CN111938572A - sleep physiological system - Google Patents

Abstract

The present invention relates to a sleep physiology system, which adopts a distributed hardware configuration architecture, so that when performing sleep breathing disorder assessment and executing sleep posture training and/or sleep physiological feedback training, physiological sensors that meet the needs can be freely selected to obtain appropriate sleep physiological information, and the type and setting location of the alarm can be freely selected, which helps to more accurately reflect the actual sleep physiological conditions and improve the training effect.

Description

sleep physiological system

technical field

The present invention relates to a sleep physiology system, in particular, to a sleep physiology system that can evaluate and improve sleep-disordered breathing.

Background technique

Sleep Apnea (Sleep Apnea) is a sleep-disordered breathing, which generally has three types: Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), and Mixed Sleep Apnea Pause (Mixed Sleep Apnea, MSA).

Obstructive sleep apnea (OSA) is characterized by a decrease or cessation of respiratory airflow for a period of time due to complete or partial obstruction of the upper airway during sleep, usually accompanied by desaturation of blood oxygen concentration. , OSA is a common sleep-disordered breathing, affecting about 25 to 40% of the middle-aged population.

Central sleep apnea (CSA) is caused by a problem with the mechanism by which the brain drives the muscles to breathe, causing short-term cessation of neural drive to the breathing muscles, and these transients, ranging from 10 seconds to 2 to 3 minutes, may Continues throughout the night. Central sleep apnea, similar to obstructive sleep apnea, causes gradual suffocation during sleep, resulting in a brief arousal of the individual from sleep and a return to normal respiratory function at the same time. And like obstructive sleep apnea, central sleep apnea can lead to disorders such as arrhythmia, high blood pressure, heart disease, and heart failure.

Mixed sleep apnea (MSA) refers to a combination of obstructive sleep apnea and central sleep apnea.

The Apnea Hypoxia Index (AHI) is an indicator of the severity of sleep apnea that combines the number of sleep apnea (Apnea) and sleep hypopnea (hypopnea) to give a simultaneous assessment of sleep ( An overall sleep apnea severity score for the number of interruptions in breathing) and the degree of oxygen saturation (blood oxygen level), where AHI is calculated by dividing the total number of sleep apnea and hypopnea events by the number of hours of sleep, usually AHI The value is divided into 5-15 times per hour as mild, 15-30 times per hour as moderate, and >30 times per hour as severe.

In addition to AHI, studies have confirmed that another important indicator for assessing or detecting sleep apnea is the Oxygen Desaturation Index (ODI), which refers to the decrease in blood oxygen levels per hour during sleep from baseline to a certain degree In general, ODI is expressed in two ways: the number of times the oxygen saturation drops by 3% (ODI3%) and the number of times the oxygen saturation drops by 4% (ODI4%). The difference between ODI and AHI is that AHI also includes possible Events that cause sleep arousal (awaken) or arousal (arousal) but do not affect oxygen levels, and studies have confirmed that ODI has a certain correlation with AHI and sleep apnea, which can be effectively used for the diagnosis of OSA.

In addition, hypoxia level is another indicator that can be used to assess the impact of sleep apnea, which refers to the ratio between the sum of the time when the blood oxygen saturation is below 90% and the total monitoring time. Since both AHI and ODI are based on the number of occurrences, they may not be able to accurately reflect the impact of continuous low blood oxygen levels without frequent blood oxygen fluctuations, and low oxygen levels can make up for this deficiency. There is also a certain correlation between hypoxia levels and sleep apnea.

Most patients with OSA have more OSA events in the supine sleeping position, because the upper airway is more susceptible to collapse under the influence of gravity, and in the literature, it is officially diagnosed as postural OSA ( Positional OSA, POSA) is based on the fact that the difference between the AHI value when lying on the back and not lying on the back is greater than a certain threshold. The AHI value at the time of POSA is more than twice; it is known from studies that the prevalence of POSA decreases with the severity of OSA, and 70% to 80% of patients with POSA have mild to moderate severity of OSA. Among them, Asian Up to 87% of patients with mild OSA can be classified as patients with POSA.

Another common sleep-disordered breathing is snoring, which affects 20% to 40% of the general population. This noise-producing symptom is caused by the vibration of soft tissues when the upper airway passes through the air during sleep. OSA and severe snoring have been It has been confirmed by research that it is highly correlated with many clinical symptoms, such as daytime sleepiness, depression, the formation of hypertension, ischemic heart disease, cerebrovascular disease, etc. Among them, snoring is the most common symptom in OSA, and snoring is the most common symptom of OSA. It is also generally regarded as a precursor phenomenon of OSA, because the causes of both are related to the physiological phenomenon of upper airway narrowing, and sleep position also affects the severity of snoring symptoms.

According to research, with the evolution of the degree of upper airway stenosis, the usual situation is that snoring symptoms related to sleeping positions first occur, and in more severe cases, snoring begins to occur easily even when not lying on the back, and begins to develop into mild snoring. OSA, and the relationship between the occurrence of snoring and sleep position gradually decreased, and further, the severity of OSA also changed from mild to moderate related to sleep position, and finally to severe cases less related to sleep position.

Sleep positional training (SPT) is a method for the treatment of postural OSA and postural snoring. In recent years, a new generation of postural training devices has been developed. The abdomen is equipped with a posture sensor, such as an accelerometer, and when the user's sleeping position is detected as lying on his back, a faint vibration warning is generated to prompt the user to change the sleeping position to avoid lying on his back, through many research reports It is pointed out that this simple but effective treatment can prevent the patient from lying on their back during sleep, thereby greatly reducing the number of OSA events.

However, there is still room for improvement in such training methods. For example, because patients with OSA or snoring have different severity and individual physiological differences, if an evaluation function can be provided before training, it can provide targeted training. Training program and expected information about the training effect; in addition, during sleep posture training, if information such as sleep and breathing can also be provided, the parameter settings of the device can also be adjusted accordingly to achieve the purpose of improving the training effect.

In addition, in addition to posture training, it would be more helpful to provide other training methods, for example, for non-postural sleep-disordered breathing, or to further strengthen on the basis of posture training.

SUMMARY OF THE INVENTION

An object of the present invention is to provide a sleep physiology system, a sleep warning device, comprising: a first wearing structure for placing the sleep warning device on a user; a first control unit, at least including a micro a controller/microprocessor; a first wireless communication module electrically connected to the first control unit; an alert unit electrically connected to the first control unit for generating at least one alert to the user; and a power module; and a sleep physiological device, comprising: a second wearable structure for placing the sleep physiological device on the user, a second control unit, at least including a microcontroller/microprocessor; a second wireless a communication module, electrically connected to the second control unit; a posture sensor, electrically connected to the second control unit, for obtaining information related to the sleeping posture of the user during sleep; and a power module, wherein the first The control unit receives a digital signal based on the sleep posture related information through the first wireless communication module; the first control unit is further configured to generate a driving signal, and after receiving the driving signal, the warning unit generates the at least an alert, and the at least one alert is provided to the user; and the driving signal is implemented at least according to the sleep posture related information compared with a preset posture range, when the sleep posture related information conforms to the preset posture range A determined warning action is generated.

Another object of the present invention is to provide the sleep physiology device in the above-mentioned sleep physiology system.

Another object of the present invention is to provide a sleep physiology system, comprising: a sleep warning device, comprising: a first wearing structure for placing the sleep warning device on a user's body; a first control unit, At least comprising a microcontroller/microprocessor; a first wireless communication module electrically connected to the first control unit; a posture sensor electrically connected to the first control unit for obtaining the user's sleep during sleep posture-related information; and a warning unit electrically connected to the first control unit for generating at least one warning to the user; and a power module; and a sleep breathing physiological device, including: a second wearing structure for to set the sleep breathing physiological device on the body of the user; a second control unit, at least comprising a microcontroller/microprocessor; a second wireless communication module, electrically connected to the second control unit; a physiological sensor , electrically connected to the second control unit for obtaining at least one sleep breathing physiological information of the user; and a power module, wherein the first control unit receives data based on the at least one sleep state through the first wireless communication module a digital signal of respiratory physiological information; the first control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning after receiving the driving signal, and provides the at least one warning to the user ; and the driving signal is implemented at least according to the sleep posture related information and a preset posture range after comparing, and when the sleep posture related information conforms to the preset posture range, and/or according to the at least one sleep breathing physiological information and After a preset condition is compared, and when the at least one sleep breathing physiological information meets the preset condition, a determined warning action is generated.

Another object of the present invention is to provide the sleep warning device in the above-mentioned sleep physiological system.

Another object of the present invention is to provide a sleep physiology system, comprising: a sleep warning device, comprising: a first wearing structure for placing the sleep warning device on a user's body; a first control unit, At least comprising a microcontroller/microprocessor; a first wireless communication module electrically connected to the first control unit; a warning unit electrically connected to the first control unit for generating at least one warning to the user; and a power module; and a sleep breathing physiological device, comprising: a second wearable structure for placing the sleep breathing physiological device on the user's body; a second control unit, at least comprising a microcontroller/microprocessor a second wireless communication module, electrically connected to the second control unit; a physiological sensor, electrically connected to the second control unit, for obtaining at least one sleep breathing physiological information of the user; and a power module, Wherein, the first wearing structure is implemented as a wrist-worn structure, so that the sleep warning device is arranged on a wrist of the user, and the at least one warning is implemented as a tactile warning, and wherein, the first control unit passes the The first wireless communication module receives a digital signal based on the at least one sleep breathing physiological information; the first control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning after receiving the driving signal and the at least one warning is provided to the user; and the driving signal is implemented to be generated according to a warning action determined by at least one sleep breathing event obtained based on the at least one sleep breathing physiological information.

Another object of the present invention is to provide the sleep breathing physiological device in the sleep physiological system.

Another object of the present invention is to provide a sleep physiology system, comprising: a first sleep physiology device, including: a first wearing structure for disposing the first sleep physiology device on a first body of a user part; a first control unit including at least a microcontroller/microprocessor; a first wireless communication module electrically connected to the first control unit; a first physiological sensor electrically connected to the first control unit; and a power module; and a second sleep physiological device, comprising: a second wearing structure for placing the second sleep physiological device on a second body part of the user; a second control unit, at least including a micro controller/microprocessor; a second wireless communication module electrically connected to the second control unit; a second physiological sensor electrically connected to the second control unit; and a power module, wherein in the user's During sleep, the first physiological sensor is configured to obtain at least one first sleep physiological information, and the second physiological sensor is configured to obtain at least one second sleep physiological information; and wherein, the system further includes at least one warning unit, for receiving at least one driving signal, and after receiving the at least one driving signal, generating at least one warning, and providing the at least one warning to the user, wherein the at least one driving signal is implemented at least according to the at least one first A sleep physiological information and/or at least one warning behavior determined by the at least one second sleep physiological information is generated; and the system further includes an information providing interface for the first sleep physiological information and the second sleep physiological information. , and/or information related to the at least one warning behavior is provided to the user.

Another object of the present invention is to provide one of the first sleep physiology device and the second sleep physiology device in the above-mentioned sleep physiology system.

Description of drawings

FIG. 1 shows a schematic circuit diagram of a sleep physiology device according to the present invention;

Fig. 2 shows the distribution diagram of the installation position of the physiological sensor according to the application of the present invention;

FIG. 3 shows a possible flow chart of the method of the present invention for improving sleep apnea;

Fig. 4 shows the main steps of evaluating the relationship between sleep posture and snoring in the present application;

Figure 5 shows the main steps of the present application to assess the relationship between sleep posture and sleep apnea/hypopnea;

Figure 6 shows the PPG signal and its time-domain characteristics;

FIG. 7 shows a flowchart of performing sleep posture training and/or sleep breathing physiological feedback training according to a preferred embodiment; and

FIG. 8 is a schematic diagram showing that in the sleep physiology system according to the application of the present invention, the casing can be combined with different wearing structures according to different needs.

