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CN111938612A - sleep physiological system - Google Patents

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CN111938612A
CN111938612A CN202010381662.3A CN202010381662A CN111938612A CN 111938612 A CN111938612 A CN 111938612A CN 202010381662 A CN202010381662 A CN 202010381662A CN 111938612 A CN111938612 A CN 111938612A
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sleep
breathing
posture
physiological
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周常安
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Priority to JP2021563148A priority Critical patent/JP2022532849A/en
Priority to US17/611,134 priority patent/US20220218293A1/en
Priority to PCT/CN2020/089965 priority patent/WO2020228725A1/en
Publication of CN111938612A publication Critical patent/CN111938612A/en
Priority to JP2023001965U priority patent/JP3243566U/en
Priority to US18/367,421 priority patent/US20240000396A1/en
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Abstract

本发明提供一种睡眠生理系统,在一较佳实施例中,该系统包括一壳体,一黏附式穿戴结构,用以将该壳体设置于一使用者的躯干,一姿势传感器,用以取得该使用者于睡眠期间的睡眠姿势相关信息,多个电极,用以取得该使用者于睡眠期间的心电信号以及躯干部位的阻抗变化,且该阻抗变化被用以取得该使用者于睡眠期间的至少一睡眠呼吸生理信息,以及通过比对该睡眠姿势相关信息以及该至少一睡眠呼吸生理信息,可产生睡眠呼吸事件姿势相关性信息。

Figure 202010381662

The present invention provides a sleep physiology system. In a preferred embodiment, the system includes a casing, an adhesive wearing structure for disposing the casing on a user's torso, and a posture sensor for Obtain the sleep posture related information of the user during sleep, a plurality of electrodes are used to obtain the ECG signal of the user during sleep and the impedance change of the torso, and the impedance change is used to obtain the user during sleep. At least one piece of sleep breathing physiological information during the period, and by comparing the sleep posture related information with the at least one sleep breathing physiological information, sleep breathing event posture correlation information can be generated.

Figure 202010381662

Description

睡眠生理系统sleep physiological system

技术领域technical field

本发明涉及一种睡眠生理系统,特别地是,涉及一种可评估及改 善睡眠呼吸障碍的睡眠生理系统。The present invention relates to a sleep physiology system, in particular, to a sleep physiology system that can assess and improve sleep-disordered breathing.

背景技术Background technique

睡眠呼吸暂停(Sleep Apnea)是一种睡眠呼吸障碍,其一般有三 种类型:阻塞型睡眠呼吸暂停(Obstructive Sleep Apnea,OSA),中 枢型睡眠呼吸暂停(Central SleepApnea,CSA),以及混合型睡眠呼 吸暂停(Mixed Sleep Apnea,MSA)。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).

阻塞型睡眠呼吸暂停(OSA)之主要特征为于睡眠期间,由于上 呼吸道完全或局部阻塞而形成一段时间内呼吸气流减少或中止之现 象,而且,通常伴随血氧浓度的饱和度下降(desaturation),OSA是 一种常见的睡眠呼吸障碍,中年人口中约有25~40%受到影响。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.

中枢型睡眠呼吸暂停(CSA)是因大脑驱动肌肉进行呼吸的机制出 现问题所造成,使得呼吸肌肉的神经驱动出现短时间的停止,且这些 从10秒到2至3分钟不等的瞬变可能会持续整个晚上的时间,中枢型 睡眠呼吸暂停,类似于阻塞型睡眠呼吸暂停,会在睡眠期间导致逐渐 窒息,结果造成个体自睡眠中被短暂的唤醒(arousal),并同时恢复正 常呼吸功能,且亦与阻塞型睡眠呼吸暂停类似的是,中枢型睡眠呼吸 暂停可导致心律不整、高血压、心脏病和心力衰竭等疾病。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.

混合型睡眠呼吸暂停(MSA)是指阻塞型睡眠呼吸暂停以及中枢 型睡眠呼吸暂停两者混合出现的情形。Mixed sleep apnea (MSA) is a combination of obstructive sleep apnea and central sleep apnea.

呼吸暂停缺氧指数(Apnea Hypoxia Index,AHI)是睡眠呼吸暂停 严重程度的一个指标,其结合了睡眠呼吸暂停(Apnea)和睡眠呼吸低 通气(hypopnea)的数量,以给出可同时评估睡眠(呼吸)中断次数以 及氧饱和度程度(血氧水平)的一整体睡眠呼吸暂停严重程度评分, 其中,AHI是通过将睡眠呼吸暂停和低通气事件的总数除以睡眠小时 数而计算获得,通常AHI值分为,每小时5-15次为轻度,每小时15-30 次为中度,每小时>30为重度。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.

除了AHI之外,研究证实,评估或检测睡眠呼吸暂停的另一个重 要指标是氧减饱和度指数(Oxygen Desaturation Index,ODI),其是指 睡眠期间每小时血中氧气水平从基线下降一定程度的次数,一般而言, ODI的表示方式有,氧饱和下降3%的次数(ODI3%)以及氧饱和下降 4%的次数(ODI4%)两种,ODI与AHI不同的是,AHI还包括了可能 引起睡眠唤醒(awaken)或觉醒(arousal),但并未影响氧气水平的 事件,而经研究证实,ODI与AHI以及睡眠呼吸暂停间有一定的相关 性,可有效用于诊断OSA。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.

另外,低氧水平也是可用来评估睡眠呼吸暂停所造成之影响的另 一项指标,其是指血氧饱和度低于90%的时间总和与总监测时间之间 的比。由于AHI以及ODI皆是以发生次数作为计算依据,因此可能无 法准确反应持续出现低血氧水平却未经常出现血氧起伏变化所造成的 影响,而低氧水平则可弥补此方面的不足,故低氧水平与睡眠呼吸暂 停间亦具有一定的相关性。In addition, the hypoxic level is another indicator that can be used to assess the impact of sleep apnea, which is the ratio of the sum of the time the blood oxygen saturation is below 90% to 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.

大多数的OSA的患者在仰躺的睡姿时会产生更多的OSA事件, 这是因为仰躺时上呼吸道更容易受重力影响而产生塌陷,在文献中, 正式被诊断为姿势性OSA(PositionalOSA,POSA)的依据是,AHI 值于仰躺与非仰躺时的差值大于某一临界值,例如,POSA其中一种常 见的定义为,于仰躺时的AHI值大于非仰躺时的AHI值两倍以上;由 研究得知,POSA的普及率随OSA之严重度增高而递减,而70%~80% 的POSA患者具轻度至中度的OSA的严重度,其中,亚洲的轻度OSA 患者最高有87%可被归类为POSA之患者。The majority of patients with OSA have more OSA events in the supine sleeping position because the upper airway is more susceptible to collapse due to the influence of gravity in the supine sleeping position. In the literature, it is officially diagnosed as postural OSA ( PositionalOSA, POSA) is based on the fact that the difference between the AHI value between supine and non-supine lying is greater than a certain threshold. For example, one of the common definitions of POSA is that the AHI value in supine lying is greater than that in non-supine lying. The AHI value of POSA is more than twice the AHI value; it is known from studies that the prevalence of POSA decreases with the severity of OSA, and 70% to 80% of POSA patients have mild to moderate severity of OSA. Up to 87% of patients with mild OSA could be classified as patients with POSA.

另一种常见的睡眠呼吸障碍为打鼾,影响总人口中的20%~40%, 此种产生噪音的症状是由于睡眠时上呼吸道气流通过时使得软组织发 生振动而产生,OSA以及严重的打鼾已被研究证实与诸多的临床症状 高度相关,如白天嗜睡,忧郁症,高血压之形成,缺血性心脏疾病, 脑血管疾病等,而其中,打鼾为OSA中最常伴随出现的症状,并且打 鼾也被普遍认为是OSA发生之前兆现象,基于两者的成因都和上呼吸 道狭窄的生理现象有关,睡眠姿势也同样的影响了打鼾症状的严重度。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 reported. It has been confirmed by research that it is highly related to 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 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.

根据研究显示,伴随着上呼吸道狭窄程度的演进,通常的情况是, 先产生与睡眠姿势相关的打鼾症状,更严重时则即使非仰躺时也开始 容易发生打鼾,并开始发展成轻度的OSA,且打鼾的发生与睡眠姿势 的相关性逐渐下降,更进一步,OSA严重度也由与睡眠姿势相关的轻 度至中度,最后变成与睡眠姿势较不相关的重度情形。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.

睡眠姿势训练(Sleep positional Training,SPT)是一种可治疗姿势 性OSA及姿势性打鼾的方法,近年已发展出新一代的姿势训练装置, 通过于身体的中轴,例如,颈部、胸部或腹部,设置姿势传感器,例 如,加速度器,并在侦测到使用者之睡姿为仰躺时,经由产生微弱的 振动警示,而促使使用者改变睡姿以避免仰躺,经由许多的研究报告 指出,通过这种简单却有效的治疗方式,即可避免患者于睡眠中仰躺, 进而大幅降低OSA事件的发生数量。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 with this simple but effective treatment, the patient can be prevented from lying on his back during sleep, thereby significantly reducing the number of OSA events.

只是,这样的训练方式尚有可改进的空间,例如,由于OSA或打 鼾的患者有不同严重程度以及个体的生理差异性,故在进行训练之前, 若能提供评估功能,便能提供针对性的训练方案以及有关训练效果的 预期信息;此外,于睡眠姿势训练期间,若还能提供睡眠及呼吸等信 息,也将可由此调整装置的参数设定,以达到提高训练效果的目的。However, there is still room for improvement in this training method. 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.

另外,除了姿势训练外,若可提供其他的训练方式,例如,针对 非姿势性睡眠呼吸障碍,或是在姿势训练的基础上再更进一步加强等, 将会更有帮助。In addition, in addition to posture training, it would be more helpful if other training methods could be provided, for example, for non-postural sleep-disordered breathing, or to further strengthen on the basis of posture training.

发明内容SUMMARY OF THE INVENTION

本发明的目的在于提供一种睡眠生理系统,包括:一壳体;一控 制单元,容置该壳体中,至少包括微控制器/微处理器;一姿势传感器, 电连接至该控制单元;一多个电极,电连接至该控制单元;一通信模 块,电连接至该控制单元;一电力模组;以及一黏附式穿戴结构,用 以将该壳体设置于一使用者的一躯干上,其中,该姿势传感器被建构 以取得该使用者于睡眠期间的睡眠姿势相关信息;以及该多个电极被 建构以取得该使用者于睡眠期间的一心电信号,以及取得该使用者于 睡眠期间的躯干部位的一阻抗变化,其中,该阻抗变化进一步被作为 基础而取得该使用者于睡眠期间的至少一睡眠呼吸生理信息,且该睡 眠呼吸生理信息包括下列的至少其中之一,包括:呼吸动作,呼吸频 率,以及呼吸振幅,以及其中,该系统被建构以根据该至少一睡眠呼 吸生理信息而决定该使用者于该睡眠期间的一睡眠呼吸事件;以及该 系统进一步被建构以决定在该睡眠姿势相关信息符合一预设睡眠姿势 范围时,以及在该睡眠姿势相关信息超出该预设睡眠姿势范围时,该 睡眠呼吸事件的分布,并据以产生一睡眠呼吸事件姿势相关性信息, 以及其中,该系统更包括一信息提供接口,用以将该睡眠呼吸事件姿 势相关性信息提供予该使用者。The object of the present invention is to provide a sleep physiology system, comprising: a casing; a control unit, accommodated in the casing, at least including a microcontroller/microprocessor; a posture sensor, electrically connected to the control unit; a plurality of electrodes electrically connected to the control unit; a communication module electrically connected to the control unit; a power module; and an adhesive wearable structure for disposing the casing on a torso of a user , wherein the posture sensor is configured to obtain information related to the sleeping posture of the user during sleep; and the plurality of electrodes are configured to obtain an ECG signal of the user during sleep, and to obtain the user during sleep An impedance change of the torso, wherein the impedance change is further used as a basis to obtain at least one sleep breathing physiological information of the user during sleep, and the sleep breathing physiological information includes at least one of the following, including: breathing motion, respiration rate, and respiration amplitude, and wherein the system is configured to determine a sleep breathing event of the user during the sleep based on the at least one sleep breathing physiological information; and the system is further configured to determine a sleep breathing event during the sleep When the sleep posture related information conforms to a preset sleep posture range, and when the sleep posture related information exceeds the preset sleep posture range, the distribution of the sleep breathing events, and accordingly generates a sleep breathing event posture correlation information, and Wherein, the system further includes an information providing interface for providing the sleep breathing event posture correlation information to the user.

本发明的另一目的在于提供一种睡眠生理系统,包括:一壳体; 一控制单元,容置该壳体中,至少包括微控制器/微处理器;至少一生 理传感器,电连接至该控制单元;一听觉警示单元,电连接至该控制 单元,用以产生至少一听觉警示;一通信模块,电连接至该控制单元; 一电力模组;以及一耳塞式穿戴结构,用以将该壳体设置于一使用者 的一耳朵上,其中,该至少一生理传感器被建构以取得该使用者于睡 眠期间的至少一睡眠生理信息,且该至少一睡眠生理信息包括下列的 至少其中之一,包括:睡眠姿势相关信息,以及睡眠呼吸生理信息; 以及该控制单元被建构以产生一驱动信号,且该警示单元在接收该驱动信号后,产生该至少一听觉警示,并将该至少一听觉警示提供予该 使用者,其中,该驱动信号进一步实施为至少根据,该至少一睡眠生 理信息与一预设姿势范围及/或一预设条件进行比较后,符合该预设姿 势范围及/或符合该预设条件时,所决定的一听觉警示行为而产生。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; at least one physiological sensor, electrically connected to the casing a control unit; an auditory warning unit electrically connected to the control unit for generating at least one auditory alert; a communication module electrically connected to the control unit; a power module; and an earplug wearable structure for the The casing is disposed on an ear of a user, wherein the at least one physiological sensor is constructed to obtain at least one sleep physiological information of the user during sleep, and the at least one sleep physiological information includes at least one of the following , including: sleep posture related information, and sleep breathing physiological information; and the control unit is configured to generate a driving signal, and the warning unit generates the at least one audible warning after receiving the driving signal, and sends the at least one audible warning A warning is provided to the user, wherein the driving signal is further implemented as at least according to the comparison between the at least one sleep physiological information and a predetermined posture range and/or a predetermined condition, and the predetermined posture range and/or When the preset condition is met, a determined audible warning behavior is generated.

