Alternative Implementation 33. The method of Alternative Implementation 32, wherein the acclimatization session occurs while the user is awake and is wearing the user interface.
[0262] Alternative Implementation 34. The method of Alternative Implementation 33, wherein the acclimatization session occurs while the user interface is fluidly coupled to the respiratory therapy device via the conduit.
[0263] Alternative Implementation 35. The method of Alternative Implementation 34, wherein the acclimatization session occurs while the respiratory therapy device is causing air to flow through the conduit and to the user interface.
[0264] Alternative Implementation 36. The method of Alternative Implementation 34, wherein the acclimatization session occurs while the respiratory therapy device is not causing air to flow through the conduit and to the user interface.
[0265] Alternative Implementation 37. The method of Alternative Implementation 33, wherein the acclimatization session occurs while the user interface is not fluidly coupled to the respiratory therapy devices via the conduit.
[0266] Alternative Implementation 38. The method of any one of Alternative Implementations 33 to 37, wherein the acclimatization session occurs when one or more valves of the user interface are open to surrounding air.
[0267] Alternative Implementation 39. The method of Alternative Implementation 32, wherein the acclimatization session occurs while the user is not wearing the user interface of a respiratory therapy system.
[0268] Alternative Implementation 40. The method of any one of Alternative Implementations 1 to 39, further comprising presenting acclimatization sounds during the acclimatization session, the acclimatization sounds presented to simulate to the use of a respiratory therapy system by the user.
[0269] Alternative Implementation 41. The method of Alternative Implementation 40, wherein presenting the first entrainment stimulus includes modulating the acclimatization sounds based at least in part on the first entrainment waveform.
[0270] Alternative Implementation 42. The method of any one of Alternative Implementations 1 to 41, wherein the entrainment coherence score includes a plurality of entrainment coherence sub-scores, and wherein each entrainment coherence sub-score of the plurality of entrainment coherence sub-scores is indicative of entrainment coherence at a respective time during the acclimatization session.
[0271] Alternative Implementation 43. The method of Alternative Implementation 42, wherein the acclimatization session occurs while a respiratory therapy device of the respiratory therapy
system is causing air to flow to a user interface that is worn by the user, and wherein each subscore of the plurality of sub-scores corresponds to a respective pressure of the air flowing to the user interface.
[0272] Alternative Implementation 44. The method of Alternative Implementation 42, wherein presenting the second entrainment program to the user during the current sleep session includes: determining, based at least in part on the second data, a current pressure of air provided to the user via a respiratory therapy system during the current sleep session; generating a second entrainment waveform based on (i) the current pressure of the air and (ii) the one of the plurality of entrainment coherence sub-scores that is associated with the current pressure; and presenting a second entrainment stimulus based on the second entrainment waveform.
[0273] Alternative Implementation 45. The method of any one of Alternative Implementations 1 to 43, further comprising: extracting second respiration information from the second data, wherein presenting the second entrainment program includes generating a second entrainment waveform; determining an additional entrainment coherence score indicative of coherence between the second respiration information and the second entrainment waveform; and in response to determining that the additional entrainment coherence score satisfies a threshold, transmitting a notification signal indicative of a need for an adjustment in the respiratory therapy system.
[0274] Alternative Implementation 46. The method of any one of Alternative Implementations 1 to 45, further comprising presenting the entrainment coherence score using a display device. [0275] Alternative Implementation 47. The method of Alternative Implementation 46, wherein presenting the entrainment coherence score occurs during the acclimatization session.
[0276] Alternative Implementation 48. The method of Alternative Implementation 46 or 47, wherein presenting the entrainment coherence score includes: generating a first trace based at least in part on the first respiration information; generating a second trace at least in part on the first entrainment waveform; presenting the first trace; and presenting the second trace adjacent to or overlying the first trace.
[0277] Alternative Implementation 49. The method of any one of Alternative Implementations 46 to 48, wherein presenting the entrainment coherence score occurs when the entrainment coherence score satisfies a threshold value.
[0278] Alternative Implementation 50. The method of any one of Alternative Implementations 1 to 49, wherein the first data, the second data, or both, include: pressure data associated with a pressure of air flowing from a respiratory therapy device of the respiratory therapy system to
a user interface worn by the user, flow rate data associated with a flow rate of the air, motion data associated with movement of the user, image data reproducible as one or more images of the user, PPG data, ECG data, EEG data, or any combination thereof.
[0279] Alternative Implementation 51. The method of any one of Alternative Implementations 1 to 50, wherein presenting the first entrainment program and generating the entrainment coherence score comprises: during the acclimatization session where the user is awake and wearing the user interface, causing air to flow from the respiratory therapy device to the user interface at a plurality of different pressure values; for each of the plurality of pressure values, presenting a plurality of entrainment stimuli to the user, each of the plurality of entrainment stimuli being based on one of a plurality of entrainment waveforms; and determining, for each distinct combination of one of the plurality of pressure values and one of the plurality of entrainment waveforms, an entrainment coherence score indicative of coherence between a respiration pattern of the user and the one entrainment waveform.
[0280] Alternative Implementation 52. The method of Alternative Implementation 51, wherein presenting the second entrainment program comprises: during the current sleep session where the user is wearing the user interface and air is flowing from the respiratory therapy device to the user interface, determining a pressure value of the air; generating a sleep session entrainment waveform based on the pressure value of the air flowing during the sleep session and the entrainment coherence scores associated with the corresponding pressure value of the air flowing during the acclimatization session; and presenting a sleep session entrainment stimulus to the user based on the sleep session entrainment waveform.
[0281] Alternative Implementation 53. The method of Alternative Implementation 52, wherein the sleep session entrainment waveform is the one of the plurality of entrainment waveforms having a maximum entrainment coherence score among all entrainment coherence scores for the corresponding pressure value of the air flowing during the acclimatization session.
[0282] Alternative Implementation 54. The method of any one of Alternative Implementations 1 to 53, wherein presenting the first entrainment program or the second entrainment program to the user comprises: determining a current pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generating an entrainment waveform based at least in part on the current pressure of the air; and presenting an entrainment stimulus to the user based at least in part on the entrainment waveform.
[0283] Alternative Implementation 55. The method of Alternative Implementation 54, wherein in response to the current pressure of the air changing to a new pressure, the method further comprises: generating a new entrainment waveform based at least in part on the new pressure
of the air; and presenting a new entrainment stimulus to the user based at least in part on the new entrainment waveform.
[0284] Alternative Implementation 56. The method of Alternative Implementation 54, wherein the generation of the entrainment waveform is further based at least in part on the entrainment coherence score determined during use of the respiratory therapy system by the user during the acclimatization session.
