CN111938575A - sleep physiological system - Google Patents

Abstract

The invention provides a sleep physiological system, which can achieve the function of obtaining various sleep physiological information at a single position by selecting a physiological sensor, a wearing structure and/or a setting position on a user body, so that the evaluation of sleep respiratory disorder is more accurate, and the training effect of improving the sleep respiratory disorder is also improved.

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, comprising: a housing; a control unit, housed in the housing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit ; a warning unit, electrically connected to the control unit; a physiological sensor, electrically connected to the control unit; a communication module, electrically connected to the control unit; a power module; on a torso or a neck of a user, wherein the posture sensor is constructed to obtain information related to the sleeping posture of the user during sleep, and the control unit is further constructed to generate a driving signal, and the warning After receiving the driving signal, the unit generates the at least one warning and provides the at least one warning to the user, wherein the driving signal is implemented by comparing the sleep posture related information with a preset posture range, and An alert determined when the sleep posture-related information meets the preset posture range, and/or after the sleep breathing physiological information is compared with a predetermined condition, and the at least one sleep breathing physiological information meets the predetermined condition generated by behavior, wherein the physiological sensor is implemented as an accelerometer to obtain at least one of the following sleep breathing physiological information from the torso or the neck, including: snoring related information, breathing action, and heart rate, and wherein the The system further includes an information providing interface for providing the sleep posture related information and/or the sleep physiological information to the user.

Another object of the present invention is to provide a sleep physiology system, comprising: a casing; a control unit, housed in the casing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit unit; a physiological sensor, electrically connected to the control unit; a communication module, electrically connected to the control unit; a power module; part, wherein the physiological sensor is implemented as an accelerometer; and wherein the posture sensor is constructed to obtain sleep posture-related information of the user during a sleep period, and the accelerometer is constructed from the torso or the neck The part detects the snoring situation of the user during the sleep period, and the system is constructed to provide the sleep posture related information and a snoring sleep posture correlation information between the snoring situations; and the system further includes an information providing The interface is used for at least providing the snoring sleep posture correlation information to the user.

Another object of the present invention is to provide a sleep physiology system, comprising: a casing; a control unit, housed in the casing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit a warning unit, electrically connected to the control unit; a physiological sensor, electrically connected to the control unit; a wireless communication module, electrically connected to the control unit; a power module; The body is arranged on a torso or a neck of a user, wherein the posture sensor is configured to obtain information related to the sleeping posture of the user during sleep, and the 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, wherein the driving signal is implemented to compare with a preset posture range according to the sleep posture related information Then, the sleep posture related information is generated when a warning behavior is determined when the preset posture range is met, wherein the physiological sensor is implemented as a light sensor to obtain a blood physiological information from the skin surface of the trunk or the neck , wherein the blood physiological information is constructed to obtain the heart rate, and the heart rate is further constructed to obtain a sleep stage-related information, and wherein the system further includes an information providing interface for the sleep posture-related information, and/or The sleep stage related information is provided to the user.

Another object of the present invention is to provide a sleep physiology system, comprising: a casing; a control unit, housed in the casing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit unit; a first physiological sensor electrically connected to the control unit; a second physiological sensor electrically connected to the control unit; a wireless communication module housed in the housing and electrically connected to the control unit; a A power module; a wearable structure for disposing the casing on a user during sleep; and an information providing interface, wherein the posture sensor is constructed to obtain a sleeping posture of the user during the sleep related information; the first physiological sensor is constructed to obtain a snoring-related information of the user during the sleep period, wherein a snoring event can be determined based on the snoring-related information, and based on the snoring event, the sleep posture-related information is consistent with A distribution of the sleep posture related information when the sleep posture range is within the preset sleep posture range and when the sleep posture related information exceeds the preset sleep posture range, a snoring event posture correlation information can be obtained, and then provided to the user through the information providing interface; and The second physiological sensor is constructed to obtain a blood physiological information of the user during the sleep period, wherein a blood physiological sleep breathing event can be determined based on the blood physiological information, and a blood physiological sleep breathing event is determined in the sleep posture based on the blood physiological sleep breathing event When the relevant information conforms to the preset sleep posture range and the distribution of the sleep posture related information exceeds the preset sleep posture range, a blood physiological sleep breathing event posture correlation information can be obtained, and then provided through the information providing interface to the user.

Another object of the present invention is to provide a sleep physiology system, comprising: at least one casing; a control unit accommodated in the casing, at least including a microcontroller/microprocessor; and a posture sensor electrically connected to the a control unit; a light sensor electrically connected to the control unit; a warning unit electrically connected to the control unit; a communication module electrically connected to the control unit; a power module; and a wearable structure for the case The body is arranged on a forehead of a user, wherein the posture sensor is configured to obtain information related to the sleeping posture of the user during sleep, and the light sensor is configured to obtain a blood physiology of the user during sleep information, and the blood physiological information includes at least a blood oxygen concentration change; and the 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 sends the at least one A warning is provided to the user, wherein the driving signal is implemented at least according to the sleep posture-related information after the sleep posture-related information is compared with a predetermined posture range, when the sleep posture-related information conforms to the predetermined posture range, and/or according to the blood After the physiological information is compared with a predetermined condition, and when the at least one sleep breathing physiological information meets the predetermined condition, a determined warning action is generated.

Another object of the present invention is to provide a sleep physiology system, comprising: a casing; a control unit, housed in the casing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit unit; a tactile warning unit electrically connected to the control unit; a wireless communication module electrically connected to the control unit; a power module; and the control unit is further configured to generate a driving signal, and after receiving the driving signal, the alert unit generates at least one tactile alert, and provides the at least one tactile alert to the user, wherein , the driving signal is implemented to be generated according to a warning behavior determined when the sleep posture related information conforms to the preset posture range after the sleep posture related information is compared with a preset posture range, and wherein, through the fixed structure A fixing force is provided, the shell is arranged on a clothing, and at least a part of the clothing can provide an elastic force to exert a force on the skin surface when the user wears the clothing, so as to form a structure including the shell , the clothing and a tight layered structure on the skin surface of the user's torso, and through the tight layered structure and the elastic force, the at least one tactile alert generated by the tactile alert unit can be reliably transmitted to the user, to increase the warning effect.

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;

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

8 shows a schematic diagram of a physiological sensor implemented as a respiratory airflow sensor and disposed between the mouth and nose according to a preferred embodiment;

FIG. 9 is a schematic diagram showing that in the sleep physiology system according to the application of the present invention, the shell can be combined with different wearing structures according to different needs;

Figures 10A-10B show possible implementations of the mouth closure aid; and

Figures 10C-10E show possible implementations of a chin strap combined with a headgear structure.