Description of symbols in the figure

200 Top area 201 Forehead area

202 Ear area 203 Mouth and nose area

204 Chin area 205 Neck area

206 Chest area 207 Abdominal area

208 Arm area 209 Finger area

210 Head area 211 Foot area

300 software programs

301, 303, 304, 305, 307, 309, 312, 314, 315, 315 Steps

317 Baseline data on historical sleep breathing events

318 Manual input by user or practitioner

402, 405, 410, 415, 418, 425, 430, 440 steps

502, 505, 510, 515, 518, 525, 530, 540 steps

Detailed ways

FIG. 1 illustrates a schematic circuit diagram of a system according to the present invention, wherein all components in the same device are connected to a control unit in the device, wherein the control unit includes at least one microcontroller/microprocessor and is preloaded There are programs to control the communication between hardware components, the control unit can achieve signal transmission between different hardware components and external applications/external devices connected to the device and/or system, and it also allows the behavior of the device to be carried out programmed to respond to different operating conditions, and the microcontroller/microprocessor also utilizes an internal timer (not shown) to generate time stamps or time differences, or to control operations.

In addition, the control unit will at least include an analog front-end (AFE) circuit for obtaining physiological signals to perform, for example, analog-to-digital conversion, amplification, filtering, and other various signal processing procedures known to those skilled in the art , since these are all existing content, so they will not be repeated.

The system may include a light sensor. In the present application, a light sensor refers to a sensor having both a light-emitting source, eg, an LED, and a light detector, eg, a photodiode, and, as is well known, utilizes PPG (photoplethysmography, photoplethysmography) principle, through the light source emits light into human tissue, and the photodetector will receive the light that penetrates the blood in the blood vessel or is reflected by the blood, and then obtains the light generated by the blood by obtaining the light. The blood physiological signal can be obtained by changing the volume, so the blood physiological signal obtained by the optical sensor is generally called the PPG signal. The resulting pulse wave, as well as the slow-moving component (DC Component, DC component), reflect slower changes in tissue blood volume, such as Respiratory Effort (that is, the expansion and contraction of the chest and abdomen during breathing), sympathetic and parasympathetic nerve activity; in addition, physiological information such as blood vessel stiffness and blood pressure can also be obtained by analyzing the PPG signal; moreover, it is known from physiological experiments that the PPG pulse wave can be analyzed in the frequency domain to obtain the relationship between the viscera and the viscera. The heart rate produces harmonic resonance, so the pulse wave heart rate harmonic resonance distribution can be applied to the diagnosis of traditional Chinese medicine and the monitoring of human blood circulation. For example, the liver and liver meridians are related to the first harmonic of the heartbeat frequency, kidney and kidney Correlates with the second harmonic of the heartbeat frequency, the third harmonic of the heartbeat frequency of the spleen and the spleen meridian, the fourth harmonic of the heartbeat frequency of the lung and lung meridians, and the fifth harmonic of the heartbeat frequency of the stomach and stomach meridians .

Generally speaking, the blood physiological information that can be obtained varies according to the type and number of light-emitting sources and light detectors included in the light sensor. For example, the light sensor may include at least one light-emitting source, such as an LED. or a plurality of LEDs, preferably green light/infrared light/red light, and at least one light detector, to obtain blood physiological information such as pulse rate/heart rate and breathing action; wherein, when measuring the pulse rate/heart rate, Green light and visible light with wavelengths below green light, such as blue light and white light, are the main light sources for measuring heart rate at present, and focus on the interpretation of the AC component. When a person breathes, the pressure in the cavity of the chest (the so-called intrathoracic pressure) changes with each breath, in which, when inhaling, the chest cavity expands and the intrathoracic pressure decreases, thereby drawing air into the lungs, During exhalation, intrathoracic pressure increases and forces air out of the lungs. These changes in intrathoracic pressure also cause changes in the amount of blood returning to the heart through the veins and the amount of blood pumped into the arteries by the heart. It is known by analyzing the DC component of the PPG signal, and in this paper, the breathing information obtained by analyzing the PPG waveform is called low-frequency breathing behavior; in addition, since the heart rate is controlled by the autonomic nerve, breathing The system affects the heartbeat to change, that is, the so-called sinus arrhythmia (Respiratory Sinus Arrhythmia, RSA). The breathing change is known by observing the heart rate, which is referred to as the RSA breathing behavior in this paper; therefore, the breathing information obtained through the optical sensor is collectively referred to as the breathing behavior.

Alternatively, the light sensor may also include at least two light sources, such as a plurality of LEDs, preferably green light/infrared light/red light, and at least one light detector to obtain blood oxygen concentration (SPO2), pulse Blood physiology information such as rate/heart rate, and breathing action, among which, when measuring blood oxygen concentration, two different wavelengths of light are required to enter the tissue, using oxygenated heme (HbO2) and non-oxygenated heme (HbO2) in the blood. ) has different degrees of absorption for two wavelengths of light, and after receiving the transmitted and reflected light, the result of the comparison between the two can determine the blood oxygen concentration. Therefore, the measurement of blood oxygen concentration is usually related to the setting position of the light sensor There are more limitations, and it is better to use the position where the light can really penetrate into the artery, such as fingers, the inner surface of the palm, the toes, the soles of the feet, etc., especially when measuring the blood oxygen concentration of infants, the toes/foots are often used, and two different wavelengths are used. It can be, for example, red light and infrared light, or green light with two wavelengths, such as green light with wavelengths of 560 nm and 577 nm, respectively. Therefore, a suitable light source can be selected according to requirements without limitation.

The wavelength ranges of the above-mentioned various light sources are, the wavelength of red light is about 620nm to 750nm, the wavelength of infrared light is about 750nm, and the wavelength of green light is about 495nm to 580nm. For example, the wavelength of red light is 660nm, the wavelength of infrared light is 895nm, 880nm, 905nm or 940nm, and the wavelength of green light is 510-560nm or 577nm. However, it should be noted that in actual use, depending on the purpose of use, the Light sources of other wavelengths can be used, for example, when only the heart rate is to be obtained, other visible light sources with wavelengths less than green light, that is, visible light with wavelengths less than 580 nm, such as blue light, are also one of the options, and, in addition to using specific wavelengths In addition to the single light source, a composite light source containing this wavelength, for example, white light, can also be used.

For example, in particular, light sources with three wavelengths can be simultaneously provided. For example, in one embodiment, the first light source is implemented as an infrared light source to generate light of the first wavelength, and the second light source is implemented as a red light source to generate light of the first wavelength. The two wavelengths of light, and the third light source is implemented as a green light source to generate a third wavelength of light, wherein the infrared light source and the red light source are used to obtain the blood oxygen concentration, and the green light source is used to obtain the heart rate; or, in another embodiment wherein the light of the first wavelength and the second wavelength is implemented as green light, and the light of the third wavelength is implemented as infrared light or red light, etc., two of the wavelengths can be used to obtain the blood oxygen concentration, and the other wavelength can be used to obtain the heart rate; or , in another embodiment, the light of the first wavelength, the second wavelength, and the third wavelength are all implemented as green light, and the blood oxygen concentration can be obtained by using the green light of two wavelengths, and the green light of the other wavelength can be used to obtain Heart rate, and since, as mentioned earlier, different types of blood physiological information can be obtained from different parts of the body, having a light source that can generate multiple wavelengths at the same time will help to achieve different body parts through the same device. For example, when blood oxygen concentration needs to be obtained, move the device to a position where light can penetrate the artery, and when heart rate or other blood physiological information needs to be obtained, as long as there are blood vessels. . Therefore, there is no limit.

Furthermore, when acquiring the heart rate, in order to eliminate noise, for example, environmental noise, noise generated by body movements during wearing, etc., more than two light sources (and the wavelength is not limited, can be green light, can also be used Light sources of other wavelengths), and the purpose of eliminating noise is achieved by calculating the PPG signals obtained by different light sources through digital signal processing, such as adaptive filter (Adaptive Filter) or mutual subtraction, so there is no limit.

The system can include a posture sensor, usually an accelerometer, preferably a three-axis (MEMS) accelerometer, which can define the posture of the device in three-dimensional space and is directly related to the user's sleeping posture, wherein , the accelerometer will return the acceleration values measured in all x, y, and z dimensions, and from these values, in addition to sleep posture, many other sleep information can be derived, such as physical activity (actigraph), movement, postural changes in standing/lying, etc., where, by analyzing physical activity during sleep, further information about sleep stages/states can be obtained; in addition, other kinds of accelerometers can also be used, for example, Gyroscopes, magnetometers, etc.

The system may include a microphone that feeds back the frequency and amplitude of the measured sound, and the use of an acoustic transducer with appropriate filtering design to detect sounds during sleep, such as snoring or breathing.

The system can include a snoring detector, which can be implemented to detect sound through the above-mentioned microphone, and can also be implemented to detect the vibration of the body cavity caused by snoring. An accelerometer or a piezoelectric vibration sensor can be used to measure the The position includes, for example, the trunk, neck, head, ears, etc., among which, the trunk and the head are the best acquisition positions, especially the nasal cavity, throat, chest cavity, etc. can transmit the vibration caused by snoring well, It is a very advantageous choice. In addition, compared with the detection of sound, the detection of vibration can not be disturbed by environmental noise, and it can also be detected when the body is covered with a covering, such as a quilt, which has a wider range of applications; Therefore, the accelerometer, which is used as a posture sensor, can also be used to obtain snoring-related information at the same time, making it more convenient to use. Furthermore, snoring-related information, such as intensity, duration, frequency, etc., is obtained from the original vibration signal by using appropriate filter design and known techniques, and due to the types of signals obtained by different sensors and the The methods are different, so different appropriate filtering designs should be adopted accordingly.

The system may include a temperature sensor to detect device temperature, ambient temperature, or body temperature to provide further physiological information of the user during sleep.

The system may include a respiratory airflow sensor, such as a thermistor, thermocouple, or respiratory airflow tube, placed between the mouth and nose to obtain changes in respiratory airflow, wherein the thermistor and thermocouple can be selected near the nostrils It is feasible to set two detection points, or to set three detection points near the nostrils and near the mouth.

The system can include an accelerometer, which can be arranged on the trunk to obtain the acceleration and deceleration caused by the rise and fall of the chest and/or abdomen during the breathing action; it can also be used to detect the vascular pulsation generated by the blood pulsation to obtain the heart rate, and to obtain the The position is not limited, for example, the head, chest, upper limbs, etc. are all available positions.

The system may include at least two impedance detection electrodes disposed on the trunk to obtain impedance changes caused by breathing.

The system can include a piezoelectric action sensor, which is arranged on the torso, and obtains a signal by exerting force on the piezoelectric action sensor through the breathing action. form.

The system may include a RIP (Respiratory Inductance Plethysmography) sensor disposed on the trunk to obtain the expansion and contraction of the chest and/or abdomen caused by the breathing action, usually implemented as a belt around the trunk. form.

The system may include at least two EEG electrodes, at least two eye electrodes, and/or at least two EMG electrodes, for example, two EEG electrodes disposed on the head and/or ears, and/or disposed on the forehead, Two EMG electrodes near the eyes, and/or two EMG electrodes installed on the body to obtain EEG, EMG, and/or EMG signals, and by analyzing EEG, EMG, And/or EMG signal, the sleep state/stage, sleep cycle, etc. during sleep can be known, which is helpful to understand sleep quality.

Here, it should be noted that, generally, when capturing electrophysiological signals, a signal capturing electrode and a grounding electrode are often provided, wherein the signal capturing electrode is used to obtain the electrophysiological signal, and the function of the grounding electrode is to remove the background. Noise, and all the electrodes described in this article belong to the signal acquisition electrodes. However, in order to avoid excessively verbose words, in the following description, "electrodes" are used to represent "signal acquisition electrodes". As for the ground electrode The setting of , is generally set selectively according to actual needs, so it will not be repeated in this article.

The information about sleep stages/states can also be obtained by analyzing heart rate. For example, there is a certain relationship between heart rate changes during sleep and sleep stages, such as heart rate changes during deep sleep and light sleep. It can be obtained by observing the heart rate distribution during sleep. In addition, it can also be obtained by other common analysis methods. For example, HRV analysis can know the activity of the autonomic nerve, and the activity of the autonomic nerve is also related to the sleep stage. , Hilbert-Huang transform (Hilbert-Huang transform, HHT) and other applicable methods can also be used to analyze heart rate changes. Moreover, heart rate and body movements are often observed simultaneously to determine sleep stage-related information.

The system may include a warning unit. Many types of alerts are available, including: audible, visual, tactile, eg, sound, flashing lights, electrical stimulation, vibration, etc., or any other alert that can be applied to notify the user, where vibration alerts are preferably used A vibrating motor is used to provide a more comfortable and non-disturbing alert to the user's sleep, but alternatively, in some environments, the alert unit may use a speaker or earphone for audible alerts (air-conduction or bone-conduction), or Use LEDs for visual alerts.