[0285] Alternative Implementation 57. The method of any one of Alternative Implementations 1 to 56, wherein presenting the first entrainment program or the second entrainment program comprises: causing air having a first pressure to flow from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generating an initial entrainment waveform based at least in part on the first pressure of the air; presenting an initial entrainment stimulus to the user based at least in part on the initial entrainment waveform; subsequently causing air having a second pressure to flow from the respiratory therapy device to the user interface, the second pressure being different than the first pressure; and presenting a subsequent entrainment stimulus to the user that is different than the initial entrainment stimulus.
[0286] Alternative Implementation 58. The method of Alternative Implementation 57, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, and is based on the initial entrainment waveform.
[0287] Alternative Implementation 59. The method of Alternative Implementation 57, further comprising generating a subsequent entrainment waveform based at least in part on the second pressure of the air that is different than the initial entrainment waveform, wherein the subsequent entrainment stimulus is based on the subsequent entrainment waveform.
[0288] Alternative Implementation 60. The method of Alternative Implementation 59, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, or is an identical type of stimulus as the initial entrainment stimulus.
[0289] Alternative Implementation 61. The method of any one of Alternative Implementations 1 to 60, wherein presenting the second entrainment program to the user during the sleep session comprises: generating an initial entrainment waveform; at a first time during the sleep session, presenting an initial entrainment stimulus to the user based at least in part on the initial entrainment waveform; and at a second time after the first time during the sleep session, presenting a subsequent entrainment stimulus to the user that is different than the initial entrainment stimulus.
[0290] Alternative Implementation 62. The method of Alternative Implementation 61, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, and is based on the initial entrainment waveform.
[0291] Alternative Implementation 63. The method of Alternative Implementation 61, further comprising generating a subsequent entrainment waveform, wherein the subsequent entrainment stimulus is based on the subsequent entrainment waveform.
[0292] Alternative Implementation 64. The method of Alternative Implementation 63, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, or is an identical type of stimulus as the initial entrainment stimulus.
[0293] Alternative Implementation 65. The method of any one of Alternative Implementations 1 to 64, wherein presenting the second entrainment program to the user during the current sleep session comprises: determining a first current respiration rate of the user; generating an initial entrainment waveform representing a first target respiration rate that is less than the first current respiration rate of the user; presenting an initial entrainment stimulus to the user based on the initial entrainment waveform; determining, after the initial entrainment stimulus has been presented to the user, a second current respiration rate of the user; and in response to determining that a difference between the second current respiration rate of the user and the first target respiration rate satisfies a threshold difference, (i) generating a first subsequent entrainment waveform representing a second target respiration rate that is less than the first target respiration rate and (ii) presenting a first subsequent entrainment stimulus to the user based on the first subsequent entrainment waveform.
[0294] Alternative Implementation 66. The method of Alternative Implementation 65, wherein the subsequent entrainment stimulus is an identical type of stimulus as the initial entrainment stimulus.
[0295] Alternative Implementation 67. The method of Alternative Implementation 65, further comprising: determining, after the subsequent entrainment stimulus has been presented to the user, a third current respiration rate of the user; and in response to determining that a difference between the third current respiration rate of the user and the second target respiration rate satisfies the threshold difference, (i) generating a second subsequent entrainment waveform representing a third target respiration rate that is less than the second target respiration rate and (ii) presenting a second subsequent entrainment stimulus to the user based on the third entrainment waveform.
[0296] Alternative Implementation 68. The method of Alternative Implementation 65, further comprising determining an elapsed time since a beginning of the sleep session, and wherein in
response to the elapsed time being greater than or equal to a threshold time, the second subsequent entrainment stimulus is a different type of stimulus than the first subsequent entrainment stimulus.
[0297] Alternative Implementation 69. The method of Alternative Implementation 68, wherein the second subsequent entrainment stimulus is an identical type of stimulus as the first subsequent entrainment stimulus in response to the elapsed time being less than the threshold time.
[0298] Alternative Implementation 70. The method of Alternative Implementation 65, further comprising: determining, after the first subsequent entrainment stimulus has been presented to the user, a third current respiration rate of the user; and in response to determining that a difference between the third current respiration rate of the user and the second current respiration rate satisfies the threshold difference, continuing to present the first entrainment stimulus.
[0299] Alternative Implementation 71. The method of any one of Alternative Implementations 1 to 70, wherein the at least one entrainment coherence score includes a plurality of entrainment coherence scores, each entrainment coherence score being associated with a respective entrainment waveform generated during the acclimatization session, a type of entrainment stimulus presented to the user based on the respective entrainment waveform, a pressure of air flowing in the respiratory therapy system when the respective entrainment waveform was generated, or any combination thereof.
[0300] Alternative Implementation 72. The method of any one of Alternative Implementations 1 to 71, wherein presenting the first entrainment program to the user during the acclimatization session comprises: while the user is awake and not wearing a user interface to which air is provided by a respiratory therapy device of the respiratory therapy system, presenting the first entrainment stimulus to the user; and while the user is awake and not wearing the user interface, subsequently presenting a second entrainment stimulus to the user.
[0301] Alternative Implementation 73. The method of Alternative Implementation 72, wherein the first entrainment stimulus is different than the second entrainment stimulus.
[0302] Alternative Implementation 74. The method of Alternative Implementation 73, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
[0303] Alternative Implementation 75. The method of Alternative Implementation 73, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
[0304] Alternative Implementation 76. The method of Alternative Implementation 73, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
[0305] Alternative Implementation 77. The method of Alternative Implementation 72, wherein the first entrainment stimulus is based on a first entrainment waveform representing a first target respiration pattern, and wherein the second entrainment stimulus is based on a second entrainment waveform representing a second target respiration pattern that is different than the first target respiration pattern.
[0306] Alternative Implementation 78. The method of Alternative Implementation 77, wherein both the first entrainment stimulus and the second entrainment stimulus comprise visual stimuli.
[0307] Alternative Implementation 79. The method of Alternative Implementation 77, wherein both the first entrainment stimulus and the second entrainment stimulus comprise audio stimuli. [0308] Alternative Implementation 80. The method of Alternative Implementation 77, wherein both the first entrainment stimulus and the second entrainment stimulus comprise haptic stimuli.
[0309] Alternative Implementation 81. The method of Alternative Implementation 77, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
[0310] Alternative Implementation 82. The method of Alternative Implementation 77, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
[0311] Alternative Implementation 83. The method of Alternative Implementation 77, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
[0312] Alternative Implementation 84. A method, comprising: receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extracting first respiration information from the first data; and presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
[0313] Alternative Implementation 85. The method of Alternative Implementation 84, wherein the first entrainment waveform is predetermined and not based on either the first data or the first respiration information.
[0314] Alternative Implementation 86. The method of Alternative Implementation 84, wherein the first entrainment waveform is based at least in part on the first data, the first respiration information, or both.
[0315] Alternative Implementation 87. The method of Alternative Implementation 86, wherein generating the first entrainment waveform includes:
[0316] generating a predetermined entrainment waveform; and
[0317] modifying the predetermined entrainment waveform based on the first data, the first respiration information, or both.