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

Baseline data for 317 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

801 housing 802 respiratory airflow sensor

901 Chin strap 902 Oral positioning fitting

903 headwear structure

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 a device with an open platform and its behavior can be controlled by a loading program 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 the auricle, 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 has occurred within a certain period of time, and if a false alarm is found, the preset conditions are adjusted in step 315 to ensure that the correct detection For sleep breathing events, if no false alarms are detected, or only a small number of false alarms within the preset range acceptable to the software program 300 or the user are detected, the preset conditions will not be adjusted in step 315, and the completion state will be entered. 320.

In the training mode, please go back 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 information from the sampled signals. value, 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 If the preset condition is not matched in step 309, 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 The user will be awakened briefly, after which the user will take a few deep breaths and return to sleep, thus ending the apnea/hypopnea condition. The process of monitoring, alerting (and adjusting preset conditions) continues throughout the training mode, resulting in a gradual reduction in the frequency and number of sleep apnea/hypopnea.

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-recumbent sleep breathing event index, or other value, and if the threshold is exceeded, the user is identified as postural sleep breathing event user, and 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, in the case of high posture dependence In situations where high position dependency is accompanied by a high non-supine respiratory event index, the user can combine, at the same time, postural training during the supine position and sleep-based breathing event-based sleep during the non-supine position. The 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 especially, when the accelerometer is selected as the physiological sensor, it can also be used as the 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 Various software programs can be preloaded in different devices according to actual needs and different 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 obtain sleep physiological information that can determine various sleep breathing events and the relationship between sleep breathing events and sleep postures in the simplest way without changing the installation position.

An implementation may be that a sleep physiological system includes a casing and a wearable structure for disposing the casing on a user's body, and the sleep physiological system also includes a control unit, at least including a microcontroller/ The processor, a communication module, and a power module, and the acquisition of sleep physiological information is achieved through a posture sensor and a physiological sensor that are electrically connected to the control unit, wherein the posture sensor is used to obtain the The sleeping posture-related information of the user during sleep, and the physiological sensor is used to obtain the snoring-related information during sleep. Here, in particular, since the acquisition of the sleeping posture-related information is based on the trunk and the neck above the trunk. Therefore, the physiological sensor uses an accelerometer to obtain snoring-related information by detecting the vibration of the body cavity caused by snoring. It can also be detected normally even when it is covered by a quilt, which is a very convenient choice.

Accordingly, through the obtained sleep posture related information and snoring related information, a snoring sleep posture related information can be obtained, which is very useful information for the user, especially only a single device needs to be simply installed on the trunk or neck , you can know whether there is snoring, and you can further understand the relationship between the occurrence of snoring and sleeping postures, such as the distribution and proportion of snoring in different sleeping postures, is a simple and effective choice, especially suitable for home detection. Here, in particular, the physiological sensor implemented as an accelerometer can also be used simultaneously as a posture sensor to further simplify the process and reduce the cost, so there is no limitation.

In addition, when the accelerometer is installed on the torso, in addition to the snoring-related information, other physiological information of sleep breathing can also be obtained as described above, such as breathing action and heart rate; in addition, other sensors such as light sensors can also be added. The physiological sensor also obtains sleep physiological information from the surface of the torso or neck, such as sleep breathing events, sleep breathing physiological information, breathing behavior, sleep stages, etc., so as to make the detection results more accurate through the mutual comparison of various sleep physiological information. to be accurate.

Furthermore, further, a warning unit can also be added to provide sleep posture training and/or sleep breathing physiological feedback training. For example, the obtained sleep posture related information can be compared with a preset posture range, and when the preset posture range is met, a warning action can be determined to provide a warning so as to perform sleep posture training; or the obtained sleep posture can also be compared. Respiratory physiological information, such as snoring-related information, breathing action, heart rate, etc., is compared with preset conditions to determine alert behavior when the conditions are met, and provide alerts to perform sleep breathing physiological feedback training; During the same sleep period, appropriate sleep posture training and sleep breathing physiological feedback training can be provided by observing the two kinds of sleep physiological information. Therefore, there are various implementation possibilities without limitation.

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 to achieve the sleep posture The purpose of training and/or sleep breathing physiological feedback training, wherein the driving signal is implemented to be generated according to the various warning behaviors determined above. Here, it should be noted that, as is well known to those skilled in the art, the operation of the device/system must have basic circuit configurations such as control unit, communication module, power module, etc. Since these are all repetitive contents, the following In the description of all the embodiments, the description will be omitted and not repeated, and the actual circuit configuration of all the devices in the application of the present invention is not limited accordingly.

Another implementation may be that a sleep physiological system includes a casing and a wearable structure for disposing the casing on a user's body, and obtaining sleep physiological information through a posture sensor and This is achieved by a physiological sensor, wherein the posture sensor is used to obtain the sleep posture-related information of the user during sleep, and the physiological sensor is implemented as a light sensor to obtain blood physiological information during sleep. Here, In particular, since the body and the neck above the body are the best positions for obtaining sleep posture-related information, the light sensor also obtains blood physiological information from the skin surface of the body or neck, such as heart rate, and especially Specifically, as mentioned above, sleep stage-related information can be obtained by further analyzing the heart rate, for example, by analyzing the heart rate distribution, or by calculating HRV (heart rate variability), performing a Hilbert-Huang transformation (Hilbert-Huang transformation). Huang transform, HHT) or other conventional analysis methods, and then, by understanding the distribution of sleep stages, for example, the proportion of deep sleep and light sleep in the overall sleep period, etc., sleep quality related information can be obtained. This is quite helpful information for users, especially, sleep posture training is to alert the sleep posture changes, thereby reducing sleep apnea/hypopnea, observe the sleep stage distribution/sleep quality during training, Helps to adjust parameter settings that provide alerts for a more comfortable training session.

In addition, when the posture sensor is implemented as an accelerometer, the accelerometer can also obtain the physical activity during sleep, which can be further analyzed together with the blood physiological information to obtain more accurate sleep stage related information. Further, the blood physiological information can also be used to obtain other sleep physiological information, such as sleep breathing physiological information, sleep breathing events, heart rate variability, and arrhythmia.

