Device for determining and monitoring neurological or muscular disorders, and method for determining movement disorders

Abstract

To provide some methods and devices for incorporating or achieving communication interfaces (one or a plurality of wearable devices, or connectivity options (including WWW, IP, LAN, WAN, addition / comparison monitoring / detection or calculation system, SAAS(including cloud computing service or NAS, peer to peer connection or the like)).SOLUTION: There is provided a device for determining and monitoring neurological or muscle disorder, the device comprises: a sensor for acquiring an electromyogram (EMG) signal of a subject, the EMG signal being used for determining a rem stage of sleep, EMG signal being used for determining presence of atony, the EMG signal being used for determining presence of rem sleep behavior disorder (RBD), the sensor being used for acquiring a signal for measuring or monitoring walking of the subject.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This application describes several inventions for obtaining, monitoring, and analyzing data of a target (consumer / patient) that include any one or any combination of the following.

Summary of the Invention

Problems to be Solved by the Invention

[0002] The present invention presents several methods and device inventions that incorporate or enable a communication interface (one or more wearable devices, or connectivity options including WWW, IP, LAN, WAN, additional / comparative monitoring / detection or computing systems, SAAS (including cloud computing services or NAS, peer-to-peer connections, etc.)).

Means for Solving the Problems

[0003] The methods and devices of the present invention have means for detecting, monitoring, tracking, storing, and / or analyzing any one or any combination of a target's physiological parameters, pathological conditions, psychological states, arousal, sleep, activity, fitness, health, other sensory states, related transition states, and / or neurological parameters, and incorporate processing functions or combinations (i.e., multivariate analysis) or clustering or ensemble characterization and determination applicable to any one or any combination of the following, including the option of automatically determining the prediction, onset, or occurrence of a health condition / disorder or event of interest.

[0004] a) A sleep, fitness, health, and sensory state monitoring system (Somfit) wearable by a patient.

[0005] b) A forehead-applied sensor system (Somfit) that incorporates a wrist-forehead interchangeable and replaceable active electronic module (Figure 1, right hand side [1], [7]) and optionally has a display function (either sleep measurement values and / or health tracking measurement values).

[0006] c) A function that continuously transmits sleep parameter information, enables the reconstruction of 20- or 30-second consecutive data epochs for analysis, and enables online sleep stage determination based on these consecutive epoch periods. The monitored sleep parameter data (left side of Figure 1, [1]) can be transferred to a second wearable device such as a smartwatch device (upper right side of Figure 1, [5]), an interconnected mobile clock, or other devices for the purpose of displaying the sleep parameter status. The monitored sleep parameter data (left side of Figure 1, [1]) can also be simultaneously transferred to a further communication network, system, or other interconnection options (including WWW, IP, LAN, WAN, additional / comparative monitoring / detection or calculation systems, SAAS (cloud computing services or NAS, peer-to-peer connections, etc.)), enabling the individualization or remote tracking, reporting, or supervision of individual sleep and related results.

[0007] d) Automatic data exchange is possible between the monitoring system applied to the first forehead and a second information display (a computer-based wristwatch system, mobile device, clock, bangle having a display such as [8] or

[10] on the left side of Figure 1 or [5] on the right side of Figure 1), and the user / patient can track the progress of sleep as well as means to track sleep deprivation or sleep quality (based on previous sleep or wake measurements and / or circadian rhythm deviation indices) during any sleep stage.

[0008] e) The monitored parameters and exchange parameters can include sleep, health, and fitness measurements, and the display functions of the display, which can include (but are not limited to) measurements and related indices including sleep efficiency (SE), wake after sleep onset (WASO), and one or more light detection, electrophysiological sleep parameter (EEG, EOG, and EMG) monitoring functions applied to the forehead.

[0009] f) Detection, monitoring, and analysis of any or all combinations of wake and sleep events, measurements, conditions, or health and environmental conditions of interest.

[0010] g) One electronic component of the wearable monitoring system (i.e., in the case of a replaceable module for daytime activity and nighttime sleep monitoring, for example), or a plurality of electronic components of the wearable monitoring system (i.e., individual modules such as an arm device that houses individual modules, or a microprocessor-based wristwatch that incorporates daytime activity and other health tracking and / or monitoring functions and houses a replaceable module for daytime activity and nighttime sleep monitoring, for example) are arranged to provide daytime activity and health monitoring and tracking, as well as nighttime homeostasis sleep monitoring functions, as part of the entire wake / sleep health monitoring and tracking system.

[0011] h) Said "one electronic component of the wearable monitoring system" (upper left hand side [1] and

[10] in FIG. 1, or lower left hand side [2] in FIG. 1, or upper right hand side [1] and [7] in FIG. 1) can comprise an electronic module, and the electronic module can include any or any combination of physiological monitoring, analysis of monitored physiological parameters, storage of monitored physiological parameters, information flow interconnection, functions for health measurement or health status display means, and the information includes sleep / wake information and / or activity information (i.e., movement, exercise, gait, activity, etc.) and / or other health information.

[0012] i) Said electronic module (Somfit) incorporates means for exchanging (i.e., any or any combination of magnetic, mechanical and / or interlocking) between a plurality of wearable health or environmental monitoring devices;

[0013] j) Said Somfit electronic module (upper left hand side [1] in FIG. 1 or lower left hand side [1] in FIG. 1) can be attached to or applied to the forehead of the subject (i.e., upper left hand side [2] in FIG. 1 or lower left hand side [2] in FIG. 1).

[0014] k) Further, to enable the use of the same Somefit electronic module during the day or during waking activities (i.e., the user can transfer more expensive electronic modules to the wristband holding device), different wearable devices such as a sleep and wristband forehead system for daytime fitness or health tracking are used to enable 24-hour, 7-day monitoring of sleep / wake or daytime / nighttime from a single Somefit module.

[0015] l) The Somefit electronic module can incorporate a display device or display to provide the user with displays of sleep / wake measurements or related indices and daytime fitness or overall health tracking functions.

[0016] m) The Somefit electronic module display can be monochromatic or graphic or alphanumeric. Alternatively, the display may be a simple bar graph or other graphic or numeric display representing a series of measurements for daytime fitness or overall health tracking functions, and the measurements include analytical measurements further detailed elsewhere throughout this document.

[0017] n) In one exemplary embodiment of the display, the Somefit module can incorporate actual sleep parameters based on sleep parameters monitored when applied to the forehead (monitoring includes any one or more or combinations of EEG, EMG, and / or EOG signals or any combination of channels) (i.e., sleep quality or sleep parameters (homeostatic sleep and / or circadian clock indices) and fitness or other overall health or daytime parameters can be displayed for 24-hour, 7-day sleep / wake health tracking functions within a single wearable display system, including FIGS. 2[3] and [2].

[0018] o) The aforementioned Somefit electronic module (i.e., the upper right hand side of FIG. 1 [1]) can be attached (i.e., connected, magnetically coupled, clipped, snap - attached, or attached by other mechanical engagement or clip insertion, etc.) to a plurality of wearable devices or as a part thereof (wearable devices include, but are not limited to, replaceable wristband devices (i.e., the list band on the upper right hand side of FIG. 1 [8])). Further, wireless or other connection functions can transfer Somefit module sleep monitoring parameters manually or automatically from the forehead Somefit monitoring module (i.e., the upper right hand side of FIG. 1 [1]) to the smart watch system (i.e., the upper right hand side of FIG. 1 [5]).

[0019] p) The "forehead - applied sensor" incorporates at least one bipolar forehead electrophysiological signal (FIG. 4; [8], [9],

[10] ,

[11] ,

[12] ).

[0020] q) The "forehead - applied sensor" includes a reusable sensor.

[0021] r) The "forehead - applied sensor" includes a disposable sensor.

[0022] s) The "forehead - applied sensor" includes sensors with or without a partial or whole circumferential headband (FIG. 4;

[13] ).

[0023] t) The "forehead - applied sensor" has a self - adhesive surface on one side of the sensor and can embed self - gelling electrophysiological electrodes, and these "electrodes" can be exposed by removing the backing paper.

[0024] u) The "forehead - applied sensor" can be provided on the non - electrode side of the "forehead - applied sensor" with means (i.e., self - adhesion, snap - attachment, magnetic, mechanical connection, or other means) for interfacing with the aforementioned "electronic module" or a device that houses or holds the "electronic module" (FIG. 4; [7]).

[0025] v) The "frontal application sensor" can monitor at least one frontal sleep parameter signal including any one or any combination of EEG, EOG, and EMG.

[0026] w) By deploying a frontal application sensor for monitoring the principle sleep parameters (EEG, EOG, EMG) of a subject in combination with a second wearable communication / display device through interconnection, a series of sleep and wake events or disorders can be tracked and managed, and the series of sleep and wake events or disorders include options for countermeasures by treatment devices or other forms of intervention.

[0027] x) Deployment of an exchangeable interconnected companion device worn by the patient (i.e., worn or associated by the subject); placement of an audio monitoring or environmental monitoring device enables further monitoring and automatic tracking of wakefulness or sleep and related respiratory disorders. A group of compatible (i.e., wireless communication and information) devices (i.e., dealt with in another place in this document); eLifeWATCH (Figure 5, [5]), eLifeWRIST (Figure 5, [8]); eLifeCHEST (Figure 5, [4]); eLifeEXG (Figure 23) eLifeNEURO (Figure 4, [2]) can automatically and dynamically exchange data between one or more of the said devices, enabling determination and related display of any combination of measured values or related indices.

[0028] y) The "measured values or related indices" can include any one or any combination of fitness, health, and / or sleep parameters (quality of an individual's sleep, efficiency / SE, wake after sleep onset / WASO, recovery cycle of the sleeping body, recovery cycle of the REM sleep brain, ongoing sleep tracking, quality of ongoing sleep, sleep diary, sleep function of a comparison group or individual, sleep debt, sleep disorders, respiratory disorders, suggestions or recommendations for sleep improvement corresponding to the causes of sleep disorders, sleep composition, sleep structure, sleep fragmentation).

[0029] z) By deploying a somnilink system with an Internet or other wireless or interconnection means that interfaces signals or obtained measurement values from a Somefit system with medical treatment or the Diagnostic Internet of Medical Devices (IOMD), Somefit can form biofeedback (a closed loop or other control that incorporates Somefit measurement values as part of the decision-making process responsible for controlling treatment operations). The treatment control can include sleep treatment devices such as oral adjustment systems, patient positioning devices or trainers, PAP, NIPPV, and other devices. The treatment control can include visual output or control for rest or meditation (i.e., control by a massage chair, or music or room lighting or video or stereoscopic video, etc.). The treatment control can include magnetic or electrical stimulation devices.

[0030] aa) The Somnisync system incorporates means to enable "dynamic data exchange" of sleep parameters or other health or fitness parameters between two or more wearable devices or associated portable wireless communication devices or computer systems.

[0031] bb) The said "dynamic data exchange" enables a wrist bangle or other wearable device to manage sleep and / or fitness and / or other health conditions or states personally.

[0032] cc) This dynamic data exchange can occur via a wireless interconnection between two or more wearable devices, enabling the automatic display of sleep monitoring parameter data and / or related sleep measurement values on wearable devices such as mobile phones (left side of Figure 1, [8]), smartwatches (Figure 1, right side, [5]), wrist bangles (right side of Figure 1, [8]), or other wearable systems.

[0033] dd) This dynamic data exchange can be via a wireless interconnection between two or more wearable devices, enabling the automatic display of sleep monitoring parameter data and / or related sleep measurements on wearable devices such as a mobile phone (left hand side of FIG. 1, [8]), a smart watch (FIG. 1, right hand side, [5]), a wrist bangle (right hand side of FIG. 1, [8]) or other wearable systems, etc.

[0034] ee) For example, remove the electronic monitoring transfer electronic module from the EEG, EOG, EMG monitoring parts of the applied forehead, and transfer the forehead applied sensors and devices and the transfer electronic module to a wearable wrist device to enhance a conventional daytime wrist pedometer or a motion-based fitness device with sleep measurement.

[0035] ff) A Somnilink forehead applied wrist device (i.e., a watch or bangle) or other wearable or attachable device can incorporate means for detecting the light conditions of a room or environment (i.e., such means includes a photoresistor or other light sensor essential for internationally recognized standard sleep indices such as sleep efficiency or middle of the night awakenings). The output information of the light sensor can be linked to online automatic measurements applicable to sleep measurements such as sleep efficiency, middle of the night awakenings, sleep duration, REM sleep (during sleep duration), deep sleep (during sleep duration), non-REM sleep, etc. The measurements derived from these light detection sensors can be displayed as part of another wearable device, providing instantaneous measurements or indicators of the object regarding sleep functions and capabilities. These sleep measurements can be displayed together with other fitness states (such as accelerometer and / or motion sensor and / or pedometer sensor measurements, etc.), providing a sleep and fitness tracking function applicable to the object via a wearable information display device (such as a watch or bangle, etc.) or other devices that the object can wear or attach.

[0036] gg) The system automatically calculates the progress and related results during and between sleep of the subject, as well as related information (disorders, measurements, indices, quality, or sleep disorders and the severity of related disorders or concerns). The present invention uses information triage means to enable the extraction of information (i.e., the triage means can include an information distribution process, such a process being according to predefined ones (i.e., but not limited to prior experimental data studies, norms or disease / disorder population data or studies), or dynamic (i.e., but not limited to decisions and / or conformations and / or adjustments based on previous monitoring or detection information), including aspects of role, eligibility, safety, and confidentiality of user access rights and privileges, as well as the appropriate user interface and the complexity level of information access or information content. Said "information content" can include REM sleep and deep sleep amounts and sleep disorders or sleep composition or wakefulness states.

[0037] hh) The present invention can automatically calculate and, when the subject has or needs further sleep, provide advice to the subject regarding the ongoing tracking and calculation of the ongoing sleep tracking results of the subject, as well as the quality of sleep and recommendations for improvement based on said results corresponding to a comparison with the subject's normal sleep requirements or a normative population database. The present invention incorporates means for referring to said database.

[0038] ii) The present invention enables the deployment of questionnaires or sleep surveys such as effective sleep evaluations or effective drowsiness evaluations, together with self-assessments, and establishes a set of criteria corresponding to the normal level or index of the subject (i.e., REM sleep, sleep duration, deep sleep, arousal index, AH breathing index, RERA index, overall quality of sleep and / or sleep deprivation status), enabling the subject or the subject's healthcare provider to improve information access and sleep management. Compare such information with the current in-sleep and between-sleep progress reports or related trends, and establish further means for recommendations and suggestions based on these results for the subject or the relevant healthcare provider (the means for comparing such information can include reference to the subject's individual sleep model established by calibration against the personal survey assessment and ongoing related "criteria", as well as comparison to a patient normative database).

[0039] jj) The present invention enables synchronization related to the sleep stages of a clock or alarm system or other clock alarm system, and selects a more optimal wake-up alarm time based on a sleep cycle that minimizes the adverse effects between the user's need for waking up and the wake-up. (That is, when the adverse effects are minimized and long-term sleep recovery is evident, or when the prediction or result of the REM sleep stage is imminent, avoid waking up during deep sleep, make the wake-up less intrusive, and enable waking up without impairing the overall sleep or time requirements).

[0040] kk) The present invention provides a minimum configuration with a single headband sensor (Somfit), which can monitor brain signals, continuously monitor sleep parameters (EEG, EOG, EMG), perform automatic online processing, and enable the determination of sleep stages (i.e., REM, non-REM stage 1, non-REM stage 2, non-REM stage 3, and stage 1).

[0041] (ll) The present invention further provides the option of monitoring room light detection (i.e., LDR) and / or monitoring breathing sounds (i.e., snoring) and / or monitoring sleep apnea by a series of other optional sensors (the sensors include any one or any combination of RIP, PVDF, piezoelectric sensors or other chest and / or abdominal belts; nasal cannula sensors; airflow sensors).

[0042] (mm) The present invention further provides the option of having a single sensor strip incorporating an embedded reflective oximeter sensor (LED with LDR), the oximeter sensor can be attached to or embedded in a forehead sensor, and realizes plethysmography and oximetry together with the related output (the output includes any one or any combination of PTT, obstructive apnea, pulse wave amplitude, autonomic markers of arterial pulse tension). Other sensors can include a "drop-down" (i.e., connector to Somfit) airflow sensor (i.e., PVDF, thermocouple, thermistor, nasal cannula, etc.), and the said sensor(s) enables the monitoring of breathing that causes abnormalities in sleep, including apnea, hypopnea, and mixed apnea / hypopnea.