[0318] Alternative Implementation 88. The method of any one of Alternative Implementations 84 to 87, wherein the first respiration information includes a current respiration pattern of the user, and wherein the first entrainment waveform represents a target respiration pattern.
[0319] Alternative Implementation 89. The method of Alternative Implementation 88, wherein presenting the first entrainment program includes displaying on a display device (i) a current waveform representing the current respiration pattern of the user, and (ii) the first entrainment waveform representing the target respiration pattern.
[0320] Alternative Implementation 90. The method of Alternative Implementation 89, wherein, on the display device, the first entrainment waveform is overlaid on the current waveform.
[0321] Alternative Implementation 91. The method of any one of Alternative Implementations 84 to 90, wherein the first respiration information includes a current respiration rate of the user, and wherein the first entrainment waveform represents a target respiration rate.
[0322] Alternative Implementation 92. The method of Alternative Implementation 91, further comprising: updating the first entrainment waveform to represent an updated target respiration rate that is different than the target respiration rate; and presenting the first entrainment stimulus based at least in part on the updated first entrainment waveform.
[0323] Alternative Implementation 93. The method of Alternative Implementation 92, wherein the first entrainment waveform is updated in response to an entrainment coherence score satisfying a threshold value, the entrainment coherence score being indicative of coherence between the current respiration rate of the user and the first entrainment waveform.
[0324] Alternative Implementation 94. The method of Alternative Implementation 93, wherein the first entrainment waveform is updated in response to the entrainment coherence score satisfying the threshold value for at least a predetermined amount of time.
[0325] Alternative Implementation 95. The method of any one of Alternative Implementations 91 to 94, wherein the target respiration rate is less than the current respiration rate.
[0326] Alternative Implementation 96. The method of any one of Alternative Implementations 84 to 95, wherein presenting the first entrainment stimulus includes (i) generating an audio stimulus; (ii) modulating an existing audio stimulus; (iii) generating a visual stimulus; (iv) modulating an existing visual stimulus; (v) generating a haptic stimulus; (vi) modulating an existing haptic stimulus; (vii) modulating a flow of air generated by the respiratory therapy system; or (viii) any combination of (i)-(vii).
[0327] Alternative Implementation 97. The method of any one of Alternative Implementations 84 to 96, wherein generating the first entrainment waveform includes inputting into a machine learning algorithm the first data, the first respiration information, or both, the machine learning algorithm being trained to output the first entrainment waveform.
[0328] Alternative Implementation 98. The method of any one of Alternative Implementations 84 to 97, wherein the respiratory therapy system includes a user interface configured to be fluidly coupled to a respiratory therapy device via a conduit, the respiratory therapy device being operable to cause air to flow through the conduit and to the user interface.
[0329] Alternative Implementation 99. The method of Alternative Implementation 98, wherein the acclimatization session occurs while the user is awake and is wearing the user interface.
[0330] Alternative Implementation 100. The method of Alternative Implementation 99, wherein the acclimatization session occurs while the user interface is fluidly coupled to the respiratory therapy device via the conduit.
[0331] Alternative Implementation 101. The method of Alternative Implementation 100, wherein the acclimatization session occurs while the respiratory therapy device is causing air to flow through the conduit and to the user interface.
[0332] Alternative Implementation 102. The method of Alternative Implementation 100, wherein the acclimatization session occurs while the respiratory therapy device is not causing air to flow through the conduit and to the user interface.
[0333] Alternative Implementation 103. The method of Alternative Implementation 99, wherein the acclimatization session occurs while the user interface is not fluidly coupled to the respiratory therapy devices via the conduit.
[0334] Alternative Implementation 104. The method of any one of Alternative Implementations 99 to 103, wherein the acclimatization session occurs when one or more valves of the user interface are open to surrounding air.
[0335] Alternative Implementation 105. The method of Alternative Implementation 98, wherein the acclimatization session occurs while the user is not wearing the user interface of a respiratory therapy system.
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[0336] Alternative Implementation 106. The method of any one of Alternative Implementations 84 to 105, further comprising presenting acclimatization sounds during the acclimatization session, the acclimatization sounds presented to simulate to the user use of a respiratory therapy system by the user.
[0337] Alternative Implementation 107. The method of Alternative Implementation 106, wherein presenting the first entrainment stimulus includes modulating the acclimatization sounds based at least in part on the first entrainment waveform.
[0338] Alternative Implementation 108. The method of any one of Alternative Implementations 84 to 107, further comprising generating an entrainment coherence score indicative of coherence between the first respiration information and the first entrainment waveform, wherein the entrainment coherence score includes a plurality of sub-scores, and wherein each sub-score of the plurality of sub-scores is indicative of entrainment coherence at a respective time during the acclimatization session.
[0339] Alternative Implementation 109. The method of Alternative Implementation 108, wherein the acclimatization session occurs while a respiratory therapy device of the respiratory therapy system is causing air to flow to a user interface that is worn by the user, and wherein each sub-score of the plurality of sub-scores corresponds to a respective pressure of the air flowing to the user interface.
[0340] Alternative Implementation 110. The method of Alternative Implementation 108 or Alternative Implementation 109, further comprising presenting the entrainment coherence score using a display device.
[0341] Alternative Implementation 111. The method of Alternative Implementation 110, wherein presenting the entrainment coherence score occurs during the acclimatization session. [0342] Alternative Implementation 112. The method of Alternative Implementation 110 or 111, wherein presenting the entrainment coherence score includes: generating a first trace based at least in part on the first respiration information; generating a second trace at least in part on the first entrainment waveform; presenting the first trace; and presenting the second trace adjacent to or overlying the first trace.
[0343] Alternative Implementation 113. The method of any one of Alternative Implementations 110 to 112, wherein presenting the entrainment coherence score occurs when the entrainment coherence score satisfies a threshold value.
[0344] Alternative Implementation 114. A method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session, the method comprising: receiving entrainment coherence data associated with one or more entrainment
stimuli presented to the user during an acclimatization session prior to the sleep session; generating an entrainment waveform based at least in part on the entrainment coherence data; and presenting an entrainment stimulus to the user based at least in part on the entrainment waveform, the entrainment coherence data, or both.
[0345] Alternative Implementation 115. The method of Alternative Implementation 114, wherein the entrainment coherence data includes a plurality of entrainment coherence scores, each entrainment coherence score being associated with a respective entrainment waveform generated during the acclimatization session, a type of entrainment stimulus presented to the user based on the respective entrainment waveform, a pressure of air flowing in the respiratory therapy system when the respective entrainment waveform was generated, or any combination thereof.