The system may include an information providing interface, preferably an LCD or LED display assembly, to provide information to the user, such as physiological information, statistical information, analysis results, stored events, operating modes, alert content, Processes, battery status, etc., are not limited.

The system may include a data storage unit, preferably a memory, eg, an internal flash memory, or a removable memory disk, to store the measured physiological information.

The system may include at least one communication module, which may be implemented as a wireless communication module, such as Bluetooth, BLE, Zigbee, WiFi, RF or other communication protocols, or may be implemented as a wired communication module, such as a USB interface, a UART interface, to communicate in the system and/or to communicate with external devices, wherein the external devices may include, but are not limited to, smart devices such as smart phones, smart bracelets, smart glasses, smart headphones, etc., tablet computers, Notebook computers, personal computers, that is, may include devices on or around the person, and communication enables information to be exchanged between these devices, as well as information feedback, remote control, and monitoring operations. Here, an intelligent device refers to an open platform and its behavior can be controlled by a loader and/or a preloaded program, and there are various possibilities.

The system may include a power module, such as a button cell, alkaline battery, or a rechargeable lithium battery, the system may also have a charging module, such as an inductive charging circuit, or via, alternatively, USB port or pogo pin for charging.

Next, please refer to FIG. 2 , which shows the positions where the above-mentioned various physiological sensors and warning units can usually be set during sleep. The sleep physiological information that can be obtained and the detailed setting details are as follows.

Sleep position (sleep position), obtained by using a posture sensor, the obtained position is around the central axis of the body, including: the top of the head area 200, the forehead area 201, the ear area 202, the mouth and nose area 203, the chin area 204, the neck area 205, the chest area The area 206 and the abdominal area 207 can be arranged on any body surface around the central axis of the body, for example, the front, the back, etc., as long as the position of the sleeping posture can be obtained by conversion, among which, the torso and the upper part of the torso are used. The neck is the most representative.

The change of blood oxygen concentration is obtained by the optical sensor, and the obtained positions include: forehead area 201 , ear area 202 , mouth and nose area 203 , arm area 208 , finger area 209 , and foot area 211 .

The heart rate can be obtained by using a light sensor, and the obtaining position is not limited. Among them, the finger area 209, the arm area 208, the ear area 202, the head area 210, etc. are more commonly used, but any position on the body can be used. The high-sensitivity accelerometer detects the blood vessel vibration generated by the blood pulsation, and then obtains the heart rate, and the obtained position is also not limited, for example, the head, chest, upper limbs, etc. are all obtainable positions.

Respiratory Effort, that is, the chest and/or abdominal movement caused by breathing, can be obtained by using an accelerometer, a piezoelectric motion sensor, a RIP sensor, or an impedance detection electrode. The obtained positions include: the chest area 206 and the abdomen area 207 .

Breathing behavior is a general term for the breathing information obtained by the light sensor. As mentioned above, it is divided into two types. The low-frequency breathing behavior is based on the breathing information obtained by analyzing the PPG waveform, and the RSA breathing behavior is calculated based on the heart rate. There is no restriction on obtaining the breathing information, among which, the finger area 209 , the arm area 208 , the ear area 202 , the head area 210 , etc. are more commonly used, but any position on the body can be used.

The respiratory airflow change is acquired by using a respiratory airflow sensor (eg, thermistor, thermocouple, airflow tube, etc.), and the acquired location is the mouth and nose area 203 .

The snoring-related information (snoring sound) and breathing sound can be obtained by using a microphone, and the location of the acquisition is not limited, and can also be obtained outside the body, such as by using a mobile phone.

The snoring related information (body cavity vibration) is obtained by using an accelerometer or a piezoelectric vibration sensor, and the obtained positions include: the head region 210 , the neck region 205 , the chest region 206 , and the abdomen region 207 .

EEG signals are obtained by using EEG electrodes, and the obtained location is the head region 210 .

The electro-oculographic signal is obtained by using the electro-oculographic electrode, and the obtained location is the forehead area 201 .

The EMG signal is obtained by using EMG electrodes, and the obtained position is not limited, for example, the forehead area 201 and the chin area 204 .

Physical activity can be obtained by using the accelerometer, and the obtained position is not limited.

In the sleep stage, it can be obtained by light sensor and/or acceleration, and the position of the acquisition is not limited. It can also be obtained by using EEG electrodes, OMG electrodes, and/or EMG electrodes. The acquisition position is mainly on the head; further, through analysis The distribution of sleep stages, for example, the proportion of deep sleep and light sleep in the total sleep time, etc., can be used to understand sleep quality.

Furthermore, the warning unit for providing the vibration warning can be installed at any position where the body can feel the vibration, and the warning unit for providing the sound warning is preferably arranged near the ear. It is better to be near the canal and the mouth of the ear canal, and when the bone conduction sound warning is used, the range that can be set is wider. Except near the ear, the entire skull can be set, preferably the place without hair, and the warning is provided Not limited to a single form, two or more forms of alerts can be provided at the same time, for example, vibration and sound can be provided at the same time. In addition, there are also different options for vibration warning methods. For example, different vibration combinations can be combined according to various changes in intensity, frequency, duration, etc. Feeling tired.

Among them, it should be noted that the ear area 202 includes the inner surface and back of the pinna, the ear canal, and the head near the ear, the arm area 208 includes the upper arm, the forearm, and the wrist, and the neck area 205 includes the front of the neck and back.

In addition, when setting, for example, when setting the housing containing the physiological sensor on the body surface, various suitable wearing structures can be used to achieve, for example, a ring body, a belt body, for example, a head can be used. , arms, fingers, neck, torso, etc.; using adhesive structures, such as forehead, torso, and other body surfaces where adhesion can be performed; using (mechanical or magnetic) clips, for example, to clamp a part of the body, such as Fingers, ears, etc., or clipped on objects arranged on the body surface, such as clothes, belts around the body, etc.; and/or using pendants, such as hanging on auricles, etc., therefore, not limited to specific form of wearing structure.

It can be seen from the above that even the same kind of physiological information can be obtained without limitation by using different types of physiological sensors and selecting different body regions. In addition, it is also possible to choose to use more than two kinds of physiological sensors and/or at the same time. Or obtain more than two kinds of physiological information and/or set it in more than two body regions, therefore, in actual implementation, there are various combinations and changes and possibilities, and therefore, the embodiments described below are only for illustration, and Without limitation, as long as it falls within the above-mentioned scope, it belongs to the claimed scope of the present application.

The PPG signal obtained by the optical sensor, in addition to obtaining the blood oxygen concentration to calculate the ODI value, hypoxia level and other data well-known to those skilled in the art, is related to the occurrence of sleep apnea/hypopnea, and also produces Other changes and sufficient as a basis for determining whether sleep apnea/hypopnea has occurred.

The occurrence of obstructive sleep apnea causes a relative bradycardia and an increase in the pulse wave amplitude (PWA) of the PPG signal, as well as a rapid increase in heart rate and strong vascularity immediately after the end of respiratory obstruction. contractions, this phenomenon is referred to herein as heart rate variability sleep breathing events, and according to research, it has been reported that in patients with sleep breathing disorder, compared with heart rate (HR) / pulse-to-peak interval (Peak- to-peak interval, PPI), and sleep breathing events and arousal caused more changes in PWA and/or pulse area (PA).

Among them, as shown in Figure 6, PPI is defined as the time difference between two consecutive peaks in the PPG signal. First, the peak value (Peak.amp) of each cycle of the PPG signal is detected, and the time stamps of all Peak.amp points are stored in the array buffer. The PPI is calculated as the time difference between consecutive Peak.amp points. In order to obtain For accurate results, a reasonable range of PPI values can be set, eg, PPI < 0.5 sec (>120 strokes/min) or PPI > 1.5 sec (<40 strokes/min) is considered abnormal and removed.

PWA is defined as the difference between the peak amplitude (Peak.amp) and the valley amplitude (Valley.amp), which are the maximum and minimum amplitude points per PPG cycle. First, all Peak.Amp and Valley.amp points are detected as the local maximum and minimum points of the PPG signal. If there is a lack of Peak.amp points, the next Valley.amp point is also discarded. The PWA is calculated by subtracting Valley.amp from Peak.amp immediately before. Since Peak.amp and Valley.amp points are only detected in pairs, otherwise they will be discarded. Therefore, there will be no PWA value error due to the absence of one of the values. In addition, if there are any abnormal Peak.amp points, they will be extracted through PPI features. filter procedure mentioned in to exclude them.

PA represents the triangular area formed by a Peak.amp point and two Valley.amp points (see Figure 6). Similar to the extraction of PWA features, all Peak.amp and Valley.amp points are detected as local maxima and local minima in the PPG signal, and since the time stamp (ie the number of samples per point) is also recorded, Therefore, the pulse area can be calculated from each pulse waveform.

Respiratory signal RIIV (Respiratory Induced Intensity Variation) is caused by respiration-synchronized blood volume changes, which can be filtered and extracted from the PPG signal through a band-pass filter, for example, 0.13-0.48Hz, 16-level bevel Bessel filter (16th degree Bessel filter), which suppresses heart-related changes in PPG signals and frequencies below the respiratory rate, such as sympathetic nerve activity and reflex changes in response to efferent vagal activity .

Therefore, in order to detect sleep apnea/hypopnea events and their onsets, PPI, PWA, PA, and RIIV from light sensors derived from PPG waveforms can also be used as index.

According to the above, the application terms of the present invention are defined as follows:

Sleep physiological information, including at least: sleep posture-related information, sleep stage, sleep physical activity, blood oxygen concentration, heart rate, breathing action, respiratory airflow change, breathing behavior, breathing sound change, snoring-related information, EEG signal, EEG signal , and EMG signals.

Physiological information of sleep breathing, including at least: blood oxygen concentration, heart rate, breathing action, changes in breathing airflow, breathing behavior, changes in breathing sound, and snoring-related information.

Sleep breathing events, including: blood physiological sleep breathing events (oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events), snoring events, sleep apnea events, and sleep apnea hypopnea events.

Next, the present application provides a sleep breathing physiological feedback training based on sleep breathing events, and FIG. 3 shows a schematic flowchart of using sleep breathing physiological feedback training to improve sleep apnea.

The main method is to use a software program to monitor sleep breathing physiological information, when the patient's sleep breathing physiological information meets a preset condition during sleep, the warning unit is triggered to generate a warning, for example, any type of hearing, touch, vision, etc. A warning to allow the user to have a partial awaken or arousal that is sufficient to interrupt sleep breathing events, thereby preventing sleep apnea/hypopnea, where, if no arousal is detected, for example, according to Obtained sleep breathing physiological information, the intensity of the alert will increase at the next sleep apnea/hypopnea.

This method of monitoring sleep breathing events and their onset, and periodically and continuously arousing the patient to sleep briefly, is a feedback exercise used to prevent sleep apnea/hypopnea by allowing the user to experience repetitive A person with sleep apnea/hypopnea instinctively learns to return to sleep after taking a few deep breaths at the time of the event. According to research and experiments, this conditioned response to alerts can effectively reduce or eliminate sleep apnea/hypopnea after a period of use.

Here, the preset condition can be changed with the acquired physiological information of sleep breathing, for example, the preset blood oxygen concentration change, the preset heart rate change, etc., which will be described in more detail in different embodiments below. , when setting, preferably, the preset value can be used at the beginning, and then adjusted for each user, for example, the historical data collected by the physiological sensor can be used to assist in determining the preset suitable for the user conditions, and this dynamic adjustment helps to reduce the incidence of false alarms and improve the accuracy of sleep event detection, which is a more advanced method.

The software program can be pre-loaded in the wearable device for obtaining sleep physiological information, or can be pre-loaded in an external device, such as a personal computer, an intelligent wearable device, without limitation.

The implementation process starts from step 301, and then, in step 303, a preset condition is set, wherein the preset condition is the value at which the alert is activated. In some embodiments, the preset condition may be automatically set in the software program 300, Or set by using preset values; alternatively, these values may be determined and manually entered 318 by the user or practitioner, and may be changed based on user-specific information. The threshold conditions/values of the preset conditions 303 may include, but are not limited to, various sleep breathing physiological information and information related to sleep breathing events, such as the user's blood oxygen level, the user's heart rate, ODI, pulse wave amplitude, etc. .