In this case, when there is an alert unit, the sleep posture-related information can be compared with a preset posture range, and an alert action can be determined when the preset posture range is met, and an alert can be provided to perform sleep posture training. Blood physiology information can be continuously detected during sleep, so that blood physiology information can be used to confirm the improvement effect of providing warnings, for example, whether the occurrence of sleep breathing events is reduced due to changes in sleep posture, and can also be obtained by The information providing interface provides users with various related information other than blood physiological information, such as the number of times and time points of alert execution, changes in sleeping postures, the ratio of different sleep postures, the number and time points of sleep breathing events, etc. The user will be able to clearly know whether the executed sleep posture training has an effect and what the effect is. Therefore, the obtained blood physiological information can also be used as a basis to adjust the warning behavior, which not only makes the provision of warnings more effective, but also It can also minimize the disturbance to the user's sleep, which is quite advantageous.

Of course, in order to understand the difference before and after using sleep posture training, it can also be implemented that the warning unit does not provide a warning at first, but only obtains the user's sleeping posture, and cooperates with the blood physiological information to know the sleep breathing event. The relationship between the occurrence of different sleep positions and different sleep positions, so that when sleep position training is started, it can further obtain the effect of providing warnings, for example, the proportion of different sleep positions changes, and whether the occurrence of sleep breathing events can be further obtained. reduce etc.

Further, the warning behavior can also be determined according to sleep posture related information and/or blood physiological information, that is, it is possible to choose to perform sleep posture training, perform sleep breathing physiological feedback training, or perform both during the same sleep period. Or, therefore, there is no limit, there are various possibilities.

Another implementation may be that a sleep physiology system includes at least a casing and a wearing structure for disposing the casing on a user's forehead, and obtaining sleep physiology information through a posture sensor and a light sensor to achieve, wherein, the posture sensor is used to obtain the sleep posture related information of the user during sleep, and the light sensor can obtain blood physiological information from the forehead during sleep, such as blood oxygen concentration, heart rate , In addition, the system further includes a warning unit to perform sleep posture training and/or sleep breathing physiological feedback training according to sleep posture related information and/or blood physiological information.

Such a system offers various advantageous implementation options. For example, the alert unit may optionally be implemented to provide alerts based on sleep posture-related information, in this case, blood physiological sleep breathing events derived from the blood physiological information, such as oxygen desaturation events, hypoxia events Level events, heart rate changes, sleep breathing events, will help users understand sleep breathing during sleep posture training, for example, the distribution of sleep breathing events in different sleep postures, and provide users with blood physiological sleep breathing events posture correlation Sexual information, such as oxygen desaturation event posture correlation information, can also understand the effect of training execution, such as the change in the number of sleep breathing events during the training process, whether it is reduced due to changing posture, etc.; in addition, the warning unit It can also be implemented to provide alerts based on sleep posture-related information and blood physiological information at the same time, so that sleep posture training and sleep breathing physiological feedback training can be provided together in the same sleep period to make the improvement effect more comprehensive; in addition, You can also choose not to provide a warning first, then through the obtained sleep physiological information, you will be able to determine whether a sleep breathing event occurs, and the correlation between the occurrence of sleep breathing events and sleep posture, and then choose to execute according to the judgment result. what kind of training.

And, most importantly, for the user, the above-mentioned various functions and options can be achieved simply by setting it on the forehead, which can be used for evaluation, can also be used to improve sleep-disordered breathing, and can also be selected according to needs Function, in particular, blood oxygen concentration change is one of the most widely accepted and correlated physiological parameters for judging sleep-breathing events, and can achieve the most effective results with the simplest configuration.

Further, other physiological sensors can also be set, for example, an acceleration or a microphone can be set to obtain snoring-related information, which can be used as a basis for providing warnings to perform snoring-based sleep posture training and/or sleep breathing physiological feedback training, and also A more comprehensive understanding of the occurrence of sleep-disordered breathing, especially, the accelerometer can also be used as a posture sensor to further simplify the process and reduce costs; Obtain EEG signals, EEG signals, and/or EMG signals, and by analyzing EEG signals, EEG signals, and/or EMG signals, you can know the sleep state/stage, sleep cycle, etc. during sleep, Furthermore, the distribution of sleep breathing events in each sleep stage and the relationship between sleep postures and sleep stages are provided, which is helpful for further understanding.

Here, since the setting position is the forehead, in addition to being implemented as a headband and/or an adhesive structure, the wearing structure can also be implemented in the form of an eye mask. Generally, the eye mask will usually cover at least the forehead when worn. Therefore, as long as the housing is placed in a position where it can touch the forehead, the light sensor can obtain the physiological information of the blood, and the use of the eye mask during sleep helps to fall asleep, which is a very advantageous choice; in addition, the forehead The setting position also increases the choice of types of warnings, which can be implemented as tactile warnings, auditory warnings, and/or visual warnings, without limitation; The shell not only helps to reduce the volume of individual shells, but also allows the setting to further conform to the curvature of the forehead, which is also advantageous.

Furthermore, when there is a need to provide information to the user, the information can be provided by setting the information providing interface, or by setting a communication module, for example, a wireless communication module such as Bluetooth, BLE, Zigbee, WiFi, RF, etc., or A wired communication module such as a USB interface or a UART interface is transmitted to another wearable device, such as a smart wearable device, or to an external device, such as a smart phone, a tablet computer, a personal computer, or other wearable devices. A device that receives information and has an information providing interface can provide information by using the information providing interface on the device, so there is no limitation.

Another implementation may be that a sleep physiological system includes a casing and a wearing structure for disposing the casing on a user, and in acquiring sleep physiological information, a posture sensor, a A first physiological sensor and a second physiological sensor are used, wherein the posture sensor is used to obtain the sleeping posture of the user during sleep, and the two physiological sensors are used to obtain two kinds of sleep breathing physiological information, and wherein, The first physiological sensor is configured to obtain snoring related information during sleep to obtain snoring events, and the second physiological sensor is configured to obtain blood physiological information during sleep to obtain blood physiological sleep breathing events, and Provided to users through an information providing interface.

As mentioned above, sleep-disordered breathing is divided into snoring and sleep apnea/hypopnea. Therefore, it would be a very convenient choice for users to provide information on these two types of sleep-disordered breathing at the same time, especially for snoring. It is generally regarded as a precursor to the development of sleep apnea/hypopnea, and the occurrence of sleep apnea/hypopnea is often accompanied by the occurrence of snoring, for example, but not limited to, a situation in which the airway is gradually blocked and breathing The sound becomes progressively heavier, and snoring occurs, and eventually sleep apnea/hypopnea occurs. Another situation is that after sleep apnea occurs, snoring occurs when breathing is resumed. Therefore, these two physiological phenomena can be found in most In addition, when blood physiological information is used as the basis for judging blood physiological sleep breathing events, such as oxygen desaturation, heart rate changes, low oxygen levels, etc., the body The movement of the physiology signal is likely to cause artificial interference (artifact) in the physiological signal, resulting in misjudgment. Therefore, through the correlation between the two kinds of physiological information, the occurrence of misjudgment can be effectively reduced and the accuracy can be improved.