附图说明Description of drawings

附图用于更好地理解本发明,不构成对本发明的不当限定。其中:The accompanying drawings are used for better understanding of the present invention and do not constitute an improper limitation of the present invention. in:

图1显示根据本发明申请睡眠生理系统的电路示意图;FIG. 1 shows a schematic circuit diagram of a sleep physiology system according to the present invention;

图2显示根据本发明申请生理传感器设置位置分布图;Fig. 2 shows the distribution diagram of the installation position of the physiological sensor according to the application of the present invention;

图3显示本发明申请改善睡眠呼吸暂停方法的可能流程图;FIG. 3 shows a possible flow chart of the method of the present invention for improving sleep apnea;

图4显示本发明申请评估睡眠姿势与打鼾间关系的主要步骤;Fig. 4 shows the main steps of evaluating the relationship between sleep posture and snoring in the present application;

图5显示本发明申请评估睡眠姿势与睡眠呼吸暂停/低通气间关 系的主要步骤;Figure 5 shows the main steps of the present application to assess the relationship between sleep posture and sleep apnea/hypopnea;

图6显示PPG信号及其时域特征;Figure 6 shows the PPG signal and its time-domain characteristics;

图7显示根据本发明申请一较佳实施例,执行睡眠姿势训练及/ 或睡眠呼吸生理反馈训练的流程图;7 shows a flowchart of performing sleep posture training and/or sleep breathing physiological feedback training according to a preferred embodiment of the present invention;

图8A-8C显示黏附式穿戴结构以及电极的实施可能;以及Figures 8A-8C show possible implementations of an adhesive wearable structure and electrodes; and

图9A-9C显示耳塞式穿戴结构的实施可能。9A-9C show possible implementations of the earplug wearable structure.

图中符号说明Description of symbols in the figure

200头顶区域 201额头区域200 Top area 201 Forehead area

202耳朵区域 203口鼻区域202 Ear area 203 Mouth and nose area

204下颏区域 205颈部区域204 Chin area 205 Neck area

206胸部区域 207腹部区域206 Chest area 207 Abdominal area

208手臂区域 209手指区域208 Arm area 209 Finger area

210头部区域 211脚部区域210 Head area 211 Foot area

300 软件程序300 software programs

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

317 历史睡眠呼吸事件基线数据317 Baseline data on historical sleep breathing events

318 使用者或执业医师手动输入318 Manual input by user or practitioner

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

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

800壳体 801贴片式电极800 shell 801 SMD electrode

802电极 803结合件802 electrode 803 combination

804干式电极 900耳塞式穿戴结构804 dry electrode 900 earplug wearable structure

901延伸杆 902耳挂件901 extension rod 902 ear pendant

具体实施方式Detailed ways

以下结合附图对本发明的示范性实施例做出说明,其中包括本发 明实施例的各种细节以助于理解,应当将它们认为仅仅是示范性的。 因此,本领域普通技术人员应当认识到,可以对这里描述的实施例做 出各种改变和修改,而不会背离本发明的范围和精神。同样,为了清 楚和简明,以下的描述中省略了对公知功能和结构的描述。Exemplary embodiments of the present invention are described below with reference to the accompanying drawings, which include various details of the embodiments of the present invention to facilitate understanding and should be considered as exemplary only. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted from the following description for clarity and conciseness.

图1举例说明根据本申请系统的一电路示意图,其中,同个装置 中所有组件皆连接至装置内的控制单元,其中,该控制单元包含至少 一微控制器/微处理器,并预载有程序,以掌控硬件组件之间的沟通, 该控制单元可达成不同硬件组件与连接至装置及/或系统的外部应用程 序/外部装置间的信号传输,并且,其亦让装置的行为可进行编程,以 响应不同的操作情况,以及该微控制器/微处理器亦会利用内部定时器 (未显示)来产生时间戳或时差、或用来控制操作。1 illustrates a schematic circuit diagram of a system according to the present application, wherein all components in the same device are connected to a control unit within the device, wherein the control unit includes at least one microcontroller/microprocessor preloaded with A program that controls the communication between hardware components, the control unit enables 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 programmed , in response 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.

另外,该控制单元常还会包括用以达成生理信号取得的模拟前端 (AFE)电路,以执行,例如,模拟数字转换,放大,滤波,以及本领 域技术人员所熟知的其他各种信号处理手续,由于此些皆为现有的内 容,故不赘述。In addition, the control unit will often include an analog front end (AFE) circuit for obtaining physiological signals to perform, for example, analog to digital conversion, amplification, filtering, and various other signal processing procedures known to those skilled in the art , since these are all existing content, so they will not be repeated.

该系统可包括光传感器,本申请中,光传感器是指同时具有发光 源,例如,LED,以及光检测器,例如,光电二极管(photodiode), 的传感器,且正如所熟知,其是利用PPG(photoplethysmography,光 体积变化描记图)原理,通过发光源发出光线进入人体组织,且光检 测器会接收穿透血管中血液、或经血液反射的光线,之后,再通过取 得光线因血液所发生的容积变化而可获得血液生理信号,故一般称由 光传感器所取得的血液生理信号为PPG信号,其中,PPG信号会包括 快速移动分量(AC Component,AC分量),反应通过动脉传送之心肌 收缩所产生的脉波,以及慢速移动分量(DC Component,DC分量), 反应组织血液体积的较慢变化,例如,呼吸动作(Respiratory Effort) (亦即,呼吸期间胸腹的扩张收缩动作),交感及副交感神经活动所 造成的影响,以及梅尔波(Mayer Waves);另外,通过分析PPG信号 也可获得相关血管硬度以及血压等生理信息;再者,经生理实验得知, PPG脉波在经频域分析后可得各脏腑与心率产生谐波共振的情形,因 而可将此脉波心率谐波共振分布应用于中医的诊断以及人体血液循环 的监测,例如,肝及肝经与心跳频率之第一谐波相关,肾及肾经与心 跳频率之第二谐波相关,脾及脾经心跳频率之第三谐波相关,肺及肺 经心跳频率之第四谐波相关,以及胃及胃经心跳频率之第五谐波相关。The system may include a light sensor, which in this application refers to a sensor having both a light-emitting source, eg, an LED, and a light-detector, eg, a photodiode, and which, 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 reflected by the blood, and then obtains the volume of the light due to the blood. The blood physiological signal can be obtained by changing, so the blood physiological signal obtained by the optical sensor is generally called the PPG signal, wherein the PPG signal will include a fast moving component (AC Component, AC component), which is generated by the contraction of the myocardium transmitted through the arteries. The pulse wave, and 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 The effects of parasympathetic nerve activity and Mayer Waves; in addition, physiological information such as blood vessel stiffness and blood pressure can also be obtained by analyzing PPG signals; After domain analysis, the harmonic resonance of each viscera and heart rate can be obtained, so the harmonic resonance distribution of pulse wave heart rate can be applied to the diagnosis of traditional Chinese medicine and the monitoring of human blood circulation. The first harmonic is related, the kidney and kidney meridian are related to the second harmonic of the heartbeat frequency, the spleen and spleen meridian are related to the third harmonic of the heartbeat frequency, the lung and lung meridian are related to the fourth harmonic of the heartbeat frequency, and the stomach and stomach meridian are related Correlation of the fifth harmonic of the heartbeat frequency.

一般而言,根据光传感器所包含发光源以及光检测器之种类以及 数量的不同,可取得的血液生理信息亦有所不同,举例而言,该光传 感器可包括至少一发光源,例如,LED或多个LED,较佳地是,红外 光、红光、绿光、蓝光、或由多个波长构成的白光,以及至少一光检 测器,以取得脉搏速率/心率以及其他血液生理信息,例如,呼吸生理 信息;其中,在测量脉搏速率/心率时,绿光以及波长在绿光以下的可 见光,例如,蓝光、白光,是当前测量心率的主要使用光源,且主要 着重在AC分量部分的解读,另外,有关呼吸动作对于血液的影响则是, 当一个人呼吸时,胸部空腔内的压力(所谓的胸内压)会随着每次呼 吸改变,其中,吸气时,胸腔会扩张而造成胸内压减少,因而将空气 抽进肺部,在呼气期间,胸内压增加并迫使空气排出肺部,这些胸内 压的改变亦会造成经由静脉回到心脏之血液量以及心脏打入动脉之血 液量的改变,而此部分的改变可通过分析PPG信号的DC分量而得知, 而在本文中,通过分析PPG波形所获得的呼吸信息即称之为低频呼吸 行为;此外,由于心率是受自律神经所控制,故呼吸会因对自律神经 系统产生影响而使得心跳出现变化,也就是,所谓的窦性心律不整 (Respiratory Sinus Arrhythmia,RSA),一般而言,吸气期间会使心跳加速,而呼气期间则使心跳减缓,故也可通过观察心率而得知呼吸 变化,在本文中,将此称之为RSA呼吸行为;故经由光传感器所取得 的呼吸生理信息统称为呼吸行为。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 multiple LEDs, preferably infrared, red, green, blue, or white light consisting of multiple wavelengths, and at least one light detector to obtain pulse rate/heart rate and other blood physiology information, such as , respiratory physiological information; among them, when measuring 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 currently used to measure heart rate, and the interpretation of the AC component is mainly focused , in addition, regarding the effect of breathing action on blood, when a person breathes, the pressure in the chest cavity (the so-called intrathoracic pressure) changes with each breath, wherein, when inhaling, the chest cavity expands and Causes a decrease in intrathoracic pressure, which draws air into the lungs. During exhalation, the intrathoracic pressure increases and forces air out of the lungs. These changes in intrathoracic pressure also cause blood flow back to the heart through the veins and heart stroke. The change in the blood volume entering the artery can be obtained by analyzing the DC component of the PPG signal. In this paper, the respiratory information obtained by analyzing the PPG waveform is called low-frequency respiratory behavior; The heart rate is controlled by the autonomic nervous system, so breathing will affect the autonomic nervous system and make the heart rate change, that is, the so-called Respiratory Sinus Arrhythmia (RSA). The heart rate is accelerated, while the heart rate is slowed down during exhalation. Therefore, the change of respiration can also be known by observing the heart rate. In this paper, this is called RSA breathing behavior; therefore, the physiological information of breathing obtained by the optical sensor is collectively referred to as respiration. Behavior.

或者,该光传感器也可包括至少二发光源,例如,多个LED,较佳 地是,绿光、红外光、及/或红光,以及至少一光检测器,以取得血氧 浓度(SPO2),脉搏速率/心率,以及其他血液生理信息,例如,呼吸 生理信息,其中,测量血氧浓度时,需要两个不同波长的光射入组织 中,利用血液中含氧血红素(HbO2)以及非含氧血红素(Hb)对两种 波长的光有不同的吸收程度,而在接收经穿透、反射的光后,两者比 较的结果可决定血氧浓度,因此,血氧浓度的测量通常对于光传感器 的设置位置有较多的限制,以光线能确实打入动脉中的位置为佳,例 如,手指,手掌内面,脚趾,脚掌等,尤其测量婴儿之血氧浓度时经 常利用脚趾/脚掌,而两种不同波长则可为,例如,红光以及红外光, 或是两种波长的绿光,如波长分别为560nm以及577nm的绿光,因此, 可依需求而选用合适的光源,没有限制。Alternatively, the light sensor may also include at least two light sources, such as a plurality of LEDs, preferably green light, infrared light, and/or red light, and at least one light detector to obtain the blood oxygen concentration (SPO2 ), pulse rate/heart rate, and other blood physiology information, such as respiratory physiology, where two different wavelengths of light are required to penetrate the tissue to measure blood oxygen concentration, using the oxygenated heme (HbO2) in the blood and Non-oxygenated hemoglobin (Hb) 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 Usually, there are more restrictions on the setting position of the light sensor, and the position where the light can really penetrate into the artery is better, for example, the 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/ The sole of the foot, and two different wavelengths can be, for example, red light and infrared light, or two wavelengths of green light, such as green light with wavelengths of 560nm and 577nm, respectively. Therefore, you can choose a suitable light source according to your needs. no limit.

上述各种光源的波长范围为,红光波长约介于620nm至750nm之 间,红外光波长约大于750nm,以及绿光波长约介于495nm至580nm 之间,而用于进行测量时,通常采用,举例而言,红光波长660nm, 红外光波长895nm、880nm、905nm或940nm,以及绿光波长510~560nm或577nm,然而,需注意地是,在实际使用时,根据使用目的的不同, 也可采用其他波长的光源,例如,当只欲取得心率时,如前所述,蓝 光、或由多个波长光源构成的白光亦是合适的选择,因此,为求更精 准描述,在接下来的叙述中,遂使用“波长组合”取代“波长”,以 涵盖使用多波长光源的可能。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 more than 750nm, and the wavelength of green light is about 495nm to 580nm. For example, the wavelength of red light is 660 nm, the wavelength of infrared light is 895 nm, 880 nm, 905 nm or 940 nm, and the wavelength of green light is 510-560 nm or 577 nm. Light sources with other wavelengths can be used. For example, when only the heart rate is to be obtained, as mentioned above, blue light or white light composed of light sources with multiple wavelengths are also suitable choices. Therefore, for a more precise description, the following In the description, "wavelength combination" is used instead of "wavelength" to cover the possibility of using multi-wavelength light sources.

另外,特别地是,可同时具有三种波长的光源,例如,在一实施 例中,第一发光源实施为红外光源产生第一波长组合的光,第二发光 源实施为红光源产生第二波长组合的光,以及第三发光源实施为绿光 源、蓝光源、或白光源产生第三波长组合的光,其中,红外光源以及 红光源用来取得血氧浓度,以及绿光源、蓝光源、或白光源用来取得 心率;或者,在另一实施例中,第一波长组合的光实施为红外光或红 光,以及第二波长组合以及第三波长组合的光实施为绿光、蓝光、及/ 或白光等,可利用其中两个波长组合取得血氧浓度,以及另一个波长 组合取得心率;或者,在另一实施例中,第一波长组合、第二波长组 合、以及第三波长组合的光皆实施为绿光,可利用其中两个波长组合 的绿光取得血氧浓度,以及另一个波长组合的绿光取得心率,而由于, 如前所示,身体不同部位可取得血液生理信息的种类不同,因此,同 时具备可产生多种波长的光源将有助于达成通过同一个装置移动至不同身体部位而取得各种所需血液生理信息的目的,例如,在需要取得 血氧浓度时,将装置移至光线可打入动脉的位置,而需要取得心率或 其他血液生理信息时,则只要有血管或微血管的位置皆可。因此,没 有限制。In addition, 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 a first wavelength combination, and the second light source is implemented as a red light source to generate a second light source. The wavelength-combined light, and the third light-emitting source implemented as a green light source, a blue light source, or a white light source to generate the third wavelength-combined light, wherein the infrared light source and the red light source are used to obtain the blood oxygen concentration, and the green light source, blue light source, Or a white light source is used to obtain the heart rate; or, in another embodiment, the light of the first wavelength combination is implemented as infrared light or red light, and the light of the second wavelength combination and the third wavelength combination is implemented as green light, blue light, and/or white light, etc., two wavelength combinations can be used to obtain blood oxygen concentration, and another wavelength combination can be used to obtain heart rate; or, in another embodiment, the first wavelength combination, the second wavelength combination, and the third wavelength combination The light is implemented as green light, the blood oxygen concentration can be obtained by the green light of the combination of two wavelengths, and the heart rate can be obtained by the green light of the other wavelength combination, and because, as mentioned before, different parts of the body can obtain blood physiological information Therefore, having a light source that can generate multiple wavelengths at the same time will help achieve the purpose of obtaining various required blood physiological information by moving the same device to different body parts, for example, when blood oxygen concentration needs to be obtained. , move the device to the position where the light can penetrate the artery, and when it is necessary to obtain the heart rate or other blood physiological information, as long as there are blood vessels or microvessels. Therefore, there is no limit.