In the learning mode, step 305, the software program 300 starts to sample the signal, which is collected by the wearable device and transmitted to the software program 300 using data transmission techniques known to those skilled in the art. Then, in step 313, Software program 300 collects sampled data comprising sleep breathing physiological information, wherein the sampled data is stored in memory or in a database using techniques known to those skilled in the art, and identifies sleep breathing events at step 314, eg, by analyzing Information about sleep breathing events.

At step 315 , the software program 300 compares the identified sleep breathing events to historical sleep breathing event baseline data 317 . In some embodiments, historical sleep breathing event baseline data 317 may include sleep breathing physiological information, such as heart rate values and blood oxygen level values, etc., provided through the guidance of a medical professional, and historical breathing event baseline data 317 may also provide indications User sleep breathing events and their originating PPG waveforms, heart rate changes, blood oxygen levels, and other medical data; in some embodiments, historical sleep breathing event baseline data 317 may be obtained from the user's historical readings, sleep breathing events Popular sources of baseline data (eg, MIT-BIH polysomnography database), or statistically derived data, etc. In step 315, the sampled data is compared with the historical sleep breathing event baseline data 317 to determine whether a false alarm occurs within a certain period of time. If a false alarm is found, the preset conditions are adjusted in step 315 to ensure correct detection. If a sleep breathing event is detected, if no false alarms are detected, or only a small number of false alarms within a preset range acceptable to the software program 300 or the user are detected, the preset conditions will not be adjusted in step 315, and Complete state 320 is entered.

In the training mode, please return to step 305. In this step, the software program 300 performs signal sampling, and then performs signal processing and corresponding algorithms in step 307 to extract sleep breathing physiological information and related values from the sampled signals. , after step 307, the software program 300 continuously checks in step 309, and determines whether it matches the preset condition by comparing the result obtained in step 307 with the preset condition set in step 303, if in step 309 If the preset condition is not matched, the signal sampling continues and no further processing is performed. If the preset condition is matched in step 309, an alert action is determined to initiate the generation of alert 312. Here, the alert will cause the use of The user is briefly awakened, then the user takes several deep breaths and returns to sleep, thus ending the apnea/hypopnea condition. The process of monitoring, alerting (and adjusting preset conditions) continues throughout the training mode, and as a result, the frequency and number of sleep apnea/hypopnea is gradually reduced.

Learning mode and training mode can be dynamically switched automatically, or manually set by the user, and can be performed on the same night or on different nights to optimize the therapeutic effect without limitation.

Next, the system provides content on assessing and improving postural sleep-disordered breathing.

Please refer to FIG. 4 , this flowchart illustrates the main steps of using the system to evaluate the relationship between sleep posture and snoring, and provides related training methods. In step 402, the device is placed on the user through a wearing structure.

In step 405, after the device wearing and setting is completed, the control unit starts data collection to acquire sleep posture-related information during the user's sleep, wherein the collected data can be transmitted to the external device through the wireless communication module, or can be stored first In the memory of the wearable device, it is then transmitted to an external device for subsequent analysis. Next, please refer to step 410. In this step, information related to snoring events will be collected. The sensors that can be used include, but are not limited to, microphones. , piezoelectric vibration sensors, accelerometers, which can be provided on wearable devices, or can also be provided on external devices, such as smart phones, without limitation.

Next, in step 415, the sleep posture-related information and the snoring event-related information are combined with each other, and the correlation between the two is calculated by a software program. For example, the supine snoring index is defined as the number of snoring events per hour when The supine snoring index was defined as the number of snoring events per hour in the supine position, and the snore index = supine snoring index + non-supine snoring index, and supine-dependent snorer was defined as supine snoring The index was higher than its non-recumbent snoring index. At step 418, a predetermined threshold is compared to, for example, the ratio of the supine snoring index to the non-recumbent snoring index, or other value, and if the threshold is exceeded, the user is identified as a positional snorer ), and then can perform Sleep Position Training (SPT) in step 425, otherwise, the user can perform sleep breathing physiological feedback training based on snoring events in step 430; In situations where high position dependency is accompanied by a high non-supine snoring index, the user can simultaneously combine postural training during supine position and snoring event-based sleep during non-supine position Respiratory Physiological Feedback Training Both. On the other hand, in the case of a high snoring index with a lower posture dependence, the user can check whether it is Postural Sleep Apnea (POSA) through step 440, because according to research, when the user's snoring index is higher, the , the more often found to be unrelated to posture, which means more severe upper airway obstruction that can lead to OSA symptoms.

Next, please refer to FIG. 5 . This flowchart illustrates the main steps of using the system to evaluate the relationship between sleep postures and sleep breathing events, and provides corresponding training methods. Here, the sleep breathing events may or may not be included. Including snoring incidents. In step 502, the device is placed on the user through a wearing structure.

In step 505, after the device wearing and setting is completed, the control unit starts data collection to obtain sleep posture related information during the user's sleep, wherein the collected data can be transmitted to the external device through the wireless communication module, or can be stored first In the memory of the wearable device, it is then transmitted to an external device for subsequent analysis. Next, please refer to step 510. In this step, the physiological information of sleep breathing will be collected. The sensors that can be used include, but are not limited to, light Sensors, accelerometers, piezoelectric vibration sensors, piezoelectric motion sensors, impedance detection electrodes, RIP sensors, respiratory airflow sensors, microphones, etc. Depending on the signal obtained, the sensor can be installed on the wearable device, or can also be installed on the wearable device. There is no limit to setting on an external device, such as a smartphone.

Next, in step 515, the sleep posture related information and the sleep breathing physiological information are combined with each other to calculate the correlation between the two through a software program. For example, the supine sleep breathing event index is defined as the sleep breathing events per hour in the supine position Quantity, the non-recumbent sleep-breathing event index is defined as the number of sleep-breathing events per hour in the non-recumbent position, and the sleep-breathing event index = supine sleep-breathing event index + non-recumbent sleep-breathing event index, additionally, postural sleep Respiratory event users were defined as having a higher supine sleep apnea event index than their non-supine sleep apnea event index. At step 518, a predetermined threshold is compared to, for example, the ratio of the supine sleep breathing event index to the non-supine sleep breathing event index, or other value, and if the threshold is exceeded, the user is identified as patient sleep breathing event user, and may then perform sleep posture training (SPT) at step 525, otherwise, the user may perform sleep breathing physiological feedback training based on sleep breathing events at step 530; or, alternatively, if high posture high position dependency with a high non-supine respiratory event index, the user can combine posture training during supine position and sleep-based breathing during non-supine position at the same time Events of sleep breathing physiological feedback training both.

Wherein, the way of posture training is, when it is detected that the sleeping posture conforms to a preset posture range, for example, lying on your back, and lasts for a period of time (for example, 5 seconds to 10 seconds), the warning unit will start a warning, for example, Vibration or sound, and the alert will gradually increase/increment intensity until it detects that the sleep position is out of the preset position range, for example, into a different sleep position, or a non-recumbent position, the alert stops immediately, if the After a preset period of time (eg, an adjustable 10 seconds to 60 seconds) without detecting a change in posture, the alert is paused and restarted after a period of time (eg, an adjustable number of minutes); in some implementations For example, the frequency/duration of the alert will be very short at the beginning and gradually increase until the user is no longer in the supine position; regardless of the intensity of the alert, there will be an interval (eg, 2 seconds) between alerts. Repeat several times (eg, 6 times).

As for the setting of the preset posture range, it can be different according to actual needs. For example, according to the definition of the supine posture, the preset posture range is changed. For example, when the accelerometer is set on the torso When the accelerometer is set on the forehead, it can be set to The angle between the normal line of the forehead plane and the normal line of the bed surface is within the range of plus or minus 45 degrees, or, when the accelerometer is set on the neck, it can have the same setting range as the head. So there is no limit and there are various options.

In addition, the posture training performed for snoring is also similar to the above situation, except that the basis for providing the warning is whether snoring is detected, which will not be repeated.

For the provision of the warning, the control unit is configured to generate a driving signal, and after receiving the driving signal, the warning unit generates at least one warning, and provides the at least one warning to the user, so as to achieve sleep posture training and/or the purpose of sleep breathing physiological feedback training, wherein the driving signal is implemented at least according to the sleep posture-related information after being compared with a predetermined posture range, and when the sleep posture-related information conforms to the predetermined posture range, and /or generated according to a determined alert action after the sleep breathing physiological information is compared with a predetermined condition and when the at least one sleep breathing physiological information meets the predetermined condition. How to provide warnings and details will be further described in the following embodiments.

Here, it should be noted that, regardless of the type of the warning generated by the above-mentioned warning unit, such as vibration or sound, there are various possibilities in implementation. For example, it can be installed in a wearable device that obtains sleep physiological information. , can also be installed in another wearable device, and can also be installed in an external device, so there is no limitation.

In addition, the provision of the warning is preferably performed after confirming that the user has fallen asleep, and is performed in a manner that does not disturb sleep. For this point, in a preferred embodiment, the present application uses detection The sleep physiological information is used to know whether the user has fallen asleep, and after falling asleep, the system enters a state where an alert can be generated and starts to provide sleep posture training and/or sleep breathing physiological feedback training.

During execution, the sleep physiological information obtained by the physiological sensor will be compared with a preset condition to determine whether the user meets a preset sleep breathing condition. Physiological conditions that only occur, such as the presence or absence of oxygen desaturation events, low oxygen level events, heart rate changes, sleep breathing events, snoring events, sleep apnea events, sleep apnea hypopnea events, breathing-specific changes, and/or heart rate When the user meets the preset sleep breathing conditions, the system enters an alert generating state, and the control unit generates a driving signal to drive the alert unit to provide alerts according to different alert behaviors.

For example, snoring can be detected as a benchmark, for example, using a microphone or an accelerometer. In particular, obstructive sleep apnea almost always occurs before snoring, which is useful for sleep posture training or sleep breathing physiological feedback. In terms of training, they are all time points that can be followed, which is quite advantageous; it is also possible to obtain sleep-related information by analyzing heart rate. rate) to understand the state of the body; it is also possible to know whether to fall asleep by analyzing breathing, for example, the breathing rate will slow down after falling asleep, etc.; it is also possible to know whether to fall asleep by knowing the sleep stage, for example, by analyzing the accelerometer The sleep stage is known from the measured actigraph, and/or the heart rate from the light sensor; alternatively, the occurrence of sleep breathing events can also be detected as a baseline for having fallen asleep. Therefore, there are many possibilities in the selection of physiological sensors, and all the above-mentioned physiological sensors that can obtain sleep physiological information can be used without limitation.

In addition, the installation position of the physiological sensor used to obtain the physiological information for judging whether the system enters the alert-generating state can also vary according to actual needs, and can be implemented as directly using the physiological sensor used in the training process. It can also be an additional physiological sensor. For example, an accelerometer, a light sensor, a microphone, etc., can be used in the device worn on the body, or an additional wearable device can be installed. The microphone in the external device, the accelerometer installed on the mattress, etc. can also be used, and there are various possibilities, all of which are available options.

Further, as shown in the flowchart in FIG. 7 , sleep posture training and sleep breathing physiological feedback training can also be performed together in the same sleep period. In this case, by arranging a posture sensor and at least one physiological sensor, sleep posture-related information and sleep breathing physiological information can be obtained in the same sleep period. Here, according to the different sleep breathing physiological information to be obtained and the setting position option, the at least one physiological sensor can be, for example, a light sensor, a microphone, an accelerometer, a piezoelectric motion sensor, a piezoelectric vibration sensor, an impedance detection electrode, a RIP sensor, and/or a respiratory airflow sensor, without limitation, and In particular, when an accelerometer is selected as a physiological sensor, it can also be used as a posture sensor at the same time.

After that, the sleep breathing physiological information analysis program is used to compare the sleep breathing physiological information with the preset conditions, the sleep breathing events of the user can be determined, and the sleep posture analysis program is used to compare the sleep posture related information with the preset posture. range comparison, wherein, when the sleep posture related information conforms to the preset posture range, a first warning condition combination is provided, and when the sleep posture related information exceeds the preset posture range, a second warning condition combination is provided , and the alarm determination program determines the alarm behavior according to different combinations of alarm conditions. Therefore, the control unit generates a drive signal according to the alarm behavior, and the alarm unit generates at least one alarm after receiving the drive signal to achieve the effect of The sleeping posture of the user and/or effects affecting the sleeping breathing state of the user.