Accordingly, in this implementation possibility, by simultaneously observing the blood physiological information and the snoring related information, when a combination of preset conditions is met, for example, the time sequence relationship and sequence of the two, it is determined whether a blood physiological sleep breathing event occurs or not. In order to achieve the purpose of providing more accurate information.

Under this premise, when choosing the installation position, the most important thing to consider is the acquisition of sleeping posture. Therefore, the installation position of the casing is preferably the head, torso, etc. When it is installed on the torso, the acquisition of snoring-related information can be achieved. Through, for example, the body cavity resonance caused by snoring is obtained by the accelerometer, and the snoring sound is obtained by the microphone, and the detection of sleep apnea can be obtained through, for example, the optical sensor to obtain blood physiological information including heart rate; Accelerators and/or microphones can also be used to obtain snoring-related information, and the detection of sleep apnea/hypopnea can obtain blood physiological information including blood oxygen concentration and heart rate through optical sensors, and then, according to the blood physiological information, namely Blood physiology sleep breathing events can be derived, eg, oxygen desaturation events, low oxygen level events, heart rate variability sleep breathing events.

Here, when disposed on the head, in addition to being implemented as a headband and/or an adhesive structure, in particular, the wearing structure can also be implemented in the form of an eye mask, especially during sleep, the use of the eye mask will help to fall asleep, Moreover, the forehead is originally suitable for setting posture sensors, and the forehead area that the eye mask will contact is just suitable for placing physiological sensors, such as light sensors, EEG electrodes, EEG electrodes, and EMG electrodes, which can obtain various insights into sleep physiology. physiological information.

Then, it is compared with the sleep posture-related information obtained by the posture sensor to obtain the snoring events and Distribution of blood physiological sleep breathing events, such as posture-related snoring index, posture-related snoring count, posture-related snoring duration, posture-related sleep apnea index, posture-related blood physiological sleep breathing events, and posture-related blood physiological sleep breathing Event duration, etc. These information are very helpful for users, not only to know whether their sleep-disordered breathing is snoring and/or sleep apnea, but also to have a deeper understanding of the occurrence and sleep of various sleep-disordered breathing disorders. The relationship between postures is powerful and easy to use.

Moreover, when installed on the head, if EEG electrodes, OMG electrodes, and/or EMG electrodes are further disposed to obtain EEG signals, EMG signals, and/or EMG signals, and then analyze the EEG signals by analyzing the EEG signals. , EMG signal, and/or EMG signal, the sleep state/stage, sleep cycle, sleep quality, etc. during sleep can be obtained, and then provide, for example, the distribution of sleep breathing events in each sleep stage, sleep posture and Various information, such as the relationship between sleep stages, and the relationship between sleep quality and sleep-disordered breathing, will help to gain further understanding.

Furthermore, further, a warning unit can also be added to provide sleep posture training and/or sleep breathing physiological feedback training. For example, the obtained sleep posture-related information can be compared with a preset posture range, and when the preset posture range is met, a warning action can be determined to provide a warning to perform sleep posture training; or the obtained snoring can also be compared. The relevant information and/or blood physiological information is compared with a preset condition, so as to determine the warning behavior when the preset condition is met, and provide a warning to perform sleep breathing physiological feedback training; or, during the same sleep period, via Observing these two kinds of sleep physiological information provides appropriate sleep posture training and sleep breathing physiological feedback training. Therefore, there are various implementation possibilities without limitation. Moreover, the warning unit can be arranged in different positions according to requirements, for example, it can be arranged in the casing, on another wearable device, or on an external device, so there are various options.

Another implementation may be that a sleep physiology system includes a housing, at least a wearable structure, a control unit, at least a microcontroller/microprocessor, at least one respiratory airflow sensor, electrically connected to the control unit, a physiological A sensor, electrically connected to the control unit, a communication module, electrically connected to the control unit, and a power module, wherein, through the at least one wearable structure, as shown in FIG. 8, the housing 801 and the at least one respiratory airflow The sensor 802 is arranged between the user's mouth and nose, that is, the human body, to obtain the sleep breathing airflow change during the user's sleep. In addition, the physiological sensor is used to obtain another piece of sleep physiological information. Therefore, the at least one respiratory airflow sensor can be implemented as a thermistor, a thermocouple, or an airflow tube, without limitation, wherein the respiratory airflow tube detects the flow rate change of the respiratory airflow, and what the thermistor and the thermocouple detect are Due to the temperature change caused by the respiratory airflow, you can choose to set two detection points (near the two nostrils) or three detection points (near the two nostrils and near the mouth).

In this configuration, in particular, as is well known, measuring respiratory airflow is the most direct way to understand the breathing situation, and hence sleep apnea events and/or sleep apnea hypopnea events. In the case of , for example, when the size is less than 20x20x20mm, as shown in Figure 8, it can be placed between the mouth and nose only through an appropriate wearing structure, and the respiratory airflow sensor can also be placed between the mouth and nose. There are many options, for example, the shell can be fixed between the mouth and nose by sticking, and can choose to stick to the area between the mouth and nose, or both sides of the mouth, or, can also be clipped on the nasal septum and/or. Or the fixing structure of the two sides of the nose is provided with a casing and a respiratory airflow sensor, or, at the same time, it is fixed by clipping and pasting, so there is no limitation, and any method that can be fixed can be achieved; In addition to the plastic shell material, the shell can also be made of soft or elastic materials to provide the best comfort.

The physiological sensor can be used to obtain more sleep physiological information during sleep. For example, it can be implemented as an accelerometer to obtain sleep posture, snoring-related information, etc., or it can be implemented as a light sensor to obtain blood oxygen concentration, heart rate, etc., It can also be implemented as a microphone to obtain snoring-related information and the like, and no matter what kind of sleep physiological information is obtained, it is a meaningful combination for further understanding of sleep-disordered breathing after being matched with changes in respiratory airflow.

The at least one wearable structure can be implemented as two wearable structures, which are respectively removably combined with the shell to place the shell on other body parts, such as forehead, ears, torso, fingers, wrists, arms, etc. At the same time, the physiological sensor can be constructed to obtain various physiological information such as blood oxygen concentration change, heart rate, snoring-related information, sleep posture, sleep physical activity, daily physical activity, etc., as another use option, here in particular , since the sampling position of the respiratory airflow sensor is defined as between the mouth and nose, when the housing is separated from the wearing structure disposed there, it can also be separated from the respiratory airflow sensor, so when it is combined with another wearing structure and When placed on other body parts, a simpler structure is possible.