在此,需注意地是,当有三个发光源时,光检测器的数量及设置 位置可根据需求而有所变化。举例而言,可实施为二个光检测器,其 中一个光检测器与单个红外光源及单个红光源用来取得血氧浓度,以 及另一个光检测器与实施为二个的绿光源一起取得心率;或者,也可 单个光检测器与各一个红外光源、红光源及绿光源用来取得血氧浓度 以及心率;又或者,也可单个光检测器除了与单个红光源及单个红外 光源取得血氧浓度外,亦与三个绿光源取得心率,因此,没有限制。Here, it should be noted that when there are three light-emitting sources, the number and arrangement positions of the photodetectors can be changed according to requirements. For example, it can be implemented as two light detectors, where one light detector is used with a single infrared light source and a single red light source to obtain blood oxygen concentration, and the other light detector is used with a green light source implemented as two to obtain heart rate ; Alternatively, a single photodetector and one infrared light source, one red light source, and one green light source can be used to obtain blood oxygen concentration and heart rate; In addition to concentration, heart rate is also obtained with three green light sources, so there is no limit.

另外,在光检测器的选择上,在检测血氧浓度时,由于环境中含 其他光源,因此,较佳地是,接收红外光的光检测器可选择较小的尺 寸,以避免因环境光而饱和;另一方面,用以接收绿光、蓝光、白光 等的光检测器,则可选择较大的尺寸,以取得有效反射光,且可进一 步采取可阻隔其他光源的制程,例如,采用滤波材质以隔绝环境中的 低频红外光,以取得具较佳S/N比的信号。In addition, in the selection of the photodetector, when detecting the blood oxygen concentration, since there are other light sources in the environment, it is preferable to select a smaller size of the photodetector that receives the infrared light to avoid ambient light On the other hand, the photodetector used to receive green light, blue light, white light, etc., can choose a larger size to obtain effective reflected light, and can further adopt a process that can block other light sources, for example, using The filter material is used to isolate low-frequency infrared light in the environment, so as to obtain a signal with a better S/N ratio.

再者,在取得心率时,为了消除噪声,例如,环境噪声,穿戴期 间身体动作所产生的噪声等,也可设置二个以上的光源(且波长不限, 可皆为绿光,也可利用其他波长的光源),并通过将不同光源所取得 的PPG信号间,通过数字信号处理,如适应性滤波器(Adaptive Filter) 或彼此相减等计算而达到消除噪声的目的,故没有限制。Furthermore, when acquiring the heart rate, in order to eliminate noise, for example, environmental noise, noise generated by body movements during wearing, etc., two or more light sources (and the wavelength is not limited, can be green light, can also be used light sources of other wavelengths), and by calculating the PPG signals obtained by different light sources through digital signal processing, such as adaptive filter (Adaptive Filter) or mutual subtraction, the purpose of eliminating noise is achieved, so there is no limit.

该系统可包括一姿势传感器,通常采用加速度器,其中较佳地是, 三轴(MEMS)加速度器,其可定义装置于三度空间的姿势,且会直接 相关于使用者的睡眠姿势,其中,该加速度器会回传于所有x,y,z三个 维度方向中所测得的加速度数值,而根据这些数值,除了睡眠姿势外, 还可衍生而得许多其他睡眠信息,例如,身体活动(actigraph)、移动、 站立/躺下的姿势变化等,其中,经由分析睡眠期间的身体活动,还可 进一步获得相关睡眠阶段/状态的信息;另外,也可使用其他种类的加 速度器,例如,陀螺仪,磁力计等。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 according to these values, in addition to sleep posture, many other sleep information can be derived, such as physical activity (actigraph), movement, changes in standing/lying posture, 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.

该系统可包括一麦克风,该麦克风会回馈所测得声音的频率及振 幅,而利用声音换能器(acoustic transducer)适当的滤波设计可侦测睡 眠中的声音,例如,鼾声或呼吸声等。The system may include a microphone that feeds back the frequency and amplitude of the measured sound, and sound during sleep, such as snoring or breathing, may be detected using an acoustic transducer with appropriate filtering design.

该系统可包括一打鼾侦测器,其可实施为通过上述的麦克风进行 声音侦测,也可实施为侦测打鼾所造成的体腔振动,可使用加速度器、 或压电振动传感器等,测得的位置包括,例如,躯干,颈部,头部, 耳朵等,其中,躯干及头部是较佳的取得位置,尤其鼻腔、喉部、胸 腔等特别能够良好地传递因打鼾所产生的振动,是十分具有优势的选 择,另外,相较于侦测声音,侦测振动可不受环境杂音干扰,也可在 身上具覆盖物,例如,棉被,的情形下进行侦测,应用范围更广;也 因此,作为姿势传感器的加速度器,也可同时被用来取得打鼾相关信 息,更添使用方便性。再者,打鼾相关信息,例如,强度,持续时间, 次数等,则是通过利用适当的滤波设计及已知的技术而自原始的振动 信号中获得,且由于不同传感器所取得的信号种类及取得方式皆不同, 故应对应地采用不同的适当滤波设计。The system can include a snoring detector, which can be implemented to detect sound through the above-mentioned microphone, or can be implemented to detect the vibration of the body cavity caused by snoring, and can use an accelerometer, or a piezoelectric vibration sensor, etc. The position of the snoring includes, for example, the trunk, neck, head, ears, etc., wherein, the trunk and the head are the preferred 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.

该系统可包括一温度传感器,以侦测装置温度、环境温度、或身 体温度,以提供睡眠期间使用者的进一步生理信息。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.

该系统可包括一呼吸气流传感器,例如,热敏电阻,热电偶,或 呼吸气流管,设置于口鼻之间,以取得呼吸气流的变化,其中,热敏 电阻及热电偶可选择于鼻孔附近设置二个侦测点,也可选择于鼻孔附 近及口部附近设置三个侦测点,皆为可行。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.

该系统可包括一加速度器,其可设置于躯干上取得呼吸动作中胸 部及/或腹部起伏所产生的加速及减速;也可用来侦测血液脉动所产生 的血管脉动,以取得心率,且取得位置不限,例如,头部、胸部、上 肢等皆为可取得的位置。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.

该系统可包括至少二阻抗侦测电极,设置于躯干,例如,胸部, 腹部,以取得人体的阻抗信号,而由于此阻抗变化来自于人体呼吸时 胸部及/或腹部起伏所造成的肌肉组织阻抗改变,因此,亦可通过分析 此阻抗变化而了解睡眠呼吸的情形,例如,可了解呼吸动作的有无, 呼吸振幅的大小,以及呼吸频率等各种呼吸相关信息。The system may include at least two impedance detection electrodes disposed on the torso, such as the chest and abdomen, to obtain the impedance signal of the human body, and the impedance change comes from the impedance of the muscle tissue caused by the chest and/or abdomen rising and falling when the human body breathes. Therefore, the state of sleep breathing can also be understood by analyzing the impedance change, for example, the presence or absence of breathing action, the size of the breathing amplitude, and the breathing frequency and other breathing-related information.

该系统可包括压电动作传感器,设置于躯干,其是通过呼吸动作 会施力于压电动作传感器上而取得信号,通常实施为环绕躯干的带体 的形式,也可实施为贴片固定的形式。The system may 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, which is usually implemented in the form of a belt around the torso, and can also be implemented as a patch fixed. form.

该系统可包括RIP(Respiratory Inductance Plethysmography,呼吸 体积感应描记法)传感器,设置于躯干,以取得呼吸动作所造成的胸 部及/或腹部的扩张及收缩情形,通常会实施为环绕躯干的带体的形式。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.

该系统可包括至少二心电电极,设置于躯干、四肢等位置,以取 得心电信号,其中,通过分析心电图波形,可详细了解睡眠期间的心 脏活动情形,例如,可得出精准的心率变化,可得知是否出现心律不 整等,也可从心率计算心跳变异率(Heart RateVariability,HRV)以 了解自律神经的活动情形,皆有助于进一步了解睡眠期间的生理状况。The system can include at least two ECG electrodes, which are arranged on the trunk, limbs, etc. to obtain ECG signals, wherein, by analyzing the ECG waveform, the heart activity during sleep can be understood in detail, for example, accurate heart rate changes can be obtained. , you can know whether there is arrhythmia, etc., you can also calculate the Heart Rate Variability (HRV) from the heart rate to understand the activity of the autonomic nervous system, which is helpful to further understand the physiological state during sleep.

该系统可包括至少二脑电电极、至少二眼电电极、及/或至少二肌 电电极,例如,设置于头部及/或耳朵上的二个脑电电极,及/或设置于 额头、眼睛附近的二个眼电电极、及/或设置于身上的二个肌电电极, 以取得脑电信号、眼电信号、及/或肌电信号,而通过分析脑电信号、 眼电信号、及/或肌电信号,则可得知睡眠期间的睡眠状态/阶段、睡眠 周期等,有助于了解睡眠质量。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 signals, EMG signals, and/or EMG signals, and analyze the EEG signals, EMG signals, And/or myoelectric signals, the sleep state/stage, sleep cycle, etc. during sleep can be known, which is helpful for understanding sleep quality.

在此,需要说明地是,一般在撷取电生理信号时,多会设置信号 撷取电极以及右腿驱动(Driven Right-Leg,DRL)电极,其中,信号 撷取电极在于取得电生理信号,而DRL电极在于消除共模杂讯 (common mode noises),如50Hz/60Hz的电源杂讯,及/或提供人体电位位准(Body Potential Level)与电路基准电位匹配,在使用时,依 照实际使用状况,可采用两极模式,利用两个电生理信号撷取电极取 得电生理信号,也可再加入DRL电极采用三极模式,配置情形可弹性 变化,没有限制。Here, it should be noted that in general, when capturing electrophysiological signals, a signal capturing electrode and a right-leg drive (Driven Right-Leg, DRL) electrode are often set, wherein the signal capturing electrode is used to obtain electrophysiological signals, The DRL electrode is used to eliminate common mode noises, such as 50Hz/60Hz power noise, and/or to provide the body potential level (Body Potential Level) to match the circuit reference potential. In some cases, the bipolar mode can be used, using two electrophysiological signal acquisition electrodes to obtain electrophysiological signals, or the DRL electrode can be added to use the tripolar mode, and the configuration can be flexibly changed without limitation.

另外,一般而言,电极分为两种,湿式电极(Wet Electrode)以及 干式电极(DryElectrode),其中,湿式电极指需通过导电介质而达成 与人体皮肤间取样接触的电极,例如,常利用导电膏、导电胶、导电 液等作为导电介质,最常见的是需设置导电膏的杯状电极,以及已预 先形成有导电胶的电极贴片;另一方面,干式电极则不需要导电介质, 其可实施为通过直接与皮肤接触的方式取得电信号,或者也可实施为 非接触形式,例如,电容式电极,感应式电极,或电磁式电极等,且 其可利用的材质很多,举例而言,一般熟知可感测到人体自发电位差 的导电材质皆可被使用作为干式电极,例如,金属,导电纤维,导电橡胶,导电硅胶等。通常被设置于壳体表面的电极,多会采用干式电 极的形式,以简化操作程序。In addition, generally speaking, electrodes are divided into two types, wet electrodes and dry electrodes. Wet electrodes refer to electrodes that need to pass through a conductive medium to achieve sampling contact with human skin. Conductive paste, conductive glue, conductive liquid, etc. are used as conductive media. The most common ones are cup electrodes that require conductive paste, and electrode patches that have been pre-formed with conductive glue; on the other hand, dry electrodes do not require conductive media. , which can be implemented to obtain electrical signals by directly contacting the skin, or can also be implemented in a non-contact form, such as capacitive electrodes, inductive electrodes, or electromagnetic electrodes, etc., and many materials can be used, such as In general, conductive materials that are generally known to sense the spontaneous potential difference of the human body can be used as dry electrodes, such as metals, conductive fibers, conductive rubber, conductive silicone, and the like. The electrodes usually arranged on the surface of the casing are mostly in the form of dry electrodes to simplify the operation procedure.

有关睡眠阶段/状态相关信息的取得,还可经由分析心率而获得, 举例而言,由于睡眠期间的心率变化与睡眠阶段间有一定的关系,例 如,在深睡及浅睡期间的心率变化情形不同,故可通过观察睡眠期间 的心率分布而得知,另外,也可利用其他常见的分析方法而获得,例 如,HRV分析可得知自律神经的活性,而自律神经的活性亦与睡眠阶 段有关,希尔伯特-黄转换(Hilbert-Huang transform,HHT)及其他适用 的方法亦可用来分析心率变化,而且,经常会同时观察心率以及身体 动作而决定睡眠阶段相关信息。The information related to sleep stages/states can also be obtained by analyzing heart rate. For example, since there is a certain relationship between heart rate changes during sleep and sleep stages, for example, 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.

该系统可包括一警示单元。许多型态的警示可用,包括:听觉, 视觉,触觉,例如,声音,闪光,电刺激,振动等,或任何其他可施 加来通知使用者的警示,其中,使用触觉警示时,较佳地是利用振动 马达,以提供较为舒适且不打扰使用者睡眠的警示,然替代地,在一些环境中,该警示单元可使用扬声器或耳机,以进行听觉警示(空气 传导形式或骨传导形式),或使用LEDs,以进行视觉警示。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 tactile 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.

该系统可包括一信息提供接口,较佳地是,一LCD或LED显示组 件,以将信息提供给使用者,例如,生理信息,统计信息,分析结果, 储存的事件,操作模式,警示内容,进程,电池状态等,不受限制。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.