Brief Description of the Drawings

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Mode for Carrying Out the Invention

[0044] Overview of eLifeWATCH A wearable wrist-based monitoring device incorporates a gyroscope or a position tracking system that can input automatic incorporation means for calculating gait, walking characteristics (including the onset of Parkinson's disease), and the automatic incorporation means includes automatically analyzing the long-term trend of automatic gait analysis, and it is possible to detect the fluidity of walking and movement, which includes predicting and assessing the results related to an individual's walking (gait) (i.e., suggesting a visit to a primary care physician or a specialist based on the detection of a trend that may have further implications), and the trend refers to the inability to swing the natural arm along with the stride, short or entangled and difficult foot movement (i.e., changes in limb movement and stride related to turning corners well), etc. Any combination of measurements such as GPS, gyroscope, movement, position data, etc. can be analyzed as a marker for the start or occurrence of a predefined event or health condition (right hand side of Figure 1, [5]).

[0045] Exemplary embodiments of the watch body module sensor - platform - system incorporate photoplethysmography, oxygen plethysmography, temperature, spring - type pressure or electrophysiological monitoring by fixed sensors (i.e., conductive rubber), galvanic skin response (GSR) monitoring means, Doppler ultrasound monitoring, optical detection monitoring, microphone monitoring (Figure 7), a smart - phone system with SAAS [1] and a series of embedded sensors, applanation pressure measurement monitoring, Doppler blood flow [3], PPG, temperature, GSR, pedometer / accelerometer, position, metabolic / calorie burn tracking (Figure 7, Figure 9, Figure 13), either or any combination thereof. SAAS includes a cloud - computing service interface and other connection options (i.e., simultaneous interconnection with additional communication networks, systems or other interconnection options, which include the WWW, IP, LAN, WAN, additional / comparative monitoring / detection or computing systems, SAAS, which includes cloud - computing services or NAS, peer - to - peer connections, etc.).

[0046] - The GSR means can include the incorporation of a plurality of non - polarizable electrodes applied to the skin surface with a small constant current (i.e., 3 to 5 uV), and the electrical resistance of the palmar skin is proportional to the potential generated between the electrodes. - This resistance is mainly due to the semi - permeable electrical properties of the sweat glands and the associated epidermis. - Sleep and wake cycles produce different electrical properties, which can be tracked as a surrogate or contributing criterion for sleep and wake state determination. - Options for the GSR technique of the present invention include switching or alternating the direction of a small constant current between the electrodes to minimize the effects of electrode polarization.

[0047] Exemplary embodiments of the watch body module - sensor - platform - system incorporate a Doppler ultrasound monitoring and / or a pressure measurement monitoring detection system. A replaceable back section (screw, pressure fitting or rotating screw rear - cover fitting; a rubber seal can ensure a waterproof or water - resistant function) (Figure 9).

[0048] Overview of eLifeBUDS The plug-in earphone (earphone) wearing monitoring device that combines sleep, health and fitness incorporates a series of physiological parameter monitoring sensors. The physiological parameters include GSR, temperature, pulse, movement and / or energy / heat profile characterization, which improves calorie burn determination (left side of Figure 1 [3]).

[0049] Overview of eLifeKIT - eLifeKIT provides a series of wearable or applicable monitoring systems. These monitoring systems can operate individually or as part of an interconnected system cluster on a common framework and health management system platform, enabling an individual's health management system framework based on compatible health tracking and management technologies.

[0050] Overview of the Multi-Point Time Synchronization Monitoring (MTM) System By incorporating a Multi-Point Time Synchronization Monitoring (MTM) system, automatic online characterization of clock characteristics (i.e., drift, offset, stability) (clock drift, offset, stability) is possible. This involves continuous tracking and calibration of the time adjustment characteristics by compensation, requires all relevant clock synchronization systems, and uses any combination or phase lock or open-loop control techniques. MTM incorporates a calibration mode and corresponding compensation mode to minimize online or data reconstruction time alignment errors on different transmission media or multiple simultaneous monitoring devices or systems under any arbitrary time or various monitoring / communication conditions of the object. MTM can be deployed on different groups of monitoring systems and communication networks by adopting self-running, master-slave or multi-mode time adjustment techniques, so as to achieve the accuracy of time record synchronization of more interconnected monitoring systems with a minimum data acquisition inconsistency. Such accuracy can reach atomic clock accuracy or, if necessary, the accuracy of relevant phase or data alignment errors applicable to dedicated or specific applications or requirements, and reduce such errors.

[0051] Overview of eLifeSLEEP eLifeSLEEP of the present invention enables true sleep monitoring and tracking by incorporating a system applied to the head (i.e., Somfit). The system applied to the head can monitor major sleep parameters and investigate sleep and sleep-related disorders. The system includes a single small electronic device that can be easily attached (i.e., magnetically attached), and a disposable self-adhesive (to avoid cross-infection or because pressure needs to be applied to an individual's head or forehead).

[0052] Overview of eLifeCHEST / eLifeSCOPE (chest band) (Figure 5 [3]; [4]; Figures 32, 33) The chest-worn monitoring device has auscultatory respiratory sounds during sleep and wakefulness, central apnea / hypopnea versus obstructive apnea / hypopnea, and other automatic sleep disorder tracking functions by a stethoscope (Figure 1 upper left hand [7]). The chest-worn monitoring device that combines sleep, health, and fitness includes a series of physiological parameter monitoring sensors. The physiological parameter monitoring sensors include auscultatory sound monitoring by a stethoscope with online automatic determination and tracking of respiratory disorders, reflectance photoplethysmography oximeter and related outputs, photoplethysmography, energy / heat profile characterization, and has an option to improve calorie burn determination (monitoring the spatio-temporal activity of body heat release using time-gated NFIR analysis to improve calorie burn determination).

[0053] The present invention further includes distinguishing obstructive apnea from central apnea by correlating respiratory movement with respiratory effort, and the respiratory effort can be determined by using EMG and / or transient pulse wave amplitude measurement and movement around the chest and / or abdomen during respiration (Figure upper left hand [7]).

[0054] Overview of the Adaptive Physiological Body Network (APM) By incorporating an Adaptive Physiological Monitoring (APM) system, it becomes possible to automatically reconfigure a group of portable companion (i.e., interconnected compatibility) monitoring systems in terms of data acquisition, system or network characteristics related to physiological parameter data acquisition, or intercommunication characteristics, resources and / or parameters, information, communication and related data prioritization, and the use and / or sharing (i.e., storage retention, transfer to a buffer) of resources on other available processing systems or communication system resources (s), devices, methods, systems and network or interconnection configurations. This enables the system to adapt to available resources or monitoring and / or communication conditions and / or available communication media, networks or other interconnection options and / or communication paths (i.e., wireless connections) at any given time. Interconnection options include simultaneous interconnection options with additional communication networks, systems or other interconnection options, and other interconnection options such as WWW, IP, LAN, WAN, additional / comparative monitoring / detection or computing systems, SAAS (including cloud computing services or NAS, peer-to-peer connections), etc., and to meet the requirements of the minimum monitoring survey format (i.e., expert medical level format or consumer level survey format, format and criteria), minimizing the risk of data damage (e.g., during degradation or interruption of a wireless connection).

[0055] The APM system uses significantly improved "adaptability" data acquisition / monitoring / detection system resources and communication to enhance the certainty and reliability of the system. This is achieved by enabling automatic compensation adaptation to changing or unpredictable monitoring conditions, such as when the subject's body obscures the wireless communication path related to the wearable device.

[0056] Overview of eLifeBAND (Portable Device and Integrated Sensor Armband) An armband-mounted metabolic monitoring device such as a mobile phone case that combines health and fitness monitoring functions incorporates a series of sensors that are particularly useful in determining an individual's energy effort in relation to the estimation or prediction of the individual's metabolic rate (calorie burn) related to exercise effort. For the estimation or prediction, measurements based on the spatio-temporal activity of body heat release (i.e., time-gated NFIR analysis) are incorporated to improve calorie burn determination, and such means can include physiological detection by any number and combination of temperature sensors or a three-dimensional infrared thermography imaging function. Heat dissipation can be measured using more advanced means such as infrared sensors that enable the characterization of the diffusion and release of body heat, imaging the physiological temperature and spatio-temporal activity heat, and enabling a more comprehensive and accurate modeling of metabolism and the associated calorie burn rate (upper left of the figure [9]).

[0057] The phone case incorporating the metabolic monitoring function is equipped with a series of sensors and related multivariate analysis, automatically calculates, and displays online (i.e., via a wireless mobile application or wearable device display, dynamic data exchange or exchangeable electronic module compatibility or interface function) metabolic or calorie burn measurements including the thermal spatio-temporal activity of body heat / energy release (i.e., time-gated NFIR analysis) (upper left of Figure 1 [9]).

[0058] Overview of eLife Doppler The present invention provides the development of a Doppler watch tracking (DWT) system, and the Doppler watch tracking (DWT) system is for any one or any combination of the following Doppler and / or ultrasonic vascular or heart characterizations based on any one or any combination of periodic or continuous monitoring: monitoring of any one or any combination of the subject's wrist, ankle, arm, and / or other limbs or body extremities of the subject - Dual-channel - radial artery and ulnar artery; - Single-channel - radial artery and ulnar artery; - Single-channel - ulnar artery; - Single-channel - radial artery.

[0059] Overview of eLifePULSE (applanation pressure measurement) The present invention includes the development of attachable / wearable / applanation pressure measurement (AAT), where AAT comprises a watch, a bangle, or other devices incorporating periodic or continuous applanation pressure measurement means (Figure 37), and said means apply a pressure sensor capable of measuring and / or characterizing the radial artery and / or ulnar artery (Figure 38) or characterizing other body artery pulsations (pulse wave waveforms). Further, the present invention can further calculate pulse wave analysis (PWA) including recording arterial pressure for a certain period (e.g., 10 seconds), obtain the rise of the associated aortic pressure wave, and from the rise of the aortic pressure wave, obtain several cardiovascular measurement values such as central aortic systolic pressure, aortic augmentation index, and central pulse pressure, and / or other cardiac function measurement values.

[0060] Name: Somfit / Somfit Background of the patent: Background of the circadian rhythm The human circadian rhythm is an endogenous (self-sustaining or "intrinsic") biological process with a physiological variation (rhythm) that can be synchronized in approximately 24 hours. A typical circadian clock can be represented by the following 24-hour cycle sequence: 0:00 Midnight - Start of the sleep period 2:00 - Deepest sleep period 4:30 - Minimum body temperature 6:45 - The blood pressure undergoes the most rapid pressure increase 7:30 - Cessation of melatonin secretion 8:30 - Possibility of defecation 8:30 - Testosterone secretion reaches its maximum 9:00 - Possibility of defecation 10:00 - Peak of agility 12:00 - Noon 14:30 - Cooperation is emphasized 15:30 - Reaction time shows the most response 17:00 - Cardiovascular efficiency and essential strength reach their maximum 18:30 - Blood pressure peak 19:00 - Body temperature peak 21:00 - Start of melatonin secretion 22:30 - Suppression of bowel movement 0:00 Midnight - Start of sleep period 2:00 - Repetition of the typical circadian cycle as described above

[0061] The circadian clock cycle has the following three aspects: 1. A self-running cycle of about 24 hours (referred to as tau or the Greek letter "τ"); 2. Entrainment characteristics that can be reset or adapted (synchronized) by exposure to external stimuli such as light or temperature changes. Examples of entrainment or regulation of the human circadian clock include cases where a person experiences unexpected or unanticipated sleep impulses due to jet lag or disruption of the conventional sleep routine. For example, this can occur after overseas travel across different time zones, during or after work shifts, or as a result of staying up late during a study period or other event that requires effort, when the body's biological clock (circadian clock or rhythm) is not adjusted or synchronized to the current routine sleep / wake cycle. 3. "Temperature compensation" characteristics. The body maintains a constant periodic nature for a range of physiological temperatures, regardless of changes in exercise (temperature and different thermal energies with respect to the molecular processes of cells). 1

[0062] The circadian clock has a significant impact on metabolism, overall health, and sleep / wake regulation. > A link has been proven between work shifts and metabolic disorders 2 ; > Studies have associated disruptions in sleep duration and circadian rhythms with a wide range of disorders such as type 2 diabetes, cancer, and gastrointestinal disorders 2 ; > "Social jet lag" (i.e., the habit of changing sleep hours on weekends is associated with weight gain) 2 ; > The circadian clock regulates energy homeostasis, and disruptions in energy homeostasis can contribute to conditions related to weight, similar to social jet lag. 2 ; >Circadian factors play an important role in the quality of sleep; that is, sleep follows its own circadian sleep cycle rather than the length of sleep depending on the homeostatic sleep factor (i.e., the circadian sleep cycle factor is dominant over sleep homeostasis (sleep drive)). 2 ; >Therefore, from a practical or productive perspective, understanding and guidance in terms of the interaction and relationship between an individual's homeostasis and circadian processes can be an important aspect. This is because it is important to stay awake for a significant amount of time, achieve high-quality sleep, have regular bedtime and wake-up times, and achieve stable sleep durations (i.e., spending more time in bed to sleep is not necessarily better quality sleep, and the most efficient and effective use of sleep time can be achieved by dealing with one's own circadian clock). 2 ; >The homeostatic sleep factor accumulates according to the previous waking state. That is, the homeostatic factor (sleep drive) increases with the length of wake time. Therefore, this factor is considered to be the main importance in the quality of sleep. For example, as shown by the increase in slow-wave EEG activity, the longer one stays awake, the deeper the subsequent sleep episodes become. 2 ; >In contrast, the circadian rhythm plays an important role in terms of the quality of sleep. For example, the sleep time is mainly determined by the bedtime.

[0063] Description of the present invention A method or device that allows a subject to control the display of the system or related display information (i.e., tap, gesture, or touch by means of capacitance surface detection or resistance surface detection, etc.) and switch between a display mode that reflects brain-based steep parameters / markers or a related index representing measurement values that reflect the monitored sleep state of the subject and other fitness / health monitoring measurements or environmental detection.

[0064] The present invention provides a method or device capable of switching between display modes in which a subject controls system display or related display information and monitors sleep measurement values or indices (i.e., sleep parameter measurement values based on EEG, EOG, and / or EMG signals and health and fitness measurement values (accelerometer or motion-based measurement values and / or physiological or psychological monitoring including "including the following" and / or "environmental detection" as detailed elsewhere in this document and / or others further detailed elsewhere in this document, etc.) or any combination thereof, or signals related to brain signals or EEG signals reflecting the same).

[0065] In one embodiment of the present invention, the subject uses a wearable device (including but not limited to a headband (Figure 25[7]); a general-purpose dipole sensor (Figure 23); an oximeter (Figure 22); a leg band (Figure 24); a wristband (Figure 2), an ankle band (Figure 2), an arm band (Figure 2), earphones (multiple) (Figure 14), a chest band (Figure 5[3]; [4]; Figure 31), other attachable devices or watches, etc.) to measure and enable the measurement of the rhythm, synchronization, fluidity, movement, various degrees of movement, and further the correlation with the movement characteristics of other limbs such as the wrist or arm.

[0066] In one embodiment of the present invention, the subject uses a wearable device (including but not limited to a wristband, an ankle band, an arm band, earphones (multiple), a chest band, other attachable devices or watches, etc.) to automatically or manually exchange data with a data interface compatibility device (i.e., including but not limited to a wireless monitoring system for head EEG, EOG, and / or EMG signal-based sleep parameters worn by the subject), enabling the subject to automatically track sleep measurement values, indices, and overall sleep quality (i.e., including mid-awakening, sleep efficiency, REM sleep amount, deep sleep amount, sleep fragmentation or normality, which may include other optional user or healthcare provider programs, accessible predictions, diagnoses, and personal care management measurements for the subject, and based on the required simplicity, complexity, and sophistication for each user, facilitating easy access and tracking of sleep debt, sleep composition, and sleep requirements).