In addition, for the consideration of hygienic use and/or availability for multiple people, even without changing the position for other detections, the respiratory airflow sensor and the housing can also be implemented in a removable form, that is, , implemented in the form of a replaceable respiratory airflow sensor, also has advantages.

The sleep physiology system may further include a wearable device, and the wearable device is provided with another physiological sensor, such as a light sensor, an accelerometer, a microphone, etc., which are arranged at positions such as the wrist, finger, torso, head, etc., to Obtain additional sleep physiological information such as blood oxygen concentration changes, heart rate, breathing action, snoring related information, sleep posture, sleep physical activity, etc. In this way, through the comparison of various sleep physiological information, more diverse For example, in the case where the respiratory airflow sensor can obtain the actual respiratory airflow change, if the accelerometer provided on the torso is used to obtain the respiratory motion, the occurrence of sleep apnea event and/or sleep apnea can be determined. A hypopnea event is either obstructive sleep apnea with chest and abdomen still up and down, or central sleep apnea with no chest and abdomen.

The sleep breathing system can also add a warning unit to provide warnings based on respiratory airflow changes and/or sleep physiological information, wherein if the sleep physiological information includes sleep posture, it can be used to perform sleep posture training and/or include respiratory airflow changes. and/or other sleep physiological information, can be used to perform sleep breathing physiological feedback training, and the warning unit can be provided in the housing, or an external device can be used, for example, to communicate with a communication module provided in the housing. Communication bracelets, watches, mobile phones, etc., so there is no limit.

So far, it can be seen that, for the sleep physiology system of the present invention, how to install it on the user is of great importance. In particular, the tactile warning provided by the warning unit, such as a vibration warning, requires a stable and stable space between the casing and the skin at the installation position. Close contact can effectively transmit vibration to the user. In addition, there are many physiological sensors that need to have good contact with the skin to obtain physiological information. Sensors, accelerometers, etc. can most effectively detect sleeping postures, body cavity vibrations caused by snoring, chest and abdomen rising and falling caused by breathing, and body movements during sleep when they are close to the skin.

One of the setting options is to stick the shell on the skin, for example, through an adhesive structure, as long as the size of the shell is suitable, it can be set; Make the shell tightly attached to the body surface.

The embodiment is to provide a fixing structure to generate a fixing force, so that the casing is arranged on a clothing, and at least a part of the clothing can provide an elastic force to exert a force on the skin surface when the user wears the clothing, In this way, a tight layered structure including the shell, the clothing and the skin surface is formed, and through the tight layered structure and the elastic force, the shell can be tightly attached to the body surface, regardless of whether it is a tactile warning. Provided, or the setting of physiological sensors, can be more effective.

There are different options for the installation position of the shell, which can be arranged on the inner side of the clothing, sandwiched between the clothing and the skin surface, or can also be arranged on the outer side of the clothing, and can be installed on the outside of the clothing through the clothing. It is attached to the watch. In addition, if the physiological sensor needs to obtain physiological information from the body surface, such as a light sensor, when setting the casing, it is also necessary to pay attention to the surface with the physiological sensor facing the skin surface of the torso.

The fixing method of the fixing structure and the clothing can be changed according to actual needs without limitation. For example, it can be implemented as adhering to the clothing, for example, the casing is attached to the clothing by using the adhesive structure; it can also be implemented as a clip There are various options for structures, such as mechanical clamping structures, magnetic clamping structures, and the like.

The preferred embodiment of the clipping structure is that there is an accommodating groove that can receive the shell, so as to achieve the combination between the shell and the clipping structure, and then the clipping structure only needs to be clipped on the clothes at the same time. It is quite convenient to achieve the setting of the casing. According to different requirements, the accommodating groove can be set on the inside or outside of the clothes. In addition, if a physiological sensor is set on the surface of the casing, when the casing is placed in the accommodating groove , it should be noted that there is no restriction on exposing the physiological sensor.

When the magnetic clamping structure is adopted, a preferred embodiment is that a magnetic attraction substance is arranged at the end of the shell to achieve the effect of magnetic attraction and fixation with another magnetic attraction substance at the other end of the clothing, wherein, The magnetic material can be arranged in the casing, for example, an additional magnetic material can be placed in the casing, or a battery made of metal that can achieve magnetic attraction can be directly used as the magnetic material, or it can be arranged outside the casing, for example, with The housings are both arranged in the accommodating groove, or embedded in the accommodating groove, which are all feasible options; in addition, between the accommodating groove and the other end having the other magnetic substance, there may be further An elastic connecting piece, which utilizes the characteristic of being bendable to form the concept of clamping.

Here, it should be noted that the elasticity of the clothing can come from the material made of the clothing, such as elastic fabrics, or it can be an additional elastic object on the clothing, such as a sewing elastic band, and the clothing can be a clothing other than clothing. , such as tights, underwear, trousers, etc., can also be provided on other clothing on the torso, for example, a surrounding belt, such as a RIP sensor provided on the torso, so there is no limitation.

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. As shown in FIG. 9 , as long as it is matched with different wearing structures, for example, it is implemented in a removable form between the shell and the wearing structure, the requirements of disposing on different body parts can be easily achieved, which is quite advantageous.

In another aspect of the present invention, in addition to using the warning unit to alert the body to perform sleep posture training and/or achieve sleep breathing physiological feedback, for the symptoms of obstructive sleep apnea, mouth closure aids can also be used to achieve an improved effect. Oral closure aids are arranged around or near the airway during sleep, so as to improve the problem of airway collapse.

The chin strap 901, as shown in FIG. 10A, is a known oral closure aid that can improve the symptoms of snoring and obstructive sleep apnea. The user's chin bone is lifted up, and the throat muscles are affected by the action of closing the mouth, so that the upper airway can be more easily maintained. In this way, even during sleep when the muscles are relaxed, the mouth can be closed and The effect of maintaining the airway unobstructed and improving the symptoms of snoring and obstructive sleep apnea.

Another oral closure aid known to improve airway constriction, and/or collapse during sleep is an oral positioning fit 902, shown in Figure 10B, which reduces the The opening of the mouth during sleep is similar to the above-mentioned chin girdle, which can affect the laryngeal muscles by maintaining the closure of the mouth, so that the upper airway can be more easily maintained. It also avoids the situation of mouth breathing, so it is also another simple and effective option.