该系统可包括数据储存单元,较佳地是,一内存,例如,一内部 闪存、或一可移除记忆磁盘,以储存所测得的生理信息。The system may include a data storage unit, preferably a memory, such as an internal flash memory, or a removable memory disk, to store the measured physiological information.

该系统可包括至少一通信模块,可实施为无线通信模块,例如, 蓝牙(Bluetooth),低功耗蓝牙(BLE,Bluetooth Low Energy),Zigbee, WiFi,或其他通信协议,也可实施为有线通信模块,例如,USB接口, UART接口,以在系统中进行沟通,及/或与外部装置进行沟通,其中, 该外部装置可包括,但不限于,智能型装置,如智能手机、智能手环、智能眼镜、智能耳机等,平板计算机,笔记本电脑,个人计算机,亦 即,可包括设置于者身上或身边的装置,而沟通则使得信息可在该些 装置间交换,也使得信息回馈、远程控制、及监测等操作可进行。The system may include at least one communication module, which may be implemented as a wireless communication module, for example, Bluetooth (Bluetooth), Bluetooth Low Energy (BLE, Bluetooth Low Energy), Zigbee, WiFi, or other communication protocols, or may be implemented as wired communication modules, 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 earphones, etc., tablet computers, notebook computers, personal computers, that is, may include devices installed on the person or around them, and communication enables information to be exchanged between these devices, as well as information feedback and remote control. , and monitoring operations can be carried out.

该系统可包括一电力模块,例如,钮扣型电池(button cell),碱 性电池,或可充电锂电池,该系统也可具有充电模块,例如,感应充 电电路,或通过,可选择地,USB埠或弹簧顶针进行充电。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.

接着,请参阅图2,其显示在睡眠期间,上述各种生理传感器以及 警示单元通常可设置的位置,可取得的睡眠生理信息及详细的设置细 节如下。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.

睡眠姿势(sleep position),利用姿势传感器取得,取得位置为身 体中轴周围,包括:头顶区域200,额头区域201,耳朵区域202,口 鼻区域203,下颏区域204,颈部区域205,胸部区域206,以及腹部 区域207,且可设置于环绕身体中轴的任何身体表面,例如,正面,背 面等,只要可通过换算的方式而取得睡眠姿势的位置皆可,其中,以 躯干以及躯干上方的颈部最具代表性。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.

血氧浓度变化,利用光传感器取得,取得位置包括:额头区域201, 耳朵区域202,口鼻区域203,手臂区域208,手指区域209,以及脚 部区域211。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.

心率,可利用光传感器取得,取得位置不限,其中,较常使用的 是手指区域209,手臂区域208,耳朵区域202,头部区域210等,但 身体任何位置皆可,另外,也可利用灵敏度高的加速度器侦测血液脉 动所产生的血管振动,进而取得心率,且取得位置同样没有不限,例 如,头部、胸部、上肢等皆为可取得的位置。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.

呼吸动作(Respiratory Effort),即为呼吸引起的胸部及/或腹部活 动,可利用加速度器、压电动作传感器、RIP传感器、或阻抗侦测电极 取得,取得位置包括:胸部区域206以及腹部区域207。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 .

呼吸行为,是利用光传感器取得之呼吸信息的统称,如前所述, 其分为两种,低频呼吸行为是根据分析PPG波形而得的呼吸信息,RSA 呼吸行为则是根据的心率计算而得的呼吸信息,取得位置不限,其中, 较常使用的是手指区域209,手臂区域208,耳朵区域202,头部区域 210等,但身体任何位置皆可。Respiratory behavior is a general term for the respiratory information obtained by using optical sensors. As mentioned above, it is divided into two types. The low-frequency respiratory behavior is based on the respiratory information obtained by analyzing the PPG waveform, and the RSA respiratory behavior is calculated based on the heart rate. There is no restriction on the position of obtaining the breathing information. 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.

呼吸气流变化,利用呼吸气流传感器(例如,热敏电阻、热电偶、 气流管等)取得,取得位置为口鼻区域203。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 .

打鼾相关信息(鼾声)以及呼吸声,利用麦克风取得,取得位置 不限,亦可于身体外部取得,如利用手机取得。The snoring related information (snoring sound) and breathing sound can be obtained by using a microphone. The location of the acquisition is not limited, and it can also be obtained outside the body, such as by using a mobile phone.

打鼾相关信息(体腔振动),利用加速度器或压电振动传感器取 得,取得位置包括:头部区域210,颈部区域205,胸部区域206,以 及腹部区域207。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.

脑电信号,利用脑电电极取得,取得位置为头部区域210。The EEG signals are obtained by using EEG electrodes, and the obtained location is the head region 210 .

眼电信号,利用眼电电极取得,取得位置为额头区域201。The electro-oculographic signal is obtained by using the electro-oculographic electrode, and the obtained location is the forehead region 201 .

肌电信号,利用肌电电极取得,取得位置不限,例如,额头区域 201,下颏区域204。The EMG signal is obtained by using EMG electrodes, and the position is not limited, for example, the forehead area 201 and the chin area 204.

身体活动,利用加速度器取得,取得位置不限。Physical activity can be obtained by using the accelerometer, and the obtained position is not limited.

睡眠阶段,可利用光传感器及/或加速度取得,取得位置不限,也 可利用脑电电极、眼电电极、及/或肌电电极取得,取得位置以头部为 主;进一步地,通过分析睡眠阶段的分布,例如,深睡、浅睡分别占 整体睡眠时间的比例等,就可了解睡眠品质。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.

再者,提供振动警示的触觉警示单元可设置于身体可感受到振动 的任何位置,以及提供声音警示的听觉警示单元则较佳地设置于耳朵 附近,例如,当采用空气传导声音警示时,设置于耳道及耳道口附近 为佳,以及当采用骨传导声音警示时,则可设置的范围较广,除了耳 朵附近外,整个头骨都是可设置的范围,较佳为无毛发处,且警示的 提供不限单种形式,亦可同时提供两种形式以上的警示,例如,同时 提供振动及声音。另外,振动警示的方式也有不同的选择,例如,可 根据强度、频率、持续时间等的各种变因而组合出不同的振动组合, 除了可让使用者选择适合的振动方式外,也有助于避免出现感觉疲乏 的现象。Furthermore, the tactile warning unit that provides the vibration warning can be arranged at any position where the body can feel the vibration, and the audible warning unit that provides the sound warning is preferably arranged near the ear. For example, when air-conducted sound warning is used, the It is better to be near the ear 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 for the ear, the entire skull can be set, preferably the place without hair, and the warning The provision of the alarm is not limited to a single form, and it can also provide two or more forms of warnings at the same time, for example, provide vibration and sound 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.

其中,需注意地是,该耳朵区域202包括耳廓内面及背面、耳道、 及耳朵附近的头部,该手臂区域208包括上臂、前臂、及手腕,以及 该颈部区域205包括颈部正面及背面。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.

另外,进行设置时,例如,将内含生理传感器的壳体设置于体表 时,可利用各种适合的穿戴结构来达成,举例而言,可利用环体、带 体,例如,环绕头部、手臂、手指、颈部、躯干等;利用黏附结构, 例如,黏附于额头、躯干等体表任何可进行黏附的位置;利用(机械力或磁力)夹子,例如,夹住身体的一部分,如手指、耳朵等,或是 夹在设置于体表的对象上,例如,衣服、环绕身上的带体等;及/或利 用挂件,例如,挂设于耳廓上等,因此,不受限特定形式的穿戴结构。In addition, when setting, for example, when setting the housing containing the physiological sensor on the body surface, various suitable wearing structures can be used to achieve, for example, a ring body, a belt body, for example, a head can be used. , arms, fingers, neck, torso, etc.; using adhesive structures, such as forehead, torso and other body surfaces where adhesion can be performed; using (mechanical or magnetic) clips, for example, to clamp a part of the body, such as Fingers, ears, etc., or clipped on objects arranged on the body surface, such as clothes, belts around the body, etc.; and/or using pendants, such as hanging on auricles, etc., therefore, not limited to specific form of wearing structure.

由上述可知,即使是同一种生理信息,不受限地,也可利用不同 种类的生理传感器以及选择不同的身体区域而取得,再加上,还可选 择同时利用两种以上的生理传感器及/或取得两种以上的生理信息及/ 或设置于两个以上的身体区域,因此,在实际实施时,有各种组合变 化及可能,也因此,接下来叙述的实施例仅作为举例说明,而非限制, 只要是落在上述范围内者皆属本申请所欲主张范畴。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 intended scope of the present application.

光传感器所取得的PPG信号,除了可取得血氧浓度以计算ODI值、 低氧水平等各种本领域技术人员所熟知的数据外,其相关于睡眠呼吸 暂停/低通气的发生,亦会产生其他变化,并足以作为判断是否发生睡 眠呼吸暂停/低通气的基础。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.

阻塞性睡眠呼吸暂停的发生会引起相对性的心跳过缓及PPG信号 的脉波振幅(Pulse wave amplitude,PWA)的增加,还有紧接在呼吸 阻塞结束后会发生的心率迅速增加及强烈血管收缩,此现象于本文中 称为心率变化睡眠呼吸事件,且根据研究,已有报告指出,对具睡眠 呼吸障碍患者而言,相较于心率(HR)/脉波之峰值间间隔(Peak-to-peakinterval,PPI)出现变化,睡眠呼吸事件和觉醒对PWA及/或脉波面积 (Pulse Area,PA)所引起的变化更多。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 intense 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).

其中,如图6所示,PPI定义为PPG信号中两个连续峰值之间的 时间差。首先,检测PPG信号的每个周期的峰值(Peak.amp),并将 所有Peak.amp点的时间标记储存在数组缓冲器中,PPI被计算为连续 Peak.amp点之间的时间差,为了获得准确的结果,可设定PPI值的合 理范围,例如,PPI<0.5秒(>120次/分钟)或PPI>1.5秒(<40次/分 钟)被认为是异常并且加以移除。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, 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定义为峰值振幅(Peak.amp)和波谷振幅(Valley.amp)之 间的差值,Peak.amp和Valley.amp是每个PPG周期的最大和最小振幅 点。首先,所有Peak.Amp和Valley.amp点都被检测为PPG信号的局 部最大和最小点,若出现缺少Peak.amp点的情况时,紧接的Valley.amp 点亦被舍弃,最后,通过从紧接在前的Peak.amp中减去Valley.amp来 计算PWA。由于Peak.amp和Valley.amp点仅成对检测,否则即舍弃, 因此,将不会因其中一个值不见而导致PWA值出错,此外,如果存在 任何异常Peak.amp点,则通过PPI特征提取中提到的滤波手续来排除。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 points are 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, the PPI feature extraction will be performed. The filtering procedure mentioned in to exclude.

PA所代表的是由一个Peak.amp点以及两个Valley.amp点所构成 的三角区域(参见图6)。与PWA特征的提取类似,所有Peak.amp 和Valley.amp点都被检测为PPG信号中的局部最大点和局部最小点, 而且,由于亦记录了时间标记(即每个点的取样数),因此,脉波面积可从每个脉波波形计算而得。PA represents the triangular area formed by one 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.

呼吸信号RIIV(Respiratory Induced Intensity Variation,呼吸引起 的强度变化),是由呼吸同步血液容积变化所引起,可通过带通滤波 器而从PPG信号中滤波提取,例如,0.13-0.48Hz,16级贝塞尔滤波器 (16th degree Bessel filter),而此滤波器则是会抑制PPG信号中,心 脏相关的变化以及低于呼吸频率的频率,例如,交感神经活性及反应传出迷走神经活动的反射性变化。Respiratory signal RIIV (Respiratory Induced Intensity Variation), which is caused by respiration-synchronized blood volume changes, 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 cardiac-related changes in the PPG signal and frequencies below the respiratory rate, such as sympathetic nerve activity and reflex changes in response to efferent vagal activity .

因此,为了侦测睡眠呼吸暂停/低通气事件及其起始(onset),亦 可利用由PPG波形导出的PPI,PWA,PA,以及来自光传感器的RIIV 等各种睡眠呼吸事件相关信息而作为指标。Therefore, in order to detect sleep apnea/hypopnea events and their onsets, various sleep breathing events related information such as PPI, PWA, PA, and RIIV from the light sensor derived from the PPG waveform can also be used as index.

根据上述,本申请名词定义如下:According to the above, the terms of this application are defined as follows:

睡眠生理信息,至少包括:睡眠姿势相关信息,睡眠阶段,睡眠 身体活动,血氧浓度,心率,呼吸动作,呼吸频率,呼吸振幅,呼吸 气流变化,呼吸行为,呼吸声变化,打鼾相关信息,心电信号,脑电 信号,眼电信号,以及肌电信号。Sleep physiological information, including at least: sleep posture related information, sleep stage, sleep physical activity, blood oxygen concentration, heart rate, breathing action, breathing frequency, breathing amplitude, respiratory airflow changes, breathing behavior, breathing sound changes, snoring-related information, heart rate Electrical signals, EEG signals, OMG signals, and EMG signals.

睡眠呼吸生理信息,至少包括:血氧浓度,心率,呼吸动作,呼 吸频率,呼吸振幅,呼吸气流变化,呼吸行为,呼吸声变化,打鼾相 关信息。Sleep breathing physiological information, including at least: blood oxygen concentration, heart rate, breathing action, breathing frequency, breathing amplitude, breathing airflow change, breathing behavior, breathing sound change, and snoring related information.

睡眠呼吸事件,包括:血液生理睡眠呼吸事件(氧减饱和度事件, 低氧水平事件,心率变化睡眠呼吸事件),打鼾事件,睡眠呼吸暂停 事件,以及睡眠呼吸低通气事件。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.

接着,本申请提供一种根据睡眠呼吸事件而进行的睡眠呼吸生理 反馈训练,以及图3显示利用睡眠呼吸生理反馈训练改善睡眠呼吸暂 停的示意流程图。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.

其主要进行的方式是,利用软件程序监测睡眠呼吸生理信息,当 患者的睡眠呼吸生理信息在睡眠期间符合一预设条件时,即触发警示 单元产生警示,例如,听觉、触觉、视觉等任何类型的警示,以让使 用者发生足以中断睡眠呼吸事件的部分唤醒(awaken)或觉醒(arous al),进而达到阻止睡眠呼吸暂停/低通气的效果,其中,若未侦测到 发生觉醒,例如,根据所取得睡眠呼吸生理信息,则警示的强度会在 下一次睡眠呼吸暂停/低通气时增加。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, Based on the acquired sleep breathing physiological information, the intensity of the alert will increase at the next sleep apnea/hypopnea.