[0346] Alternative Implementation 116. A method of presenting an entrainment program during use of a respiratory therapy system by a user, the respiratory therapy system including a respiratory therapy device configured to cause pressurized air to flow to a user interface worn by the user, the method comprising: during an acclimatization session where the user is awake and wearing the user interface, causing air to flow from the respiratory therapy device to the user interface at a plurality of different pressure values; for each of the plurality of pressure values, presenting a plurality of entrainment stimuli to the user, each of the plurality of entrainment stimuli being based on one of a plurality of entrainment waveforms; determining, for each distinct combination of one of the plurality of pressure values and one of the plurality of entrainment waveforms, an entrainment coherence score indicative of coherence between a respiration pattern of the user and the one entrainment waveform; during a sleep session where the user is wearing the user interface and air is flowing from the respiratory therapy device to the user interface, determining a pressure value of the air; generating a sleep session entrainment waveform based on the pressure value of the air flowing during the sleep session and the entrainment coherence scores associated with the corresponding pressure value of the air flowing during the acclimatization session; and presenting a sleep session entrainment stimulus to the user based on the sleep session entrainment waveform.
[0347] Alternative Implementation 117. The method of Alternative Implementation 116, wherein the sleep session entrainment waveform is the one of the plurality of entrainment waveforms having a maximum entrainment coherence score among all entrainment coherence scores for the corresponding pressure value of the air flowing during the acclimatization session.
[0348] Alternative Implementation 118. A method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session, the method comprising: determining a current pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generating an entrainment waveform based at least in part on the current pressure of the air; and presenting an entrainment stimulus to the user based at least in part on the entrainment waveform.
[0349] Alternative Implementation 119. The method of Alternative Implementation 118, wherein in response to the current pressure of the air changing to a new pressure, the method further comprises: generating a new entrainment waveform based at least in part on the new pressure of the air; and presenting a new entrainment stimulus to the user based at least in part on the new entrainment waveform.
[0350] Alternative Implementation 120. The method of Alternative Implementation 118, wherein the generation of the entrainment waveform is further based at least in part on an entrainment coherence score determined during use of the respiratory therapy system by the user during an acclimatization session.
[0351] Alternative Implementation 121. A method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session, the method comprising: causing air having a first pressure to flow from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generating a first entrainment waveform based at least in part on the first pressure of the air; presenting a first entrainment stimulus to the user based at least in part on the first entrainment waveform; subsequently causing air having a second pressure to flow from the respiratory therapy device to the user interface, the second pressure being different than the first pressure; and presenting a second entrainment stimulus to the user that is different than the first entrainment stimulus.
[0352] Alternative Implementation 122. The method of Alternative Implementation 121, wherein the second entrainment stimulus is a different type of stimulus than the first entrainment stimulus, and is based on the first entrainment waveform.
[0353] Alternative Implementation 123. The method of Alternative Implementation 121, further comprising generating a second entrainment waveform based at least in part on the second pressure of the air that is different than the first entrainment waveform, wherein the second entrainment stimulus is based on the second entrainment waveform.
[0354] Alternative Implementation 124. The method of Alternative Implementation 123, wherein the second entrainment stimulus is a different type of stimulus than the first entrainment stimulus, or is an identical type of stimulus as the first entrainment stimulus.
[0355] Alternative Implementation 125. A method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session, the method comprising: generating a first entrainment waveform; at a first time during the sleep session, presenting a first entrainment stimulus to the user based at least in part on the first entrainment waveform; and at a second time after the first time during the sleep session, presenting a second entrainment stimulus to the user that is different than the first entrainment stimulus.
[0356] Alternative Implementation 126. The method of Alternative Implementation 125, wherein the second entrainment stimulus is a different type of stimulus than the first entrainment stimulus, and is based on the first entrainment waveform.
[0357] Alternative Implementation 127. The method of Alternative Implementation 125, further comprising generating a second entrainment waveform, wherein the second entrainment stimulus is based on the second entrainment waveform.
[0358] Alternative Implementation 128. The method of Alternative Implementation 127, wherein the second entrainment stimulus is a different type of stimulus than the first entrainment stimulus, or is an identical type of stimulus as the first entrainment stimulus.
[0359] Alternative Implementation 129. A method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session, the method comprising: determining a first respiration rate of the user; generating a first entrainment waveform representing a first target respiration rate that is less than the current respiration rate of the user; presenting a first entrainment stimulus to the user based on the first entrainment waveform; determining, after the first entrainment stimulus has been presented to the user, a second respiration rate of the user; and in response to determining that a difference between the second respiration rate of the user and the first target respiration rate satisfies a threshold difference, (i) generating a second entrainment waveform representing a second target respiration rate that is less than the first target respiration rate and (ii) presenting a second entrainment stimulus to the user based on the second entrainment waveform.
[0360] Alternative Implementation 130. The method of Alternative Implementation 129, wherein the second entrainment stimulus is an identical type of stimulus as the first entrainment stimulus.
[0361] Alternative Implementation 131. The method of Alternative Implementation 129, further comprising: determining, after the second entrainment stimulus has been presented to the user, a third respiration rate of the user; and in response to determining that a difference between the third respiration rate of the user and the second respiration rate satisfies the threshold difference, (i) generating a third entrainment waveform representing a third target
respiration rate that is less than the second target respiration rate and (ii) presenting a third entrainment stimulus to the user based on the third entrainment waveform.
[0362] Alternative Implementation 132. The method of Alternative Implementation 131, further comprising determining an elapsed time since a beginning of the sleep session, and wherein in response to the elapsed time being greater than or equal to a threshold time, the third entrainment stimulus is a different type of stimulus than the second entrainment stimulus.
[0363] Alternative Implementation 133. The method of Alternative Implementation 132, wherein the third entrainment stimulus is an identical type of stimulus as the second entrainment stimulus in response to the elapsed time being less than the threshold time.
[0364] Alternative Implementation 134. The method of Alternative Implementation 129, further comprising: determining, after the second entrainment stimulus has been presented to the user, a third respiration rate of the user; and in response to determining that a difference between the third respiration rate of the user and the second respiration rate satisfies the threshold difference, continuing to present the second entrainment stimulus.
[0365] Alternative Implementation 135. A method of presenting stimuli during an acclimatization session to a user who uses a respiratory therapy system during a sleep session, the respiratory therapy system including a respiratory therapy device configured to provide air to a user interface worn by the user during the sleep session, the method comprising: while the user is awake and not wearing the user interface, presenting a first entrainment stimulus to the user; and while the user is awake and not wearing the user interface, subsequently presenting a second entrainment stimulus to the user.
[0366] Alternative Implementation 136. The method of Alternative Implementation 135, wherein the first entrainment stimulus is different than the second entrainment stimulus.
[0367] Alternative Implementation 137. The method of Alternative Implementation 136, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
[0368] Alternative Implementation 138. The method of Alternative Implementation 136, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
[0369] Alternative Implementation 139. The method of Alternative Implementation 136, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
[0370] Alternative Implementation 140. The method of Alternative Implementation 135, wherein the first entrainment stimulus is based on a first entrainment waveform representing a
first target respiration pattern, and wherein the second entrainment stimulus is based on a second entrainment waveform representing a second target respiration pattern that is different than the first target respiration pattern.