However, the improvement of snoring and obstructive sleep apnea/hypopnea due to the provision of mouth closure aids varies from person to person. For example, the structure of each person's larynx is different, and the sleeping position is also different, so that the effect of opening the airway is also different. Therefore, if you can obtain physiological information during use, such as snoring-related information, blood oxygen concentration, heart rate, respiratory airflow changes, breathing movements, etc., to know whether the symptoms of airway stenosis are improved, for example, oxygen reduction Whether the occurrence of saturation breathing events, low oxygen level breathing events, heart rate variation breathing events, snoring events, sleep apnea events, and/or sleep apnea hypopnea events is reduced, which will be more beneficial to the user combination.

Therefore, it can be used with physiological sensors, such as light sensors, accelerometers, respiratory airflow sensors, piezoelectric motion sensors, impedance detection electrodes, RIP sensors, piezoelectric vibration sensors, and/or microphones. For example, the user can first use a light sensor to detect during sleep, and if a blood physiological sleep breathing event is found, such as oxygen desaturation breathing event, low oxygen level breathing event, heart rate change breathing event, or use acceleration device, microphone, and/or piezoelectric vibration sensor to obtain snoring-related information to know whether there is a snoring breathing event, or other physiological sensors to obtain other sleep breathing events, and then further use mouth closure during sleep. aids to maintain airway patency, and use physiological sensors again for physiological monitoring while in use, so that the improvement effect brought by the use of mouth closure aids can be clearly understood, for example, the occurrence of sleep breathing events It is very convenient to reduce whether it is reduced; furthermore, in addition to knowing the effect achieved by using it, it can also be used as a basis for adjusting the setting of the mouth closing aid, such as the tightness of the chin strap, the setting angle, etc., or It is the viscosity and coverage of the mouth positioning fitting, which helps to further improve the use effect.

In a preferred embodiment, the mouth closure aid can be used with a sleep physiology device, which includes a control unit, including at least a microcontroller/microprocessor, and a physiological sensor electrically connected to the control unit for obtaining A user's sleep breathing physiological information during a sleep period, a communication module, a power module, and a wearable structure are installed on the user through the wearable structure, wherein the control unit analyzes the sleep breathing physiological information to The sleep breathing events are obtained and provided to the user through the information providing interface, so that the user can know the improvement effect obtained by using the mouth closure aid, which is quite convenient. And because there are various available physiological sensors as above, and there are many options for setting positions, for example, it can be set on fingers, wrists, torso, forehead, ears, mouth and nose, etc. Therefore, as long as it is matched with various wearing structures , For example, finger-wearing structure, wrist-wearing structure, head-wearing structure, belt body, patch, etc., or directly arranged on the mouth closing aid, can be easily achieved, which is extremely advantageous.

Further, a posture sensor can be used to obtain sleep posture related information. In this case, by comparing the obtained sleep breathing physiological information and sleep posture related information, it can be known whether it is posture related. Sleep-disordered breathing is more helpful for understanding the types of sleep-disordered breathing.

Furthermore, it can also be equipped with a warning unit to provide a warning to the user when a sleep breathing event occurs, and perform sleep breathing physiological feedback training. In this way, the combination of the upper mouth closure aid can help maintain the airway unobstructed. The effect is added, which is more advantageous. Furthermore, when both a physiological sensor and a posture sensor are provided, the warning unit can also be implemented to perform sleep posture training and/or sleep breathing physiological feedback training during sleep. Therefore, there are various possibilities and no limit.

On the other hand, the mouth closure aid can also perform sleep posture training together with the posture sensor and the warning unit. For example, in a preferred embodiment, a sleep physiology device can be used, which includes a control unit, including at least a microcontroller/microprocessor, and a posture sensor, which is electrically connected to the control unit for obtaining a sleep posture related information of the user during a sleep period, an alert unit electrically connected to the control unit for generating at least one alert for the user during the sleep period, a communication module, a power module, and a wearable structure , and is set on the user through the wearing structure to perform sleep posture training. In this case, with the help of the mouth closing aid, the upper airway becomes more unobstructed, which will make the effect of sleep posture training more effective. Significantly, and through the information-providing interface, the user will be able to understand the impact of the use of mouth closure aids on sleep posture and alert behavior; in another preferred embodiment, physiological sensors, such as light Sensors, respiratory airflow sensors, accelerometers, piezoelectric motion sensors, impedance detection electrodes, RIP sensors, piezoelectric vibration sensors, microphones, etc., obtain physiological information of sleep breathing during sleep, and obtain sleep breathing events, and then provide information through An interface is provided to the user, so that the effect of using the mouth closure aid for improving sleep-disordered breathing can be known. Therefore, there are various possible combinations without limitation.

The implementation of the above sleep posture training and/or sleep breathing physiological feedback training is that the sleep posture related information is compared with a preset posture range, and when the preset posture range is met, a warning behavior is determined, and a warning is provided to perform sleep posture training. , In addition, sleep breathing physiological information, such as snoring-related information, blood oxygen concentration, breathing action, heart rate, etc., is compared with a preset condition to determine alert behavior when the preset condition is met, and provide alerts to perform sleep Respiratory Physiological Feedback Training. The above-mentioned warning is provided in that 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 to achieve the sleep posture The purpose of training and/or sleep breathing physiological feedback training, wherein the driving signal is implemented to be generated according to the various warning behaviors determined above.

The implementation of the above-mentioned physiological sensor, posture sensor, and/or warning unit can be achieved, for example, by using any suitable sleep physiological device, sleep breathing physiological device, or sleep warning device in the above-mentioned embodiments, or, alternatively, It is implemented to be disposed in another wearable device or an external device, without limitation, and further, if the disposition position of the mouth closing aid is exactly the position where the physiological sensor, the posture sensor, and/or the warning unit can be disposed , can also be used as a medium for setting, for example, it can be used to set the respiratory airflow sensor between the mouth and nose, and the posture sensor/accelerometer/microphone can be set on the top of the head or the chin, etc., which makes the setting easier.

In particular, when a head-mounted structure is used, especially in the form of a belt body, it can be further implemented that the head-mounted structure and the chin strap are combined with each other to further increase the stability of the arrangement.

The common chin strap is in the form of Figure 10A. Because it is covered on the hair, it is often prone to slippage, resulting in a decrease in the stability of the setting, and it is often unnoticed when it falls off during sleep, which ultimately leads to a poor use effect. As shown in FIG. 10C , when combined with the head-mounted structure 903 , since the setting position is the forehead and the setting direction just crosses the chin strap 901 , the combination of the two will further provide a lateral direction for the chin strap. That is, through the mutual interference between the horizontal and vertical belt bodies, the phenomenon that the top part of the chin belt is easy to slide can be effectively reduced, and the overall setting is more stable.