这种监测睡眠呼吸事件及其起始、并定期及连续地短暂唤醒患者 睡眠的方法,是一种用来预防睡眠呼吸暂停/低通气的反馈训练,以让 使用者在使用本系统时经历重复的睡眠呼吸暂停/低通气时,会本能地 在事件发生时学习到进行几次深呼吸后返回睡眠。根据研究及实验, 在使用一段时间后,这种对警示的条件反应可有效减少或消除睡眠呼 吸暂停/低通气。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 is effective in reducing or eliminating sleep apnea/hypopnea after a period of use.

在此,该预设条件可随所取得的睡眠呼吸生理信息而改变,例如, 预设的血氧浓度变化,预设的心率变化等,接下来在不同实施例中有 更详细的叙述,再者,在设定时,较佳地是,可在一开始使用预设值, 然后再针对每个使用者进行调整,例如,可使用生理传感器所收集的 历史数据来协助决定适合使用者的预设条件,而此动态调整则有助于 降低假警示的发生率,并提高睡眠事件侦测的准确性,是一种较为进 步的方法。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. , 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 value 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.

而软件程序则可预载于用来取得睡眠生理信息的穿戴装置内,也 可预载于一外部装置,例如,智能型装置,如智能手机、智能手环、 智能眼镜、智能耳机等,平板计算机,笔记本电脑,个人计算机,没 有限制。The software program can be pre-loaded in the wearable device used to obtain sleep physiological information, or can be pre-loaded in an external device, for example, a smart device such as a smart phone, smart bracelet, smart glasses, smart earphones, etc., tablet Computers, laptops, personal computers, no limit.

其实施流程从步骤301开始,之后,在步骤303设定预设条件, 其中,预设条件是警示被启动的数值,在一些实施例中,预设条件可 以是软件程序300内自动设定、或通过使用预设值而设定;替代地, 这些值也可由使用者或执业医师决定并手动输入318,并且,可基于使 用者特定信息而改变。预设条件303的阈值条件/数值,可包括,但不 限于,各种睡眠呼吸生理信息及睡眠呼吸事件相关信息,例如,使用 者的血氧水平,使用者的心率,ODI,脉波振幅等。The implementation process starts from step 301, and then sets a preset condition in step 303, 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. .

在学习模式中,步骤305,软件程序300开始进行信号取样,其是 通过穿戴装置进行收集,并利用本领域技术人员已知的数据传输技术 而被传送到软件程序300,接着,在步骤313,软件程序300收集包含 睡眠呼吸生理信息的取样数据,其中,该取样数据是利用本领域技术 人员已知的技术而被储存在内存或数据库中,并于步骤314辨识睡眠 呼吸事件,例如,通过分析睡眠呼吸事件相关信息。In the learning mode, step 305, the software program 300 begins to sample the signals, which are collected by the wearable device and transmitted to the software program 300 using data transmission techniques known to those skilled in the art, and 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.

在步骤315,软件程序300将所辨识的睡眠呼吸事件与历史睡眠呼 吸事件基线数据317进行比较。在一些实施例中,历史睡眠呼吸事件 基线数据317可包括睡眠呼吸生理信息,例如,通过医疗专业人员的 指导而提供的心率值及血氧水平值等,历史呼吸事件基线数据317也 可提供指示使用者睡眠呼吸事件及其起始的PPG波形、心率变化、血 氧值,及其他医疗数据;在一些实施例中,历史睡眠呼吸事件基线数 据317可获取自使用者的历史读数、睡眠呼吸事件基线数据的热门来 源(例如,MIT-BIH多导睡眠数据库)、或统计推导的数据等。在步 骤315中,取样数据与历史睡眠呼吸事件基线数据317进行比较,以 决定在特定时段内是否发生假警示,如果发现假警示,则在步骤315 中对预设条件进行调整,以确保正确侦测到睡眠呼吸事件,如果没有 侦测到假警示,或仅侦测到软件程序300或使用者可接受的预设范围 内少量假警示,则在步骤315中将不对预设条件进行调整,并进入完 成状态320。At step 315, the software program 300 compares the identified sleep breathing events to historical sleep breathing event baseline data 317. In some embodiments, historical sleep breathing event baseline data 317 may include sleep breathing physiological information, such as heart rate values and blood oxygen level values, etc., provided through the guidance of a medical professional, and historical breathing event baseline data 317 may also provide indications User sleep breathing events and their originating PPG waveforms, heart rate changes, blood oxygen levels, and other medical data; in some embodiments, historical sleep breathing event baseline data 317 may be obtained from the user's historical readings, sleep breathing events Popular sources of baseline data (eg, MIT-BIH polysomnography database), or statistically derived data, etc. In step 315, the sampled data is compared with the historical sleep breathing event baseline data 317 to determine whether a false alarm occurs within a specific period of time. If a false alarm is found, the preset conditions are adjusted in step 315 to ensure correct detection. If a sleep breathing event is detected, if no false alarms are detected, or only a small number of false alarms within a preset range acceptable to the software program 300 or the user are detected, the preset conditions will not be adjusted in step 315, and Complete state 320 is entered.

在训练模式中,请回到步骤305,在此步骤,软件程序300进行信 号取样,然后在步骤307中执行信号处理和相应的算法,以自取样的 信号中提取出睡眠呼吸生理信息及相关数值,在步骤307后,软件程 序300在步骤309中连续检查,并通过将步骤307获得的结果与步骤 303中设置的预设条件进行比较,而决定与预设条件是否匹配,若在步 骤309中未与预设条件匹配,则信号取样继续,且不执行进一步处理, 若在步骤309中与预设条件匹配,则决定一警示行为,以启动警示312 的产生,在此,该警示将让使用者被短暂地唤醒,然后,使用者会进 行几次深呼吸并返回睡眠,因而停止呼吸暂停/低通气状况。在整个训 练模式中,监控、警示(和调整预设条件)的过程会持续进行,而此 过程的结果则使得睡眠呼吸暂停/低通气的频率和数量逐渐减少。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 values from the sampled signals. , after step 307, the software program 300 continuously checks in step 309, and determines whether it matches the preset condition by comparing the result obtained in step 307 with the preset condition set in step 303, if in step 309 If the preset condition is not matched, the signal sampling continues and no further processing is performed. If the preset condition is matched in step 309, an alert action is determined to initiate the generation of an alert 312. Here, the alert will cause the use of The user is briefly awakened, then the user takes several deep breaths and returns to sleep, thus ending the apnea/hypopnea condition. The process of monitoring, alerting (and adjusting preset conditions) continues throughout the training mode, and as a result, the frequency and number of sleep apnea/hypopnea is gradually reduced.

学习模式和训练模式可以自动地、或由使用者手动设置地动态转 换,且可在同一夜晚或不同夜晚执行,以优化治疗效果,没有限制。Learning mode and training mode can be switched dynamically automatically, or manually set by the user, and can be performed on the same night or on different nights to optimize the treatment without limitation.

接下来,本系统提供有关评估及改善姿势性睡眠呼吸障碍的内容。Next, the system provides content on assessing and improving postural sleep-disordered breathing.

请参照图4,此流程图举例说明利用本系统评估睡眠姿势与打鼾间 关系的主要步骤,并提供了相关的训练方法。在步骤402,装置通过一 穿戴结构而设置于使用者身上。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.

在步骤405,当装置穿戴设置完成后,控制单元即开始数据收集, 以在使用者的睡眠期间获取睡眠姿势相关信息,其中,收集的数据可 通过无线通信模块传输到外部装置,或者可先保存在可穿戴装置的内 存中,然后再传输到外部装置进行后续分析,接着,请参照步骤410, 在此步骤中,会进行打鼾事件相关信息的收集,可使用的传感器包括, 但不限于,麦克风,压电振动传感器,加速度器,其可设置于可穿戴 装置上,或者也可设置于外部装置上,例如,智能型手机,没有限制。In step 405, after the device wearing 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 available sensors 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.

接着,在步骤415,睡眠姿势相关信息以及打鼾事件相关信息会相 互结合,并通过软件程序计算两者的相关性,例如,仰躺打鼾指数定 义为仰躺姿势时每小时打鼾事件的数量,非仰躺打鼾指数定义为仰躺 姿势时每小时打鼾事件的数量,以及打鼾指数=仰躺鼾声指数+非仰躺 鼾声指数,另外,仰躺性打鼾者(supine-dependent snorer)定义为仰躺 打鼾指数高于其非仰躺打鼾指数。在步骤418,一预定阈值会与,例如, 仰躺打鼾指数和非仰躺打鼾指数的比率,或是其他数值,进行比较, 如果超过阈值,则使用者被识别为姿势性打鼾者(positional snorer), 并接着可在步骤425进行睡眠姿势训练(Sleep PositionTraining,SPT), 否则,使用者可在步骤430进行以打鼾事件为根据的睡眠呼吸生理反 馈训练;或可选地,若为高姿势依赖性(high position dependency)伴 随高非仰躺打鼾指数(high non-supine snore index)的情况,则使用者 可同时结合,于仰躺姿势期间进行姿势训练以及于非仰躺姿势期间进 行基于打鼾事件的睡眠呼吸生理反馈训练两者。另一方面,若为高打 鼾指数伴随较低姿势依赖性的情况,则使用者可通过步骤440检查是 否为姿势性睡眠呼吸暂停(POSA),因为根据研究,当使用者的打鼾 指数越高时,越常被发现与姿势无关,这意味着是可能导致OSA症状 的更严重上呼吸道阻塞。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; or alternatively, if it is a high posture dependence 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.

接着,请参考图5,此流程图举例说明使用本系统评估睡眠姿势与 睡眠呼吸事件间关系的主要步骤,并提供了相应的训练方法,而在此, 该睡眠呼吸事件则是可包括或不包括打鼾事件。在步骤502,装置通过 一穿戴结构而设置于使用者身上。Next, please refer to FIG. 5 , which 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 wearable structure.

在步骤505,当装置穿戴设置完成后,控制单元即开始数据收集, 以在使用者的睡眠期间获取睡眠姿势相关信息,其中,收集的数据可 通过无线通信模块传输到外部装置,或者可先保存在可穿戴装置的内 存中,然后再传输到外部装置进行后续分析,接着,请参照步骤510, 在此步骤中,会进行睡眠呼吸生理信息的收集,可使用的传感器包括, 但不限于,光传感器,加速度器,压电振动传感器,压电动作传感器, 阻抗侦测电极,RIP传感器,呼吸气流传感器,麦克风等,而根据取得 信号的不同,传感器则是可设置于穿戴装置上,或者也可设置于外部 装置,例如,智能型手机,没有限制。In step 505, after the device wearing 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 an external device through a 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, sleep breathing physiological information 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 obtained signal, the sensor can be installed on the wearable device, or can be There is no limit to setting on an external device, such as a smartphone.

接着,在步骤515,睡眠姿势相关信息以及睡眠呼吸生理信息会相 互结合,以通过软件程序计算两者的相关性,例如,仰躺睡眠呼吸事 件指数定义为仰躺姿势时每小时睡眠呼吸事件的数量,非仰躺睡眠呼 吸事件指数定义为非仰躺姿势时每小时睡眠呼吸事件的数量,以及睡 眠呼吸事件指数=仰躺睡眠呼吸事件指数+非仰躺睡眠呼吸事件指数, 另外,姿势性睡眠呼吸事件使用者被定义为仰躺睡眠呼吸事件指数高 于其非仰躺睡眠呼吸事件指数。在步骤518,一预定阈值会与,例如, 仰躺睡眠呼吸事件指数与非仰躺睡眠呼吸事件指数的比率,或是其他 数值,进行比较,如果超过阈值,则使用者被识别为患者睡眠呼吸事 件使用者,并接着可在步骤525进行睡眠姿势训练(SPT),否则,使 用者可在步骤530进行以睡眠呼吸事件为根据的睡眠呼吸生理反馈训 练;或者,可选地,若为高姿势依赖性(high position dependency)伴 随高非仰躺睡眠呼吸事件指数(high non-supinerespiratory event index) 的情况,则使用者可同时结合,于仰躺姿势期间进行姿势训练以及于 非仰躺姿势期间进行基于睡眠呼吸事件的睡眠呼吸生理反馈训练两 者。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 sleep breathing event index = supine sleep breathing event index + non-recumbent sleep breathing event index, additionally, postural sleep Respiratory event users were defined as having a higher supine sleep apnea event index than their non-supine sleep apnea event index. At step 518, a predetermined threshold is compared to, for example, the ratio of the supine sleep breathing event index to the non-supine sleep breathing event index, or other value, and if the threshold is exceeded, the user is identified as patient sleep breathing event user, and may then perform sleep posture training (SPT) at step 525, otherwise, the user may perform sleep breathing physiological feedback training based on sleep breathing events at step 530; or, alternatively, if high posture high position dependency with a high non-supinerespiratory event index, the user can combine, at the same time, postural training during supine positions and sleep-based sleep during non-supine positions Sleep breathing physiological feedback training of respiratory events both.

其中,姿势训练的方式为,当侦测到睡眠姿势符合一预设姿势范 围,例如,仰躺姿势,并持续一段时间(例如,5秒至10秒)时,警 示单元会启动警示,例如,振动或声音,且该警示会逐渐增加/增量强 度,直到侦测到睡眠姿势脱离该预设姿势范围,例如,变成不同的睡 眠姿势、或非仰躺姿势,则警示立即停止,若在一预设期间(例如, 可调整的10秒至60秒)后未侦测到姿势发生改变,则警示会暂停, 并在一段时间(例如,可调整的数分钟)后重新开始;在一些实施例 中,该警示一开始的频率/持续时间会非常短,并逐渐地增加,直到使 用者不再呈现仰躺姿势为止;无论警示的强度为何,都会具警示间间 隔(例如,2秒)的重复数次(例如,6次)。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 will pause and restart 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).

至于预设姿势范围的设定,则是可依实际需求而有所不同,举例 而言,根据对于仰躺姿势定义的不同,预设姿势范围即有所改变,例 如,当加速度器设置于躯干时,可设定为躯干平面法线与床面法线夹 角落在正负30度的范围,或者,当加速度器设置于额头时,由于头部 可能有较多的动作,因此可设定为额头平面法线与床面法线夹角落在 正负45度的范围,又或者,当加速度器设置于颈部时,可与头部有同 样的设定范围等。因此,没有限制,有各种选择。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.

另外,针对打鼾所执行的姿势训练也是类似上述的情形,只在于 提供警示的根据为是否侦测到打鼾,即不再赘述。In addition, the posture training performed for snoring is also similar to the above-mentioned situation, except that the basis for providing the warning is whether snoring is detected, which is not repeated here.