[0067] In one embodiment of the present invention, the object can automatically or manually exchange a data interface compatibility device with an alarm clock or a mobile phone or other communication compatibility device by means of a wearable device (but not limited to, a headband (Figs. 25, 3, 4), a wristband (Fig. 2), an ankle band (Fig. 2), an armband (Figs. 2; 32; 33), earphones (plural possible) / miniature earphones (Fig. 14), a chest band (Fig. 31), other attachable devices or watches (Figs. 6; 7; 9; 13), etc.).

[0068] For example, the information that can be exchanged includes information related to user / patient guidance (recommendations or guides for improving health or current health status), and this information includes daily health, fitness / activity and sleep monitoring parameters (including, but not limited to, sleep parameter measurements based on EEG, EOG and / or EMG signals), and / or indicators that can recommend sleep requirements based on any combination of environmental monitoring inputs (i.e., temperature, humidity, air pollutants, pollen or other airborne pollutants carried in the air, etc.).

[0069] Minimum configuration of Somfit The present invention provides monitoring functions for any or any combination of physiological channels including, but not limited to, EEG / P1, EEG / P2, EEG / Pz, EOG / L / P7, EOG / R / P8, patient posture, or, if possible, multi-axis composite patient position and patient movement, infrared respiration detection, microphone respiration sound monitoring, light detection (i.e., photodetector), optional reflective oximeter, optional wireless interconnection, and the wireless interconnection involves any or any combination of sensors required for the categorized format applicable to types or levels 1 to 4 described in more detail herein.

[0070] The present invention includes physiological or environmental monitoring including any or any combination of the following: Audio monitoring; stethoscope auscultation sensor, monitoring and automatic analysis, classification, tracking and detection functions; acoustic noise cancellation system; motion detection; REM sleep behavior disorder (RBD); pulse sensor integrated watch (band or bangle) of other wrist-worn devices; pulse wave analysis (PWA) and pulse wave velocity (PWV) monitoring and analysis functions; PWA and PWV sensors; PWA sensor measurement; electrocardiography; position, location and motion detection and monitoring; gait or motion tracking and characterization of events of interest; motion and position information; ECG sensor(s) and monitoring; optical sensor(s) and monitoring; respiratory band·sensor and monitoring; EMG sensor and monitoring; GSR; cardiac function; heart rate; sleep training system; photoplethysmography oximetry; transient pulse amplitude measurement; temperature, energy effort / metabolism monitoring (EM) as proxy calorie burn measurement; sleep parameters; physiological and / or sleep and / or wakefulness markers; sleep parameters; sleep architecture measurement; environmental sensing; "dynamic link function"; mental state.

[0071] The present invention includes detection, monitoring, data acquisition, signal processing, analysis, storage, and information access, and the information access includes online automatic characterization of the physiological, neurological, nervous system, locomotor, muscular, psychological, pathological conditions, events of interest and / or health status of the subject / individual, and the characterization includes any one or any combination of the following: Rapid eye movement (REM) sleep characterization; sleep disorder classification; selected sleep disorders; dream state; hallucination state; dissociation state; hypnosis state; and others detailed further elsewhere in this patent application document.

[0072] The present invention provides environmental monitoring or detection of any one or any combination of the following: - Environmental sensing (alarm or warning or display or interface to related portable device, messaging, email, automatic voice message of phone and other information or communication systems), weather elements, wind, humidity, temperature, ionization monitoring, ionization smoke alarm, methane monitoring, toxic gas monitoring, toxic chemical monitoring, CO2 gas monitoring, methane gas monitoring, other toxic gases, other toxic chemicals and / or thermometer, and / or including "physiological or psychological monitoring" and / or "environmental sensing" detailed further elsewhere in this document;

[0073] In one embodiment of the present invention, the subject can automatically or manually exchange data with a data interface compatibility device by means of a wearable device (but not limited to, a headband (FIGS. 25 and 4), a wristband (FIG. 2), an ankle band (FIG. 2), an armband (FIGS. 2, 32, and 33), earphones (plural) (FIG. 14), a chest band (FIG. 31), other attachable devices or a watch, etc.). The data interface compatibility device includes a thermostat (or other communication compatibility device) in the subject's room and can optimize the sleep environment conditions according to the subject's preferences and / or based on environmental monitoring, and / or based on subject-specific or biological synchronization characterization (i.e., there are options for automatic sleep training feedback or notification (i.e., recommendations, suggestions, predictions, diagnostic support data access for medical providers, etc.) to a person (merely an example) who snores unpleasantly with sleep disorders (plural) without the sound being biologically synchronized with a partner, such as drawing the line with a snoring partner), i.e., for automatic sleep training feedback or notification to a person (merely an example) who snores unpleasantly with sleep disorders (plural) without the sound being biologically synchronized with a partner.

[0074] In one embodiment of the present invention, the subject can automatically or manually exchange data with a data interface compatibility device by means of a wearable device (but not limited to, a wristband, an ankle band, an armband, earphones (plural), a chest band, other attachable devices or a watch, etc.). The data interface compatibility device includes a thermostat (or other communication compatibility device) in the subject's room and can optimize the sleep environment conditions according to the subject's preferences and / or based on environmental monitoring, and / or based on subject-specific or biological synchronization characterization (i.e., there are options for automatic sleep training feedback or notification (i.e., recommendations, suggestions, predictions, diagnostic support data access for medical providers, etc.) to a person (merely an example) who snores unpleasantly with sleep disorders (plural) without the sound being biologically synchronized with a partner, such as drawing the line with a snoring partner), i.e., for automatic sleep training feedback or notification to a person (merely an example) who snores unpleasantly with sleep disorders (plural) without the sound being biologically synchronized with a partner.

[0075] In one exemplary embodiment of the present invention, the subject is a wearable device (but not limited to, a wristband, ankle band, armband, earphone(s), chest band, other attachable device or watch, etc.), snores (merely an example), is related to another person, and causes sleep disorders to the user or wearer of the present invention. Based on the characterization or biological synchronization characterization and determination of the subject, data can be automatically or manually exchanged with a data interface compatible device. The notification includes an automatic MWM (i.e., mobile phone message, alarm, calendar input, event, and / or sleep training system, etc.), or recommendations, suggestions, predictions, or diagnostic support data access applicable to other sleep disorder suppression elements for the medical provider or treatment adjustment (i.e., automatic; any one or any combination of biofeedback or manual adaptation, adjustment, or reconfiguration) of the user or subject wearing the present invention or other person(s) nearby.

[0076] In one embodiment of the present invention, the subject can automatically or manually exchange data with a data interface by means of a wearable device (but not limited to, a wristband, ankle band, armband, earphone(s), chest band, other attachable device or watch, etc.). The data interface can include any network connection and / or available communication medium, network, or other interconnection option (the interconnection option includes simultaneous interconnection with a further communication network, system, or other interconnection option such as WWW, IP, LAN, WAN, additional / comparative monitoring / detection or calculation system, SAAS, etc., and SAAS includes cloud computing services or NAS, peer-to-peer connection, etc.).

[0077] Full disclosure of online physiological parameters The present invention comprises a portable device (i.e., a portable wireless system, a wristband, a smartwatch, a phone, a PDA, a headband, a head-mounted device, an attachable or pocket device, etc.), the portable device incorporating means for displaying and / or tracking any or any combination of the sleep performance / function, sleep parameters, fitness or exercise parameters, fitness or exercise performance / function, health parameters and / or health performance / function, and the present invention further comprises any or any combination of the following: - As means for switching any of the said parameters or performance / function measurements or indices, activation gestures (i.e., tapping movements, switches, finger slides, arm swings, etc.); - A wireless monitoring function enabling online monitoring of sleep parameters (i.e., EEG, EMG, EOG, etc.); - The full disclosure ability of online monitoring of sleep parameters (i.e., EEG, EMG, EOG, etc.).

[0078] Full disclosure includes primary monitored raw data (i.e., physiological waveform data), secondary monitored data (i.e., an overview of compressed data) and / or tertiary data (i.e., without limitation, analysis and conversion (multiple possible) of primary data or secondary data such as indices, spectral analysis, signal dynamics analysis (i.e., non-linear dynamic analysis), etc., correlation analysis, coherence analysis, multivariate analysis, FFT and related outputs, etc., and means for displaying any or any combination thereof: - Incorporation of the MTM function; - Incorporation of the APM function; - Incorporation of the HDCM function; - synch somnisync (handled elsewhere in this patent application document); - A wearable headband device incorporating means enabling full disclosure (i.e., disclosure is raw data such as EEG, EMG and / or EOG electrophysiological signal variations, including functions enabling the bandwidth of all sleep and other neurological events, the bandwidth including HFO, spikes, spindles, slow waves, or other events, or health conditions handled elsewhere in this document). - Incorporating means "spectral compensation" and "other compensation" such that the EEG signal is subject to an analysis transformation applicable to normalization (i.e., AASM or K and K - extended recommendations or standards), or any particular or conventional EEG electrode positions.

[0079] "Spectral compensation" and "other compensation" can include spectral transfer characteristics, phase transfer characteristics, signal amplitude, signal distortion, multiple signal superposition, and in other cases, neural source positions attenuated by non - impairment monitoring constraints (i.e., positions such as Fp1, Fp2, F7, F8 and / or Fz, etc., frontal positions below the hairline) versus (but not limited to) normalization positions such as EEG positions used for conventional EEG sleep monitoring parameters (i.e., including F4 - M1; C4 - M1; O2 - M2; and backup monitoring electrodes including F3 - M2; C3 - M2; o1 - M2 sleep monitoring electrode positions).

[0080] The EEG signal compensation transfer characteristics incorporate means to emulate EEG signal characteristics similar to another "designated alternative position" or "conventional position".

[0081] The determination of the "designated alternative position" can include forward or reverse source position identification calculations.

[0082] The determination of the "designated alternative position" can include transfer characteristics based on empirical data studies that investigate comparative EEG signal characteristics of different EEG positions during sleep states, enabling the relationships and associated transfer functions necessary for transformation.

[0083] The EEG signal at the first monitoring position can be processed by a transfer function that can generate (model) a data set applicable to the approximate data set values of the second monitoring EEG position.

[0084] The transfer function is modeled to most accurately simulate the data at the second position applicable to different sleep stages (i.e., AASM or R&K sleep scoring recommendations).

[0085] The present invention enables means for full-disclosure online signal monitoring and in-progress analysis of sleep stages, the means including the function of accessing each sample or accessing real-time monitoring information sampled at regular intervals, calculating measurements showing only raw data without interruption, or summary or compressed versions of the data, enabling the quality of diagnosis and industry standards (i.e., ASSM and / or R&K scoring recommendations for human sleep, respiration, and other related aspects), generating accurate measurements of monitored sleep variables, extracting measurements of sleep progression, performance, and state (i.e., other sleep measurements further outlined in the section on "physiological and / or sleep and / or arousal markers" without limitation), and enabling online remote or local online analysis.

[0086] The analysis and monitoring functions can be updated online or in virtual real-time, allowing an individual to view the display (including a wireless monitoring system linked to sleep parameters (i.e., EEG, EMG, and / or EOG)) at any time during the subject's sleep or related arousal state using a patient-worn or portable or remote computer device or information access system.

[0087] The present invention enables a wearable and portable monitoring system, the wearable and portable monitoring system comprising means for arousal and / or sleep health monitoring and surveillance, the means including (without limitation) a) a forehead-mounted physiological monitoring sensor, b) a reusable or disposable sensor, c) a reusable or disposable sensor automatic reload inserter device, d) continuous online sleep parameter (EEG, EOG, EMG) monitoring and sleep analysis, e) wearable monitoring, f) a dynamic data exchange and exchange / compatible part, g) an infrared respirator or body movement monitor, h) body position and / or location and / or movement, i) movement and / or motion, j) an oximeter, k) PPG, or any combination of the descriptions presented elsewhere in this patent document.

[0088] a) Forehead-applied physiological monitoring sensor The present invention enables monitoring of one or more forehead-mounted grooming and monitoring sensors, and optionally derives a plurality of sleep parameters from any one or more of said sensors (plural); - Optionally, the "sleep parameter" monitoring includes any or any combination of EEG, EOG, EMG and / or ECG; - Optionally, the "sleep parameters" include any or any combination of those further detailed in the subheading "eLifeKIT:" and the name: "eLifeCHEST / eLifeSCOPE (chest band) (Fig. 5[3];[4]; Fig. 16; Fig. 31)" described elsewhere in this patent application document; - Optionally, the forehead-mounted electrodes can include the effective range of part or all of the head, forehead and / or face; - By means of an option of a self-adhesive forehead-mounted strip, a pressure interface for achieving a high-quality electrode connection is not required to monitor sleep parameters from the forehead of a patient / subject; - Option of a disposable self-adhesive forehead-mounted strip.

[0089] b) Reusable or disposable sensors The present invention provides an option of a disposable self-adhesive forehead-mounted strip having an electrode inserter device, the electrode inserter device being able to automatically discard an old sensor and replace it with a new sensor;

[0090] c) Reusable or disposable sensor automatic reload inserter device The present invention provides an option of a disposable self-adhesive forehead-mounted strip having an electrode inserter device, the electrode inserter device being able to automatically discard an old sensor and replace it with a new sensor, and said sensor insertion device being part of a packaging system for a pack of new self-adhesive sensors.

[0091] The present invention provides an option of a disposable self - adhering forehead - mounted strip with an electrode inserter device, the electrode inserter device being able to automatically discard an old sensor and replace it with a new sensor, said sensor insertion device being part of a packaging system for a pack of new self - adhering sensors, said insertion device being able to (but not limited to) a) enable the replacement of the monitoring sensor from the forehead monitoring strip, b) - the sensor insertion and removal process removes the used sensor, safely stores and accommodates it, while then fitting a new sensor, and by an optional single - push operation, discards the old sensor and refills with a new sensor; including any one or any combination of these;

[0092] For example, the forehead sensor strip can be press - loaded and then drawn in from said sensor inserter device as a means (i.e., a spring - stress inserter mechanism propels a new replacement sensor onto the forehead sensor holder device while simultaneously removing and discarding the used sensor. Next, the refilled sensor and the forehead sensor can be removed by pressing a single - push button / lever to access the refilled sensor system.

[0093] Thus, the packaging of the disposable electrode can be loaded into the sensor refill device, and by a single - push operation, it is possible to remove and discard the used sensor from the Somfit device, while removing the backing paper of the new sensor for adhesion preparation to the Somfit device. Then, while inserting the Somfit into the sensor inserter device, a further spring - type mechanism is activated at the downstream end, the new sensor (with the backing paper peeled off here) is pressured by the sensor spring - type mechanism, and finally, when the Somfit is removed from the sensor inserter device, it brings the loaded sensor. Optionally, a quality control code is transmitted from the inserter device, the operation is verified, and in case a fake sensor is used, a warranty violation and a danger code are sent.

[0094] The present invention provides continuous and uninterrupted monitoring of sleep parameters, which includes (but is not limited to) online accurate, continuous, and uninterrupted sleep / wake hypnograms and EEG, EMG, EOG monitoring for related sleep quality determination and guidance, and / or any or any combination of intelligent clock interfaces (i.e., wristwatch or alarm clock settings).

[0095] d) Continuous online monitoring of sleep parameters (EEG, EOG, EMG) and sleep analysis The present invention provides continuous EEG monitoring and related analysis, which can determine epochification (time period segmentation) and epoch-based sleep stages (i.e., but not limited to, N1, N2, N3, REM, etc.) and / or sleep events (i.e., but not limited to, spindles, K-complexes, spikes, alpha bursts, body movements, awakenings, etc.) and / or sleep measurements (i.e., but not limited to, the measurements dealt with in other parts of the item) or indices (i.e., but not limited to, sleep efficiency / SE, wake after sleep onset (WASO), respiratory event-related arousal (RERA), treatment event-related arousal (TERA), apnea / hypopnea index (AHI), sleep disorder index (SDI), respiratory disturbance index (RDI), sleep fragmentation, the proportion and amount of each sleep stage, total sleep time (TST), hypopnea during sleep, regression factors of post-sleep regression syndrome, residual daytime sleepiness (RDS), arousal index (AI), and, but not limited to, the frequency and other sleep measurements of sleep disorders or other notable events (i.e., including those containing the "definitions" of notable events described in other parts of this document)).

[0096] The determination of the epochs includes segmenting the data within a time block such as 20 to 30 seconds.

