Patent Application
20210275108
This non-provisional application claims the benefit under 35 U.S.C. § 119(e) to patent application No. 109107544 filed in Taiwan on Mar. 6, 2020, which is hereby incorporated in its entirety by reference into the present application.
The present invention relates to a method and a system for generating synthetic composite waveforms for determining an individual's physiological state.
Sleep disorder refers to abnormalities in falling asleep and/or maintaining normal sleep, or behavioral abnormalities or physiological events that occur during sleep or during sleep arousal transition, which include variations in the amount of sleep manifested as too little sleep or too much sleep. There are also variations in sleep quality, such as sleep Apnea syndrome and sleepwalking. The clinical manifestations of sleep disorders are diverse, with different etiology and pathology respectively. Sleep disorder itself can induce or cause a variety of diseases in the body, and diseases in various systems of the body can be concurrent with or accompanied by sleep disorders. Among them, sleep-related breathing disorder is a disease characterized by abnormal breathing rhythm and/or abnormal airway ventilation during sleep, with or without daytime breathing disorder. Sleep-related breathing disorders include obstructive sleep Apnea, central sleep Apnea, sleep-related hypopnea diseases, sleep-related hypoxemia, snoring, and sleep moaning.
Obstructive Sleep Apnea (OSA) means that the Apnea and the hypopnea are caused by repeated collapse and obstruction of the upper airway during sleep. OSA in turn leads to frequent hypoxemia, hypercapnia, significant fluctuations in intrathoracic pressure, and disturbance of sleep structure, and can lead to long-term impairments in multiple-organ system functions. Patients' snoring and recurrent Apnea during sleep are usually accompanied by symptoms of daytime sleepiness, lack of concentration, emotional disturbance, insomnia, fatigue, etc. Obstructive sleep Apnea is a chronic disease that requires comprehensive multidisciplinary treatments, nevertheless an individualized treatment should be followed. The main causes and risk factors of OSA include: obesity (body mass index BMI≥28 kg/m2), age (incidence rate increases with adult age), gender (more males than females), abnormal upper airway anatomy which includes increased nasal resistance: nasal polyps, nasal cavity tumors, nasal valve stenosis, nasal septum deflection, chronic hypertrophic rhinitis, allergic rhinitis, etc., and hypertrophy of soft tissues of the pharynx: hypertrophy of the tongue, hypertrophy of the tonsils and adenoids, hypertrophy and/or lowering of the soft palate, etc., long-term heavy drinking and/or sedative hypnotics intake, long-term heavy smoking, genetic predisposition, and secondary diseases such as endocrine system diseases, chronic heart dysfunction, craniofacial developmental deformity, etc. Obstructive Apnea is often accompanied by hypopnea, or coexists with central sleep Apnea, and any restriction of airflow caused by airway obstruction or central nervous regulation often causes hypoxemia.
At present, objective methods of sleep diagnosis and evaluation are mainly performed by polysomnography (PSG). Subjects need to sleep overnight in the examination room of the medical institution, and the tests are assisted by a technician. The process includes multiple physiological signal acquisitions, including brain waves, electrooculogram, electromyograms, electrocardiograms, thoracoabdominal respiratory mobility, oral and nasal airflow, snoring, blood oxygen saturation, limb mobility, body posture and synchronized recorded images, etc. These signals are collected by the body surface sensors and recorded by the computer, and finally the results of the examination are interpreted by a sleep medicine specialist. The acquisition of multiple physiological signals of PSG, especially the monitoring of a large number of signals on the skull and face, requires the subject to be affixed with many electrodes, so a large number of wires are disposed around the subject's head, affecting the subject to fall asleep and causing poor subject experiences. In addition, during the test in the examination room, changes in the sleeping environment cause many subjects to change their sleeping behaviors, resulting in differences between the examination results and the sleeping behaviors of the subjects in their natural states. Furthermore, the amount of sleep physiological examinations and the physiological signal analysis information thereof is large and inconvenient for utilization; in addition, the detection system of multiple physiological examinations for sleep is expensive, and it is difficult to promote and use the system. Although the existing Cardiopulmonary Coupling (CPC) technology can reduce the difficulty of collecting multiple physiological signals, the amount of information it analyzes is large and there are certain limitations in the refinement of time intervals. Therefore, there is an urgent need to develop a method that is easy to measure, implement, and truly reflect the physiological state of the subject's natural state.