Further, other variations are also possible. For example, as shown in FIG. 10D , more belts may be provided on the top of the head; so that the chin strap can be implemented to encircle only the lower half of the head longitudinally, and when implemented in this case, it can be further changed, for example, the headband part can be changed to have an overhead shielding part, or Hats, etc., which do not have a covering part on the top of the head. So there are all kinds of possibilities without limitation.

Furthermore, the manner in which the chin strap and the head-wearing structure are combined can also vary according to the actual implementation. The removable form can also be implemented as a direct suture form, which is not limited, as long as the combination between the two can be achieved.

So far, it should 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 (42)

1. A sleep physiology system comprising: a shell; a control unit, accommodated in the housing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit; a warning unit, electrically connected to the control unit; a physiological sensor electrically connected to the control unit; a communication module, electrically connected to the control unit; a power module; and a wearing structure for disposing the casing on a torso or a neck of a user, in, The posture sensor is configured to obtain information related to the sleeping posture of the user during sleep, and the 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 alert is provided to the user, wherein the driving signal is implemented as a result of comparing the sleep posture-related information with a predetermined posture range, and when the sleep posture-related information conforms to the predetermined posture range, and/ Or 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, a determined warning action is generated, in, The physiological sensor is implemented as an accelerometer to obtain at least one of the following sleep breathing physiological information from the torso or the neck, including: snoring related information, breathing action, and heart rate, and in, The system further includes an information providing interface for providing the sleep posture related information and/or the sleep physiological information to the user. 2. The system of claim 1, wherein the posture sensor is further implemented as the accelerometer. 3. The system of claim 1, wherein the information providing unit is implemented as one of the following, comprising: being disposed on the surface of the casing, electrically connected to the control unit, and disposed on another wearable device , and set on an external device. 4. The system of claim 1, wherein the wearing structure is implemented as a securing structure for disposing the housing on one of the following, including: the user's skin surface, and the wearer's wear a piece of clothing. 5. The system of claim 4, wherein the securing structure is implemented as one of: a magnetic clamping structure, a mechanical clamping structure, and an adhesive structure. 6. A sleep physiology system comprising: a shell; a control unit, accommodated in the housing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit; a physiological sensor electrically connected to the control unit; a communication module, electrically connected to the control unit; a power module; and a wearing structure for disposing the casing on a torso or a neck of a user, in, The physiological sensor is implemented as an accelerometer; and in, The posture sensor is constructed to obtain information related to the sleeping posture of the user during a sleep period, and the accelerometer is constructed to detect the snoring of the user during the sleep period from the torso or the neck, and the The system is constructed to provide the sleep position related information and a snoring sleep position related information between the snoring situation; and The system also includes an information providing interface for providing at least the snoring sleep posture related information to the user. 7. The system of claim 6, further comprising an alert unit electrically connected to the control unit to provide at least one alert. 8. The system of claim 7, wherein the 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 For the user, wherein the driving signal is implemented by comparing the sleep posture related information with a preset posture range, and when the sleep posture related information conforms to the preset posture range, and/or the snoring situation is related to a predetermined posture range. After the set conditions are compared, and when the snoring situation meets the preset condition, a determined warning action is generated. 9. The system of claim 6, wherein the wearing structure is implemented as a fixed structure for disposing the housing on one of the following, including: the user's skin surface, and the wearer's wear a piece of clothing. 10. The system of claim 9, wherein the securing structure is implemented as one of: a magnetic clamping structure, a mechanical clamping structure, and an adhesive structure. 11. The system of claim 6, wherein the accelerometer is configured to further obtain at least one of the following, including: snoring related information, breathing movements, and heart rate. 12. The system of claim 6, wherein the posture sensor is implemented as the accelerometer. 13. The system of claim 6, further comprising a light sensor electrically connected to the controller to obtain at least one of the following sleep physiological information from the body or the skin surface of the neck, including: sleep Respiratory events, heart rate, respiratory behavior, and sleep stages. 14. A sleep physiology system comprising: a shell; a control unit, accommodated in the housing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit; a warning unit, electrically connected to the control unit; a physiological sensor electrically connected to the control unit; a communication module, electrically connected to the control unit; a power module; and a wearing structure for placing the casing on a torso or a neck of a user, in, The posture sensor is configured to obtain information related to the sleeping posture of the user during sleep, and the 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 alert is provided to the user, wherein the driving signal is implemented as a determined one determined when the sleep posture-related information is in compliance with the predetermined posture range after the sleep posture-related information is compared with a predetermined posture range. warning behavior, in, The physiological sensor is implemented as a light sensor to obtain a blood physiological information from the skin surface of the torso or the neck, wherein the blood physiological information is constructed to obtain a heart rate, and the heart rate is further constructed to obtain a sleep stage correlation information, and in, The system further includes an information providing interface to provide the user with the sleep posture related information and/or the sleep stage related information. 15. The system of claim 14, wherein the blood physiological information is further used as a basis to obtain at least one of the following physiological information, including: sleep breathing physiological information, sleep breathing events, heart rate variability, and arrhythmia . 16. The system of claim 15, wherein the driving signal is further implemented according to at least when the sleep posture related information is compared with the preset posture range and the sleep posture related information conforms to the preset posture range , and/or 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, another determined warning action is generated. 17. The system of claim 14, wherein the posture sensor is implemented as an accelerometer, further configured to obtain a physical activity of the user during the sleep period, and the sleep stage-related information is further implemented by analyzing the physical activity and the heart rate. 18. The system of claim 14, wherein the information providing unit is implemented as one of the following, comprising: being disposed on the surface of the casing, electrically connected to the control unit, disposed on another wearer on the device, and on an external device. 19. A sleep physiology system comprising: a shell; a control unit, accommodated in the housing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit; a first physiological sensor, electrically connected to the control unit; a second physiological sensor, electrically connected to the control unit; a communication module, accommodated in the housing, and electrically connected to the control unit; a power module; a wearing structure for disposing the casing on a user during sleep; and an information providing interface, in, The posture sensor is constructed to obtain information related to a sleep posture of the user during the sleep period; The first physiological sensor is constructed to obtain a snoring-related information of the user during the sleep period, wherein a snoring event can be determined based on the snoring-related information, and the sleep posture-related information based on the snoring event complies with a preset The distribution of the sleep posture related information when the sleep posture range is outside the preset sleep posture range can obtain a snoring event posture correlation information, and then provide the information to the user through the information providing interface; and The second physiological sensor is constructed to obtain a blood physiological information of the user during the sleep period, wherein a blood physiological sleep breathing event can be determined based on the blood physiological information, and a blood physiological sleep breathing event is determined in the sleep posture based on the blood physiological sleep breathing event When the relevant information conforms to the preset sleep posture range and the distribution of the sleep posture related information exceeds the preset sleep posture range, a blood physiological sleep breathing event posture correlation information can be obtained, and then provided through the information providing interface to the user. 20. The system of claim 19, wherein the blood physiological sleep breathing event comprises at least one of the following: an oxygen desaturation event, a low oxygen level event, and a heart rate variation sleep breathing event. 