警示的提供则为,控制单元会被建构以产生一驱动信号,且警示 单元在接收该驱动信号后,会产生至少一警示,并将该至少一警示提 供予该使用者,以达成睡眠姿势训练及/或睡眠呼吸生理反馈训练的目 的,其中,该驱动信号实施为至少根据该睡眠姿势相关信息与一预设 姿势范围进行比较后,且该睡眠姿势相关信息符合该预设姿势范围时, 及/或根据该睡眠呼吸生理信息与一预设条件进行比较后,且该至少一 睡眠呼吸生理信息符合该预设条件时,所决定的一警示行为而产生。 有关如何提供警示以及详细内容则在接下来实施例中有进一步叙述。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 drive signal is implemented at least according to the sleep posture-related information after being compared with a preset posture range, and when the sleep posture-related information conforms to the preset 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.

在此,需注意地是,上述的警示单元,无论所产生之警示的类型 为何,例如,振动或声音,在实施时皆有各种可能,例如,可设置于 取得睡眠生理信息的穿戴装置内,也可设置于另外的穿戴装置中,也 可设置于外部装置中,故没有限制。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.

另外,警示的提供,较佳地是,在确认使用者已入睡后再执行, 以最不打扰睡眠的方式进行,而针对此点,在一较佳实施例中,本申 请是利用侦测睡眠生理信息来了解使用者是否已入睡,并在入睡后系 统才进入一警示可产生状态并开始提供睡眠姿势训练及/或睡眠呼吸生 理反馈训练。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 the detection of 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.

在执行时,生理传感器所取得的睡眠生理信息会与一预设条件进 行比较,以决定使用者是否符合一预设睡眠呼吸条件,在此,该预设 睡眠呼吸条件所采用的是已入睡后才会发生的生理状况,例如,是否 出现氧减饱和度事件,低氧水平事件,心率变化睡眠呼吸事件,打鼾 事件,睡眠呼吸暂停事件,睡眠呼吸低通气事件,呼吸特定变化,及/ 或心率特定变化,而当使用者符合该预设睡眠呼吸条件时,该系统即 进入警示可产生状态,控制单元产生驱动信号,以驱动警示单元依照 不同的警示行为而提供警示。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 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.

举例而言,可以侦测到打鼾为基准,例如,利用麦克风或加速度 器,尤其,阻塞型睡眠呼吸暂停在发生前,几乎都会先出现打鼾,而 这对进行睡眠姿势训练或进行睡眠呼吸生理反馈训练而言,都是可以 依循的时间点,相当具优势;也可通过分析心率而获得相关睡眠的信 息,例如,睡着时心率会出现特定的变化,或可根据心率计算获得HRV (心跳变异率)而了解身体的状态;也可通过分析呼吸而得知是否入 睡,例如,睡着后呼吸速率会变慢等;也可通过了解睡眠阶段而得知 是否入睡,例如,可通过分析加速度器所测得的身体活动(actigraph), 及/或光传感器所取得的心率而了解睡眠阶段;替代地,也能够将侦测 到发生睡眠呼吸事件作为已经入睡的基准。因此,在生理传感器的选 择上有许多可能,上述所有可取得睡眠生理信息的生理传感器皆可利 用,没有限制。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 Sleep stage is known from measured actigraph, and/or heart rate from light sensor; alternatively, detection of sleep breathing events can be used 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.

此外,用来取得判断系统是否进入该警示可产生状态的生理信息 的该生理传感器,其设置位置同样可依实际需求而有所不同,而且, 可实施为直接利用执行训练过程所使用的生理传感器,也可以是另外 再增加设置的生理传感器,例如,可以利用配戴于身上之装置内的加 速度器、光传感器、麦克风等,或是另外再设置一穿戴装置,也可利 用放置于床边的外部装置内的麦克风,也可利用设置于床垫上的加速 度器等,有各种可能,皆为可使用的选择。In addition, the location of the physiological sensor used to obtain the physiological information for judging whether the system has entered the alert-generating state can also vary according to actual needs, and can be implemented as a direct use of 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.

进一步地,如图7所示的流程图,睡眠姿势训练与睡眠呼吸生理 反馈训练也可在同一个睡眠期间内一起进行。在此情形下,通过设置 姿势传感器以及至少一生理传感器,就可在同一个睡眠期间内取得睡 眠姿势相关信息以及睡眠呼吸生理信息,在此,根据欲取得之睡眠呼 吸生理信息的不同及设置位置的选择,该至少一生理传感器可以是, 例如,光传感器,麦克风,加速度器,压电动作传感器,压电振动传 感器,阻抗侦测电极,RIP传感器,及/或呼吸气流传感器,没有限制, 且特别地是,当选用加速度器作为生理传感器时,其亦可同时作为姿 势传感器。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 may be, for example, a light sensor, a microphone, an accelerometer, a piezoelectric motion sensor, a piezoelectric vibration sensor, an impedance detection electrode, a RIP sensor, and/or a respiratory airflow sensor, without limitation, and In particular, when an accelerometer is selected as a physiological sensor, it can also be used as a posture sensor at the same time.

之后,利用睡眠呼吸生理信息分析程序,以将睡眠呼吸生理信息 与预设条件进行比较,可决定该使用者的睡眠呼吸事件,以及利用睡 眠姿势分析程序,以将睡眠姿势相关信息与预设姿势范围进行比较, 其中,当该睡眠姿势相关信息符合该预设姿势范围时,提供一第一警 示条件组合,以及当该睡眠姿势相关信息超出该预设姿势范围时,提 供一第二警示条件组合,而警示决定程序则根据不同的警示条件组合 而相应地决定警示行为,因此,控制单元根据该警示行为产生一驱动 信号,而警示单元在接收该驱动信号后,产生至少一警示,以达到影 响该使用者的睡眠姿势及/或影响该使用者的睡眠呼吸状态的效果。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 warning decision program determines the warning behavior accordingly according to different combinations of warning conditions. Therefore, the control unit generates a driving signal according to the warning behavior, and the warning unit generates at least one warning after receiving the driving signal to achieve the effect of The sleeping posture of the user and/or effects affecting the sleeping breathing state of the user.

其中,该第一警示条件组合至少会包括时间范围条件以及睡眠呼 吸事件条件的至少其中之一,举例而言,时间范围条件可实施为以绝 对时间为基准,例如,凌晨1点;也可实施为以特定生理条件为基准, 例如,已躺下,已入睡,或其他各种生理条件后1小时;也可实施为 延迟时间,例如,在装置启动经过1小时后,如此一来,就可根据实 际的时间需求而选择是否在符合预设姿势范围的情形下提供警示,有 助于提供较舒适的使用体验,另外,睡眠呼吸事件条件则提供了是否 在同一个睡眠期间内一起进行睡眠姿势训练以及睡眠呼吸生理反馈训 练的选择,让训练效果进一步提升。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.

另外,该第二警示条件组合则是至少会包括该时间范围条件以及 该睡眠呼吸事件条件,举例而言,当睡眠姿势相关信息超出预设姿势 范围时,例如,处于非仰躺状态时,产生警示的最主要条件是发生睡 眠呼吸事件,且同样地,如前所述,能够选择要执行睡眠呼吸生理反 馈训练的时间,例如,以绝对时间作为基准,或以特定生理条件作为 基准,或设置延迟时间等。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.

再者,也可增设其他条件,例如,警示强度条件、警示频率条件 等,以在刚入睡时提供强度较弱的警示,经一段时间后,再增加强度, 因此,通过警示条件组合的提供,能够更符合需求且让使用者感觉更 不受打扰地执行训练。Furthermore, other conditions can also be added, such as a warning intensity condition, a warning frequency condition, etc., to provide a weaker warning when just falling 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.

而且,由于睡眠姿势在睡眠期间是随时改变的,因此,将是动态 地适用该第一警示条件组合以及该第二警示条件组合,适用顺序没有 限制。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.

在本申请系统中,根据所执行的功能不同,会相应地具有各种软 件程序,包括,但不限于,睡眠生理信息分析程序,睡眠呼吸生理信 息分析程序,睡眠呼吸事件分析程序,警示决定程序等,以根据生理 传感器所取得的生理信号而得出各种生理信息,且不受限地,各种软 件程序可根据实际需求及实施方式的不同而预载于不同装置中。The system of the present application has various software programs according to different functions, including, but not limited to, sleep physiological information analysis program, sleep breathing physiological information analysis program, sleep breathing event analysis program, and warning decision program etc., so as to obtain various physiological information according to the physiological signals obtained by the physiological sensor, and without limitation, various software programs can be preloaded in different devices according to actual requirements and different implementations.

根据上述以睡眠呼吸生理信息为基础所进行睡眠呼吸生理反馈训 练(图3),以及以睡眠姿势为基础所进行的睡眠呼吸障碍检测及训练 (图4及图5),配合上可取得相关生理信号之生理传感器的各种可能 设置位置(如图2所示),本申请不受限地有下述各种实施可能,也 因此,上述的各种训练内容及组合,可通过接下来叙述之任何合适的 实施例来实现,即不再重复赘述。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. The various possible setting positions of the physiological sensor of the signal (as shown in Figure 2), the application has the following various implementation possibilities without limitation, and therefore, the above-mentioned various training contents and combinations can be described in the following. It can be realized by any suitable embodiment, that is, the detailed description will not be repeated.

在一较佳实施例中,一睡眠生理系统包括一壳体,以及一黏附式 穿戴结构,用以将该壳体设置于一使用者的躯干上,该睡眠生理系统 还包括一控制单元,至少包括微控制器/处理器,并容置于该壳体中, 一通信模块,电连接至该控制单元,以及一电力模组,而在取得睡眠 生理信息方面,则是通过电连接至该控制单元的一姿势传感器以及多 个电极来达成,其中,该姿势传感器是用来取得该使用者于睡眠期间 的睡眠姿势相关信息,而该多个电极则是用来取得睡眠期间该使用者 的心电信号以及该使用者之躯干部位所产生的阻抗变化,另外,该睡 眠生理系统亦包括一信息提供接口,用以将信息提供给该使用者。In a preferred embodiment, a sleep physiology system includes a casing and an adhesive wearing structure for disposing the casing on a user's torso, the sleep physiology system further includes a control unit, at least It includes a microcontroller/processor and is accommodated in the casing, a communication module, which is electrically connected to the control unit, and a power module, and in terms of obtaining sleep physiological information, it is electrically connected to the control unit. A posture sensor and a plurality of electrodes of the unit are used to achieve this, wherein the posture sensor is used to obtain information related to the sleeping posture of the user during sleep, and the plurality of electrodes are used to obtain the heart of the user during sleep. The electrical signal and the impedance change produced by the torso of the user, in addition, the sleep physiology system also includes an information providing interface for providing information to the user.

在此,特别地是,由于设置位置为躯干,因此,该多个电极可一 起取得心电信号以及阻抗变化,在实际实施时,心电信号可实施为利 用二个电极,以二极模式取得,也可再加入DRL电极,以三极模式进 行撷取,没有限制,另外,阻抗变化则实施为由二个电极形成迴路而 取得,或者,替代地,也可实施为二个电极同时取得心电信号以及阻 抗变化,又或者,也可实施为仅一个电极共同,因此不受限,可根据 实际情形而变化。Here, in particular, since the installation location is the trunk, the plurality of electrodes can acquire the ECG signal and impedance change together. In actual implementation, the ECG signal can be acquired by using two electrodes in a two-pole mode. , DRL electrodes can also be added to capture in a three-pole mode, there is no limitation, in addition, the impedance change is implemented as a loop formed by two electrodes to obtain, or, alternatively, can also be implemented as two electrodes at the same time. The electrical signal and impedance change, alternatively, can also be implemented as common to only one electrode, so it is not limited and can be changed according to the actual situation.

正如前述,由于阻抗变化来自于人体呼吸时胸部及/或腹部起伏所 造成的肌肉组织阻抗改变,因此,通过分析阻抗变化,将能获得许多 的睡眠呼吸生理信息,例如,可取得呼吸动作,了解胸部及/或腹部于 呼吸时是否出现起伏,也可取得呼吸振幅变化,了解呼吸胸腹起伏的 振幅大小,以及也可取得呼吸频率变化。另外,心电信号可用来了解 睡眠期间的心脏活动情形,例如,心率,心跳变异率,心律不整等。As mentioned above, since the impedance change comes from the impedance change of the muscle tissue caused by the ups and downs of the chest and/or abdomen when the human body breathes, a lot of physiological information of sleep breathing can be obtained by analyzing the impedance change. Whether the chest and/or abdomen rises and falls during breathing can also be obtained, and the change in the breathing amplitude can also be obtained. In addition, ECG signals can be used to understand cardiac activity during sleep, such as heart rate, heart rate variability, arrhythmia, etc.

上述这些睡眠呼吸生理信息对于了解睡眠呼吸暂停有相当大的助 益。如前所述,阻塞型睡眠呼吸暂停以及中枢型睡眠呼吸暂停的成因 不同,据此,可通过观察发生睡眠呼吸暂停时,呼吸动作是否随之停 止而做出区别,而这也是决定要提供睡眠姿势训练及/或睡眠呼吸生理 反馈训练的重要因素之一,例如,阻塞型睡眠呼吸暂停可根据情况不 同而选择执行睡眠姿势训练及/或睡眠呼吸生理反馈训练,而中枢型睡 眠呼吸暂停则较适合执行睡眠呼吸生理反馈训练。The above physiological information of sleep breathing is of considerable help in understanding sleep apnea. As mentioned earlier, obstructive sleep apnea and central sleep apnea have different causes and can be distinguished by observing whether breathing stops when sleep apnea occurs, which is also the decision to provide sleep One of the important factors of posture training and/or sleep breathing physiological feedback training, for example, obstructive sleep apnea can choose to perform sleep posture training and/or sleep breathing physiological feedback training according to different situations, while central sleep apnea is more Suitable for performing sleep breathing physiological feedback training.

另外,呼吸振幅变化、呼吸频率变化、以及根据心电信号所取得 的心率变化也可用于了解使用者是否出现睡眠呼吸暂停事件及/或睡眠 呼吸低通气事件,例如,当发生阻塞型睡眠呼吸暂停/低通气事件时, 呼吸振幅会随着阻塞越来越严重而逐渐减小,再逐渐恢复,直到下一 次呼吸事件发生;另外,呼吸频率会在发生部分唤醒或觉醒时出现急 遽上升,接着逐渐恢复,直到下一次呼吸事件发生;心率变化会随着 睡眠呼吸暂停/低通气事件的发生而逐渐变慢,并在发生部分唤醒或觉 醒时出现急遽上升,接着逐渐恢复,直到下一次呼吸事件发生。In addition, changes in breathing amplitude, respiratory rate, and heart rate obtained from ECG signals can also be used to understand whether the user has a sleep apnea event and/or sleep apnea event, such as when obstructive sleep apnea occurs. During a hypopneic event, the respiratory amplitude will gradually decrease as the obstruction becomes more severe, and then gradually recover until the next respiratory event; in addition, the respiratory rate will increase sharply during partial arousal or arousal, and then gradually Recovery until the next respiratory event; heart rate change gradually slows with sleep apnea/hypopnea, spikes with partial arousal or arousal, and then recovers gradually until the next respiratory event .