[0097] The epoch-based sleep stage determination can include local (a microprocessing device or DSP system forming part of the monitoring sensor or device) and / or available communication media, networks, or other interconnection options (including simultaneous interconnection with additional or further communication networks, systems, or other interconnection options such as WWW, IP, LAN, WAN, additional / comparative monitoring / detection or computing systems, SAAS, etc., where the SAAS includes cloud computing services or NAS or peer-to-peer connections).

[0098] e) Wearable monitoring The wearable monitoring (including portable wireless interconnection options) device or related system of the present invention can include any one or any combination of the exemplary monitoring embodiments according to FIGS. 1 to 94.

[0099] f) Exchangeable / replaceable parts with dynamic data exchange The present invention incorporates means for connectivity and / or means for exchangeable parts between two or more wearable devices / systems as a means to enable information access applicable to sleep health and overall health, and the present invention includes any one or any combination of the following.

[0100] The "connectivity means" can include available communication media, networks, or other interconnectivity options (including simultaneous interconnection with additional or further communication networks, systems, or other interconnection options such as WWW, IP, LAN, WAN, additional / comparative monitoring / detection or computing systems, SAAS, etc., where the SAAS includes cloud computing services or NAS or peer-to-peer connections), various data communication channels and / or different media, cellular networks, optical communication networks, Wi-Fi, blue-tooth, satellite, SMS, copper communication networks, Wi-Fi, pager alerts, automatic telephone alerts, calendar updates, connectivity with social or work information interfaces, etc., or any combination thereof.

[0101] The "interchangeable component" can comprise attachment means (i.e., without limitation, connection, mechanical connection, adhesive connection, connection of materials or objects, etc.), or electronic elements or components of a first wearable device having interconnectivity with a second wearable device and / or other nearby devices.

[0102] The "means for enabling access to information applicable to sleep health and overall health" can include sharing, exchanging, indicating, displaying, data storing, data processing, derivation of indices, of sleep monitoring parameters or related measured derivatives (i.e., EEG, EOG, EMG, respiratory sounds, room or environmental sounds, room light conditions, air flow, reflectance photoplethysmography oximetry and related outputs (pulse wave amplitude / PWA, *pulse arterial tension / PAT, pulse arterial tension / PTT, an oscillatory amplitude autonomic marker of obstructive apnea enabling discrimination from central apnea (i.e., increased activity of respiratory muscles induces further blood flow which appears as discriminable oscillations or amplitude variations and can be detected by use of signal morphology, spectral and other event extraction techniques), and combinations of other monitored sleep parameters or related measurements outlined elsewhere in this document) and other health monitoring parameters or related measurements.

[0103] The present invention provides that "individual or combined sleep and / or health and / or fitness measurements and / or information" are indicated or displayed as part of any wearable device (i.e., list device, wristwatch, clock, etc.).

[0104] The "means for enabling access to information applicable to sleep health and overall health" can include dynamic exchange (i.e., dynamic data exchange / DDE) data including any of the said "individual or combined sleep and / or other health and / or fitness measurements and / or information" or other health states or progress.

[0105] g) Infrared respiratory / thermal airflow or body heat flux monitoring The present invention can incorporate one or more "mounted infrared" respiratory monitoring sensors and / or skin heat flux monitoring centers (for the energy dissipation or calorie combustion / metabolic activity of the body of interest).

[0106] IR sensor / lens In one embodiment of the present invention, one or more infrared sensors with optional associated lenses can be provided, whereby the sensors are incorporated as part of the forehead sensors that can be placed and are targeted at detecting the respiration of the subject and related respiratory disorders.

[0107] IR lens The "infrared sensor" can be incorporated with one or more lens systems, and the lens systems can be focused on the thermal changes associated with the inhalation and exhalation of the mouth and / or nose respiration of the subject directed towards the infrared sensor.

[0108] IR heat The "infrared sensor" can include (but is not limited to) any one or any combination of thermal sensors of the photodiode, photoconductive, photovoltaic, pyroelectric type.

[0109] Photonic The "infrared sensor" can include a photonic (photodetector), and the photonic includes (but is not limited to) any one or any combination of a charge-coupled device or a complementary metal-oxide-semiconductor (CMOS).

[0110] h) Body position and / or location and / or movement The present invention can incorporate one or more body / position sensors of the subject / patient.

[0111] i) Movement and / or motion The present invention can incorporate one or more movement and / or motion sensors (i.e., one or more accelerometers, but not limited to) detailed elsewhere in the section entitled "Position, Location and Movement Detection and Monitoring".

[0112] j) Oximeter and / or PPG The present invention can incorporate one or more attachable photoplethysmography (PPG) sensors (s) with an optional plethysmography measurement function, and / or one or more reflective oximeters (s), which are detailed elsewhere in the section entitled "Capacitive Plethysmography Measurement Oximetry and / or Photoplethysmography (PPG)".

[0113] k) Forehead or head or body-mounted hot air flow monitoring Wearable sound monitoring (i.e., but not limited to, a forehead or head or body-mounted microphone) incorporates a combination of breath sounds (i.e., but not limited to, a microphone) and other physiological signals (i.e., but not limited to, hot air flow monitoring including an infrared sensor capable of tracking changes in air flow temperature related to the breathing subject / patient) as a means of distinguishing the subject / patient / user of interest from other people (i.e., but not limited to, the snoring of a sleeping partner).

[0114] The present invention combines one or more wearable monitoring systems (i.e., but not limited to, a sound or heat monitoring sensor (s) and / or a head-mounted or applied device having one or more microphone sensors capable of distinguishing two or more sound sources for detecting the breathing sounds of one or more subjects / (s) / patients / (s) / individuals / (s) / users / (s).

[0115] - The means for monitoring breath sounds (i.e., a criterion for monitoring any or any combination of sounds, air flow, and thermal breathing characteristics related to inhalation and / or exhalation and / or inhalation and / or nasal inhalation and / or oral inhalation of the subject / partner / user) can incorporate breath tracking in combination with other sleep breathing disorders, such as in the case of hypopnea (i.e., but not limited to, a decrease in breathing over a certain period) and / or apnea (a cessation of breathing for a certain period) and / or hypoxemia (i.e., but not limited to, the persistence of decreased breathing). Such monitoring can incorporate means for determining one or more sleep / wake states or stages of the subject / patient / user.

[0116] l) A forehead sensor having multifunctional physiological parameters applicable to the diagnosis and prediction of the true homeostasis sleep / wakefulness, circadian clock, and related sleep disorder elements of a subject / patient The present invention incorporates means for monitoring any one or any combination of sleep parameters (i.e., EEG, EOG, EMG), and involves (but is not limited to) any one or any combination of the following monitoring, determination, and / or tracking, providing a wearable forehead sensor (one or more sensors and / or electrophysiological electrodes) strip sleep monitoring system.

[0117] Sleep disordered breathing monitoring and determination of related events (i.e., microphone and / or thermal respiration determination - i.e., infrared respiration detection) and / or environmental light detection (i.e., a photoresistor enabling the calculation of sleep efficiency and other measurements).

[0118] Body temperature measurements applicable to the estimation or determination or contribution to circadian clock cycle calculation.

[0119] One or more "clock" determinations (circadian clock (CC) elements (and for the subject / individual's travel, work, social, relationships, schedule (i.e., any one or any combination of (but not limited to) sleep / wakefulness, work, social activities, leisure, relaxation, sports or exercise activities); "clock" refers to the daily or weekly schedule following the individual's social schedule (i.e., "social clock") or work schedule (i.e., work clock) or itinerary / schedule (travel clock), etc.).

[0120] Determination of environmental time (i.e., via integrated GSM, GPS information access, or interconnection with mobile devices, clocks, clock settings, clocks, or time applications, etc.).

[0121] Monitoring, determination, and / or tracking of activity or movement detection as actigraphy and / or measurements of patient position.

[0122] Circadian clock cycles or deviations and other elements related to an environmental clock, time zone conditions and / or other applicable subject / user time elements (i.e., social clock, work clock, leisure clock, sleep / wake clock, and CC and the risk of sleep quality (i.e., due to asynchrony with CC), the risk of sleep drive (i.e., previous sleep / wake history information), a calendar or schedule or itinerary information access enabling determination of results including no risk of sleep duration vs. sleep quality due to CC deviation elements or deviation from synchronization or cues).

[0123] An audio envelope analog signal or digital data processing function (i.e., the ability to track an audio envelope, e.g., in terms of more advanced bandwidth audio waveform signal processing where memory storage and processing requirements would otherwise be prohibitive (i.e., as a data reduction mechanism for sleep apnea monitoring, the audio envelope can be extracted before or after data acquisition, signal processing or memory storage).

[0124] In a further option, incorporate a forehead oximeter (including a reflectance photoplethysmography measurement option having a function to derive an oximeter output, where the oximeter output includes means to distinguish apnea (i.e., occurrence of photoplethysmography waveform oscillations corresponding to evidence of autonomic disorder during obstructive sleep apnea syndrome) including any one or any combination of pulse wave amplitude (PWA), pulse arterial tension (PAT), characterization of photoplethysmography amplitude).

[0125] A wearable forehead strip sleep monitoring system incorporates active circuit elements and can be exchanged with a wrist-mounted monitoring system (i.e., including interaction with mobile phone motion detection as a criterion for symmetry and / or synchrony of movement, position, gait (gait applicable to neurological disorders such as movement or gait dysfunction in Parkinson's disease) and arm movement).

[0126] Multi-axis accelerometer (i.e., gait / fall / cardiovalistogram; spectral segmentation according to the primary energy band of various monitoring targets such as stride objectivity or synchronization between the target's distal end or limb and the body) or characterization of the movement, body movement, and body vibration of the target by using a plurality of single-axis or multi-axis accelerometer sensors can monitor and determine any or all combinations of physiological or movement monitoring of the target / patient, including any of the following or all combinations. 1) Cardiovalistogram via detection of heartbeat fluctuations, etc.; 2) Body position / pose of the target / patient; 3) The gait or stride characteristics of the target include, but are not limited to, stride objectivity or synchronization between the target's distal end or limb and the body applicable to tracking activities or impairments (i.e., movement disorders in Parkinson's disease); 4) Footsteps of the target / patient during walking, jogging, or running; 6) Determination of falls / stumbles / staggers;

[0127] "Means for monitoring and / or characterizing the movement, body movement, and body vibration of the target by using a multi-axis accelerometer" can include any of the following or all combinations.

[0128] The first step includes monitoring the target by one or more physiological signal channels, and the physiological signal channels include sensor monitoring channels for motion detection (i.e., accelerometers on one or more axes), cardiovalistogram measurement, and pressure sensor channels such as pulse or eye pressure blood pressure changes.

[0129] The second processing step (sensor signal processing) involves signal processing (i.e., amplification and / or filtering of the accelerometer) of one or more signals from a single-axis or multi-axis (i.e., three or more axes without limitation) accelerometer.

[0130] The third processing step (acquisition) involves acquisition (i.e., similar to signal acquisition or digital data acquisition according to sensor format or requirements).

[0131] A further fourth processing step (Analysis - Spectrum Option) involves, in terms of the signal source (i.e., in terms of the association of the differentiated movement signal according to movement characterization and the relevant movement sources such as the objectivity and / or synchrony of stride and arm movement applicable to neurological disorders such as movement or gait dysfunction in Parkinson's disease), FFT or other analysis correlation or dispersion techniques between two or more sensor outputs, amplitude or power analysis designed to characterize the characteristics of the movement, body movement, and body vibration of the subject; fall detection; activities with associated muscle tone (i.e., REM sleep without atonia) versus idiopathic RBD; footstep; movement; hyperkinesia (exaggeration of unnecessary movement) such as dystonia or writhing in Huntington's disease or Tourette syndrome; tremor or other movement; diagnosis and treatment of movement disorders including Parkinsonian tremor, restless legs syndrome, dystonia, Wilson's disease or Huntington's disease; slowness of movement (i.e., slowness of motion) and abnormal movement (i.e., voluntary movement; reduction of involuntary movement), incorporating, without limitation, any or any combination of the analysis techniques addressed elsewhere in this document including Figures 1 to 99, in particular, variants of the analysis applicable to a gait or movement analyzer including, for example, determination of the onset signs of Parkinson's disease and / or complex SBD sleep behavior disorder (Figure 45[5]), Figure 75

[20] ;

[22] ; "excessive movement associated with muscle process disorders such as REM without atonia, restless legs syndrome, fibromyalgia, etc. as in the case of RBD"; the headings "Movement Detection and / or Actigraphy", "REM Sleep Behavior Disorder (RBD)", "Other Wrist - Worn Devices (Band or Bangle) with Integrated Pulse Sensor Watch"; "Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV) Monitoring and Analysis Function"; "PWA and PWV Sensors; "Pulse Wave Analysis (PWA) Sensor Measurement"; "Electrocardiography"; "Detection and Monitoring of Position, Location and Movement"; "Movement and Location Information"; "Tracking of Gait or Movement and Characterization of Notable Events", which are further detailed and addressed elsewhere in the section "eLifeCHEST / eLifeSCOPE" of this document.

[0132] In a further fourth processing step (analysis spectrum option), between two or more sensor outputs, amplitudes or power analyses designed to characterize the characteristics of the movement, body movement, body vibration of the subject in terms of the signal source (i.e., in terms of the associated movement sources such as the differentiated movement signal according to movement characterization, and the objectivity and / or synchrony of the stride and arm movement applicable to neuropathy such as movement or Parkinson's disease gait dysfunction, etc.); FFT or other analysis correlation or dispersion techniques; fall detection; activities associated with related muscle tone (i.e., REM sleep without atony) vs. idiopathic RBD; foot placement; movement; hyperkinesia (exaggeration of unnecessary movement) such as dystonia or writhing in Huntington's disease or Tourette syndrome; tremors or other movements; diagnosis and treatment of movement disorders including Parkinsonian tremors, restless legs syndrome, dystonia, Wilson's disease or Huntington's disease; slowness of movement (i.e., slowness of movement) and abnormal movements (i.e., voluntary movements; reduction of involuntary movements), including but not limited to any or any combination of the analysis techniques dealt with elsewhere in this document including Figures 1 to 99, in particular, variants of the analysis applicable to a gait or movement analyzer including, for example, the determination of the onset symptoms of Parkinson's disease and / or complex SBD sleep behavior disorder (Figure 45[5]), Figure 75

[20] ;

[22] ; "excessive movements related to muscle process disorders such as REM without atony, restless legs syndrome, fibromyalgia, etc. as in the case of RBD"; headings "Movement Detection and / or Actigraphy", "REM Sleep Behavior Disorder (RBD)", "Other Wrist-Worn Devices (Band or Bangle) with Pulse Sensor Integrated Watch"; "Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV) Monitoring and Analysis Functions"; "PWA and PWV Sensors; "Pulse Wave Analysis (PWA) Sensor Measurement"; "Electrocardiography"; "Detection and Monitoring of Position, Location and Movement"; "Movement and Location Information"; "Tracking of Gait or Movement and Characterization of Attention Events", which are described in more detail and dealt with elsewhere in the section "eLifeCHEST / eLifeSCOPE" of this document.

[0133] In the fourth processing step, the movement and / or patient position analysis techniques include any or all combinations dealt with elsewhere in this document, including but not limited to "detection and monitoring of position, location and movement", "movement and location information", and "tracking of gait or movement and characterization of events of interest" dealt with elsewhere in the section "eLifeCHEST / eLifeSCOPE" of this document. These analyses can be applied to any or all combinations of sensor outputs (i.e., including multiple accelerometer axes).

[0134] In the fourth processing step, it can include gyro-sensor position output as measurements of the subject / patient's gait and / or smoothness and / or stagger or walking (based on vertical or horizontal positioning), and the movement and / or patient position analysis techniques include any or all combinations of the analysis techniques dealt with elsewhere in this document, including but not limited to the provisions further detailed in the heading "detection and monitoring of position, location and movement" dealt with elsewhere in the section "eLifeCHEST / eLifeSCOPE" of this document.

[0135] In the fifth processing step, the analysis results can be developed as part of the prediction or diagnostic decision for the subject / individual.

[0136] In the sixth processing step, the analysis results and / or related results can be distributed as messages, events, calendar information or data access, information networks (social, work, occupation, etc.).

[0137] Local environment and / or sleep / wake / activity / work for circadian temperature cycle determination The gist of the personal health management system of the present invention is to automatically determine and display guidance, warnings, messages, CC synchronization stimuli applicable to the subject / patient / user, and the CC synchronization stimuli are based on a series of scenarios including input elements, interrelationships or the quality and length of sleep related to the manner in which the subject copes with natural CC.