Wherein, the first warning condition combination includes at least one of a time range condition and a sleep breathing event condition. For example, the time range condition may be implemented based on absolute time, for example, 1:00 am; it may also be implemented To be based on a specific physiological condition, for example, 1 hour after lying down, falling asleep, or various other physiological conditions; it can also be implemented as a delay time, for example, 1 hour after the device is activated, so that it can be According to the actual time requirement, whether to provide warnings in the case of conforming to the preset posture range is helpful to provide a more comfortable user experience. In addition, the sleep breathing event condition provides whether to perform sleep postures together in the same sleep period. The choice of training and sleep breathing physiological feedback training further improves the training effect.

In addition, the second warning condition combination includes at least the time range condition and the sleep breathing event condition. For example, when the sleep posture related information exceeds the preset posture range, for example, in a non-recumbent state, the The predominant condition for alerting is the occurrence of a sleep breathing event, and again, as previously described, the time at which the sleep breathing physiological feedback training is to be performed can be selected, for example, based on absolute time, or based on specific physiological conditions, or set delay time etc.

Furthermore, other conditions can also be added, such as warning intensity conditions, warning frequency conditions, etc., to provide a weaker warning when you just fall asleep, and then increase the intensity after a period of time. Therefore, by providing a combination of warning conditions, Training can be performed more in-demand and with less interruption to the user.

Moreover, since the sleeping posture changes at any time during sleep, the first warning condition combination and the second warning condition combination will be dynamically applied, and the order of application is not limited.

In the application system of the present invention, according to the different functions performed, there will be various software programs, including, but not limited to, sleep physiological information analysis program, sleep breathing physiological information analysis program, sleep breathing event analysis program, alarm decision Programs, etc., to obtain various physiological information according to the physiological signals obtained by the physiological sensors, and without limitation, various software programs can be preloaded in different devices according to actual needs and implementations.

According to the above-mentioned sleep breathing physiological feedback training based on sleep breathing physiological information (Figure 3), and sleep breathing disorder detection and training based on sleep posture (Figure 4 and Figure 5), relevant physiological information can be obtained. Various possible installation positions of the physiological sensor of the signal (as shown in Figure 2), the application of the present invention has the following various implementation possibilities without limitation, and therefore, the above various training contents and combinations can be described in the following It can be realized by any suitable embodiment, that is, it will not be repeated.

The content of the present application is to evaluate the relationship between the user's sleeping posture and sleep disordered breathing, and further about how to improve postural sleep disordered breathing.

The main idea is to achieve the best use effect through a decentralized setup.

When the decentralized form is adopted, how the decentralized devices communicate with each other and/or with external devices is very important, because it is not only related to the feasibility of implementation, but also related to the convenience of use. The decentralized system of the invention application refers to including two or more devices that can operate independently and each has a circuit configuration such as a control unit, a power module, a communication module, etc., wherein the communication module can be further implemented in a wireless form. Utilize digital signals and communicate wirelessly for maximum ease of use.

As mentioned in the technical background, the prior art mostly uses a single device to simultaneously detect sleep physiological information and provide warnings. However, since the position of obtaining the sleeping posture is preferably near the central axis of the body, or it can be calculated by using a conversion method. Therefore, it is easy to cause the inability of both detection and warning to be taken into account.

When the decentralized form is adopted, first, the setting position of the warning unit and the form of the warning become freely selectable. For example, some people are more sensitive to vibration, and some people are more sensitive to sound; The sensitivity of the alerts also varies.

Furthermore, the decentralized form also allows for more selectivity in the acquisition of sleep physiological information. As mentioned above, various physiological sensors can be used to obtain sleep physiological information and can be set in various positions, so the adoption of a decentralized form will help make the measurement more close to the actual needs, for example, the sleep breathing of different users The symptoms of the disorder may be different, and the actual physiological conditions can be more accurately reflected by the selection. In addition, it can also be adapted to the usage habits of different users. For example, each person has different feelings about the body setting objects, and there is no binding is designed to allow users to choose the setting location that is least disturbing to sleep.

One implementation may be that a sleep physiology system is implemented as including two devices, a sleep warning device and a sleep physiology device, the sleep warning device includes a first wearable structure, a first control unit, at least including a micro-controller a processor/processor, a first wireless communication module electrically connected to the control unit, a warning unit electrically connected to the control unit, and a power module, wherein the first wearable structure is used to set the sleep warning device on a user, so that the warning unit generates at least one warning to the user; in addition, the sleep physiological device includes a second wearing structure, a second control unit, at least a microcontroller/processor, a first Two wireless communication modules are electrically connected to the control unit, a posture sensor is electrically connected to the control unit, and a power module, wherein the second wearable structure is used for disposing the sleep physiological device on the user, so as to The posture sensor can obtain sleep posture-related information during the user's sleep, and serve as a reference for providing the at least one warning.

The above-mentioned sleep physiology system is a decentralized sleep posture training system. Through this setting, the warning unit can be freely selected in the form of vibration or audio, and set in any suitable position. In addition, the posture sensor does not need to be accommodated. If it must be installed on the body where the warning can be felt, it can be installed at any suitable position on the body.

Therein, in particular, the sleep physiology device for obtaining a sleeping position can be implemented as being arranged on the torso, for example, the abdomen, the chest, etc., and can be arranged on the torso by means of straps, adhesive structures, etc., or can also be implemented In the form of being fixed on the clothes, and because the information about the sleeping posture can be obtained without touching the skin, the device can also be arranged outside the clothes, which is quite convenient; in addition, the sleep warning device can be implemented in a place where ordinary users often Wearing position, such as wrist, finger, etc., and adopt the form widely accepted by users, such as wrist-worn form, finger-worn form, etc., to provide vibration warning; the combination of the two is very convenient to use, and also There is no burden on the body, for example, the sleep physiological device can be placed on the chest and the sleep warning device can be placed on the wrist.

Of course, without limitation, the sleep physiological device can also be set at other positions, such as the forehead, neck, etc., and the sleep warning device can also be set at other positions and use other forms of warning, for example, it can be implemented as a set In and/or near the ear to provide sound warnings, and can be further implemented as an earphone connected to an external device. For example, the external device can communicate with the sleep physiological device, and then drive the connection according to the sleep posture provided by the sleep physiological device. The earphone generates a sound warning; further, the sleep warning device can also be implemented in the form of a smart earphone, that is, a form that can directly communicate with the sleep physiological device wirelessly. Therefore, various implementations can be made according to actual needs. way, no limit.

As for how the acquired physiological information is transmitted among the distributed devices, there are many options. For example, in a preferred embodiment, both the sleep physiological information analysis program and the alert decision program can be preloaded in the sleep physiological device , that is, the sleep posture-related information is first compared with a preset posture range to know whether the sleep posture-related information conforms to the pre-set posture range, and a warning action is determined when it conforms to the pre-set posture range, After that, the warning behavior is transmitted to the sleep warning device through a digital signal, and after receiving the digital signal, the control unit in the sleep warning device generates a driving signal according to the warning behavior, and then drives the warning unit to generate at least one warning , and provided to the user to achieve a warning effect, for example, to cause the user to spontaneously change their posture. Such an approach will help to save the power consumption of the sleep warning device, for example, if the battery needs to be replaced, the battery replacement cycle can be extended.

Alternatively, it can also be implemented that the sleep alert device receives the sleep posture related information from the sleep physiological device, and uses a preloaded program to analyze and determine the provision of alerts. In this case, the sleep posture related information The signal is sent to the sleep warning device, and then compared with a preset posture range to determine the warning behavior. After that, the control unit of the sleep warning device generates a driving signal according to the warning behavior, and then drives the warning unit to generate at least one A warning is provided to the user to achieve a warning effect; or, alternatively, the sleep posture-related information can be analyzed in the sleep physiological device to obtain whether it conforms to the preset posture range, and then the The digital signal transmits the comparison result to the sleep warning device, and determines the warning behavior. After that, the control unit of the sleep warning device generates a driving signal according to the warning behavior, and then drives the warning unit to generate at least one warning, which is provided to the user. , in order to achieve the warning effect. Therefore, there are various implementation possibilities, which can be changed according to actual needs and are not limited.

When there is an external device, there are more options. For example, the sleep physiological information analysis program and the warning decision program can be pre-loaded in the external device. In this case, the sleep physiological device obtains the sleep posture related information after obtaining , will be sent to the external device, and then the external device will execute the sleep physiological information analysis program and the alarm decision program to determine whether to provide an alarm and how to provide an alarm, and transmit the alarm behavior to the sleep alarm device through a digital signal, and After receiving the digital signal, the control unit of the sleep warning device generates a driving signal to drive the warning unit to provide warnings; or, alternatively, only the sleep physiological information analysis program or only the warning decision program can be preloaded externally In the device, therefore, it can be changed according to the actual operation process and actual needs, and there is no limit.

Further, a physiological sensor can also be added to obtain other physiological information of sleep breathing. On the one hand, it can be used to confirm the effect of performing sleep posture training, for example, whether the occurrence of sleep apnea events is reduced. The basis of the breathing physiological feedback training is to be performed together with the sleep posture training during the same sleep period to increase the effect. For example, it can be set on the sleep physiological device, and set at different body axis positions according to the sleep physiological device, There are different combinations of options, for example, when the device is placed on the forehead, light sensors, accelerometers, microphones, piezoelectric vibration sensors, etc. can be used to obtain blood oxygen concentration, heart rate, snoring-related information, etc.; when the device is placed on the nose and mouth When the device is placed on the torso, the respiratory airflow sensor, light sensor, accelerometer, microphone, piezoelectric vibration sensor, etc. can be used to obtain respiratory airflow change, heart rate, snoring-related information, etc.; when the device is placed on the torso, the optical sensor, accelerometer , microphone, piezoelectric motion sensor, impedance detection electrode, RIP sensor, etc., to obtain heart rate, snoring-related information, breathing action, etc.; in addition, additional physiological sensors can also be installed on sleep warning devices or external devices, and according to the settings The selection of suitable physiological sensors depends on the location and is not limited. The above-mentioned sleep breathing physiological information can be further used to obtain sleep apnea events, sleep apnea hypopnea events, oxygen desaturation events, low oxygen level events, heart rate change sleep breathing events, snoring events, etc., so there is no limit.

In the following description, the content of the distributed architecture is a wireless distributed architecture composed of two or more devices that can operate independently. If the devices perform wireless communication, the situation is similar. Therefore, the above-mentioned different devices The content of various implementation options, such as information transmission methods between and/or with external devices, information analysis, and decision of warning behaviors, are also applicable, and thus will not be repeated.

In addition, it should also be noted that, as well known to those skilled in the art, the operation of each device in the wireless distributed system must have the basic circuit configuration of the control unit, the wireless communication module and/or the wired communication module, the power module, etc. All of these are repetitive contents, so in the descriptions of all the following embodiments, they will be omitted and not repeated, and the actual circuit configurations of all the devices in the application of the present invention are not limited accordingly.

Next, another implementation may be that a sleep physiological system is implemented to include two devices, a sleep warning device and a sleep breathing physiological device, both of which are installed on a user through a wearable structure, wherein the sleep warning The device has a posture sensor to obtain information about the sleeping posture of the user, and a warning unit to provide at least one warning to the user, and the sleep breathing physiological device has a physiological sensor to obtain the sleep breathing of the user during sleep Physiological information; in this example, because sleep posture and sleep breathing physiological information can be obtained, whether it is postural sleep breathing disorder or non-postural sleep breathing disorder can be solved in this system, It is equivalent to combining both sleep posture training and sleep breathing physiological feedback training, which can comprehensively improve sleep breathing disorders, and advantageously, the warning unit located in the sleep warning device can selectively respond to different sleep physiological information. Generate alerts, for example, alerts can be generated based on sleep posture related information, alerts can be generated based on sleep breathing physiological information, and alerts can be generated based on both sleep posture related information and sleep breathing physiological information. One type of patient, or a patient with mixed symptoms, or a patient who does not yet know what type they are, can effectively provide a solution, which is quite advantageous.

Wherein, the sleep posture related information is compared with a preset posture range to know whether it conforms to the preset posture range, and the sleep breathing physiological information is compared with a preset condition to know whether it conforms to the preset Therefore, the decision of the warning behavior can be selected based on one of the two or a combination of the two, without limitation.