[0371] Alternative Implementation 141. The method of Alternative Implementation 140, wherein both the first entrainment stimulus and the second entrainment stimulus comprise visual stimuli.
[0372] Alternative Implementation 142. The method of Alternative Implementation 140, wherein both the first entrainment stimulus and the second entrainment stimulus comprise audio stimuli.
[0373] Alternative Implementation 143. The method of Alternative Implementation 140, wherein both the first entrainment stimulus and the second entrainment stimulus comprise haptic stimuli.
[0374] Alternative Implementation 144. The method of Alternative Implementation 140, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
[0375] Alternative Implementation 145. The method of Alternative Implementation 140, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
[0376] Alternative Implementation 146. The method of Alternative Implementation 140, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
[0377] Alternative Implementation 147. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extract first respiration information from the first data; present a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating at least a first entrainment waveform and presenting at least a first entrainment stimulus based at least in part on the first entrainment waveform; generate at least one entrainment coherence score indicative of coherence between the first respiration information and at least the first
entrainment waveform; receive second data associated with a user engaging in a current sleep session; and present a second entrainment program to the user during the current sleep session that is based at least in part on the second data, the at least one entrainment coherence score, or both.
[0378] Alternative Implementation 148. The system of Alternative Implementation 147, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of any one of Alternative Implementations 2-83.
[0379] Alternative Implementation 149. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extract first respiration information from the first data; and present a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
[0380] Alternative Implementation 150. The system of Alternative Implementation 149, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of any one of Alternative Implementations 85 to 113.
[0381] Alternative Implementation 151. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive entrainment coherence data associated with one or more entrainment stimuli presented to the user during an acclimatization session prior to a sleep session; generate an entrainment waveform based at least in part on the entrainment coherence
data; and present an entrainment stimulus to the user based at least in part on the entrainment waveform, the entrainment coherence data, or both.
[0382] Alternative Implementation 152. The system of Alternative Implementation 151, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of Alternative Implementation 115.
[0383] Alternative Implementation 153. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: during an acclimatization session where the user is awake and wearing the user interface, cause air to flow from the respiratory therapy device to the user interface at a plurality of different pressure values; for each of the plurality of pressure values, present a plurality of entrainment stimuli to the user, each of the plurality of entrainment stimuli being based on one of a plurality of entrainment waveforms; determine, for each distinct combination of one of the plurality of pressure values and one of the plurality of entrainment waveforms, an entrainment coherence score indicative of coherence between a respiration pattern of the user and the one entrainment waveform; during a sleep session where the user is wearing the user interface and air is flowing from the respiratory therapy device to the user interface, determine a pressure value of the air; generate a sleep session entrainment waveform based on the pressure value of the air flowing during the sleep session and the entrainment coherence scores associated with the corresponding pressure value of the air flowing during the acclimatization session; and present a sleep session entrainment stimulus to the user based on the sleep session entrainment waveform.
[0384] Alternative Implementation 154. The system of Alternative Implementation 153, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions to implement the method of Alternative Implementation 117 [0385] Alternative Implementation 155. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the
machine-readable instructions to: determine a current pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generate an entrainment waveform based at least in part on the current pressure of the air; and present an entrainment stimulus to the user based at least in part on the entrainment waveform.
[0386] Alternative Implementation 156. The system of Alternative Implementation 155, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of Alternative Implementation 84 or Alternative Implementation 120.
[0387] Alternative Implementation 157. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: cause air having a first pressure to flow from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generate a first entrainment waveform based at least in part on the first pressure of the air; present a first entrainment stimulus to the user based at least in part on the first entrainment waveform; subsequently cause air having a second pressure to flow from the respiratory therapy device to the user interface, the second pressure being different than the first pressure; and present a second entrainment stimulus to the user that is different than the first entrainment stimulus.
[0388] Alternative Implementation 158. The system of Alternative Implementation 157, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of any one of Alternative Implementations 122 to 124.
[0389] Alternative Implementation 159. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: generate a first entrainment waveform; at a first time during the sleep session, present a first entrainment stimulus to the user based at least in part on the first entrainment waveform; and at a second time after the first time during the sleep session,
present a second entrainment stimulus to the user that is different than the first entrainment stimulus.
[0390] Alternative Implementation 160. The system of Alternative Implementation 159, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of any one of Alternative Implementations 116 to 128.
[0391] Alternative Implementation 161. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: determine a first respiration rate of the user; generate a first entrainment waveform representing a first target respiration rate that is less than the current respiration rate of the user; present a first entrainment stimulus to the user based on the first entrainment waveform; determine, after the first entrainment stimulus has been presented to the user, a second respiration rate of the user; and in response to determining that a difference between the second respiration rate of the user and the first target respiration rate satisfies a threshold difference, (i) generate a second entrainment waveform representing a second target respiration rate that is less than the first target respiration rate and (ii) present a second entrainment stimulus to the user based on the second entrainment waveform.
[0392] Alternative Implementation 162. The system of Alternative Implementation 161, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of any one of Alternative Implementations 130 to 134.
[0393] Alternative Implementation 163. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: while the user is awake and not wearing the user interface, present a first entrainment stimulus to the user; and while the user is awake and not wearing the user interface, subsequently presenting a second entrainment stimulus to the user.
[0394] Alternative Implementation 164. The system of Alternative Implementation 163, wherein the one or more processors of the control system are further configured to execute the machine-readable instructions of any one of Alternative Implementations 136 to 146.
[0395] Alternative Implementation 165. A system comprising: a control system including one or more processors; and a memory having stored thereon machine readable instructions; wherein the control system is coupled to the memory, and the method of any one of Alternative Implementations 1-146 is implemented when the machine-readable instructions in the memory are executed by at least one of the one or more processors of the control system.
[0396] Alternative Implementation 166. A system for personalized entrainment, the system including a control system configured to implement the method of any one of Alternative Implementations 1-146.
[0397] Alternative Implementation 167. A computer program product comprising instructions which, when executed by a computer, cause the computer to carry out the method of any one of Alternative Implementations 1-146.
[0398] Alternative Implementation 168. The computer program product of Alternative Implementation 167, wherein the computer program product is a non-transitory computer readable medium.
[0399] While the present disclosure has been described with reference to one or more particular embodiments or implementations, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present disclosure. Each of these implementations and obvious variations thereof is contemplated as falling within the spirit and scope of the present disclosure. It is also contemplated that additional implementations or alternative implementations according to aspects of the present disclosure may combine any number of features from any of the implementations described herein, such as, for example, in the alternative implementations described below.
Claims
1. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extract first respiration information from the first data; present a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating at least a first entrainment waveform and presenting at least a first entrainment stimulus based at least in part on the first entrainment waveform; generate at least one entrainment coherence score indicative of coherence between the first respiration information and at least the first entrainment waveform; receive second data associated with a user engaging in a current sleep session; and present a second entrainment program to the user during the current sleep session that is based at least in part on the second data, the at least one entrainment coherence score, or both.