[0138] Furthermore, the present invention can provide for intervention by a device wearable by a subject, or several entrainment scenarios such as environmental lighting as a means for advancing or delaying the phase response curves of various subjects (i.e., subject-integrated circadian curve phase relationships having external clock elements according to social, time of day, work, work shift, study requirements, etc.), and is applicable to minimizing Delayed Sleep Phase Disorder (DSPD) or Advanced Sleep Wake Phase Disorder (ASPD) according to the medical supervision or intervention of the subject and / or personal preferences or requirements and / or occupational risks, safety considerations.

[0139] The present invention can activate the intensity and type of light via automatic or manual assistance (i.e., for longer wavelength light, visible blue light having a shorter wavelength, and a higher intensity melatonin-suppressing effect can be developed as part of an automatically calculated CC entrainment treatment plan) and the time adjustment function of such light therapy (i.e., evening light therapy can delay the CC phase while midday light therapy can bring about an advancement of the CC phase).

[0140] The present invention can automatically (or via a manual intervention option) control entrainment elements (i.e., lighting time adjustment and / or lux intensity and / or melatonin dosage and dosage time adjustment or recommendation) and, optionally, recommendations or settings for bedtime or wake-up clock settings according to the social, work, travel requirements or environmental elements of the subject / patient (or medical advisor).

[0141] The present invention can advise / guide and / or automatically adjust the CC entrainment according to the preferences, choices or personal scenario selections of the subject / patient / user (i.e., more aggressive adjustment over a shorter number of days, or a more gentle CC adjustment over a longer number of days).

[0142] The present invention can automatically access a travel schedule based on any or any combination of these or other CC and sleep homeostasis elements below: > Sleep duration; > Sleep time; > Bedtime; >Quality of sleep; >Sleep drive or deficit >Work clock, social clock; >CC phase deviation by any of the other said clocks: >Alarm clock setting: >Visual commentary by a map application showing possible CC adjustment results such as various travel schedules, and jet lag factors that vary between east-to-west travel and west-to-east travel; >Various travel schedules, etc. In one embodiment, the present invention can automatically access or interface with travel information related to one or more trips as a means of generating an optimal itinerary according to the peak energy CC level of the subject or CC synchronization options or optimal subject / patient / user performance results from the perspective of the optimal sleep bedtime and / or sleep duration of the subject; >The schedule interface for the travel scenario is based on the user's preferences in terms of prioritizing the said elements, various alarm clock schedule scenarios; >Various map applications include comments or related information comments on other environmental clocks / jet lag / social / work / sleep deficit-drive / sleep duration / quality of sleep, etc. for CC; >Alarm clock schedule scenarios are applicable to the individual subject / patient / user preferences for sleep CC pair, social clock, work clock, solar clock, time zone clock, sleep duration, quality of sleep, bedtime, sleep duration, taking into account known things such as sleep, based on the prioritization of the said elements for the subject / patient / user.

[0143] The present invention can measure environmental lighting conditions, is applicable to a subject / patient / user (i.e., via a wearable device such as a watch, mobile device, etc.), provides guidance or advice, treats winter depression or other forms of depression or Delayed Sleep Phase Disorder (DSPD), or compensates for the deviation between the CC and the environment (i.e., time zone or social clock element or behavioral clock characteristic (i.e., social clock, work clock, work shift, travel / jet lag clock, clock and related requirements or preferences of the plan / schedule)), and the guidance can include CC deviation therapy (i.e., light therapy, melatonin drug therapy, and can include the adaptation of the homeostatic sleep element (i.e., optimally increasing the waking time of the subject / patient / user, enabling high-quality sleep, and the alignment of the CC by the sleep pattern (and vice versa)).

[0144] The present invention can automatically incorporate all CC synchronization elements, display modes, wake-up clock functions, light detection functions, guidance and / or messaging and / or warning functions into a single application or as part of a wearable or mobile device.

[0145] The present invention can determine the circadian clock nadir element (i.e., the interval from body temperature and / or the nadir of body temperature to sleep deviation), and the circadian clock nadir element includes the Delayed Sleep Phase Syndrome (DSPS) of the subject / patient / user, optimizes CC synchronization (i.e., includes light therapy that projects blue light as a stimulus towards the retina of the subject / patient / user - the blue light can be blocked from the forward projection based on the shaded or blocked section above the glasses, minimizing the disturbing or intense nature of such treatment), exposure to light before the nadir of the central body temperature rhythm can cause a phase delay, while light therapy (high-intensity light therapy) administered after the nadir can cause a phase advance.

[0146] The present invention can track the sleep-wake rhythm and characterize the absence of an clearly distinguishable circadian pattern of sleep-wake times as a marker or potential prediction.

[0147] The present invention can track the sleep-wake rhythm and characterize the lack of a clearly distinguishable circadian pattern of sleep-wake times as a marker or potential prediction of work shift disorder (SWD), and / or questionnaire results related to excessive sleepiness, non-refreshing sleep and / or insomnia that vary according to the work schedule.

[0148] Circadian algorithm; Modeling of circadian-autoregressive analysis with situation analysis Conventional scientific laboratory standards for circadian clock temperature cycles suggest that in-body measurements (rectal temperature probe monitoring) are generally not suitable for daily or circadian monitoring, while the gist of the present invention is to enable the derivation of an individual's (subject / patient / user) natural and unique (endogenous) circadian temperature by means of circadian autoregressive analysis modeling with one or more external inputs (CRX).

[0149] The circadian autoregressive analysis modeling can incorporate situation analysis.

[0150] a) Circadian algorithm processing: Situation analysis The situation analysis (but not limited to) can include, in one exemplary embodiment of the model, inputs to the model that include an individual's unique circadian rhythm clock information, and the individual's unique circadian rhythm clock information can include (but not limited to) any one or any combination of the following.

[0151] b) Circadian algorithm input; Survey(s) or tracking subject / patient information Input data by patients or other persons based on survey(s) or tracking subject / patient information, Epworth Sleepiness Scale or other surveys / scales / measurements, or sleep tendency or sleepiness information such as daily sleep, wakefulness, work, leisure and / or other active daily life, health applications, calendars, schedules, health applications, similar data obtained from applications such as wearable or portable devices, etc.

[0152] c) Circadian algorithm input: Sleep survey information Data is accessed by computer assistance related to sleep survey information or is input automatically or manually.

[0153] d) Circadian algorithm input: sleep monitoring survey or application Data is accessed by computer assistance related to a sleep monitoring survey or application related to the monitoring system, application, or other application functions of the present invention (i.e., not limited to those further outlined elsewhere in this document, etc.) or is input automatically or manually.

[0154] e) Circadian algorithm input: information related to fitness, health monitoring, and / or related applications Information is related to fitness, health monitoring, and / or related applications related to a sleep monitoring survey or application related to the monitoring system, application, or other application functions of the present invention (i.e., not limited to those further outlined elsewhere in this document, etc.), and data is accessed by computer assistance or is input automatically or manually.

[0155] f) Circadian algorithm input: circadian algorithm input information or derivation of information based on sleep, fitness, or other health applications, devices, and / or systems Information or derivation from any combination of information such as (but not limited to) watches or mobile phones or other software applications or systems related to the activities, sports, work, sleep, wakefulness, alarm clocks, schedules or routines, or time adjustment data of the subject / patient.

[0156] g) Circadian algorithm input: local or new time zone information Local or new time zone information (i.e., not limited to GSM, GPS, radio clocks, or other time adjustment sources).

[0157] h) Circadian algorithm output: phase shift between the proprietary circadian clock and the local environmental time zone The output of the situation analysis model can, in one example embodiment of the model, include any or any combination of the following (without limitation): - The phase shift between the endogenous circadian rhythm and the local environmental time zone characteristics, or the associated subject / patient schedule or required routines and / or time periods.

[0158] i) Circadian algorithm output: Circadian algorithm output: Optimal wake-up clock or scheduling guidance or recommendations Guidance or recommendations for an optimal wake-up clock or scheduling or time management manner based on any or any combination of the model inputs;

[0159] j) Circadian algorithm processing: Autoregressive estimation of the natural or endogenous estimation for the local or new environmental circadian clock / rhythm - Autoregressive estimation of the natural or endogenous subject / patient circadian clock / rhythm; - Autoregressive estimation of the subject / patient circadian clock / rhythm in the local or new environment.

[0160] k) Circadian algorithm processing option: By autoregressive estimation / determination of the wearable or attachable temperature sensor / probe of the subject, the low-pass filter function can emphasize the low-frequency periodic changes and derive the natural / endogenous or new environmental circadian clock / rhythm state or requirements. The autoregressive analysis can be performed on the wearable or attachable temperature sensor / probe of the subject, and the low-pass filter function can emphasize the low-frequency periodic changes (i.e., the external environment or shorter-term activities or exercises unrelated to the circadian body temperature change with respect to the 24-hour circadian body temperature change).

[0161] l) Circadian algorithm input: "External input" includes the derivation of the natural circadian clock The "external input" can include any or any combination of the following (without limitation): - Derivation of the natural or natural circadian clock (i.e., by any or any combination of temperature measurement values and / or EEG measurement values).

[0162] m) Circadian algorithm processing option: New environment or 24-hour cycle of time zone - New environment or 24-hour cycle of time zone (i.e., based on the determination of GSM, GPS, radio clock, mobile phone or clock, etc.).

[0163] n) Circadian algorithm input: Actual sleep monitoring sleep / wake cycle The actual sleep monitoring sleep / wake cycle of the subject / patient (including, but not limited to, sleep parameter-based (i.e., including any or any combination of EEG, EOG, EMG measurements and related sleep stages or sleep cycles or sleep hypnogram derivations)).

[0164] o) Circadian algorithm input: Existing known knowledge based on the relationship between sleep / wake Existing known knowledge based on the relationship between sleep / wake and the natural periodic circadian clock and / or sleep cycle and / or body temperature cycle (i.e., low body temperature during REM sleep, etc.). A collection of knowledge (i.e., knowledge accumulation, and information transfer to knowledge by self-learning functions of artificial intelligence or expert systems, Figure 77, knowledge base, real-world input, inference engine and workspace: Figure 78; Figure 79, from the central block to Figure 80,

[12] ,

[13] , "14").

[0165] p) Circadian algorithm input: "Temperature sensor / probe that the subject can wear or attach" The "temperature sensor / probe that can be worn or attached to the subject" can include any one or any combination of one or more temperature sensors that are attached or embedded as part of a small earphone / earplug in combination with an auditory monitoring function described elsewhere in this patent. Further, the present invention can further define the external temperature by one or more temperature sensors arranged to detect the current ambient temperature (i.e., incorporated as part of any one or any combination of wearable devices / probes (i.e., watches, mobile phones, small earphones, chest wall monitors, armband monitors, head, body extremities, body outlets, etc.)).

[0166] q) Circadian algorithm processing option: Mapping of the body's transition state or short-term variations Furthermore, for further mapping of the body's transition state or short-term variations (such as by gymnastics, etc.) and the central circadian-related temperature, the CRX analysis of the present invention can compare and contrast heat flux measurements, the external environment, body temperature, and skin temperature measurements (i.e., for example, as just one example, a temperature probe directly above the skin surface can reflect the heat flux emitted from the skin surface, while a deeper small earphone measurement reflects body temperature more, and in contrast, an external ambient temperature sensor is not as closely related to the temperature change).

[0167] Circadian temperature Circadian algorithm processing option: Wearable health monitoring and / or tracking system / device The present invention provides a circadian function within a wearable health monitoring and / or tracking system / device, and such a function includes any one or any combination of the following.

[0168] a) Circadian algorithm: Monitoring of physiological variables (plural possible) related to natural (intrinsic) wearable health monitoring, tracking, and time management elements, determination and / or guidance of the local time of the subject / patient and / or the current or required routine sleep / wake / work / leisure cycle. Means for monitoring physiological variables (plural possible) related to natural (intrinsic) or related elements (i.e., sleep / wake) and / or required time management elements (external elements; wake, sleep, work, leisure, etc., schedule and related time or performance management requirements) that affect the said "intrinsic" circadian cycle (i.e., EEG, temperature, sleep / wake stage determination or related cycle; noise, activity, etc.).

[0169] b) Circadian algorithm output: "Self-running" or intrinsic circadian rhythm cycle; Means for determining the "self-running" or "intrinsic" circadian rhythm cycle of the subject / patient (i.e., by analysis of monitoring circadian rhythm physiological parameters of underlying periodic tendencies).

[0170] c) Circadian algorithm processing option: Determination and / or guidance of the local time of the subject / patient and / or the current and / or required and / or optimal routine sleep / wake / work / leisure cycle. Means for determining and / or guiding the local time of the subject / patient and / or the current and / or required and / or optimal routine sleep / wake / work / leisure cycle (i.e., through such elements - i.e., alarm clock, time zone clock, GPS or GSM location information, clock related to sleep questionnaire / survey, wristwatch, information accessible or input by the subject / patient or others).

[0171] d) Circadian algorithm processing option: Comparison and / or contrast of the synchronization of environmental time zone elements with the natural "intrinsic" circadian cycle of the subject / human Means for comparing and / or contrasting the natural "intrinsic" circadian cycle of the subject / human at any time with the required or current or new environmental sleep / wake cycle requirements or expectations of the said subject / human at any time.

[0172] e) Circadian algorithm processing option: Analysis of the phase difference between the said "intrinsic" natural sleep / wake cycle time and the current or required sleep / wake cycle time Means for analyzing the phase difference related to the said "intrinsic" natural sleep / wake cycle time and the current or required sleep / wake cycle time (i.e., by any one or any combination of a table or graph or user interface, or a two-way user interface, vibration or sound or other notification or warning means, covering or incorporating a link or circadian "intrinsic" clock and / or any other clock or time adjustment information on the watch face), resulting in a measured value of the "required" deviation time element with respect to the circadian "intrinsic" deviation time element.

[0173] f) Circadian algorithm output: Supply of external circadian stimuli External stimuli (i.e., means for supplying temperature changes related to wearable, environmental, bed or bed material or bedroom, etc., or output related to lighting and / or light related to color and / or frequency).

[0174] g) Circadian algorithm output: "Circadian deviation time element" Means for incorporating a measured value of the circadian deviation time element as part of a biofeedback or control decision matrix by applying an external stimulus to the said subject / patient, and minimizing the said "circadian deviation time element".

[0175] h) Circadian algorithm input: Mounted temperature sensor for circadian rhythm determination The present invention can incorporate one or more mounted temperature sensors for circadian rhythm determination and / or (but not limited to) other physiological measurements, and optionally has a capacitance plethysmogram measurement format further detailed in the "Temperature" section of Chapter eLifeCHEST / eLifeSCOPE, or Chapter eLifeBUDS, and other places in this document that explain temperature monitoring and analysis.

[0176] Circadian EEC EEG brain region monitoring targeting forward equalization, including circadian clock function The present invention incorporates forward uniform source location identification such as monitoring and derivation of measurement values related to the natural circadian rhythm of a subject / patient (but not limited to), and monitors related brain regions (i.e., the suprachiasmatic nucleus (circadian clock) region) applicable to circadian EEG cycle signals (for example, for determining the circadian clock cycle of the subject / patient).

[0177] In one example of an embodiment based on an EEG sensor monitoring system configuration (i.e., but not limited to, examples according to FIGS. 1 to 3, FIGS. 5, 14, 16, 21, 23, 25, 27, 28, 46 to 55), in combination with the present invention that monitors a target and monitors related wearable monitoring minimization calculations (FIG. 45), the present invention can calculate and determine sensitivity and / or filtering and / or other processing formats (including any or any combination of interconnectivity of NLDBTV, STV, SR, ER, ER clusters, SR clusters, spectral EOI, the above (i.e., coherence and / or dipole sequences and / or related clusters, sequences and / or ensembles)), and / or neurological amplitudes, powers, morphological signals or values) in the context of optimal forward uniformization in combination with corresponding nerve channels (or physiological channels of applicable scenarios), most effectively "point out" or locate the anatomical source of interest (i.e., the circadian clock EEG signal), contribute to, for example, the determination of the human phase sleep-wake clock, and can be used as part of a therapeutic agent, light therapy, or other sleep guidance or recommendation suggestions to re-align the circadian clock or sleep-wake phase cycle of the subject / patient.