Further, such a system may also operate in different ways. Since the sleep warning device itself already has a posture sensor and a warning unit, it can be used alone for sleep posture training, or it can work together with the sleep breathing physiological device to increase the effect, which provides the user with another A selection possibility, for example, to choose how many devices are to be placed on the body, and which sleep physiological information is to be selected as the basis for the alert, etc. And this is also the advantage of using a decentralized form of design.

Wherein, when the sleep warning device is implemented on the torso, it is preferably a vibration warning, and when it is installed on the forehead or neck, a vibration warning or a sound warning can be selected, which is not limited.

Furthermore, the advantage brought by the decentralized form is that the type and installation position of the physiological sensor, as well as the type of the acquired sleep breathing physiological information, can be selected differently. The setting conditions will also be different with the selected physiological sensor, and the wearing structure used to set the sleep breathing physiological device will also be different.

For example, the sleep breathing physiology device can optionally adopt various implementations that can be integrated into general living habits, such as wrist-worn or finger-worn forms, and can use light sensors or microphones to obtain sleep breathing physiological information, such as , heart rate, blood oxygen concentration, breathing behavior, snoring-related information, breathing sound changes, etc. In this case, smart wearable devices, such as smart watches, smart bracelets, smart headphones, etc., are suitable for use in this situation. , it can also be implemented in a non-wearable form arranged near the body. For example, the microphone in the smart phone can be used to detect snoring and breathing sound to obtain sleep breathing physiological information, and according to the obtained sleep breathing physiological information, sleep The respiratory event analysis program can further obtain various sleep breathing events, such as oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events, snoring events, sleep apnea events, and sleep apnea hypopnea events. There are all possibilities, no limit. In this way, it only needs to be equipped with a sleep warning device installed on the trunk/head/neck to provide sleep posture detection and vibration warning, and the sleep physiological system that provides two training methods can be used in ordinary daily life. Integrated together, it is quite advantageous for the popularity of use. For example, the sleep warning device can be installed on the forehead and the sleep breathing physiological device can be installed on the fingers. In addition, the sleep warning device can also be installed on the back of the neck and The sleep breathing physiological device can be implemented as a smart phone, so there are various possibilities.

Another implementation may be that a sleep physiology system includes two devices, a sleep warning device and a sleep breathing physiology device, both of which are installed on a user through a wearable structure, wherein the sleep warning device has a warning unit is used to provide at least one warning to the user, and the sleep breathing physiological device has a physiological sensor to obtain at least one sleep breathing physiological information of the user during sleep, and, through wireless communication, the sleep breathing physiological device The acquired sleep breathing physiological information is used as the basis for the warning unit to generate the warning, wherein the sleep breathing physiological information will be used as the basis to obtain at least one sleep breathing event, and determine a warning action, and generate a warning action according to the warning action. A driving signal of the alarm unit will drive the alarm unit to generate at least one alarm and provide it to the user to achieve the alarm effect, for example, the user can be briefly awakened and the normal breathing function can be restored.

The above-mentioned sleep physiological system is a decentralized sleep breathing physiological feedback training system, and through this setting, the warning unit will be freely selected in the form of tactile or auditory, and set in any suitable and can effectively feel the warning position. , In addition, the types of physiological sensors and the physiological information of sleep breathing to be obtained can also be freely selected. For example, different users have different sleep-disordered breathing conditions, and the suitable physiological sensors are also different. Therefore, through the decentralized design, the application range can be changed. Broader and more flexible, for example, physiological sensors can be implemented as, for example, light sensors, accelerometers, respiratory airflow sensors, piezoelectric motion sensors, impedance detection electrodes, RIP sensors, piezoelectric vibration sensors, and/or or microphone, and by setting it on, for example, head, ear, neck, torso, wrist, fingers, etc., to obtain information including, but not limited to, snoring-related information, breathing sound changes, breathing movements, breathing airflow changes , breathing behavior, heart rate, blood oxygen concentration and other sleep breathing physiological information, and then determine various sleep breathing events, such as oxygen desaturation events, low oxygen level events, heart rate changes sleep breathing events, snoring events, sleep apnea events , and sleep apnea hypopnea events.

Further, the sleep breathing physiology device may further include a posture sensor to obtain information related to sleep postures. In this way, options for performing sleep posture training and/or sleep breathing physiological feedback training are provided. At this time, it is necessary to pay attention to Select a setup location such as head, neck, torso, etc., to obtain a sleeping position.

In particular, in a preferred embodiment, the sleep warning device can choose to adopt tactile warning and set it on the wrist to increase the convenience of use. Wearable devices, such as smart watches, smart bracelets, etc., are used as warning devices, and can also directly use the information providing interface on the wearable device to provide various information, which will be a very cost-effective choice for users. Of course, an information providing interface on an external device, such as a smart phone, may also be utilized, without limitation.

Furthermore, another implementation may be that a sleep physiology system includes two devices, a first sleep physiology device has a first sleep physiology sensor to obtain a first sleep physiology information, and a second sleep physiology device has A second sleep physiology sensor to obtain second sleep physiology information, and at least one alarm unit can be implemented to be located in the first sleep physiology device and/or the second sleep physiology device, so as to detect the sleep physiology information according to the sleep physiology information. Alerting is provided, and through wireless communication, the alerting unit may be implemented to provide alerts according to the first sleep physiological information, the second sleep physiological information, or the first sleep physiological information and the second sleep physiological information.

The first sleep physiology device and the second sleep physiology device are both implemented in a wearable form, and the physiological sensors used and the sleep physiology information that can be obtained are correspondingly different according to the different positions. For example, the positions that can be set include, but are not limited to, the head, neck, torso, upper limbs, etc. The physiological sensors that can be used include, but are not limited to, light sensors, accelerometers, respiratory airflow sensors, impedance detectors Measuring electrodes, RIP sensors, piezoelectric motion sensors, piezoelectric vibration sensors, microphones, EEG electrodes, OMG electrodes, and EMG electrodes, and the available sleep physiological information includes, but is not limited to, snoring-related information, respiration Voice changes, breathing movements, respiratory airflow changes, respiratory behavior, heart rate, blood oxygen concentration, EEG, OMG, EMG, sleep posture, sleep physical activity, and sleep stages, and derived sleep breathing events Including, but not limited to, oxygen desaturation events, low oxygen level events, snoring events, heart rate variability sleep breathing events, sleep apnea events, and sleep apnea hypopnea events. That is, in this implementation possibility, the decision of the warning behavior will have various possibilities without limitation, for example, the snoring-related information can be matched with the blood oxygen concentration, or the heart rate can be matched with the blood oxygen concentration, or the sleeping posture can be matched with the breathing action, etc. Alternatively, alert behavior can be determined based on only a single sleep physiological information, while another is used to understand the physiological state during sleep. So there are all kinds of possibilities, no limit.

For example, in a preferred embodiment, the first sleep physiology device can be installed on the wrist, and use a light sensor, an accelerometer, and/or a microphone to obtain heart rate, breathing behavior, snoring-related information, and breathing sound changes , sleep physical activity, and/or sleep stage, and then with the second sleep physiological device installed on the finger, using the light sensor to obtain the blood oxygen concentration, so that two kinds of sleep physiological information can be obtained on the same upper limb, which is equivalent to have an advantage.

Of course, in addition to the above-mentioned embodiments, the first sleep physiological device and the second sleep physiological device can also be set in any wearable position according to actual use requirements, for example, the head, ears, torso, arms, wrists, fingers etc., to obtain more sleep physiological information by using the same or different physiological sensors.

In addition, in particular, when one of the first sleep physiology device and the second sleep physiology device is implemented to obtain a sleep posture, the warning unit will be able to detect the sleep posture according to the sleep posture related information and/or sleep breathing physiology information. Provide a warning, and then perform sleep posture training and/or sleep breathing physiological feedback training. On the other hand, if the first sleep physiological device and the second sleep physiological device are both implemented to obtain sleep breathing physiological information, the warning unit is based on At least one of the two types of sleep breathing physiological information provides an alert, so that the two sleep breathing physiological information can be complementary.

Furthermore, when the wearing form used is the same as the smart wearable device used in daily life, for example, the wrist-worn form, the ear-worn form, etc., the above-mentioned behavior can also be achieved by using the smart wearable device, which is quite convenient in use; A sleep physiology device and the second sleep physiology device with an alarm unit can be further selected to be used alone to perform sleep-disordered breathing training, or can be selected to work together with another device to provide more functions.

In addition, in addition to the training for improving sleep-disordered breathing, the decentralized system can also be applied to the assessment of sleep-disordered breathing to make the assessment results more accurate.

One possible implementation is that a sleep physiology system is implemented to include two devices, a sleep physiology device and a sleep breathing physiology device. The sleep physiology device has a posture sensor and is disposed on the user's body to obtain sleep during sleep. posture, and the sleep breathing physiological device has physiological sensors to obtain sleep breathing physiological information, and through the decentralized design, whether it is sleep posture related information, or sleep breathing physiological information, can be more accurately in the appropriate position The advantage of this is that different physiological information of sleep breathing can be provided flexibly according to different physiological conditions, for example, because it is no longer limited by the position where the sleep posture is obtained, it is possible to freely choose to detect snoring You can also choose to detect oxygen desaturation events, or other sleep breathing events, no matter which can be accurately evaluated, and then analyze it together with sleep posture, and naturally more accurately determine the occurrence of sleep breathing events. , which is in line with the preset posture range and the ratio beyond the preset posture range, for example, the ratio between lying on the back and not lying on the back, so it can provide the user, for example, through the information providing interface, a sleep breathing event posture correlation information, and then Understand whether the correlation between occurrence of sleep breathing events and sleep position is high or low.

Furthermore, in the same way, such a configuration also enables a smart device to be further applied as the sleep breathing physiological device to detect sleep breathing physiological information, for example, a light sensor, a microphone, or a smart watch can be used. Microphones on smartphones, etc., and advantageously, since this system focuses on assessing whether there is sleep-disordered breathing and its relationship to sleep posture, the provision of information is particularly important, so it is natural to take advantage of both Some information providing interfaces, such as screens, LEDs, sound components, etc., are used as the information providing interfaces of the system. Using the display component on the smartphone, such a configuration is not only simple and convenient, but also conforms to the user's daily use behavior.

For example, in actual use, a sleep physiology device can be installed on the trunk of the body, and the sleep breathing physiology device can be installed on the finger to obtain the blood oxygen concentration and the ODI that can be further calculated by using the optical sensor, or can also be set On the wrist, use the optical sensor to obtain the average blood oxygen concentration change, heart rate, breathing behavior, or use the microphone to obtain various sleep breathing related physiological information such as snoring related information, so as to know the relationship between the occurrence of sleep breathing events and sleep posture. , the ear is also a very suitable setting position, you can set the light sensor, and according to the PPG signal obtained according to the different setting positions, you can get the blood oxygen concentration, breathing behavior, heart rate, etc., you can also set the microphone to get the snoring data. The sound generated, or the vibration generated by the snoring obtained by the accelerometer, and the respiratory airflow sensor can also be arranged between the mouth and nose to know whether a sleep apnea event and/or a sleep apnea hypopnea event occurs. Therefore, various setting positions are possible without limitation.

Among them, when choosing to set on the body to obtain physiological information, it can be set by using a wearable structure, for example, an adhesive structure, a strap, a head-mounted structure, a finger-mounted structure, a wrist-mounted structure, an ear-mounted structure, etc., and two wearable structures can be used at the same time. The wearing structure can be changed according to the actual implementation situation, and there is no limit.

Still further, a warning unit can also be set in the system, for example, in a sleep physiological device, and/or a sleep breathing physiological device, to improve sleep breathing disorder, for example, if sleep breathing during supine lying is found High event rates, alerts may be issued during supine lying, e.g., vibrating modules vibrate to achieve spontaneous sleep position changes to improve postural sleep apnea/hypopnea, snoring, and/or Analyzing the sleep breathing events derived from the physiological information of sleep breathing to give alerts, for example, when a snoring event occurs, or when an oxygen desaturation event occurs, to perform sleep breathing physiological feedback training, in this case, the system becomes available. Taking into account the two processes of evaluation and improvement of training at the same time, for example, at the beginning, the user may not execute the warning first, but use two devices to evaluate before the sleep period, so as to know whether there is sleep disordered breathing, and its The relationship between sleep posture and sleep posture. Later, when it is found that the occurrence of sleep breathing events is indeed highly correlated with sleep posture, for example, when lying on the back, there is a high incidence rate. At this time, the improvement training function of this system can be further used. To perform sleep posture training, or find that the correlation between sleep breathing events and sleep posture is low, you can choose to perform sleep breathing physiological feedback training, which means that one system can provide multiple functions, which is extremely advantageous.