2. The system of claim 1, wherein the first entrainment waveform is predetermined and not based on either the first data or the first respiration information.
3. The system of claim 1, wherein the first entrainment waveform is based at least in part on the first data, the first respiration information, or both.
4. The system of claim 3, wherein to generate the first entrainment waveform, the one or more processors are further configured to execute the machine-readable instructions to: generate a predetermined entrainment waveform; and modify the predetermined entrainment waveform based on the first data, the first respiration information, or both.
5. The system of any one of claims 1 to 4, wherein the first respiration information includes a current respiration pattern of the user, and wherein the first entrainment waveform represents a target respiration pattern.
6. The system of claim 5, wherein the target respiration pattern includes a target inspiration/expiration ratio.
7. The system of claim 5, wherein the target respiration pattern includes a target inspiration duration, a target inspiration hold duration, a target expiration duration, and a target expiration hold duration.
8. The system of any one of claims 5 to 7, wherein presenting the first entrainment program includes displaying on a display device (i) a current waveform representing the current respiration pattern of the user, and (ii) the first entrainment waveform representing the target respiration pattern.
9. The system of claim 8, wherein, on the display device, the first entrainment waveform is overlaid on the current waveform.
10. The system of any one of claims 1 to 9, wherein the first respiration information includes a current respiration rate of the user, and wherein the first entrainment waveform represents a target respiration rate.
11. The system of claim 10, wherein the one or more processors are further configured to execute the machine-readable instructions to: update the first entrainment waveform to represent an updated target respiration rate that is different than the target respiration rate; and
present the first entrainment stimulus based at least in part on the updated first entrainment waveform.
12. The system of claim 11, wherein the first entrainment waveform is updated in response to the entrainment coherence score satisfying a threshold value.
13. The system of claim 12, wherein the first entrainment waveform is updated in response to the entrainment coherence score satisfying the threshold value for at least a predetermined amount of time.
14. The system of any one of claims 10 to 13, wherein the target respiration rate is less than the current respiration rate.
15. The system of any one of claims 1 to 14, wherein presenting the first entrainment stimulus includes (i) generating an audio stimulus; (ii) modulating an existing audio stimulus; (iii) generating a visual stimulus; (iv) modulating an existing visual stimulus; (v) generating a haptic stimulus; (vi) modulating an existing haptic stimulus; (vii) modulating a flow of air generated by the respiratory therapy system; or (viii) any combination of (i)-(vii).
16. The system of any one of claims 1 to 15, wherein generating the first entrainment waveform includes inputting into a machine learning algorithm the first data, the first respiration information, or both, the machine learning algorithm being trained to output the first entrainment waveform.
17. The system of any one of claims 1 to 16, wherein the second entrainment program is based at least in part on both the second data and the entrainment coherence score.
18. The system of any one of claims 1 to 17, wherein to present the second entrainment program to the user during the current sleep session, the one or more processors are further configured to execute the machine-readable instructions to: generate a second entrainment waveform; and present a second entrainment stimulus based at least in part on the second entrainment waveform.
19. The system of claim 18, wherein the second entrainment stimulus is different than the first entrainment stimulus.
20. The system of claim 18 or 19, wherein the first entrainment stimulus includes a visual stimulus, and wherein the second entrainment stimulus includes an audio stimulus, a haptic stimulus, a modulation of a flow of air generated by the respiratory therapy system, or any combination thereof.
21. The system of claim 18, wherein the second entrainment stimulus is identical to the first entrainment stimulus.
22. The system of claim 18 or 21, wherein the first entrainment stimulus and the second entrainment stimulus both include an audio stimulus, a visual stimulus, a haptic stimulus, a modulation of a flow of air generated by the respiratory therapy system, or any combination thereof.
23. The system of any one of claims 18 to 22, wherein presenting the second entrainment stimulus includes (i) generating an audio stimulus; (ii) modulating an existing audio stimulus; (iii) generating a visual stimulus; (iv) modulating an existing visual stimulus; (v) generating a haptic stimulus; (vi) modulating an existing haptic stimulus; (vii) modulating a flow of air generated by the respiratory therapy system; or (viii) any combination of (i)-(vii).
24. The system of claim 23, wherein modulating the flow of air includes modulating a pressure of the air.
25. The system of claim 24, wherein modulating the flow of air includes modulating the pressure of the air in accordance with a target respiration pattern.
26. The system of any one of claims 17 to 23, wherein to present the second entrainment program, the one or more processors are further configured to execute the machine-readable instructions to: generate a temporary entrainment waveform; and update the temporary entrainment waveform based at least in part on the coherence score to generate the second entrainment waveform.
27. The system of claim 26, wherein updating the temporary entrainment waveform is further based on the second data.
28. The system of claim 26 or 27, wherein the temporary entrainment waveform represents an initial target respiration pattern, and wherein to update the temporary entrainment waveform, the one or more processors are further configured to execute the machine- readable instructions to: determine an updated target respiration pattern based at least in part on the initial target respiration pattern and the coherence score; and update the temporary entrainment waveform so that the second entrainment waveform represents the updated target respiration pattern.
29. The system of claim 27, wherein determining the updated target respiration pattern is further based on the second data.
30. The system of any one of claims 18 to 23, wherein generating the second entrainment waveform includes inputting into a machine learning algorithm the second data, the coherence score, or both, the machine learning algorithm being trained to output the second entrainment waveform.
31. The system of any one of claims 18 to 30, wherein the one or more processors are further configured to execute the machine-readable instructions to access historical acclimatization information associated with one or more prior acclimatization sessions, the historical acclimatization information including historical respiration information and a historical entrainment coherence score for each session of the one or more prior acclimatization sessions, wherein generating the second entrainment waveform is based at least in part on the historical acclimatization information.
32. The system of any one of claims 1 to 31, wherein the respiratory therapy system includes a user interface configured to be fluidly coupled to a respiratory therapy device via a conduit, the respiratory therapy device being operable to cause air to flow through the conduit and to the user interface.
33. The system of claim 32, wherein the acclimatization session occurs while the user is awake and is wearing the user interface.
34. The system of claim 33, wherein the acclimatization session occurs while the user interface is fluidly coupled to the respiratory therapy device via the conduit.
35. The system of claim 34, wherein the acclimatization session occurs while the respiratory therapy device is causing air to flow through the conduit and to the user interface.
36. The system of claim 34, wherein the acclimatization session occurs while the respiratory therapy device is not causing air to flow through the conduit and to the user interface.
37. The system of claim 33, wherein the acclimatization session occurs while the user interface is not fluidly coupled to the respiratory therapy devices via the conduit.
38. The system of any one of claims 33 to 37, wherein the acclimatization session occurs when one or more valves of the user interface are open to surrounding air.
39. The system of claim 32, wherein the acclimatization session occurs while the user is not wearing the user interface of a respiratory therapy system.