据此,通过设置多个电极,本申请的睡眠生理系统除了能分别出 睡眠呼吸暂停/低通气事件的发生与否外,亦能分辨出其种类为阻塞型 或中枢型,极具优势,而且,更进一步地,还可再配合上姿势传感器 所取得的睡眠姿势相关信息,进而得知是否为姿势性睡眠呼吸暂停/低 通气,举例而言,通过将睡眠呼吸事件与睡眠姿势相关信息进行比对, 以了解在符合预设姿势范围情形下,以及在超出预设姿势范围情形下, 分别发生的睡眠呼吸事件的分布状况,并获得睡眠呼吸事件姿势相关 性信息,例如,姿势相关睡眠呼吸暂停指数,姿势相关睡眠呼吸事件 次数,以及姿势相关睡眠呼吸事件持续时间等,将有助于更深入地了 解睡眠呼吸障碍的发生与睡眠姿势之间的关係,之后,再通过信息提 供接口而提供使用者。这等于单个系统的设置以及单次的使用就能通 盘了解有关睡眠呼吸暂停/低通气的全貌,十分具有优势。Accordingly, by arranging a plurality of electrodes, the sleep physiology system of the present application can not only distinguish the occurrence of sleep apnea/hypopnea, but also distinguish whether the type is obstructive or central, which is very advantageous, and , and further, it can also be combined with the sleep posture related information obtained by the posture sensor, so as to know whether it is postural sleep apnea/hypopnea. For example, by comparing sleep breathing events with sleep posture related information Yes, in order to know the distribution of sleep breathing events that occur in the case of conforming to the preset posture range and in the case of exceeding the preset posture range, and obtain the posture-related information of sleep breathing events, for example, posture-related sleep apnea The index, the number of posture-related sleep-breathing events, and the duration of posture-related sleep-breathing events, etc., will help to better understand the relationship between the occurrence of sleep-disordered breathing and sleep posture, and then provide use through the information provision interface By. This equates to a single system setup and a single use to get a complete picture of sleep apnea/hypopnea, which is very advantageous.

在此,信息提供接口可以实施为设置于壳体上,例如,设置于壳 体上的LED,也可实施为设置于通过该通信模块而与该控制单元进行 沟通的一外部装置上,例如,智慧型装置、电脑装置的LED、LCD、 喇叭等,有各种实施可能,没有限制。Here, the information providing interface can be implemented on the casing, for example, an LED on the casing, or can be implemented on an external device that communicates with the control unit through the communication module, for example, There are various implementation possibilities for LEDs, LCDs, speakers, etc. of smart devices and computer devices, and there is no limit.

再者,当该姿势传感器实施为加速度器时,还可进一步通过侦测 打鼾所产生的体腔振动而取得打鼾相关信息,等于另一项常见的睡眠 呼吸障碍--打鼾的信息亦可同时取得,并也可获得打鼾的发生与睡眠姿 势之间的关係,例如,姿势相关打鼾指数,姿势相关打鼾次数,姿势 相关打鼾持续时间等,更具优势,而且,利用加速度器侦测打鼾时, 能够不受外界环境声音影响,且即使在被衣物或棉被遮蔽的情形下, 例如,设置于躯干上时,亦可正常进行侦测,是相当有利的选择,此 外,加速度器亦可取得其他的睡眠生理信息,例如,呼吸动作可用于 与阻抗变化所取得的呼吸动作作为对照,睡眠身体活动可提供有关睡 眠阶段/状态的信息。替代地,亦可通过另外增设一加速度器来获得上 述的各种生理信息,没有限制。Furthermore, when the posture sensor is implemented as an accelerometer, the snoring-related information can be further obtained by detecting the body cavity vibration generated by snoring, which is equivalent to another common sleep-disordered breathing-the information of snoring can also be obtained at the same time. The relationship between the occurrence of snoring and sleep posture can also be obtained, for example, posture-related snoring index, posture-related snoring frequency, posture-related snoring duration, etc., which is more advantageous. Moreover, when snoring is detected by the accelerometer, it can not be detected. Affected by the sound of the external environment, and even when it is covered by clothing or quilts, for example, when it is installed on the torso, it can be detected normally, which is a very advantageous choice. In addition, the accelerometer can also obtain other sleep Physiological information such as breathing action can be used as a contrast to breathing action taken from impedance changes, and sleep physical activity can provide information about sleep stage/state. Alternatively, the above-mentioned various physiological information can also be obtained by adding an accelerometer, without limitation.

接着,进一步地,也可增设警示单元,例如,触觉警示单元,以 提供睡眠姿势训练及/或睡眠呼吸生理反馈训练。举例而言,可将所取 得的睡眠姿势相关信息与预设姿势范围进行比较,并在符合该预设姿 势范围时决定警示行为,提供警示,例如,振动警示,以执行睡眠姿 势训练;或者也可将所取得的睡眠呼吸生理信息,例如,呼吸动作, 呼吸振幅,呼吸频率,心率,打鼾相关信息等,与预设条件进行比较, 并在符合该预设条件时决定警示行为时,提供警示,例如,振动警示, 以执行睡眠呼吸生理反馈训练;又或者,可在同一个睡眠期间,经由 观察此两种睡眠生理信息而提供适当的睡眠姿势训练以及睡眠呼吸生 理反馈训练。有各种实施可能,没有限制。Then, further, an alert unit, such as a tactile alert 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, an alert action can be determined, and an alert, such as a vibration alert, can be provided to perform sleep posture training; or The obtained physiological information of sleep breathing, such as breathing motion, breathing amplitude, breathing frequency, heart rate, snoring-related information, etc., can be compared with the preset conditions, and when the preset conditions are met, the alarm behavior is determined, and the alarm is provided. For example, vibrating alerts to perform sleep breathing physiological feedback training; alternatively, by observing the two sleep physiological information during the same sleep period, appropriate sleep posture training and sleep breathing physiological feedback training can be provided. Various implementations are possible, without limitation.

而警示的提供则为,控制单元会被建构以产生一驱动信号,且警 示单元在接收该驱动信号后,会产生至少一警示,并将该至少一警示 提供予该使用者,以达成睡眠姿势训练及/或睡眠呼吸生理反馈训练的 目的,其中,该驱动信号实施为根据上述所决定的各种警示行为而产 生。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.

如此一来,在单个系统中,除了能详细了解睡眠呼吸暂停/低通气 的发生情形外,还能同时提供改善的训练程序,功能齐备,对使用者 而言,是极具优势的选择。In this way, in a single system, in addition to the detailed understanding of the occurrence of sleep apnea/hypopnea, it can also provide an improved training program at the same time, and it is a very advantageous choice for the user.

在电极的实施形式方面,同样有多种可能。其中一种具优势的选 择是,利用贴片式电极,正如所熟知,贴片式电极为预先形成有导电 胶的现有常见电极,而通过该导电胶,电极可稳定地黏附于皮肤表面, 因此,通过此黏附特性,就可进一步将其实施作为承载壳体的该黏附 式穿戴结构,亦即,将贴片式电极同时实施为电极与黏附式穿戴结构, 在此情形下,如图8A所示,只需将壳体800实施为可结合于贴片式电 极801上,就能完成设置,相当方便,举例而言,一般的贴片式电极 常见的实施形式为钮扣扣合的形式,例如,突出的公扣端,因此,壳 体可形成相对应的钮扣扣合结构,例如,内凹的母扣端,如此一来, 就可同时达成电极与控制单元间的电连接,以及壳体与穿戴结构间的 机械连接,相当方便。在此,需注意地是,该贴片式电极可实施为一 个电极一个贴片的形式,也可实施为多个电极一个贴片的形式,可依 实际需求而改变,没有限制。There are also many possibilities with regard to the embodiment of the electrodes. One of the advantageous options is to use patch electrodes. As is well known, patch electrodes are existing common electrodes pre-formed with conductive glue, and through the conductive glue, the electrodes can be stably adhered to the skin surface, Therefore, through this adhesive property, it can be further implemented as the adhesive wearable structure of the carrier shell, that is, the patch electrode can be implemented as the electrode and the adhesive wearable structure at the same time, in this case, as shown in FIG. 8A As shown in the figure, it is only necessary to implement the casing 800 to be combined with the patch electrode 801 to complete the setting, which is quite convenient. For example, the common implementation form of the general patch electrode is the form of button fastening , for example, a protruding male snap end, so the housing can form a corresponding button snap-fit structure, for example, a concave female snap end, so that the electrical connection between the electrode and the control unit can be achieved at the same time, And the mechanical connection between the shell and the wearing structure is quite convenient. Here, it should be noted that the patch-type electrode can be implemented in the form of one electrode and one patch, or can be implemented in the form of multiple electrodes one patch, which can be changed according to actual needs without limitation.

另一种具优势的选择是,将电极设置于该黏附式穿戴结构与皮肤 接触的表面上,由于该黏附式穿戴结构被建构来承载该壳体,并用以 设置于躯干的皮肤表面,因此,若可将电极直接设置于穿戴结构与皮 肤接触的表面上,等于单次的设置动作即可同时完成电极以及壳体的 设置,相当方便。在实际实施时,该至少二电极被设置于该黏附式穿 戴结构的下表面,并电连接至位于壳体中的控制单元,在此,该等电 极可实施为湿式电极或干式电极,其中,当实施为湿式电极时,如图 8B所示,电极802形成于穿戴结构的下表面,再于其上设置导电介质, 例如,导电胶,此时,可直接利用导电介质提供黏附功能进行固定, 也可在电极以外位置设置黏附物质来增加黏附力,例如,设置黏胶; 而当实施为不需导电介质的干式电极时,为了确保电极与皮肤间的稳 定接触,可采用不同的实施方式,如图8C所示,穿戴结构上设置有结 合件803,可用以与至少二干式电极804进行结合,例如,该结合件形成内凹的结合结构,以对应干性电极上的凸出结合结构,在此情形下, 由于干性电极可单独进行固定,例如,利用胶带固定,故与皮肤间能 有稳定的接触,即使穿戴结构出现移动也不受影响。Another advantageous option is to place electrodes on the skin-contacting surface of the adhesive wearable structure, since the adhesive wearable structure is constructed to carry the housing and to be placed on the skin surface of the torso, therefore, If the electrodes can be directly arranged on the surface of the wearable structure in contact with the skin, it is equivalent to a single setting action to complete the setting of the electrodes and the casing at the same time, which is quite convenient. In actual implementation, the at least two electrodes are disposed on the lower surface of the adhesive wearable structure, and are electrically connected to the control unit located in the housing. Here, the electrodes may be implemented as wet electrodes or dry electrodes, wherein , when implemented as a wet electrode, as shown in FIG. 8B , the electrode 802 is formed on the lower surface of the wearable structure, and then a conductive medium, such as conductive glue, can be arranged on it. At this time, the conductive medium can be directly used to provide an adhesion function for fixing , Adhesive substances can also be arranged outside the electrodes to increase the adhesion, for example, adhesives; and when implemented as dry electrodes that do not require conductive media, in order to ensure stable contact between the electrodes and the skin, different implementations can be used. In this way, as shown in FIG. 8C , the wearing structure is provided with a binding member 803, which can be used for binding with at least two dry electrodes 804. For example, the binding member forms a concave binding structure to correspond to the protrusion on the dry electrode. In combination with the structure, in this case, since the dry electrode can be fixed separately, for example, with adhesive tape, it can have a stable contact with the skin, even if the wearing structure moves, it will not be affected.

在此,无论是湿式电极或干式电极的形式,该壳体与该穿戴结构 间都可进一步实施为可移除的形式,并藉此提供变换电极的可能,例 如,可通过更换穿戴结构而改变电极间的距离及/或电极的分布位置, 或是改变电极的种类,如由干式电极更换为湿式电极,或是更换新的 电极,如当湿式电极的导电胶失去黏性时进行更换,因此,有各种可 能,没有限制。Here, whether in the form of wet electrodes or dry electrodes, the housing and the wearable structure can be further implemented in a removable form, thereby providing the possibility of changing electrodes, for example, by changing the wearable structure. Change the distance between electrodes and/or the distribution position of the electrodes, or change the type of electrodes, such as changing from dry electrodes to wet electrodes, or replace new electrodes, such as when the conductive glue of wet electrodes loses its viscosity. , therefore, there are all possibilities, no limit.

或者,替代地,电极以及该黏附式穿戴结构也可实施为彼此独立, 例如,该黏附式穿戴结构用来设置壳体,电极则利用导线自壳体延伸 而出,再行固定,同样是可行的方式,没有限制。Or, alternatively, the electrodes and the adhesive wearable structure can also be implemented independently of each other. For example, the adhesive wearable structure is used to set a casing, and the electrodes are extended from the casing by wires and then fixed, which is also feasible. way, no limit.

在另一较佳实施例中,一睡眠生理系统包括一壳体,以及一耳塞 式穿戴结构,用以将该壳体设置于一使用者的一耳朵上,该睡眠生理 系统还包括一控制单元,至少包括微控制器/处理器,并容置于该壳体 中,一通信模块,电连接至该控制单元,以及一电力模组,另外,该 睡眠生理系统亦包括至少一生理传感器,电连接至该控制单元,用以 取得该使用者于睡眠期间的至少一睡眠生理信息,以及一听觉警示单 元,电连接至该控制单元,用以产生至少一听觉警示。In another preferred embodiment, a sleep physiology system includes a casing and an earplug-type wearing structure for disposing the casing on an ear of a user, and the sleep physiology system further includes a control unit , including at least a microcontroller/processor, and accommodated in the housing, a communication module, electrically connected to the control unit, and a power module, in addition, the sleep physiology system also includes at least one physiological sensor, electrical It is connected to the control unit for obtaining at least one sleep physiological information of the user during sleep, and an auditory alert unit is electrically connected to the control unit for generating at least one auditory alert.

首先,基于采用的是耳塞式穿戴结构,耳朵为主要设置位置,极 为适合利用声音提供警示,因此,警示形式遂采用听觉警示,让设置 步骤简化,使用也变得方便,在实施上,则可利用通过发声元件来产 生声音,例如,扬声器,蜂鸣器等。First of all, based on the earplug-type wearing structure, the ear is the main setting position, which is very suitable for using sound to provide warnings. Therefore, the form of warning adopts auditory warning, which simplifies the setting steps and makes the use more convenient. In implementation, it can be The use of sound-producing elements, such as speakers, buzzers, etc., is used to generate sound.