[0178] Circadian source location identification based on pre-diagnosis The present invention incorporates EEG monitoring and source location identification means. The source location identification includes source reconstruction based on research of the subject / patient by pre-diagnosis or general population data based on the signal source or brain source of interest.

[0179] In this way, the spectrum and sensitivity characteristics of signal processing are applicable to a plurality of sensors (including, but not limited to, FIGS. 3, 4, 21, 23, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56). For example, based on the modeling of EEG signal attenuation in the skin layer, skull, and brain parenchyma, in combination with the EEG electrode position and a specific distance from the target brain region to be monitored, each EEG sensor can specify the sensitivity (amplification) and spectrum (filtering) characteristics according to the EEF forward source reconstruction, where the neutral origin is known, but the head surface electrode position signal can be calculated (using the forward uniform modeling). In this way, the present invention can provide optimal compensation. This is because the compensation is related to the electrode position designed for the convenience of the subject / patient (i.e., a wearable monitor minimization format such as that in FIG. 45, or a sensor configuration such as the Somfit frontal sensor according to FIGS. 16; 28[4]).

[0180] Using this forward uniform source reconstruction analysis method, the present invention can determine the optimal EEG signal processing applicable to specific (i.e., according to Somfit) electrode positions in the sensor monitoring system, and emulate the standardized AASM sleep monitoring manual recommendations (i.e., F4-M1; C4-M1; O2-M2; backup monitoring electrodes are F3-M2; C3-M2; o1-M2 including Somfit Fp1, Fp2, F7, F8 and / or Fz sleep monitoring electrode positions).

[0181] Using this forward uniform source reconstruction analysis method, the present invention can determine the optimal EEG signal processing (i.e., determine the adaptation of the frequency, phase, and / or amplitude of the sensor signal) applicable to specific (i.e., according to Somfit) electrode positions in the sensor monitoring system, and emulate the location of the relevant brain region (i.e., the suprachiasmatic nucleus (circadian clock) region) or other brain regions (i.e., including, but not limited to, the source position specific region in FIG. 66) applicable to the circadian EEG cycle signal (such as for determining the circadian clock cycle of the subject / patient).

[0182] Monitoring and tracking of the circadian clock Circadian-based sleep deprivation determination The present invention provides means for monitoring and displaying one or more measurements related to the circadian rhythm of a subject, including the incorporation of measurements of the subject's brain or temperature, as part of a wearable monitoring or portable wireless system, and the present invention can include (but is not limited to) any one or any combination of the following.

[0183] a) Temperature circadian clock measurement Short-term temperature changes over time such as temperature applicable to the subject's exercise or gymnastics (e.g., spontaneous or short-term measurements) may distort the more gradual changes in body temperature trends applicable to the circadian cycle in other cases, but means for monitoring or analyzing the subject's temperature (including, but not limited to, regression analysis, etc.) to determine the 24-hour periodic nature of the subject's body temperature. Thus, low-pass filtering of the temperature changes with respect to the 24-hour cycle, in combination with the exclusion of temperature measurements not applicable to the typical circadian cycle, can compensate and derive the underlying circadian cycle of the subject).

[0184] b) Brain / EEG circadian clock measurements Means for enabling circadian clock synchronization determination related to EEG incorporate the determination of the phase or rhythmic pulsation of signals from the circadian clock brain region via one or more monitored EEG signals. In the first processing step, the frequency or periodic nature of the circadian brain region (i.e., the suprachiasmatic nucleus (circadian clock) region) is applicable to the circadian EEG periodic signal, and the circadian EEG periodic signal is related to the determination of the circadian clock cycle of the subject / patient and / or the consciousness switch (i.e., the thalamus), or other brain regions (i.e., including, but not limited to, the source location identification region of FIG. 66).

[0185] The brain area can be monitored and / or analyzed as a means for calculating measurements of the sleep tendency of any subject (i.e., sleep deprivation; post-sleep regression syndrome; recommendations for sleep recovery). The present invention further enables means for analyzing the periodic nature of EEG signals generated from the human brain or body circadian clock, such that for a small sample, it is only necessary to monitor a continuous and uninterrupted circadian clock output signal, and to accurately calculate or infer the position of the period or phase at any time or period of the human body or brain circadian clock (body clock).

[0186] c) Determination of the circadian clock period, and incorporation with a portable or other map, calendar, messaging, community application The present invention can automatically determine, predict, and display the deviation between an individual's natural circadian cycle, sleep / wake pattern, and the schedule of travel, social, work, recreation, leisure, or other scheduled schedules.

[0187] That is, through the comments of the calendar application, a display regarding the individual deviation between the natural circadian cycle and the planned travel itinerary and activity / event schedule can be incorporated. For example, if an individual needs to attend a business negotiation after a certain period of travel at a future point in time, the present invention can consider the time zone change and travel schedule (i.e., automatically link to the travel website or the individual's managed flight schedule or the flight data of the travel agency), and then provide a measurement of the sleep impulse based on a series of assumptions or individual data input or selection or default elements. For example, if it is assumed that there is an important business negotiation following an 8-hour flight and the individual cannot obtain sleep time during the pre-negotiation flight, the present invention can estimate the likelihood of the sleep impulse during a meaningful period for the subject (i.e., based on the fact that there is no or almost no sleep time from departure to the scheduled negotiation, it is estimated that the individual may have a sleep tendency similar to staying awake until 3 hours after the normal sleep time or until 3 AM based on the normal sleep / wake cycle) (output blocks [4] to

[10] in Figure 96).

[0188] Similarly, from the point of view of optimal schedule determination for an individual's ability or mood factors and time efficiency factors, the present invention relates to an individual's a) schedule or tentative schedule (Figure 96[1]), b) itinerary (Figure 96[1]), c) natural circadian clock cycle (Figure 96[1]), d) homeostatic sleep / wake monitoring (i.e., including automatic access to the routine sleep monitoring function of the present invention and related individual's normal homeostatic sleep elements, and / or actigraphy, and / or environmental light conditions handled elsewhere in this document) (Figure 96[1]), e) preferences of the individual from the point of maintaining optimal sleep quality (i.e., adjusting to a new environmental time zone, considering previous sleep periods and current or expected sleep periods), or f) adjustment factors as a background from the points of time zone deviation and various adjustment periods, etc. (Figure 96[1]), g) preferences of the individual from the points of minimizing jet lag, social clock elements, work clock elements, and individual circadian clock elements (in terms of the accuracy of determining the individual's previous and latest circadian clock cycle states, backward phase, forward phase, stability and reliability levels of backward movement) (Figure 96[3]), based on the determination of any or any combination of these, enables the calculation and presentation of more complex scenarios (i.e., map settings or comments, calendar settings or comments, clock settings, alarms or comments).

[0189] The present invention enables the incorporation of all these functions and capabilities into one or more wearable or portable devices (i.e., smart watches, mobile phones, Somfit sleep monitoring headbands, and / or others handled elsewhere in this patent application document such as, but not limited to, the wearable device examples presented in Figure 1).

[0190] In another embodiment of the present invention, an individual (i.e., a traveler) incorporates CC calculation parameters as part of the automatic synchronization (i.e., according to FIGS. 96 [1], [7]) programming of a CC processing system (i.e., high-intensity light therapy including glasses or sunglasses (i.e., as an example, half-hidden glasses, glasses with a lightly colored upper part of the lens)), the glasses can include reflective eye movement recording (i.e., according to FIG. 43), and the reflective eye movement recording can be used as a sleepiness marker to detect the synchronization of light therapy and / or the movement and / or opening of the eyelids, enabling a biofeedback synchronization function to adjust the CC cycle deviation element and / or the sleep tendency and / or the sleep impulse element. For example, the present invention can incorporate a series of blue LEDs or other blue lighting configurations that are automatically controlled via a wireless interconnection, and based on the individual's current circadian clock and the calculations of the present invention regarding social, travel, time zone and / or work or leisure schedule / watch requirements, a synchronization treatment plan designed to allow the individual to select and adjust the circadian advance or alternation can be realized (i.e., according to FIG. 96 [1]).

[0191] Similarly, the present invention can be automatically linked (i.e., via wireless or other interconnection communication and information access means) to a messaging system (such as SMS of a mobile phone, email, calendar, application, etc.) when considering the individual's current circadian clock in terms of optimal ability, energy, sleep impulse, occupational health risk of sleepiness, indication of fatigue, and other elements that the individual may be interested in for activities, regarding social, travel, time zone and / or work or leisure schedule / watch requirements, enabling tracking and / or comment / health guidance and / or sleep scheduling (i.e., according to FIG. 96 [7]).

[0192] One embodiment of the present invention enables an integrated mapping application (i.e., a geographical map or a road map) or related displays or comments, incorporates, displays, or symbolizes additional notes or related information related to various travel scenarios (i.e., a single sine wave period with marked normal sleep periods and a new environmental time clock with respective start and end times corresponding to a new time zone environment), and displays the CC phase shift or clue elements so that an individual can associate a travel plan with a related itinerary having CC and jet lag elements.

[0193] Furthermore, the CC synchronization proposal / health guidance involves the estimation or speculation of sleep tendency elements or aspects of sleep quality (i.e., issues based on the phase relationship between the previous wake period of CC and the homeostatic sleep pattern). In this way, an individual can visually, automatically, immediately, integrally, or seamlessly (i.e., the personal portable planning application includes mapping or route setting related functions or applications or processes, wearable devices, etc.) associate a travel plan with the impact on related health management and preventive measures or countermeasures, and optimize the individual's sleep quality, sleep duration, sleep time adjustment, daytime energy, sleep tendency, mood, and other elements. Thereby, through the circadian health management system of the present invention (i.e., the health management system of block [3] in FIG. 96, and related inputs [1] and [2] and attached system options [3Α] and outputs [4] to

[10] ; FIG. 97, four-stage synchronization adaptation monitoring system), the understanding of information access can be clearly managed, improved, and controlled.

[0194] In one embodiment, the present invention enables an integrated calendar or scheduling / planning application(s) (i.e., geographical or roadmap) to display or comment and, optionally, display or symbolize (i.e., mark) additional notes or relevant information related to various travel scenarios (i.e., a single sine wave period with marked normal sleep periods and a new environmental time clock with respective start and end times corresponding to a new time zone environment), along with various (i.e., different legs or schedules for travel, social events, work events, study, etc.) CC phase patterns, CC phase lags, or adjustments / synchronizations (i.e., strategies involving melatonin dosage and timing adjustments and / or high-intensity light dosage and timing adjustments for treatment, etc.), which attempt to align these opposing time cycles (i.e., the inherent CC and the actions contrary to the social clock) (i.e., based on the natural CC wake / sleep requirements and the contrary clock time cycle requirements) and synchronize the CC phase pattern or phase lag elements.

[0195] In this way, an individual can visually, automatically, immediately, integrally, or seamlessly (i.e., including mapping or routing-related functions or applications or processes, wearable devices, etc. in a personal portable planning application) associate travel planning with the impact on related health management and preventive measures or countermeasures, and optimize the quality of the individual's sleep, sleep duration, sleep time adjustment, daytime energy, sleep tendency, mood, and other factors, thereby clearly managing, improving, and controlling the understanding of information access through the circadian health management system of the present invention (i.e., the health management system of block [3] in FIG. 96, and related inputs [1] and [2] and attached system options [3Α] and outputs [4] to

[10] ; the four-stage synchronization compliance monitoring system in FIG. 97).

[0196] In one embodiment, the present invention enables a wristwatch or clock application to program CC clock cycles and / or relevant information regarding an individual's required schedule clock requirements (i.e., travel clock, time zone change, social clock, work clock, leisure clock, special event clock), and a strategy or scenario can design a travel program or sequence, minimizing disruptions to the quality of sleep or an individual's performance in work, sports, play, leisure, etc. Such respective or clock display surface configurations can be structured with synchronization, strategy, personal preferences, planning functions, etc. in various CC embodiments, stored in a library, or easily called, enabling the user to establish an ideal CC HMS personal configuration library (i.e., from block [3] health management system and related inputs [1] and [2], auxiliary system options [3Α] and outputs [4] to

[10] in FIG. 96; by the four-stage synchronization adaptation monitoring system in FIG. 97).

[0197] Furthermore, the CC HMS of the present invention enables a shared or dedicated selection grouping function, allowing medical experts to provide guidance, advice, support, and intervention when tracking, diagnosing, and supporting an individual's expert safety aspects, sports performance aspects, overall health aspects, depression, and other psychological disorders significantly affected by appropriate CC management (i.e., from block [3] health management system and related inputs [1] and [2], auxiliary system options [3Α] and outputs [4] to

[10] in FIG. 96; by the four-stage synchronization adaptation monitoring system in FIG. 97).

[0198] Furthermore, when it comes to an individual's current circadian clock in terms of optimal performance, energy, sleep drive, occupational health risks of drowsiness, signs of fatigue, and other factors in which the individual may be interested in activities, regarding social, travel, time zone, and / or work or leisure schedule / clock requirements, the present invention can be automatically linked to the individual's time reference (i.e., alarm clock, watch, mobile phone clock, or other application) (i.e., via wireless or other interconnected communication and information access means), automatically set or propose alarm settings, and / or enable sleep scheduling tracking and / or comment / health guidance.

[0199] For example, one of the said estimation or prediction scenarios can be based on the assumption that the subject / patient's sleep pattern or behavior / quality (e.g., sleep duration, sleep time, sleep fragmentation, sleep composition, sleep-wake, sleep disorder, respiratory disorder, REM sleep amount and structure, deep sleep amount and structure) remains unchanged, with mild modifications (i.e., gentle modifications of sleep quality or reduction of sleep deprivation), moderate modifications or extreme modifications (i.e., dosing, light therapy, improvement of sleep hygiene or environment (i.e., reduction of external arousal states related to audible noise, temperature, humidity, air pollution or other respiratory or asthma antagonists or any combination thereof), etc., having various degrees of modification.

[0200] Furthermore, the present invention provides "means for calculating a circadian cycle" based on the estimation or prediction of a sleep-circadian-cycle scenario, which is based on the assumption that the subject / patient is reducing or impairing sleep for a certain period (i.e., during an investigation period or during a special event, travel, etc.). The said means can also provide typical criteria for sleepiness or tendency based on a comparison situation (i.e., in a very dangerous situation where one falls asleep within 10 seconds of closing the eyes (i.e., between about 1 second and 30 seconds of receiving a specific scenario), one should not drive, take on a financial decision, or take on a job related to the risk of occupational work for oneself or others, etc.). Furthermore, (by way of example only) a predicted sleep deprivation scenario can be related to other equivalent reaction times or attentiveness or sleepiness criteria, such as an expected equivalent Epworth sleepiness scale result or blood alcohol level, etc.

[0201] The "means for calculating the circadian cycle" includes, for example, without limitation, investigating information before monitoring circadian physiological variables (i.e., temperature, EEG suprachiasmatic brain region, etc.) and investigating such variables together with other factors that affect the deviation of the circadian clock cycle (i.e., the sleep parameters of the subject / patient and related sleep measurements), and based on the history or prior changes and the resulting measurements of the deviation of the sleep circadian clock, i.e., by a subject / patient-specific learning algorithm (ASL) system or a wearable device minimization (WM) system, for the purpose of investigating the monitoring target for the subject / patient's prior and / or current and / or (in a specified scenario) prediction and / or training (i.e., improving or optimizing sleep management based on the user's choice of going to the capital and / or scenario and / or hypothesis, and / or various desired sleep qualities and work / play schedule preferences), so as to determine the function of investigating the monitoring target (Figure 45[1]) (i.e., according to Figure 45 shown as an example in the background of the present invention). Next, in this context, advise the user on a more complex monitoring configuration(s) (Figure 45[2]) (e.g., clinical supervision or requirements or considerations, consumer or family doctor supervision guidance), then enable the monitoring, analysis, and decision of the results, and then statistically evaluate the accuracy of the diagnostic or prediction results, so as to determine the reconfiguration requirements for the monitoring sensor configuration(s) or wearable monitoring sensors(s) and related devices and the related wearable monitoring compliance (10, 11, 12 in Figure 45 - In the situation of non-circadian monitoring, the same principle applies. This is because neurological minimization excludes the consideration of a wide range of physiological parameters and related wearable monitoring configurations that include, without limitation, direct or proxy measurements of body temperature monitoring, homeostatic sleep measurements, and / or daytime activity measurements. Instead, still, based on the achievement of appropriate accuracy related to the diagnostic and / or prediction purposes and results applicable to the specific or individual requirements of the user and the user's health community (personalized based on the user's privacy, safety, and preferences or permission for function and intervention participation), the sensor and wearable configuration is minimized or rationalized / minimized (Figure 45[8], [9],

[10] ).