40. The system of any one of claims 1 to 39, wherein the one or more processors are further configured to execute the machine-readable instructions to present acclimatization sounds during the acclimatization session, the acclimatization sounds presented to simulate to the use of a respiratory therapy system by the user.
41. The system of claim 40, wherein presenting the first entrainment stimulus includes modulating the acclimatization sounds based at least in part on the first entrainment waveform.
42. The system of any one of claims 1 to 41, wherein the entrainment coherence score includes a plurality of entrainment coherence sub-scores, and wherein each entrainment coherence sub-score of the plurality of entrainment coherence sub-scores is indicative of entrainment coherence at a respective time during the acclimatization session.
43. The system of claim 42, wherein the acclimatization session occurs while a respiratory therapy device of the respiratory therapy system is causing air to flow to a user interface that is worn by the user, and wherein each sub-score of the plurality of sub-scores corresponds to a respective pressure of the air flowing to the user interface.
44. The system of claim 42, wherein to present the second entrainment program to the user during the current sleep session, the one or more processors are further configured to execute the machine-readable instructions to: determine, based at least in part on the second data, a current pressure of air provided to the user via a respiratory therapy system during the current sleep session; generate a second entrainment waveform based on (i) the current pressure of the air and (ii) the one of the plurality of entrainment coherence sub-scores that is associated with the current pressure; and present a second entrainment stimulus based on the second entrainment waveform.
45. The system of any one of claims 1 to 43, wherein the one or more processors are further configured to execute the machine-readable instructions to: extract second respiration information from the second data, wherein presenting the second entrainment program includes generating a second entrainment waveform; determine an additional entrainment coherence score indicative of coherence between the second respiration information and the second entrainment waveform; and in response to determining that the additional entrainment coherence score satisfies a threshold, transmit a notification signal indicative of a need for an adjustment in the respiratory therapy system.
46. The system of any one of claims 1 to 45, the one or more processors are further configured to execute the machine-readable instructions to present the entrainment coherence score using a display device.
47. The system of claim 46, wherein presenting the entrainment coherence score occurs during the acclimatization session.
48. The system of claim 46 or 47, wherein to present the entrainment coherence score, the one or more processors are further configured to execute the machine-readable instructions to: generate a first trace based at least in part on the first respiration information; generate a second trace at least in part on the first entrainment waveform; present the first trace; and present the second trace adjacent to or overlying the first trace.
49. The system of any one of claims 46 to 48, wherein presenting the entrainment coherence score occurs when the entrainment coherence score satisfies a threshold value.
50. The system of any one of claims 1 to 49, wherein the first data, the second data, or both, include pressure data associated with a pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user, flow rate data associated with a flow rate of the air, motion data associated with movement of the user, image data reproducible as one or more images of the user, PPG data, ECG data, EEG data, or any combination thereof.
51. The system of any one of claims 1 to 50, wherein to present the first entrainment program and generate the entrainment coherence score, the one or more processors are further configured to execute the machine-readable instructions to: during the acclimatization session where the user is awake and wearing the user interface, cause air to flow from the respiratory therapy device to the user interface at a plurality of different pressure values; for each of the plurality of pressure values, present a plurality of entrainment stimuli to the user, each of the plurality of entrainment stimuli being based on one of a plurality of entrainment waveforms; and determine, for each distinct combination of one of the plurality of pressure values and one of the plurality of entrainment waveforms, an entrainment coherence score indicative of coherence between a respiration pattern of the user and the one entrainment waveform.
52. The system of claim 51, wherein to present the second entrainment program, the one or more processors are further configured to execute the machine-readable instructions to:
during the current sleep session where the user is wearing the user interface and air is flowing from the respiratory therapy device to the user interface, determine a pressure value of the air; generate a sleep session entrainment waveform based on the pressure value of the air flowing during the sleep session and the entrainment coherence scores associated with the corresponding pressure value of the air flowing during the acclimatization session; and present a sleep session entrainment stimulus to the user based on the sleep session entrainment waveform.
53. The system of claim 52, wherein the sleep session entrainment waveform is the one of the plurality of entrainment waveforms having a maximum entrainment coherence score among all entrainment coherence scores for the corresponding pressure value of the air flowing during the acclimatization session.
54. The system of any one of claims 1 to 53, wherein to present the first entrainment program or the second entrainment program to the user, the one or more processors are further configured to execute the machine-readable instructions to: determine a current pressure of air flowing from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generate an entrainment waveform based at least in part on the current pressure of the air; and present an entrainment stimulus to the user based at least in part on the entrainment waveform.
55. The system of claim 54, wherein in response to the current pressure of the air changing to a new pressure, the one or more processors are further configured to execute the machine- readable instructions to: generate a new entrainment waveform based at least in part on the new pressure of the air; and present a new entrainment stimulus to the user based at least in part on the new entrainment waveform.
56. The system of claim 54, wherein the generation of the entrainment waveform is further based at least in part on the entrainment coherence score determined during use of the respiratory therapy system by the user during the acclimatization session.
57. The system of any one of claims 1 to 56, wherein to present the first entrainment program or the second entrainment program, the one or more processors are further configured to execute the machine-readable instructions to: cause air having a first pressure to flow from a respiratory therapy device of the respiratory therapy system to a user interface worn by the user; generate an initial entrainment waveform based at least in part on the first pressure of the air; present an initial entrainment stimulus to the user based at least in part on the initial entrainment waveform; subsequently cause air having a second pressure to flow from the respiratory therapy device to the user interface, the second pressure being different than the first pressure; and present a subsequent entrainment stimulus to the user that is different than the initial entrainment stimulus.
58. The system of claim 57, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, and is based on the initial entrainment waveform.
59. The system of claim 57, wherein the one or more processors are further configured to execute the machine-readable instructions to generate a subsequent entrainment waveform based at least in part on the second pressure of the air that is different than the initial entrainment waveform, wherein the subsequent entrainment stimulus is based on the subsequent entrainment waveform.
60. The system of claim 59, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, or is an identical type of stimulus as the initial entrainment stimulus.
61. The system of any one of claims 1 to 60, wherein to present the second entrainment program to the user during the sleep session, the one or more processors are further configured to execute the machine-readable instructions to: generate an initial entrainment waveform; at a first time during the sleep session, present an initial entrainment stimulus to the user based at least in part on the initial entrainment waveform; and at a second time after the first time during the sleep session, present a subsequent entrainment stimulus to the user that is different than the initial entrainment stimulus.
62. The system of claim 61 , wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, and is based on the initial entrainment waveform.
63. The system of claim 61, wherein the one or more processors are further configured to execute the machine-readable instructions to generate a subsequent entrainment waveform, wherein the subsequent entrainment stimulus is based on the subsequent entrainment waveform.
64. The system of claim 63, wherein the subsequent entrainment stimulus is a different type of stimulus than the initial entrainment stimulus, or is an identical type of stimulus as the initial entrainment stimulus.