Another implementation may be that a sleep physiology system is implemented as including two devices, a sleep warning device and a sleep breathing physiology device, the sleep warning device has a posture sensor and is disposed on the user's body to obtain sleep during sleep. The posture and the warning unit are used to provide at least one warning to the user, and the sleep breathing physiological device has a physiological sensor to obtain the sleep breathing physiological information of the user during sleep. In this configuration, first, the sleep warning Since the unit can provide alerts, it can be used alone to provide alerts according to sleep posture, that is, to provide sleep posture training, and further, when used with the sleep breathing physiological device, the sleep breathing physiological device obtains The physiological information of sleep breathing will be used to confirm the improvement effect of providing warnings, for example, whether the occurrence of sleep breathing events such as sleep apnea and snoring has been reduced due to changes in sleep posture. Knowing various relevant information, such as the number of times and time points of alert execution, the distribution and proportion of different sleep postures, the number and time points of sleep breathing events, etc., the user will be able to clearly know the sleep posture training performed. Whether it has an effect and what the effect is is also quite advantageous.

In addition, in order to understand the difference before and after using sleep posture training, it can also be implemented that the warning unit in the sleep warning device does not provide a warning at first, but only obtains the user's sleeping posture, and then cooperates with the sleep breathing physiology. The device obtains the physiological information of sleep breathing during sleep, and by combining the two, the relationship between the occurrence of sleep breathing events and different sleep postures can be known. In this way, when the sleep posture training is started, it can further obtain and provide warnings. The effect of whether or not, for example, the proportion of different sleep positions changes, and whether the occurrence of sleep breathing events is reduced, etc.

Furthermore, through such a setting, it is equal to long-term continuous detection, for example, daily usage tracking, sleep physiological information during sleep posture training, so the setting value related to the warning behavior can be adjusted according to the obtained sleep physiological information, On the one hand, the provision of the alert can be more effective, and on the other hand, the sleep disturbance of the user can be minimized.

Moreover, since the sleep warning device has both a posture sensor and a warning unit, when the user has confirmed that his sleep-disordered breathing is highly correlated with sleep posture, and has also confirmed that the provided warning can achieve an improvement effect, The sleep warning device can be used alone to simplify the configuration on the body, and then, after a period of time, for example, once a month, it can be used together with the sleep breathing physiological device again in response to possible changes in physiological conditions, and Accordingly, the content of the warning behavior can be adjusted, so that the effect of sleep posture training continues; in addition, after a period of sleep posture training, the human body will achieve the habit of sleeping posture, for example, become accustomed to sleeping in a non-recumbent position In this case, you can also try to suspend sleep posture training, and only perform the detection of sleep posture and/or sleep breathing physiological information, and then use it as a basis for adjusting the use situation.

In actual use, for example, the sleep warning device installed near the torso, head, or neck of the body can cooperate with the sleep breathing physiological device installed on the finger to obtain the blood oxygen concentration and ODI through the optical sensor, or also It can cooperate with the sleep breathing physiological device installed on the wrist, and obtain various sleep breathing related physiological information such as the average blood oxygen concentration change, heart rate, breathing behavior, etc. through the optical sensor for confirmation and/or sleep breathing physiological feedback training. In addition, the ear It is also a very suitable setting position. The light sensor can be set, and the blood oxygen concentration can be obtained according to the PPG signal obtained according to the different setting positions, and the breathing behavior, heart rate, etc. can also be obtained. Sound, or the vibration generated by snoring can be obtained by an accelerometer, and a respiratory airflow sensor can also be arranged between the mouth and nose to know whether a sleep apnea event and/or a sleep apnea hypopnea event occurs. Therefore, various setting positions are possible without limitation.

In addition to the above-mentioned various possible implementations of obtaining physiological information and providing warnings, other related contents under the distributed architecture will be further elaborated next.

First, there are also multiple implementation options regarding the provision of information. For example, the information providing interface can be provided on one of the two devices, or both devices have the information providing interface, or an external device, such as a mobile phone, a watch, can be used as the information providing interface, and the provided There are also various possibilities for the content of the information, such as sleep posture-related information, sleep physiological information, sleep breathing physiological information, sleep breathing events, warning behaviors, the effect achieved by the warning, and the time when the warning is provided, etc. All kinds of information during sleep are It can be provided to users through an information providing interface without limitation.

Furthermore, when the distributed architecture of the present application adopts wireless communication, it should be noted that the control between two or more devices in the whole system and how to integrate the physiological information obtained by different devices.

First, the manipulation of the system, such as start/end operations, parameter setting, etc., has various possibilities depending on the operation mode. For example, it can be operated through an external device, such as loading an application program in a mobile phone, and controlling the system through an operation interface and wireless communication; Another device for communication, etc.; in addition, there are also various possibilities for how to start the system to start running. For example, in addition to controlling the start through the operation interface, it can also be set to start automatically, for example, it can be detected due to It starts automatically until it is set on the body surface of the user, or it can be set to start at a timed time or the like. Therefore, the appropriate method can be selected according to the actual needs, and there is no limit.

Next, in terms of information storage, it can be directly stored in the device that obtains the physiological information. At this time, a data storage unit, such as a memory, is required. In addition, the information can also be stored in a single device, for example, where One device wirelessly transmits information to another device and stores it in the memory of the other device; after the sleep period ends, the stored information can be transmitted wirelessly or by wire, for example, using wireless communication , for example, bluetooth, or wired communication, such as USB interface, and transmission to external devices, such as mobile phones, computers, etc., can also be removed and read the memory card; on the other hand, you can also choose two The information of the device is transmitted to the external device in real time. For example, the two devices transmit the information to the external device through wireless communication, and then the external device stores the information. Alternatively, one of the devices can first transmit the information to the other device. and then send it to the external device together. Therefore, there are various implementation possibilities without limitation.

In addition, since various kinds of information are obtained by two devices respectively before being provided to the user, it is very important how to align the time series between the various kinds of information, so as to achieve the effect of effectively utilizing the information.

For example, the alignment of the time axis between the provision of the alert and the sleeping position is the basis for confirming whether the alert has achieved its effect. In addition, the relationship between the obtained physiological information and sleep posture is an important basis for confirming whether it is postural sleep disordered breathing. For example, by analyzing the physiological information It is possible to know whether a sleep breathing event occurs, and to further confirm the sleep posture when the sleep breathing event occurs. Therefore, for the decentralized sleep physiology system of the present application, the time-series alignment between various information will be the basis of all analysis and operations.

As for how to do timing alignment, there are many possibilities. For example, time stamps can be used and information integration can be done by aligning the time axis, or time synchronization can be run before the entire process starts, there are various possibilities, no restrictions, and whatever is used The way, preferably, is performed at the same time as the whole process is started, for example, when the start key is pressed, or when it is started wirelessly by an external device, which can make the operation more convenient.

Here, it should be noted that although the above embodiments are described based on two devices, the content of the distributed architecture in the application of the present invention is not limited thereby, and can be implemented as more devices, for example, three , Four devices, which can be changed according to actual needs.

So far, it can be seen that, in different embodiments, the sleep physiology system of the present invention has different implementations according to different usage requirements and differences in hardware configuration. And change the setting position, etc. Therefore, as shown in FIG. 8 , as long as different wearing structures are matched, for example, it is implemented in a removable form between the shell and the wearing structure, it is easy to achieve the installation on different body parts. demand, quite advantageous.

It should also be noted that, in the above-mentioned embodiments, the analysis of physiological information, the determination of whether a sleep breathing event occurs, the determination of whether to provide a warning, and/or the decision of the warning behavior, etc., are achieved through various software programs, and Various software programs, without limitation, can be implemented in any wearable device and/or in an external device to perform operations, so as to achieve the most convenient operation mode for users, so it can be changed according to actual needs, no limit.

In the above-mentioned embodiment, the wearing structure used for disposing the posture sensor, the physiological sensor, the casing, the device, and/or the system on the user's body can be changed according to the actual requirements of the disposing position. For example, the material can be Variations, and where appropriate, the same type of wearing structure can also be provided on different body parts, for example, the wearing structure in the form of straps can be provided on any part of the body that can be looped, such as headbands, neckbands , chest straps, abdominal straps, arm straps, wrist straps, finger straps, leg straps, etc., and can be implemented in various materials, such as fabric, silicone, rubber, etc. In addition, adhesive structures, such as patches, are almost There is no restriction on the setting position, as long as it can be attached to the position, and it can also be attached to the clothing of the user; in addition, a specific body position can also have a dedicated wearing structure, for example, the head can use an eye mask , especially suitable for use during sleep, the arm can be an arm-worn structure, the wrist can be a wrist-worn structure, and the finger can be a finger-worn structure, etc. Therefore, the actual use form will not be limited by the description of the above embodiments, there may be various a possibility.

Moreover, when various possible wearable structures are used to carry the shell/device, there are also various implementation possibilities for the combination between the two. For example, it can be combined by means of adhesion or by means of clipping. For example, mechanical clipping, magnetic clipping, can also be combined by means of sleeve, for example, the wearing structure has a structure that can be sleeved with a shell/device, and can also be combined by plugging, for example, when wearing The structure has a structure in which the casing/device can be plugged, as long as the combination of the casing/device and the wearing structure can be a suitable choice, and various combination methods can also be implemented as non-removable or removable. form of removal. Therefore, it can be changed according to actual needs and is not limited to the description of the above embodiment.

In the above embodiment, any information, whether directly obtained by using a physiological sensor, or obtained by an analysis program, or other information about the operation process, is provided to the user through the information providing interface, and the information is provided to the user. The interface may be implemented to be provided on any one or more devices in the system, without limitation.

In addition, the various content of obtaining sleep physiological information in the above-mentioned embodiments can be applied to any kind of physiological sensor mentioned above, any setting position, and any calculation method performed according to the obtained physiological information. The principles described in detail are repeated without enumerating them one by one, but the scope of the rights claimed by the application of the present invention is not limited thereby.

In addition, each device proposed in the above-mentioned embodiments should also be applicable to the circuit configuration mentioned above, and can be changed according to the different physiological information to be obtained and the different setting positions of the various embodiments. The same is based on non-repetitive The principles described in detail are not listed one by one, but the scope of the rights claimed by the present application is not limited thereby.

In addition, each of the above-mentioned embodiments is not limited to be implemented alone, and parts or whole of two or more embodiments can also be combined or implemented in combination, which all belong to the scope claimed by the present application and are not limited.

Claims (28)

1. A physiological system for sleep is composed of a sleep unit,

a sleep alert device comprising:

the first wearing structure is used for arranging the sleep warning device on a user;

a first control unit at least comprising a microcontroller/microprocessor;

a first wireless communication module electrically connected to the first control unit;

a warning unit electrically connected to the first control unit for generating at least one warning to the user; and

a power module; and

a sleep physiological apparatus comprising:

a second wearing structure for arranging the sleeping physiological device on the user,

a second control unit at least comprising a microcontroller/microprocessor;

a second wireless communication module electrically connected to the second control unit;

a posture sensor electrically connected to the second control unit for obtaining the sleep posture related information of the user during the sleep period; and

a power module, a power supply module and a control module,

wherein,

the first control unit receives a digital signal based on the sleep posture related information through the first wireless communication module;

the first control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning and provides the at least one warning to the user after receiving the driving signal; and

the driving signal is generated according to an alarm behavior determined when the sleep posture related information conforms to a preset posture range after the sleep posture related information is compared with the preset posture range.

2. The system of claim 1, further comprising a physiological sensor for acquiring sleep breathing physiological information of the user, comprising at least one of: optical sensors, accelerometers, respiratory airflow sensors, piezoelectric motion sensors, impedance sensing electrodes, RIP sensors, piezoelectric vibration sensors, and microphones.

3. The system of claim 2, wherein the sleep breathing physiological information is further used to obtain sleep breathing events of the user during the sleep period, including at least one of: oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events, snoring events, sleep apnea events, and sleep hypopnea events.

4. The system of claim 2, wherein the physiological sensor is implemented to be located in at least one of the following, including: the sleep warning device, the sleep physiological device and an external device.