21. The system of claim 19, wherein the blood physiological sleep breathing event is implemented as determined when the blood physiological information and the snoring related information meet a predetermined combination of conditions. 22. The system of claim 21, wherein the preset condition combination is implemented as a time sequence relationship including the snoring event and the blood physiological sleep breathing event. 23. The system of claim 19, wherein the second physiological sensor is implemented to include a light sensor, and the blood physiological information is implemented to include at least one of the following, including: blood oxygen concentration, and heart rate. 24. The system of claim 19, wherein the housing is implemented to be disposed on one of the following body parts of the user, including: a head, and a torso. 25. The system of claim 19, wherein the wearable structure is implemented as at least one of the following, including: an adhesive structure, a strap, and an eye mask. 26. The system of claim 19, wherein the first physiological sensor is implemented as at least one of the following, including: an accelerometer, and a microphone. 27. The system of claim 19, further comprising at least one of the following, including: EEG electrodes, OMG electrodes, and EMG electrodes. 28. The system of claim 19, wherein the information providing interface is used to provide at least one of the following information to the user, including: the sleep posture related information, the snoring event, the blood physiological sleep breathing event, the posture correlation information of the snoring event, the posture correlation information of the blood physiological sleep breathing event, and the distribution of the snoring event and the blood physiological sleep breathing event along the time axis. 29. The system of claim 19, wherein the snoring event posture-related information is implemented to include at least one of the following, including: a posture-related snoring index, a posture-related snoring count, and a posture-related snoring duration. 30. The system of claim 19, wherein the blood physiological sleep breathing event posture-related information is implemented to include at least one of the following, including: a posture-related sleep apnea index, a posture-related blood physiological sleep breathing event number, and duration of postural-related blood-physiological sleep-breathing events. 31. The system of claim 19, further comprising an alert unit for providing at least one alert to the user, wherein the control unit is further configured to generate a drive signal, and the alert unit is receiving the drive After the signal, the at least one warning is generated, and the at least one warning is provided to the user, wherein the driving signal is implemented to be generated at least according to a warning action determined by at least one of the following, including: the sleeping posture The related information, the snoring related information, the blood physiological information, and the warning unit are implemented as at least one of the following, including: being arranged in the casing, electrically connected to the control unit, and arranged in another wearable device , and set in an external device. 32. A sleep physiology system comprising: at least one shell; a control unit, accommodated in the housing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit; a light sensor, electrically connected to the control unit; a warning unit, electrically connected to the control unit; a communication module, electrically connected to the control unit; a power module; and a wearing structure for placing the casing on a forehead of a user, in, The posture sensor is configured to obtain information related to the sleeping posture of the user during sleep, and the optical sensor is configured to obtain a blood physiological information of the user during sleep, and the blood physiological information at least includes a blood oxygen concentration changes; and The 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, wherein the driving signal is implemented at least according to After the sleep posture-related information is compared with a predetermined posture range, when the sleep posture-related information conforms to the predetermined posture range, and/or after the blood physiological information is compared with a predetermined condition, the at least one sleep When the respiratory physiological information meets the preset condition, a determined warning action is generated. 33. The system of claim 32, wherein the wearable structure is implemented as at least one of the following, including: an adhesive structure, a headgear, and an eye mask. 34. The system of claim 32, wherein the at least one alert is implemented as at least one of the following, including: a tactile alert, an audible alert, and a visual alert. 35. The system of claim 32, wherein the blood physiological information is further used to derive an oxygen desaturation event, and the sleep posture-related information based on the oxygen desaturation event conforms to the predetermined sleep posture range and when the sleep posture related information exceeds the preset sleep posture range, the oxygen desaturation event posture correlation information can be obtained. 36. The system of claim 32, further comprising at least one of the following, including: an accelerometer, and a microphone, and electrically connected to the control unit to obtain a snoring-related information of the user during sleep , wherein the warning unit further provides the at least one warning according to the snoring related information. 37. The system of claim 32, further comprising at least one of the following, including: EEG electrodes, OMG electrodes, and EMG electrodes. 38. The system of claim 32, further comprising an information providing interface for providing information to the user, implemented as at least one of the following, comprising: being disposed on the housing and electrically connected To the control unit, it is arranged on another wearable device, and is arranged on an external device. 39. A sleep physiology system comprising: a shell; a control unit, accommodated in the housing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit; a tactile warning unit, electrically connected to the control unit; a communication module, electrically connected to the control unit; a power module; and a fixed structure; in, The posture sensor is constructed to obtain information about the sleeping posture of the user during sleep; and The control unit is further configured to generate a drive signal, and the alert unit generates at least one tactile alert after receiving the drive signal, and provides the at least one tactile alert to the user, wherein the drive signal is implemented according to After the sleep posture-related information is compared with a predetermined posture range, the sleep posture-related information is generated by a warning action determined when the sleep posture-related information conforms to the predetermined posture range, and in, Through a fixing force provided by the fixing structure, the shell is arranged on a garment, and at least a part of the garment can provide an elastic force, so that when the user wears the garment, a force is applied to the skin surface to form a A tight layered structure including the shell, the clothing and the skin surface of the user's torso, and through the tight layered structure and the elastic force, the at least one tactile alert generated by the tactile alert unit can be reliably transmitted to the user to increase the effect of the warning. 40. The system of claim 39, wherein the securing structure is implemented as one of: a magnetic clamping structure, a mechanical clamping structure, and an adhesive structure. 41. The system of claim 39, wherein the elastic force is implemented by at least one of the following methods, comprising: using elastic fabric to make the garment, and disposing elastic objects on the garment. 42. The system of claim 39, wherein the system further comprises a physiological sensor electrically connected to the control unit to obtain sleep physiological information of the user during sleep, wherein the physiological sensor comprises at least the following One of them includes: light sensor, accelerometer, piezoelectric vibration sensor, piezoelectric motion sensor, RIP sensor, impedance detection electrode, respiratory plethysmography sensor, and microphone.

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