65. The system of any one of claims 1 to 64, wherein to present the second entrainment program to the user during the current sleep session, the one or more processors are further configured to execute the machine-readable instructions to: determine a first current respiration rate of the user; generate an initial entrainment waveform representing a first target respiration rate that is less than the first current respiration rate of the user; present an initial entrainment stimulus to the user based on the initial entrainment waveform; determine, after the initial entrainment stimulus has been presented to the user, a second current respiration rate of the user; and
in response to determining that a difference between the second current respiration rate of the user and the first target respiration rate satisfies a threshold difference, (i) generate a first subsequent entrainment waveform representing a second target respiration rate that is less than the first target respiration rate and (ii) presenting a first subsequent entrainment stimulus to the user based on the first subsequent entrainment waveform.
66. The system of claim 65, wherein the subsequent entrainment stimulus is an identical type of stimulus as the initial entrainment stimulus.
67. The system of claim 65, wherein the one or more processors are further configured to execute the machine-readable instructions to: determine, after the subsequent entrainment stimulus has been presented to the user, a third current respiration rate of the user; and in response to determining that a difference between the third current respiration rate of the user and the second target respiration rate satisfies the threshold difference, (i) generate a second subsequent entrainment waveform representing a third target respiration rate that is less than the second target respiration rate and (ii) present a second subsequent entrainment stimulus to the user based on the third entrainment waveform.
68. The system of claim 65, wherein the one or more processors are further configured to execute the machine-readable instructions to determine an elapsed time since a beginning of the sleep session, and wherein in response to the elapsed time being greater than or equal to a threshold time, the second subsequent entrainment stimulus is a different type of stimulus than the first subsequent entrainment stimulus.
69. The system of claim 68, wherein the second subsequent entrainment stimulus is an identical type of stimulus as the first subsequent entrainment stimulus in response to the elapsed time being less than the threshold time.
70. The system of claim 65, wherein the one or more processors are further configured to execute the machine-readable instructions to:
determine, after the first subsequent entrainment stimulus has been presented to the user, a third current respiration rate of the user; and in response to determining that a difference between the third current respiration rate of the user and the second current respiration rate satisfies the threshold difference, continue to present the first entrainment stimulus.
71. The system of any one of claims 1 to 70, wherein the at least one entrainment coherence score includes a plurality of entrainment coherence scores, each entrainment coherence score being associated with a respective entrainment waveform generated during the acclimatization session, a type of entrainment stimulus presented to the user based on the respective entrainment waveform, a pressure of air flowing in the respiratory therapy system when the respective entrainment waveform was generated, or any combination thereof.
72. The system of any one of claims 1 to 71, wherein to present the first entrainment program to the user during the acclimatization session, the one or more processors are further configured to execute the machine-readable instructions to: while the user is awake and not wearing a user interface to which air is provided by a respiratory therapy device of the respiratory therapy system, present the first entrainment stimulus to the user; and while the user is awake and not wearing the user interface, subsequently present a second entrainment stimulus to the user.
73. The system of claim 72, wherein the first entrainment stimulus is different than the second entrainment stimulus.
74. The system of claim 73, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
75. The system of claim 73, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
76. The system of claim 73, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
77. The system of claim 72, wherein the first entrainment stimulus is based on a first entrainment waveform representing a first target respiration pattern, and wherein the second entrainment stimulus is based on a second entrainment waveform representing a second target respiration pattern that is different than the first target respiration pattern.
78. The system of claim 77, wherein both the first entrainment stimulus and the second entrainment stimulus comprise visual stimuli.
79. The system of claim 77, wherein both the first entrainment stimulus and the second entrainment stimulus comprise audio stimuli.
80. The system of claim 77, wherein both the first entrainment stimulus and the second entrainment stimulus comprise haptic stimuli.
81. The system of claim 77, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises an audio stimulus.
82. The system of claim 77, wherein the first entrainment stimulus comprises a visual stimulus, and the second entrainment stimulus comprises a haptic stimulus.
83. The system of claim 77, wherein the first entrainment stimulus comprises an audio stimulus, and the second entrainment stimulus comprises a haptic stimulus.
84. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system;
extract first respiration information from the first data; and present a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
85. A system comprising: a respiratory therapy system including: a respiratory therapy device configured to supply pressurized air; and a user interface coupled to the respiratory therapy device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user; a memory device storing machine-readable instructions; and a control system coupled to the memory device, the control system including one or more processors configured to execute the machine-readable instructions to: receive entrainment coherence data associated with one or more entrainment stimuli presented to the user during an acclimatization session prior to a sleep session; generate an entrainment waveform based at least in part on the entrainment coherence data; and present an entrainment stimulus to the user based at least in part on the entrainment waveform, the entrainment coherence data, or both.
86. The system of claim 85, wherein the entrainment coherence data includes a plurality of entrainment coherence scores, each entrainment coherence score being associated with a respective entrainment waveform generated during the acclimatization session, a type of entrainment stimulus presented to the user based on the respective entrainment waveform, a pressure of air flowing in the respiratory therapy system when the respective entrainment waveform was generated, or any combination thereof.
87. A method comprising: receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extracting first respiration information from the first data;
presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating at least a first entrainment waveform and presenting at least a first entrainment stimulus based at least in part on the first entrainment waveform; generating at least one entrainment coherence score indicative of coherence between the first respiration information and the first entrainment waveform; receiving second data associated with a user engaging in a current sleep session; and presenting a second entrainment program to the user during the current sleep session that is based at least in part on the second data, the at least one entrainment coherence score, or both.
88. A method, comprising: receiving first data associated with a user engaging in an acclimatization session for use of a respiratory therapy system; extracting first respiration information from the first data; and presenting a first entrainment program to the user during the acclimatization session, the presenting of the first entrainment program including generating a first entrainment waveform and presenting a first entrainment stimulus based at least in part on the first entrainment waveform.
89. A method of presenting an entrainment program during use of a respiratory therapy system by a user during a sleep session, the method comprising: receiving entrainment coherence data associated with one or more entrainment stimuli presented to the user during an acclimatization session prior to the sleep session; generating an entrainment waveform based at least in part on the entrainment coherence data; and presenting an entrainment stimulus to the user based at least in part on the entrainment waveform, the entrainment coherence data, or both.
90. A system comprising: a control system including one or more processors; and a memory having stored thereon machine readable instructions, wherein the control system is coupled to the memory, and the method of any one of claims 87 to 89 is implemented when the machine-readable instructions in the
memory are executed by at least one of the one or more processors of the control system.
91. A system for personalized entrainment, the system including a control system configured to implement the method of any one of claims 87 to 89.
92. A computer program product comprising instructions which, when executed by a computer, cause the computer to carry out the method of any one of claims 87 to 89.
93. The computer program product of claim 92, wherein the computer program product is a non-transitory computer readable medium.
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