[0202] d) Intrinsic (natural) circadian clock The present invention provides means for characterizing, determining and / or adapting to the natural circadian clock means and / or the natural circadian rhythm of a subject / patient, and application-link means and / or application-link means.

[0203] The characterization of the circadian clock can include, as described in more detail elsewhere in this document, a gradual change in the temperature of the subject / patient, or typically a 24-hour cycle of typical sleep and wake phases, and monitoring of EEG related to (i.e., related to or directly implicating) the suprachiasmatic nucleus (circadian clock) region according to FIG. 66.

[0204] The natural circadian clock device means or application-link means includes (but is not limited to) one or more time management systems and / or sleep / wake management systems, and has an interrelationship between such aspects. The natural circadian clock device and application-link time management system means includes any one or any combination of the following: - Alarm clock setting, mobile phone clock setting, map application, calendar application, any scheduling application, any project management application, any travel planning application, wristwatch setting, computing device, online application, social media application, social network application, or other system applicable to an individual's sleep / wake management.

[0205] The natural circadian clock device and application-link sleep / wake therapy health management system means includes any one or any combination of the following (but is not limited to): - A health or personal planning application, any expert health management planning application, any health insurance expert risk and health application, 3D or other glasses, lighting system, curtain control system, room temperature or environmental control system, glasses for a subject having a light therapy function (i.e., enabling light therapy to regulate sleep latency or sleep quality), sleep / wake guidance, sleep / wake recommendations, sleep / wake arousal clock or recommendations or suggestions for a subject / patient's clock, or therapeutic intervention for an individual's sleep / wake plan, or adaptation of an intervention for a time adjustment schedule or cycle (including a natural circadian clock aspect), other systems applicable to adjustment.

[0206] The present invention enables adjustment and / or optimization of an individual's time management system and / or sleep / wake management system, and has such an interrelationship in accordance with the optimization of an individual's health. Optimization of an individual's health includes (but is not limited to) adjustment of sleep latency syndrome, undesirable or unsafe sleep tendencies or sleep impulses, and / or adjustment and / or adaptation of the natural circadian clock of the subject / patient.

[0207] The present invention can include a computer system programmed by steps including a decision matrix incorporating adjustable characteristics, and the adjustable characteristics are related to a natural circadian clock device or application-link means related to a time management system and / or a sleep / wake management system and interrelationship elements.

[0208] e) Further circadian clock aspects The present invention further enables: i) Natural circadian clock cycle parameters; ii) The user's essential wake-up time parameters (i.e., work, study, travel appointments, etc.); iii) Calendars, travel, and other schedule applications with details of related appointments or plans; iv) The length of a journey having automatic world time zone calculation results in terms of the relationship, comparison, and contrast with other time-related (i.e., from a) to c)) in this specification; v) Optimize the adjustment or readjustment of the natural (circadian) time clock of the subject / patient / user, and adapt the time adjustment structure that can reduce or most appropriately recover sleep deprivation over a specified (i.e., user preference or essential need) time period. A world travel map application as a travel route planning means at a travel route or route-designated point; vi) Messaging or other mobile phones, watches or other users (or other designated or recognized locations or parties - i.e., for example, transport drivers / pilots or shift workers or work shift managers who can better manage or provide guidance on expert vigilance or safety, or daytime sleep deprivation / tendencies and real-world solutions); vii) A clock warning or alarm system - i.e., an application that forms part of the wake-up clock setting, mobile phone clock setting, watch design, existing mobile phone, wake-up clock or other device settings and functions; viii) An individual rhythm or clock health management system - i.e., the ability for the subject / patient / user to adjust the time adjustment display and / or wake-up clock function and / or calendar planning guidance or suggestions and / or messaging system guidance or suggestions according to the optimization of the schedule or adaptation / regulation of the individual's circadian rhythm (i.e., for example, recovery from or avoidance of more harmful sleep deprivation). These optimize the sleep-wake cycle according to mild, moderate, significant, or extreme realignment (i.e., the user can configure the optimal sleep / wake cycle for the immediate sleep / wake period or any future period, thereby enabling the adjustment of sleep deprivation or non-habitual (i.e., deviation from the standard sleep / wake cycle time due to travel, leisure activities, work requirements, study for exams, jet lag, work shifts, etc.)); ix) A health or sleep guidance application that can advise, adjust, or control various options or programs for the subject / patient / user's clock and time adjustment schedule in a series of devices or systems (i.e., wired or wireless means of the Internet of Things, Internet of Medical Things, or other interconnected systems). The application has options such as calendar reservations and wake-up calls via an alarm clock, and can adjust the influence of room temperature, room lighting, or related lighting adjustments and other sleep / wake environments.

[0209] f) Forward uniform source analysis The present invention provides a forward uniform source analysis function based on the anatomical location of the brain of known typical circadian clocks, such as the optic chiasm region (circadian clock) and / or other brain functions or structural locations of related control or interconnected regions of the brain. That is, optionally (but not limited to), the locations outlined in FIGS. 66, Talairach Atlas; current map tools; Harvard Whole Brain Atlas; MNI template, The standard template of SPM and International Consortium for Brain Mapping; Atlas of the Developing Human Brain; all functional locations including Brodmann areas, gyri, sulci, etc.

[0210] The present invention can provide compensation for electrode positions based on a compensation signal according to amplification, attenuation, filtering, phase adjustment, and any other elements, and simulate or emulate the conditions applicable to the targeting of monitoring of any one or any combination of locations or other brain functions or structural locations, brain regions, or connection modes (i.e., coherence or dipole measurement). For example, in the simplest modeling scenario, the present invention - In the first step, it is assumed that all EEG electrodes are presented with exactly the same signal. - In the second step, the location or other brain function or structural location of interest is defined. - In the third step, based on the skin, skull, and brain tissue attenuation factors applicable between each electrode and the brain region of interest, the most likely attenuation, spectral filtering characteristics, and phase shifts are determined. - In the fourth step, from the perspective of signal processing for each respective EEG electrode, the determined attenuation, spectral filtering characteristics, and phase shift characteristics are applied. - In the fifth step, the determined attenuation, spectral filtering characteristics, and phase shift characteristics can be further improved by comparison with and against actual subject / patient imaging / diagnostic evaluation data.

[0211] In this way, by forward uniform source modeling, it is possible to specifically monitor or analyze the targeted regions of the brain using only the smallest wearable monitoring sensor system (Figure 45, according to an exemplary process embodiment of a sensor minimization demonstration example where the targeted brain region can be targeted using the smallest possible sensor or electrode). Further, even for a more complex monitoring sensor system (such as the example in Figure 55), by using such forward analysis modeling and minimization processes, it can be rationalized or minimized with an improved source localization function (according to Figures 46 to 54 which provide (but are not limited to) different wearable monitoring formats. The formats range from the simplest consumer-level monitoring options to more complex clinical diagnostic options).

[0212] g) Intelligent circadian-based clock, alarm, scheduling, guidance, biofeedback, control system) The present invention provides intelligent circadian-based measurements through interlinking to a clock, alarm, scheduling, guidance, biofeedback, and associated control systems, and intelligent wrist or wake-up clock settings can include (but are not limited to) any one or any combination of the following: a) Actual subject / patient circadian clock-based alarm setting or clock time display function; b) Conventional (i.e., time zone adjustment) time or alarm display); c) Sleep guidance recommendations, for example, recommending modifications to the subject's sleep / wake behavior in terms of regulating the sleep cycle, compensating for or minimizing the temporal phase offset between the subject / patient's current natural circadian clock cycle and the subject / patient's desired sleep / wake phase requirements (i.e., adjusting jet lag, work shifts, studying until late at night, nightlife, etc.); d) Interlinking (e.g., wireless communication) with other devices applicable to the regulation, compensation, or display of an individual's sleep cycle and circadian cycle (i.e., display, comparison, or contrast between the natural circadian phase cycle and the individual's required or desired sleep / wake cycle), including but not limited to light therapy (i.e., conventional room lighting or special (i.e., any output, brightness, lighting color, light frequency, radiation spectrum, etc.) lighting); mobile phone or wearable device interface (i.e., smart watch or mobile phone or intelligent alarm clock, etc.); room temperature or electric blanket, and activation or adjustment of other environmental controls that can affect and contribute to the regulation or modification of the circadian rhythm.

[0213] e) The present invention provides means for managing, guiding, or making dosing decisions and has the following dosing prescription means, online, automatic, or assisted (including regulatory, safety, privacy, and individual authorization and access requirements), based on any one or any combination of the following, without limitation: i) Dosing schedule, ii) Online access to the prescribed dose, iii) Determination of the dose based on any of the sleep / wake monitoring results, the subject / patient's medical information, the subject / patient's individual circadian rhythm, the subject / patient's sleep / wake monitoring results, the subject / patient's HMS results or related information, the subject / patient's health survey and other health information records, the subject / patient's natural circadian rhythm, the ongoing sleep / wake schedule requirements, the subject / patient's circadian monitoring results (i.e., EEG circadian clock, temperature, and other circadian physiological monitoring measurements and related analysis or obtained results). iv) Dosage and administration or dosing dispenser or dosing guidance (i.e., guidance on the drug, including recommended dosage, and a dosage schedule programmed and / or control-linked to an automated and / or automated dosing dispenser system (i.e., programmed to best compensate for the shift between the natural circadian rhythm / clock and a new environment (i.e., change in time zone or day-night activity) or sleep / wake / work requirements)); v) User interface for a watch or alarm system (i.e., a smartwatch, wake-up clock or mobile phone application that enables the user to select between an optimal circadian rhythm synchronized time display (i.e., most natural alarm setting or calendar scheduling, etc.) and a clock, alarm or scheduling means based on the actual world time zone);

[0214] h) Wearable portable health tracking and display means The present invention provides means for monitoring, calculating and tracking the circadian rhythm of a subject / patient, and display means (i.e., means including integrating any measurement or combination of measurements into a smartwatch device), and any measurement or combination of measurements includes, but is not limited to, temperature detection of the subject, galvanic skin resistance of the subject, photoplethysmography, ECG, oximetry or volume-oscillating oximetry, all of which have a very slow underlying circadian periodic component, and the circadian periodic component can be obtained using any such measurement, and optionally incorporates local / distributed analysis of other wearable or portable wireless monitoring systems outlined elsewhere in this document.

[0215] Such means can include conventional 24-hour clock and / or date and / or calendar and / or sleep schedule means (i.e., such means can include calendar, messaging, clock display, or actual subject / patient circadian cycle, one or more predicted or projected circadian cycles, display of inclusion of normal variations, or any or all combinations of a series of sleep deprivations and / or excesses that can be adapted without mild, moderate or extreme consequences. (Furthermore, this information may also be based on a comparative population database, or subject / patient specific monitoring or other integrated input information (i.e., by means of an artificial intelligence or expert system analysis according to FIG. 77[A], the knowledge base is accumulated based on the evaluation of input from the interface to the real world [8] and the association of a rule interpreter, and the rule interpreter is based on formal scoring rules applicable to a disease, disorder, or health condition of interest).

[0216] Said "health condition of interest" can include, for example but not limited to, sleep disorders, where sleep disorders refer to the American Academy of Sleep Medicine's rules for staging sleep-scored sleep-related breathing disorders (i.e., the name "Monitoring, determination, and tracking of sleep, wakefulness, and other mental states, events of interest, or health conditions", according to the eLifeCHEST / eLifeSCOPE section), can refer to the prediction or diagnosis of epilepsy, and the prediction or diagnosis of epilepsy can include the detection of events or event clusters such as HFO, ripples, spikes, K-complexes, or spindles, as further detailed in the automatic analysis model determination of FIG. 75

[29] .

[0217] The "health condition of interest" can include, for example but not limited to, the diagnosis or prediction of Parkinson's disease. The determination of the "health condition of interest" can include, for example but not limited to, the identification of biomarkers and the monitoring and analysis of related "expert system rules" (i.e., according to FIG. 77[D]). This identification involves the analysis of events of interest (i.e., symptoms corresponding to the diagnosis or prediction of a disorder, health condition, or disease of interest). The "expert system rules" described elsewhere include sleep behavior disorders in combination with movement (i.e., movement or activity characteristics), and are further addressed in the monitoring and analysis of prediction and / or diagnostic movement disorder markers related to Parkinson's disease or other movement, muscle, or nervous system disorder markers (i.e., other movement, muscle, or nervous system disorders refer to vibration or sudden uncontrolled movement, the objectivity, fluidity, or movement of movement, the synchronization of movement between two or more body parts, or include the section entitled "Gait or Movement Tracking and Characterization of Events of Interest" (with automatic analysis option) as further detailed in the section "Description of the Invention" of the heading eLifeCHEST / eLifeSCOPE, for example but not limited to). The determination (with automatic analysis option) of sleep behavior disorders as diagnostic or predictive markers for Parkinson's disease is enabled by the combination of monitoring and analysis (or evaluated as an independent element) or by, for example but not limited to, FIGS. 75

[21] ,

[24] and related features. Similarly, such artificial intelligence or expert system analysis processes can be deployed to automatically analyze circadian deviation elements (i.e., include the section entitled "Local Environment and / or Sleep / Wake / Activity / Work for Circadian Temperature Cycle Determination" in the section "Description of the Invention" of the heading Somfit, for example but not limited to).

[0218] The "health condition of interest" can include, for example but not limited to, the diagnosis or prediction of other neurological disorders such as ASD, and is further detailed in the combination of measurements addressed in the section "Title of the Patent: Dementia / Alzheimer's Disease / ASD / ASP", the related section "Description of the Invention", and the section "eLifeALERT" and the related section "Description of the Invention".

[0219] The "health condition of interest" can include, for example but not limited to, the diagnosis or prediction of other neuropathies such as ASD, and will be further detailed in the heading "eLifeALERT" and the related "Description of the Invention".

[0220] Furthermore, some of the input elements into the expert system or artificial intelligence processing term index analysis (i.e., to evaluate and grade the accuracy of the expert system or population system analysis, compare with the comparative expert analysis results, control the quality, continuously improve the prediction and diagnostic analysis results of the present invention from the perspective of constant verification by expert medical or scientific experts, and ultimately bring the highest quality medical and health tracking for the subject / user) can be automatically deployed and verified, and if necessary, continuously correct and improve the interpreter rule diagram 77[D], improve the accuracy of the knowledge base [A], and ultimately improve the diagnosis or prediction diagram 78[2];[5] of the subject / patient.

[0221] The present invention can incorporate minimization rules as part of the artificial intelligence or expert system self - learning function of the system, and based on a wide range of monitoring criteria or narrow - range monitoring criteria or monitoring goals, the present invention can continuously verify, improve, rationalize, and adapt the wearable monitoring sensors and related prediction and diagnostic analysis that are personalized or specific to the subject / patient, and can be adjusted again for a specific patient / subject. The artificial analysis or expert system analysis self - learning function can be part of one or more forms and / or a wearable monitoring system, or can be added through the interconnection of software networks or related services or resources (i.e., SAAS including cloud computing services, LAN, WAN, peer - to - peer, etc.).

[0222] Furthermore, as outlined in Figure 78, the input from experts (including consideration of the diagnosis by block [1] in Figure 78 or the expert's supervisory observation), the patient's investigation or monitoring data can be considered, for example, within the prediction module 78[2] or the diagnosis module 78[5] in the context of artificial intelligence or expert analysis (outlined in Figure 77 as above).

[0223] In one embodiment, the timekeeping of a conventional clock face can be augmented by overlaying a series of circadian clock overlays, where the circadian clock overlays display the actual circadian cycle state of the subject / patient and / or one or more predicted circadian sleep cycle scenarios, and / or are interconnected with a local smart watch, and / or are interconnected with a remote (i.e., wireless or portable wirelessly linked) alarm clock application that is designed to maximize or minimize the quality of sleep and / or maximize or minimize work scheduling and / or recommend sleep alarms for any compromise point or equilibrium position. Further, the light in one or more rooms or the home of the subject / patient and / or wireless-linked light can be controlled in the context of light therapy to regulate or optimize the circadian cycle of the subject / patient.