再者,该至少一睡眠生理信息实施为可包括睡眠姿势相关信息, 及/或睡眠呼吸生理信息,据此,该至少一生理传感器有许多实施可能, 举例而言,可利用光传感器在耳朵上取得心率及/或血氧浓度等睡眠呼 吸生理信息;也可利用加速度器在耳朵上取得睡眠姿势相关信息、打 鼾相关信息、及/或心率等各种睡眠生理信息;也可利用麦克风在耳朵 上取得打鼾相关信息及/或呼吸声变化等睡眠呼吸生理信息;并且,也 可同时设置二个以上的生理传感器,例如,在利用加速度器取得睡眠 姿势相关信息以及打鼾相关信息的同时,亦利用光传感器取得心率及/ 或血氧浓度。因此,有各种可能,没有限制。Furthermore, the implementation of the at least one physiological sleep information may include sleep posture related information and/or sleep breathing physiological information, according to which, the at least one physiological sensor may be implemented in many ways, for example, a light sensor may be used on the ear Obtain sleep breathing physiological information such as heart rate and/or blood oxygen concentration; you can also use the accelerometer to obtain sleep posture-related information, snoring-related information, and/or heart rate and other various sleep physiological information on the ear; You can also use the microphone on the ear Obtain snoring-related information and/or sleep breathing physiological information such as breathing sound changes; and more than two physiological sensors can also be set at the same time. Sensors obtain heart rate and/or blood oxygen concentration. Therefore, there are various possibilities and no limit.

根据上述的这些睡眠生理信息,举例而言,将可了解使用者于睡 眠期间的睡眠姿势为仰躺及/或非仰躺,也可了解使用者是否于睡眠期 间发生睡眠呼吸事件,例如,血液生理睡眠呼吸事件,打鼾事件等, 而这些也都是执行睡眠姿势训练及睡眠呼吸生理反馈训练的基础,正 好可配合系统中设置的听觉警示单元,根据睡眠姿势相关信息是否符 合一预设姿势范围,及/或所取得的睡眠呼吸生理信息是否符合一预设 条件,而提供听觉警示,亦即,具优势地可选择仅执行睡眠姿势训练 或睡眠呼吸生理反馈训练,也可同时执行两者,如此一来,单个设置 于耳朵上的睡眠生理系统即能提供多重的功能,包括,但不限于,睡眠姿势的侦测,是否出现睡眠呼吸障碍的评估,以及睡眠姿势训练及/ 或睡眠呼吸生理反馈训练的提供等,成就了极简单却也极为强大的睡 眠生理系统。According to the above-mentioned sleep physiological information, for example, it will be possible to know whether the user's sleeping position during sleep is supine and/or non-recumbent, and whether the user has sleep breathing events during sleep, such as blood Physiological sleep breathing events, snoring events, etc., and these are also the basis for performing sleep posture training and sleep breathing physiological feedback training, which can be matched with the auditory warning unit set in the system, according to whether the sleep posture related information conforms to a preset posture range. , and/or whether the acquired sleep breathing physiological information complies with a preset condition to provide an auditory warning, that is, it is advantageous to choose to perform only sleep posture training or sleep breathing physiological feedback training, or to perform both at the same time, In this way, a single sleep physiology system on the ear can provide multiple functions, including, but not limited to, detection of sleep posture, assessment of sleep disordered breathing, and sleep posture training and/or sleep breathing physiology. The provision of feedback training, etc., has achieved a very simple yet extremely powerful sleep physiological system.

在此,同样地,听觉警示的提供为,控制单元会被建构以产生一 驱动信号,且听觉警示单元在接收该驱动信号后,会产生至少一听觉 警示,并将该至少一听觉警示提供予该使用者,以达成睡眠姿势训练 及/或睡眠呼吸生理反馈训练的目的,其中,该驱动信号则实施为如上 述,至少是根据该至少一睡眠生理信息与预设姿势范围及/或预设条件 进行比较后,符合该预设姿势范围及/或符合该预设条件时,所决定的 一听觉警示行为而产生。Here, similarly, the provision of the audible warning is that the control unit will be configured to generate a driving signal, and after receiving the driving signal, the audible warning unit will generate at least one audible warning, and provide the at least one audible warning to the The user, in order to achieve the purpose of sleep posture training and/or sleep breathing physiological feedback training, wherein the driving signal is implemented as described above, at least according to the at least one sleep physiological information and the preset posture range and/or preset After the conditions are compared, when the predetermined posture range is met and/or the predetermined condition is met, a determined auditory warning behavior is generated.

至此,需要注意地是,上述实施例中所提出的各个装置,亦应适 用本文前面所提及的电路配置,且可因应各个实施例欲取得之生理信 息不同以及设置位置不同而有所变化,同样是基于不重复赘述的原则 而未逐一列举,但本申请所主张的权利范围并不因此而受限。So far, it should be noted that each device proposed in the above-mentioned embodiments should also be applicable to the circuit configuration mentioned above, and may vary according to the different physiological information to be obtained in each embodiment and the different setting positions, It is also based on the principle of not repeating redundant descriptions and not enumerating them one by one, but the scope of the rights claimed in this application is not limited thereby.

此外,上述的各个实施例,不限于单独实施,亦可二个或多个实 施例的部分或整体结合或结合实施,同属本申请所主张的范围,不受 限制。In addition, each of the above-mentioned embodiments is not limited to being implemented alone, and can also be implemented in part or in combination or in combination with two or more embodiments, which all belong to the scope claimed by the present application and are not limited.

上述具体实施方式,并不构成对本发明保护范围的限制。本领域 技术人员应该明白的是,取决于设计要求和其他因素,可以发生各种 各样的修改、组合、子组合和替代。任何在本发明的精神和原则之内 所作的修改、等同替换和改进等,均应包含在本发明保护范围之内。The above-mentioned specific embodiments do not constitute a limitation on the protection scope of the present invention. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions may occur depending on design requirements and other factors. Any modifications, equivalent replacements and improvements made within the spirit and principle of the present invention should be included within the protection scope of the present invention.

Claims (15)

1.一种睡眠生理系统,其特征在于,包括:1. a sleep physiology system, is characterized in that, comprises: 一壳体;a shell; 一控制单元,容置该壳体中,至少包括微控制器/微处理器;a control unit, accommodated in the housing, at least including a microcontroller/microprocessor; 一姿势传感器,电连接至该控制单元;a posture sensor, electrically connected to the control unit; 一多个电极,电连接至该控制单元;a plurality of electrodes electrically connected to the control unit; 一通信模块,电连接至该控制单元;a communication module, electrically connected to the control unit; 一电力模组;以及a power module; and 一黏附式穿戴结构,用以将该壳体设置于一使用者的一躯干上,an adhesive wearing structure for disposing the casing on a torso of a user, 其中,in, 该姿势传感器被建构以取得该使用者于睡眠期间的睡眠姿势相关信息;以及The posture sensor is constructed to obtain information about the sleeping posture of the user during sleep; and 该多个电极被建构以取得该使用者于睡眠期间的一心电信号,以及取得该使用者于睡眠期间的躯干部位的一阻抗变化,The plurality of electrodes are constructed to obtain an ECG signal of the user during sleep, and to obtain an impedance change of the user's torso during sleep, 其中,in, 该阻抗变化进一步被作为基础而取得该使用者于睡眠期间的至少一睡眠呼吸生理信息,且该至少一睡眠呼吸生理信息包括下列的至少其中之一,包括:呼吸动作,呼吸频率,以及呼吸振幅,以及The impedance change is further used as a basis to obtain at least one piece of sleep breathing physiological information of the user during sleep, and the at least one sleep breathing physiological information includes at least one of the following, including: breathing action, breathing frequency, and breathing amplitude ,as well as 其中,in, 该系统被建构以根据该至少一睡眠呼吸生理信息而决定该使用者于该睡眠期间的一睡眠呼吸事件;以及The system is configured to determine a sleep breathing event of the user during the sleep based on the at least one sleep breathing physiological information; and 该系统进一步被建构以决定在该睡眠姿势相关信息符合一预设睡眠姿势范围时,以及在该睡眠姿势相关信息超出该预设睡眠姿势范围时,该睡眠呼吸事件的分布,并据以产生一睡眠呼吸事件姿势相关性信息,以及The system is further configured to determine the distribution of the sleep breathing events when the sleep posture-related information conforms to a predetermined sleep posture range and when the sleep posture-related information exceeds the predetermined sleep posture range, and generate a Posture-related information for sleep breathing events, and 其中,in, 该系统还包括一信息提供接口,用以将该睡眠呼吸事件姿势相关性信息提供予该使用者。The system further includes an information providing interface for providing the sleep breathing event posture correlation information to the user. 2.根据权利要求1所述的系统,其还包括至少一警示单元,以提供至少一警示,以及还包括一警示决定程式,用以根据该睡眠姿势相关信息及/或该睡眠呼吸事件而决定一警示行为,以及该警示单元根据该警示行为而产生该至少一警示,并提供予该使用者。2 . The system according to claim 1 , further comprising at least one warning unit for providing at least one warning, and further comprising a warning decision program for deciding according to the sleep posture related information and/or the sleep breathing event. 3 . an alert action, and the alert unit generates the at least one alert according to the alert action, and provides the alert to the user. 3.根据权利要求1所述的系统,其中,该系统进一步被建构以根据该呼吸动作以及该呼吸振幅,以得出该睡眠呼吸事件为阻塞型睡眠呼吸暂停事件或中枢型睡眠呼吸暂停事件。3 . The system of claim 1 , wherein the system is further configured to determine whether the sleep breathing event is an obstructive sleep apnea event or a central sleep apnea event according to the breathing action and the breathing amplitude. 4 . 4.根据权利要求1所述的系统,其中,该多个电极实施为设置于该黏附式穿戴结构上。4. The system of claim 1, wherein the plurality of electrodes are implemented to be disposed on the adhesive wearable structure. 5.根据权利要求1所述的系统,其中,该多个电极的至少其中之一被建构以同时用于取得该心电信号以及该阻抗变化。5. The system of claim 1, wherein at least one of the plurality of electrodes is configured for simultaneous acquisition of the ECG signal and the impedance change. 6.根据权利要求1所述的系统,其还包括一加速度器,以取得下列生理信息的至少其中之一,包括:打鼾生理信息,呼吸动作,以及睡眠身体活动信息。6. The system of claim 1, further comprising an accelerometer to obtain at least one of the following physiological information, including: snoring physiological information, breathing action, and sleep physical activity information. 7.根据权利要求6所述的系统,其中,该姿势传感器实施为该加速度器。7. The system of claim 6, wherein the posture sensor is implemented as the accelerometer. 8.根据权利要求1所述的系统,其中,该系统进一步被建构以根据该心电信号而得出下列的至少其中之一,包括:心率,心跳变异率,以及心律不整。8. The system of claim 1, wherein the system is further configured to derive at least one of the following from the ECG signal, including: heart rate, heart rate variability, and arrhythmia. 9.一种睡眠生理系统,其特征在于,包括:9. A sleep physiological system, comprising: 一壳体;a shell; 一控制单元,容置该壳体中,至少包括微控制器/微处理器;a control unit, accommodated in the housing, at least including a microcontroller/microprocessor; 至少一生理传感器,电连接至该控制单元;at least one physiological sensor, electrically connected to the control unit; 一听觉警示单元,电连接至该控制单元,用以产生至少一听觉警示;an audible warning unit electrically connected to the control unit for generating at least one audible warning; 一通信模块,电连接至该控制单元;a communication module, electrically connected to the control unit; 一电力模组;以及a power module; and 一耳塞式穿戴结构,用以将该壳体设置于一使用者的一耳朵上,an earplug-type wearing structure for disposing the casing on an ear of a user, 其中,in, 该至少一生理传感器被建构以取得该使用者于睡眠期间的至少一睡眠生理信息,且该至少一睡眠生理信息包括下列的至少其中之一,包括:睡眠姿势相关信息,以及睡眠呼吸生理信息;以及The at least one physiological sensor is configured to obtain at least one sleep physiological information of the user during sleep, and the at least one sleep physiological information includes at least one of the following, including: sleep posture related information, and sleep breathing physiological information; as well as 该控制单元被建构以产生一驱动信号,且该警示单元在接收该驱动信号后,产生该至少一听觉警示,并将该至少一听觉警示提供予该使用者,其中,该驱动信号进一步实施为至少根据,该至少一睡眠生理信息与一预设姿势范围及/或一预设条件进行比较后,符合该预设姿势范围及/或符合该预设条件时,所决定的一听觉警示行为而产生。The control unit is configured to generate a driving signal, and the warning unit generates the at least one audible warning after receiving the driving signal, and provides the at least one audible warning to the user, wherein the driving signal is further implemented as At least according to an auditory warning behavior determined when the at least one sleep physiological information is compared with a predetermined posture range and/or a predetermined condition, when the predetermined posture range and/or the predetermined condition are met. produce. 10.根据权利要求9所述的系统,其中,该至少一生理传感器实施为一加速器,以取得下列睡眠生理信息的至少其中之一,包括:睡眠姿势,打鼾相关信息,以及心率。10. The system of claim 9, wherein the at least one physiological sensor is implemented as an accelerator to obtain at least one of the following sleep physiological information, including sleep posture, snoring-related information, and heart rate. 11.根据权利要求9所述的系统,其中,该至少一生理传感器实施为一光传感器,以取得下列睡眠生理信息的至少其中之一,包括:血氧浓度,以及心率。11. The system of claim 9, wherein the at least one physiological sensor is implemented as a light sensor to obtain at least one of the following sleep physiological information, including: blood oxygen concentration and heart rate. 12.根据权利要求9所述的系统,其中,该至少一生理传感器实施为一麦克风,以取得下列睡眠生理信息的至少其中之一,包括:打鼾相关信息,以及呼吸声变化。12 . The system of claim 9 , wherein the at least one physiological sensor is implemented as a microphone to obtain at least one of the following sleep physiological information, including: snoring related information and breathing sound changes. 13 . 13.根据权利要求9所述的系统,其中,该耳塞式穿戴结构实施为具有一进入耳道部分。13. The system of claim 9, wherein the earplug wearable structure is implemented with an ear canal entry portion. 14.根据权利要求9所述的系统,其中,该睡眠生理系统实施为一无线耳机。14. The system of claim 9, wherein the sleep physiology system is implemented as a wireless headset. 15.根据权利要求9所述的系统,还包括一信息提供接口,用以至少将该至少一生理信息提供给该使用者。15. The system of claim 9, further comprising an information providing interface for providing at least the at least one physiological information to the user.
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