The present invention relates to a synthetic composite waveform for determining an individual's physiological state, and a generating method and a generating system thereof. The present invention collects an individual ECG signal through a lightweight ECG signal detection instrument, analyzes and generates synthetic basic waveforms of the individual's physiological signals and the synthetic basic waveforms combined to generate synthetic composite waveforms, and through the synthetic composite waveforms, analyzes an individual's physiological signals. The method and system of the present invention can be used to detect the physiological state of an individual, including the sleep states of the individual during sleep, the sleep Apnea index, the type of sleep Apnea, the duration of sleep Apnea, the sleep state of the individual when sleep Apnea occurs, and the individual's stable and unstable physiological states during the non-sleep time interval.
The method and system of the present invention analyze individual physiological signals and generate individualized synthetic basic waveforms and synthetic composite waveforms, and then analyze the physiological signals of the individual through the synthetic basic waveforms and the synthetic composite waveforms without collecting physiological signals and statistical analysis of a large number of subjects. In addition to reducing the amount of information to be analyzed, it can also overcome the problem of not being able to establish a standardized model by statistical analysis methods due to differences among individuals.
The implementation location of the method and system for generating synthetic composite waveforms of the present invention is not limited to the examination room of a medical institution, and can be performed in the subject's residential environment as well. In addition, the lightweight instrument also improves the subject's comfort during examination, therefore an individual's physiological status can be truly reflected.
The method and system of the present invention reduce the amount of information to be analyzed after the examination through automated analysis, thereby providing examination results more quickly, and providing references to physicians for the prescription of medication and the like.
A purpose of the present invention is to provide a method for generating synthetic composite waveforms for determining an individual's physiological state, which includes the steps of: (A) obtaining an individual's periodic physiological signal within a time frame; (B) analyzing the periodic physiological signal to obtain peak-to-peak intervals of the periodic physiological signal and converting the peak-to-peak interval into frequencies; (C) establishing a physiological variation waveform according to variations of the frequencies; (D) according to frequency trend or fluctuation amplitude of the physiological variation waveform, defining at least one synthetic basic waveform; (E) combining at least two said synthetic basic waveforms to generate at least one synthetic composite waveform; and (F) respectively defining each one of the at least one synthetic composite waveform as a physiological state.
In one embodiment, the physiological signal is a single signal.
In one embodiment, the physiological signal is an electrocardiogram (ECG) signal or a photoplethysmogram (PPG) signal.
In one embodiment, the fluctuation amplitude refers to a difference between two adjacent sets of signal values.
In one embodiment, the signal values refer to frequencies.
In one embodiment, the synthetic basic waveforms include a stable wave, a state wave, and an irregular wave, wherein the stable wave means that the fluctuation amplitude appears stable, and the state wave means that the fluctuation amplitude gradually rises or gradually falls, and the irregular wave means that the fluctuation amplitude exhibits irregular variations.
In one embodiment, the stable wave is classified into a stable wavelet, a stable medium wave, and a stable big wave according to the fluctuation amplitude.
In one embodiment, the physiological state is a sleeping state or a non-sleeping state.
In one embodiment, the sleeping state and the non-sleeping state are determined by combining an individual's physiological signal waveform and body position information.
In one embodiment, the method for generating synthetic composite waveforms further includes the step of: (G) determining a physiological state of the individual during the time frame.
The present invention also provides a synthetic composite waveform generation system for determining an individual's physiological state, which includes: A. a detection module for obtaining a periodic physiological signal of an individual within a time frame; B. a storage module for storing the physiological signal; C. a computing module for:
c1. analyzing the periodic physiological signal to obtain peak-to-peak intervals of the periodic physiological signal, and converting the peak-to-peak intervals into frequencies;
c2. establishing a physiological variation waveform according to variations in the frequencies;
c3. defining at least one synthetic basic waveform according to frequency trend or fluctuation amplitude of the physiological variation waveform;
c4. combining at least two of the synthetic basic waveforms to generate at least one synthetic composite waveform; and
c5. defining each of the at least one synthetic composite waveform respectively as a physiological state.
In one embodiment, the physiological signal is a single signal.
In one embodiment, the physiological signal is an electrocardiogram (ECG) signal or a photoplethysmogram (PPG) signal.
In one embodiment, the fluctuation amplitude refers to a difference between two adjacent sets of signal values.
In one embodiment, the signal values refer to frequencies.
In one embodiment, the synthetic basic waveform includes a stable wave, a state wave, and an irregular wave, wherein the stable wave means that the fluctuation amplitude appears stable, the state wave means that the fluctuation amplitude gradually rises or gradually falls, and the irregular wave means that the fluctuation amplitude exhibits irregular variations.