5. The system of claim 1, further comprising an alert decision process preloaded with at least one of the following: the sleep warning device, the sleep physiological device and an external device are used for generating the driving signal.

6. The system of claim 1, wherein the first wear structure comprises one of: a wrist-worn structure, a finger-worn structure, and an ear-worn structure.

7. A sleep physiological device is contained in a sleep physiological system, and the sleep physiological system comprises a sleep warning device and the sleep physiological device, wherein the sleep warning device comprises a first wearing structure used for being arranged on a user body, a first control unit, a warning unit electrically connected to the first control unit and used for generating at least one warning for the user, and a first wireless communication module, the sleep physiological device comprises:

the second wearing structure is used for arranging the sleeping physiological device on the body of the user;

a second control unit at least comprising a microcontroller/microprocessor;

a second wireless communication module electrically connected to the second control unit;

a posture sensor electrically connected to the second control unit for obtaining the sleep posture related information of the user during the sleep period; and

a power module, a power supply module and a control module,

wherein,

the first control unit receives a digital signal based on the sleep posture related information through the wireless communication module;

the first control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning and provides the at least one warning to the user after receiving the driving signal; and

the driving signal is generated according to an alarm behavior determined when the sleep posture related information conforms to a preset posture range after the sleep posture related information is compared with the preset posture range.

8. A sleep physiology system comprising:

a sleep alert device comprising:

the first wearing structure is used for arranging the sleep warning device on the body of a user;

a first control unit at least comprising a microcontroller/microprocessor;

a first wireless communication module electrically connected to the first control unit;

a posture sensor electrically connected to the first control unit for obtaining sleep posture related information of the user during sleep; and

a warning unit electrically connected to the first control unit for generating at least one warning to the user; and

a power module; and

a sleep breathing physiological apparatus, comprising:

the second wearing structure is used for arranging the sleep breathing physiological device on the body of the user;

a second control unit at least comprising a microcontroller/microprocessor;

a second wireless communication module electrically connected to the second control unit;

a physiological sensor electrically connected to the second control unit for obtaining at least one sleep respiration physiological information of the user; and

a power module, a power supply module and a control module,

wherein,

the first control unit receives a digital signal based on the at least one sleep breathing physiological information through the first wireless communication module;

the first control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning and provides the at least one warning to the user after receiving the driving signal; and

the driving signal is generated according to a warning behavior determined when the sleep posture related information is compared with a preset posture range and the sleep posture related information meets the preset posture range and/or when the sleep breathing physiological information is compared with a preset condition and the sleep breathing physiological information meets the preset condition.

9. The system of claim 8, wherein the physiological sensor comprises at least one of the following, including: optical sensors, accelerometers, microphones, respiratory airflow sensors, piezoelectric motion sensors, impedance sensing electrodes, RIP sensors, and piezoelectric vibration sensors.

10. The system of claim 9, wherein the at least one sleep breathing physiological information is further used to obtain sleep breathing events of the user during the sleep period, including at least one of: oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events, snoring events, sleep apnea events, and sleep hypopnea events.

11. The system of claim 8, further comprising an alert decision process preloaded with at least one of: the sleep warning device, the sleep breathing physiological device and an external device are used for determining the warning behavior.

12. The system of claim 8, further comprising a sleep respiration physiology information analysis program for obtaining sleep respiration physiology information of the user as, and preloaded in, at least one of: the sleep warning device, the sleep breathing physiological device and an external device.

13. A sleep warning device is contained in a sleep physiological system, and the sleep physiological system comprises the sleep warning device and a sleep breathing physiological device, wherein the sleep breathing physiological device comprises a wearing structure used for being arranged on a user body, a control unit, a physiological sensor electrically connected to the control unit so as to obtain at least one sleep breathing physiological information of the user during a sleep period, and a wireless communication module, the sleep warning device comprises:

another wearing structure for arranging the sleep warning device on the body of the user;

a further control unit comprising at least a microcontroller/microprocessor;

another wireless communication module electrically connected to the another control unit;

a posture sensor electrically connected to the other control unit for obtaining the sleep posture related information of the user during the sleep period; and

a warning unit electrically connected to the other control unit for generating at least one warning to the user; and

a power module, a power supply module and a control module,

wherein,

the other control unit receives a digital signal based on the at least one sleep breathing physiological information through the other wireless communication module;

the control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning and provides the at least one warning to the user after receiving the driving signal; and

the driving signal is generated according to a warning behavior determined when the sleep posture related information is compared with a preset posture range and the sleep posture related information meets the preset posture range and/or when the sleep breathing physiological information is compared with a preset condition and the sleep breathing physiological information meets the preset condition.

14. A sleep physiology system comprising:

a sleep alert device comprising:

the first wearing structure is used for arranging the sleep warning device on the body of a user;

a first control unit at least comprising a microcontroller/microprocessor;

a first wireless communication module electrically connected to the first control unit;

a warning unit electrically connected to the first control unit for generating at least one warning to the user; and

a power module; and

a sleep breathing physiological apparatus, comprising:

the second wearing structure is used for arranging the sleep breathing physiological device on the body of the user;

a second control unit at least comprising a microcontroller/microprocessor;

a second wireless communication module electrically connected to the second control unit;

a physiological sensor electrically connected to the second control unit for obtaining at least one sleep respiration physiological information of the user; and

a power module, a power supply module and a control module,

wherein,

the first wearing structure is implemented as a wrist wearing structure to dispose the sleep warning device on a wrist of the user, and the at least one warning is implemented as a tactile warning, and

wherein,

the first control unit receives a digital signal based on the at least one sleep breathing physiological information through the first wireless communication module;

the first control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning and provides the at least one warning to the user after receiving the driving signal; and

the driving signal is generated according to an alarm behavior determined by at least one sleep respiration event obtained based on the at least one sleep respiration physiological information.

15. The system of claim 14, wherein the at least one sleep respiratory event comprises at least one of: oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events, snoring events, sleep apnea events, and sleep hypopnea events.

16. The system of claim 14, wherein the sleep breathing physiological apparatus is disposed in one of the following through the second wearing structure, comprising: fingers, wrists, torso, neck, forehead, and ears.

17. The system of claim 14, further comprising a position sensor disposed in the sleep breathing physiological apparatus and connected to a second control unit to obtain sleep position related information of the user during sleep, wherein the sleep breathing physiological apparatus is disposed in one of the following through the second wearing structure, comprising: torso, neck, and head.

18. A sleep breathing physiological device is contained in a sleep physiological system, and the sleep physiological system comprises a sleep warning device and the sleep breathing physiological device, wherein the sleep warning device comprises a first wearing structure which is arranged on a wrist of a user, a first control unit, a warning unit which is electrically connected to the first control unit and used for generating at least one touch warning for the user, and a first wireless communication module, the sleep breathing physiological device comprises:

the second wearing structure is used for arranging the sleep breathing physiological device on the body of the user;

a second control unit at least comprising a microcontroller/microprocessor;

a second wireless communication module electrically connected to the second control unit;

a physiological sensor electrically connected to the second control unit for obtaining at least one sleep respiration physiological information of the user; and

a power module, a power supply module and a control module,

wherein,

the first control unit receives a digital signal based on the at least one sleep breathing physiological information through the first wireless communication module;

the first control unit is further configured to generate a driving signal, and the warning unit generates the at least one warning and provides the at least one warning to the user after receiving the driving signal; and

the driving signal is generated according to an alarm behavior determined by at least one sleep respiration event obtained based on the at least one sleep respiration physiological information.

19. A sleep physiology system comprising:

a first sleep physiological apparatus comprising:

a first wearing structure for disposing the first sleep physiology apparatus on a first body part of a user;

a first control unit at least comprising a microcontroller/microprocessor;

a first wireless communication module electrically connected to the first control unit;

a first physiological sensor electrically connected to the first control unit; and

a power module; and

a second sleep physiological apparatus comprising:

a second wearable structure for positioning the second sleep physiology apparatus on a second body part of the user;

a second control unit at least comprising a microcontroller/microprocessor;

a second wireless communication module electrically connected to the second control unit;

a second physiological sensor electrically connected to the second control unit; and

a power module, a power supply module and a control module,

wherein,

during sleep of the user, the first physiological sensor is configured to acquire at least one first sleep physiological information, and the second physiological sensor is configured to acquire at least one second sleep physiological information; and

wherein,

the system also comprises at least one warning unit, which is used for receiving at least one driving signal, generating at least one warning after receiving the at least one driving signal and providing the at least one warning to the user, wherein the at least one driving signal is generated according to at least one warning behavior determined by the at least one first sleep physiological information and/or the at least one second sleep physiological information; and

the system also includes an information providing interface for providing the first sleep physiological information, the second sleep physiological information, and/or the at least one alert to the user.

20. The system of claim 19, wherein the first physiological sensor and the second physiological sensor comprise at least one of: optical sensors, accelerometers, respiratory airflow sensors, piezoelectric motion sensors, impedance detection electrodes, RIP sensors, piezoelectric vibration sensors, microphones, electroencephalogram electrodes, electromyography electrodes, and electrooculography electrodes.

21. The system of claim 20, wherein the at least one first sleep physiological information and the at least one second sleep physiological information comprise at least one of: snoring related information, respiratory sound changes, respiratory motion, respiratory airflow changes, low frequency respiratory behavior, RSA respiratory behavior, heart rate, blood oxygen concentration, brain electrical signals, sleep posture related information, sleep body activity, and sleep stage.

22. The system of claim 20, wherein the first sleep physiology information and the second sleep physiology information are further used to obtain sleep respiratory events of the user during the sleep period, including at least one of: oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events, snoring events, sleep apnea events, and sleep hypopnea events.

23. The system of claim 19, wherein the at least one first sleep physiological information is implemented as sleep posture related information and the at least one second sleep physiological information is implemented as sleep breathing physiological information, and wherein the at least one alert action is determined according to a comparison between the sleep posture related information and a predetermined posture range, the sleep posture related information being within the predetermined posture range, and/or a comparison between the sleep breathing physiological information and a predetermined condition, the sleep breathing physiological information being within the predetermined condition.

24. The system of claim 19, wherein the at least one first sleep physiological information is implemented as a sleep respiration physiological information and the at least one second sleep physiological information is implemented as another sleep respiration physiological information, and wherein the at least one warning action is determined when the sleep respiration physiological information is compared with a predetermined condition and the sleep respiration physiological information meets the predetermined condition, and/or the another sleep respiration physiological information is compared with another predetermined condition and the another sleep respiration physiological information meets the another predetermined condition.

25. The system of claim 19, wherein the first and second wearing structures are implemented to respectively position the first and second sleep physiological apparatuses on two of the following body parts, including: head, neck, torso, and upper limbs.

26. The system of claim 19, further comprising an alert decision process preloaded with at least one of: the first sleep physiological device, the second sleep physiological device and an external device are used for determining the at least one warning behavior.

27. The system of claim 19, further comprising a sleep physiology information analysis program for deriving sleep physiology information of the user and pre-loading in at least one of the following, including: the first sleep physiological device, the second sleep physiological device and an external device.

28. A sleep physiological device is included in a sleep physiological system, and the sleep physiological system includes the sleep physiological device, another sleep physiological device and an information providing interface, wherein, the another sleep physiological device includes a wearing structure arranged on a first body part of a user, a control unit, a physiological sensor electrically connected to the control unit to obtain at least a first sleep physiological information of the user during a sleep period, and a wireless communication module, the sleep physiological device includes:

a second wearable structure for positioning the sleep physiology apparatus on a second body part of the user;

a further control unit comprising at least a microcontroller/microprocessor;

another wireless communication module electrically connected to the another control unit;

a warning unit electrically connected to the other control unit;

a further physiological sensor electrically connected to the further control unit; and

a power module, a power supply module and a control module,

wherein,

during sleep of the user, the other physiological sensor is configured to acquire at least one second sleep physiological information; and

wherein,

the other control unit receives a digital signal based on the at least one first sleep breathing physiological information through the other wireless communication module;

the other control unit is further configured to generate a driving signal, and the warning unit generates at least one warning after receiving the driving signal and provides the at least one warning to the user, wherein the driving signal is generated according to at least one warning behavior determined by at least one first sleep physiological information and/or at least one second sleep physiological information; and

the information providing interface is configured to provide the first sleep physiology information, the second sleep physiology information, and/or the information related to the at least one alert behavior to the user.

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