In one embodiment, the stable wave is classified into a stable wavelet, a stable medium wave, and a stable big wave according to the fluctuation amplitude.
In one embodiment, the physiological state is a sleeping state or a non-sleeping state.
In one embodiment, the sleeping state and the non-sleeping state are determined by combining an individual's physiological signal waveform and body position information.
In one embodiment, the system for generating a combined composite waveform further includes an output module for outputting a physiological state of the individual during the time frame.
In the following, the technical solutions in the embodiments of the present invention will be clearly and fully described with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, but not all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by a person of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.
The “individuals” described herein include, but are not limited to, human individuals; SAHS refers to Sleep Apnea Hypopnea Syndrome; AHI refers to sleep Apnea-Hypopnea index i.e. number of Apnea plus Hypopnea per hour during sleep.
The synthetic basic waveforms and the synthetic composite waveforms of the present invention can be generated through different periodic physiological signals.
Analysis of the difference between two adjacent sets of signal values (hereinafter referred to as fluctuation amplitude) or fluctuation trend for the ECG variation waveform or the PPG variation waveform can obtain several synthetic basic waveforms as shown in
Since there is a coupling relationship between the individual's ECG and respiration and such relationship will also show different coupling characteristics in different states, each synthetic basic waveform corresponds to one respective state.
Taking the sleep states as an example, the correspondences between each sleep state and each synthetic basic waveform are shown in Table 1.
The aforementioned synthetic basic waveforms are further combined to obtain several composite synthetic waveforms as shown in
Taking the non-sleep state (when active) as an example, the correspondences between synthetic basic waveforms and activity states are shown in Table 3:
The aforementioned synthetic basic waveforms are further combined to obtain several synthetic composite waveforms as shown in
Table 5 shows the results of analyzing the sleep state of individual case A through using the synthetic waveforms generated by the ECG signal.
Based on the results of the above analysis, the sleep quality of the individual can be known, and it can be determined whether the individual sufficiently rests during the sleep.
In addition, according to the aforementioned method, the sleep states whenever SAHS occurs and the number of occurrences of SAHS within the examination time of the individual case A can also be obtained. The analysis results of an individual case A are shown in the table below:
The above analysis can obtain the number of times that the individual has for different degrees of SAHS (the more+signs, the more serious the degree of SAHS) during this time interval of sleep, the state of sleep that the individual was in when SAHS occurred, and the duration of SAHS.
Furthermore, if the individual's heart rhythm is examined during the examination of the individual by the aforementioned method, it can be combined and presented in combination with the time of occurrence, duration, recovery time and heart rate change of the individual when SAHS occurs, as shown in the table below.
Table 8 shows the results of analyzing the sleep states of the synthetic waveforms generated by the individual case B using the PPG signal.
Based on the above analysis results, the sleep quality of the individual can be known, and it can be determined whether the individual has sufficiently rested during the sleep.
In addition, according to the aforementioned method, the sleep states and the number of occurrences of the individual when the SAHS occurred during the examining time can also be detected. The analysis results of the individual case B are shown in the following table:
It can be known from the above analysis regarding the number of times that a person had various degrees of SAHS (the more+signs indicating the more serious) during this time interval of sleep, and the state of sleep that the individual was in when SAHS occurred, and the duration of SAHS.
Furthermore, if the individual's heart rhythm is a so detected during the examination of the individual by the aforementioned method, it can be thereby combined and presented in combination with the time of occurrence, duration, recovery time and heart rate change of the individual, as shown in the table below:
A person of ordinary skill in the art may understand that the implementation of all or part of the processes in the methods of the aforementioned embodiments may be performed by a computer program instructing related hardware. The synthetic basic waveform and/or synthetic composite waveforms may be stored in a computer-readable storage medium. When the computer program is executed, the computer program may include the processes of the foregoing methods. The storage medium may be a magnetic disk, an optical disk, a read-only memory (ROM), a random access memory (RAM), or a cloud storage device.
The aforementioned are preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principles of the present invention, certain improvements and retouches of the present invention can still be made which are nevertheless considered as within the protection scope of the present invention.
Even though numerous characteristics and advantages of the present invention have been set forth in the foregoing description, together with details of the structure and function of the invention, the disclosure is illustrative only. Changes may be made in detail, especially in matters of shape, size, and arrangement of parts within the principles of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.
| Number | Date | Country | Kind |
|---|---|---|---|
| 109107544 | Mar 2020 | TW | national |