[0224] i) Determination of the optimal circadian sleep cycle The present invention enables the current or new environmental (i.e., time zone of the world clock) time along with the current sleep / wake, and optionally compares work and / or leisure time cycles - i.e., via calendar and / or clock settings of the subject's / patient's / user's portable device and / or sleep / wake monitoring, and performs a comparative analysis with the normal rhythm or typical cycle or phase nature of the subject / patient / user, the individual's health or peak sleep performance or health status (i.e., via ESS or other sleep tendency or sleep scale performance, sleep / wake survey, sleep survey results, where the sleep survey results indicate normal or healthy sleep tendencies or daytime individual performance).

[0225] Display means such as clock faces, portable devices, alarm clocks, linked alarm clocks, etc. (i.e., indicating the clock time and / or phase lag or gain of the actual clock with the body, and / or recommendations or guidance on the potential amount of sleep that can be regained without excessive adverse effects on sleep or sacrificed sleep).

[0226] In one mode, the circadian properties of the human body clock can be determined, and the circadian cycle or time of the human clock can be calculated and compared against a typical circadian cycle for a specific subject / patient, or a typical normalized set of circadian cycles of healthy individuals.

[0227] Link lighting / glasses / drug timing adjustments, recommended dosages or administrations to each other, and modify or realign the natural body clock (circadian) to the desired clock and scheduling requirements.

[0228] The present invention can incorporate the importance from a private or personalized perspective in terms of sleep tendency or sleep impulse risk, sleep debt factors, sleep impulse factors, importance of working hours, labor productivity or ability factors, leisure time or enjoyment of leisure, sleep duration, high-quality sleep and other sleep, wakefulness, circadian clock, sleep health and general health-related factor points into a triage health clock or a scheduling / activity / calendar application or shared social media or business media information, enable explicit health data at the individual or community / group level, or treatment guidance and / or support (i.e., the adjustment synchronization of the light therapy circadian clock is linked to the Internet of Things or various lighting and other related controllers), support the management of essential sleep stages such as deep sleep (physical recovery) or REM sleep (brain repair) that the user / subject can prioritize or weight, circadian clock alignment, etc. (i.e., the health realignment between the subject's homeostatic sleep / wake stages / local vs. travel clock, work schedule, leisure schedule, relaxation schedule, and the reconciliation and management of opposing or other social or work or travel schedules / itineraries), and affect and / or influence and / or modify and / or adapt the scheduling or wake-up clock setting or calendar function and availability, and the scheduling or wake-up clock setting or calendar function and availability can be differentiated by color coding, etc. according to various influences that affect homeostatic or circadian sleep alignment, sleep debt, sleep impulse and other sleep health factors.

[0229] For example, in one exemplary embodiment of the present invention, a wireless personalized portable device or wearable device (i.e., a watch, phone, computer, etc.) can incorporate a clock function with switching capabilities through which a user can apply to the targeted homeostatic sleep / wake stage / local vs. travel clock, work schedule, leisure schedule, relaxation schedule, and any or all combinations of opposing or other social or work or travel schedules / itineraries. Further, the present invention can guide, direct, and recommend calendar inputs, activity scheduling, clock warnings or alarms, work shift schedules, or sleep / wake plans according to an individual's preferred labor productivity and / or focus / attention (i.e., work mode), individualized occupational work hazard or risk factors (i.e., incorporating health status monitoring, analysis, correlation, and alerting), where the health status is, for example, excessive sleep / wake disorders, etc., high-quality sleep of essential aspects such as REM sleep amount, deep sleep amount, and circadian clock deviation factors, (as just one example) group norm requirements, individual requirements, etc., work level or hazard or responsibility (i.e., driving a truck in the case of snoring or signs of OSA sleep disorder can be displayed on an individualized and individual safety management level, which, although private information, can potentially support essential individual health), and cognitive ability (i.e., mental mode), leisure time (fun not considered sleep deprivation, or fun considered various degrees of sleep deprivation or sleep urge, or fitness or training guidance, sleep training or guidance, work schedule or guidance, leisure schedule or guidance, and / or relaxation schedule or guidance related weighted factors in terms of the present invention).

[0230] j) Sleep surveys and artificial intelligence The present invention enables self - assessment means for a subject / patient via sleep or other health surveys (i.e., but not limited to the Epworth Sleepiness Scale), tracks sleep impulses or sleep tendencies according to an individual's sleep pattern, and can determine (i.e., but not limited to, by artificial intelligence or expert - system means according to FIGS. 77, 78, 79) a sleep pattern and / or sleep start and end times that minimize sleep impulses and daytime sleepiness.

[0231] The present invention can further associate, determine, display, and control a treatment device with these measured values and monitored sleep measurements, related sleep scoring (scoring of human sleep by sleep - stage analysis) and / or respiratory scoring (i.e., detection of sleep - disordered breathing), minimizing sleep disorders or sleep fragmentation, maximizing the quality of sleep architecture, and / or minimizing sleep - disordered breathing while considering sleep tendencies or daytime sleepiness (or residual daytime sleepiness). This involves minimizing or eliminating treatment - event - related arousals and / or respiratory - event - related arousals (TERA and RERA) events. Calculation of an individual's circadian clock cycle can be based on any one or any combination of the following: - The temperature of the subject / patient and / or the periodic EEG signal indicating the circadian clock of the brain and / or the activity or movement of the subject / patient and / or the homeostatic sleep - monitoring characteristics and / or sleep / wake or other health - survey information.

[0232] The present invention enables the wearable wireless monitoring of information and the derivation of the natural circadian rhythm of a subject / patient. Such means can be based on a measurement sensor that is attached to or forms part of a smartwatch, wristband, forehead sensor, armband, or other wearable monitoring sensor system incorporating measurements, thereby enabling the analysis of slow (typically a slow 24-hour change cycle measurement) based on monitoring of temperature and / or galvanic skin resistance and / or heat flux and photoplethysmography (PPG) measurements such as pulse, and / or heart rate variability, etc. (which can be derived based on monitoring that is physiologically consistent with the natural 24-hour circadian clock function).

[0233] In addition to monitoring and calculating measurements of excessive residual sleepiness (RES), the present invention can calculate, compare, and contrast measurements (multiple possible) of any one or any combination of the following as means for determining the TERA and other elements as mechanisms for optimizing auto-titration of positive airway pressure, maximizing the elimination of sleep disordered breathing, optimizing cardiac function, and optimizing the quality of sleep with a circadian clock (CC) or homeostasis element (i.e., an element asynchronous with the CC in relation to sleep propensity - i.e., a backward or forward CC phase). 1) Sleep parameters of the subject / patient (i.e., but not limited to, any one or any combination of EEG, EMG, EOG), 2) sleep disordered breathing, 3) treatment event related arousals (TERA) 3~5 , 4) respiratory event related arousals (RERA), 5) circadian clock elements, 6) previous sleep duration(s), 7) previous wake period, 8) previous time awake, 9) previous sleep period in terms of sleep architecture, 10) previous sleep period in terms of deep sleep (i.e., N3 and / or REM sleep), 11) CC for the previous sleep period, 12) current sleep duration(s), 13) current wake period, 14) current time awake, 15) current sleep period in terms of sleep architecture, 60) current sleep period in terms of deep sleep (i.e., N3 and / or REM sleep), 16) CC for the current sleep period, 17) current sleep in terms of sleep architecture 6 .

[0234] Somfit or other forehead monitoring devices with a sleep posture training function The built-in (self - contained) training system can detect snoring (i.e., based on any one or any combination of the following, through the built - in breathing sound or snoring monitoring function (i.e., through the vibration of the accelerometer or the microphone sensor), it can issue an alarm to the subject / patient or wake up the subject / patient (including the vibration or sound alarm device of the attached headband): 1) Sleep alarm settings (i.e., clock, mobile phone, alarm clock, etc.), 2) Determination of sleep stages including waking, N1, N2, N3, REM, non - REM, waking, spindle waves, K - complexes, alpha - burst waves, EMG burst waves, EMG atony state, etc., 3) The position of the subject / patient, 4) The preference of the subject / patient's posture when snoring is least obvious (i.e., lateral recumbent position, supine position, etc.), 5) The biological synchronization of the subject / patient with the respiratory cycle (such as obtained from either a monitoring sensor including an infrared heat beam or the respiratory signal of the subject / patient, etc. To reduce the risk of detecting the respiratory measurement (or snoring) of the sleeping partner against the actual snoring measurement of the subject / patient; 6) In one exemplary embodiment, the present invention can (by way of example) do the following: - In the first processing step, determine the amount of time from the user selection of the alarm request until the alarm is activated, - In the second processing step, while tracking the sleep stages (i.e., waking, N1, N2, N3, REM) and sleep events (i.e., spindle waves, waking, K - complexes), continuously evaluate the time until the alarm is activated, - In the third processing step, and in situations where the subject / patient is prone to or defined as being prone to "staggering" or "fatigue" when sleep is interrupted or awakened, or is in a sleep state that is likely to cause such, the present invention can activate an alarm in a more favorable sleep state that is less likely to cause such "morning fatigue". For example, if the subject / patient sets an alarm for a one-hour nap during the day and is trying to alleviate jet lag or other forms of sleep disorders or sleep tendencies, the present invention, when it determines or tracks (via an online sleep analysis function) that the user / subject is in REM sleep (e.g., not as detrimental to recovery as the N3 deep sleep state), sounds the alarm with the selected alarm setting; - In the fourth processing step, and for example, when the present invention determines or tracks (via an online sleep analysis function) that the user / subject is transitioning from REM to the NI / deep sleep stage (e.g., more likely to have a negative impact on recovery than the REM stage), and the alarm setting time is about 10 minutes until activation and the maximum pre-awakening alarm time is set to exceed 10 minutes (by default), the present invention can sound the alarm in a preferred REM state for a possible N3 deep sleep state and wake up the subject / patient.

[0235] The maximum pre-awakening alarm time is a setting related to the maximum time allowed before being awakened, and the present invention can use this processing function to optimize the awakening event based on the sleep stage of the subject / patient.

[0236] The maximum pre-awakening alarm time can be set according to the sleep time (i.e., hours and minutes), or the sleep time (i.e., the percentage of the total sleep time if the typical sleep start, end time or typical total sleep time period is input or set as the default by the system), or can be selected at a point in time, for example, 10% of the total sleep period, prior to the alarm.

[0237] Patent for a Circadian Drug Delivery Clock The present invention includes (in one exemplary embodiment) a biofeedback drug delivery system (BFDD) and / or a "related therapy" system that can be attached or integrated with a smartwatch function (embedded or incorporated as part of a smartwatch and / or a wireless interconnect processing system(s)), and the biofeedback drug system can comprise any one or any combination of: a) a drug delivery dispenser system, b) an automated analysis system, and / or c) a drug delivery control system.

[0238] The "drug delivery dispenser system" can comprise any attachable drug delivery system including a manual or automated controlled drug dispenser that can "optimally dispense drugs" including any one or any combination of the following: A) Dispensing of drugs at optimal times and / or rates, B) And / or compounding (i.e., mixing of drug types or drug compounds including, but not limited to, melatonin) and / or C) Concentration and / or delivery concentration and / or D) Delivery rate.

[0239] To minimize the effects on the subject's sleep / wake cycle and / or work cycle / schedule / watch / calendar (i.e., work shift) and / or social cycle / schedule / watch / calendar and / or travel cycle / schedule / watch / calendar (i.e., itinerary), the "optimal drug dispensing" can be applied to any physiological and / or neurological and / or sleep disorder and / or other harmful health conditions.

[0240] The "biofeedback" system and / or "related therapy" system can include any one or any combination of the following: i) A circadian rhythm synchronization system; ii) A circadian rhythm synchronization system including light emission control or light emission; iii) An Internet or other interconnected circadian rhythm synchronization system including light emission control or light emission.

[0241] As outlined elsewhere in this document, the "automated analysis system" can include determination of a subject's sleep / wake pattern and / or homeostatic sleep characterization and / or determination of an individual's circadian clock cycle.

[0242] The "drug delivery control system" can include a drug dispensing mechanism (including, but not limited to, a cartridge-loaded drug dispenser), configured to dispense drugs / pharmaceuticals so as to minimize sleep latency or sleep phase syndrome, and can be configured for moderate, extreme, or other incremental entrainment (i.e., ensuring an individual's sleep latency or circadian clock phase element).

[0243] The "biofeedback drug delivery system" can be part of any one or any combination of a) any wireless portable system; b) any wearable monitoring system; c) any telemedicine system.

[0244] Automated Sleep / Wake / Circadian Medication and / or Therapy System The present invention provides a mobile wireless phone or wearable device or individual portable device, and an optional automated or manual drug dispenser system (i.e., a sleep suppressant such as melatonin or an antagonist, etc.), and an optional sleep / wake cycle analysis system (local or built-in, automated or manual processing and / or interconnected processing, network or cloud computing or other wireless interconnect formats, etc.), and an optional circadian rhythm analysis system (automated or manual), and an optional light therapy entrainment (i.e., the Internet of things including light and / or alarm or music and / or voice control designed to regulate an individual's circadian rhythm cycle), and an optional medication and / or associated music and / or voice, and an option to link the one or more treatment types with biofeedback including processing brain signals (i.e., EEG) and / or other physiological signals (i.e., temperature, oxygen saturation, heart rate, sweating or galvanic skin resistance, ECG, EMG, EOG, room lighting status, subject movement, subject location, subject position and / or subject activity).

[0245] (Automatic Monitoring and Model Configuration Function; Fig. 83) The present invention provides decision-making, selection, and configuration means, which include (but are not limited to): automatic means for sleep monitoring survey type and / or sleep survey configuration and / or display of the required sleep monitoring kit (including a single selection option of a sleep survey device(s) monitoring kit and / or a consumable sensor kit), selection or adjustment of a computer and other related local or remote devices and computer resources applicable to the required survey format, including any or all combinations of functions (the survey format includes "High Dependency Connectivity Monitoring (HDCM)" or "Adaptive Physiological Body Network (APN / APM)", consideration of automatic sensor connectivity requirements and connection or quality status, pre-acquisition signal automatic processing (i.e., filtering, sensitivity, etc.) configuration, automatic data acquisition configuration (i.e., analog-digital sampling rate, sample resolution / step for each monitoring, analysis, transmission, storage, and / or display channel), automatic sensor or electrode position information registered on each monitoring channel, post-acquisition signal automatic processing (i.e., filtering, sensitivity, etc.), automatic interconnectivity and / or intercommunication related to data characteristics (i.e., including but not limited to sampling rate, sample resolution / step for each monitoring, analysis, transmission, storage, local display, remote display, report, warning, alarm, and / or other communication access or transmission).

[0246] The present invention provides means for determining or enabling a configuration that includes any or all combinations of (but is not limited to) automatic wireless or wired interface interconnectivity means (having an automatic configuration option).

[0247] The present invention can automatically detect the type of subject / patient / user survey, and the survey type includes a predefined set of or monitoring protocols, which can be classified according to physiological monitoring parameters and qualities or characteristics related to each said physiological channel and specific monitoring signal characteristics (including, but not limited to, pre-acquisition signal automatic processing (i.e., filtering, sensitivity, etc.) configuration, automatic data acquisition configuration (i.e., analog-digital sampling rate, sample resolution / step for each monitoring, analysis, transmission, storage, and / or display channel), automatic sensor or electrode position information registered on each monitoring channel, post-acquisition signal automatic processing (i.e., filtering, sensitivity, etc.), automatic interconnectivity and / or intercommunication related to data characteristics, "high-dependency connectivity monitoring (HDCM)" or "adaptive physiological body network (APN / APM)", automatic sensor connectivity requirements, and considerations for connection or quality status).

[0248] The predefined set of or monitoring protocols that can be classified includes automatic research adjustment or update type and / or level and / or categorization and / or scope outside of in-clinical and out-of-clinical research methods (or "scoping device" and / or recommendation and / or health insurance requirements or guidelines and / or government health rebates, etc.), as well as related sleep monitoring research scope, which includes types and categorizations of sleep monitoring, cardiovascular, oximetry, position, effort, and / or respiration monitoring requirements).

[0249] The present invention provides corresponding configurations for automatic determination and sleep monitoring system configuration.

[0250] The determination can include consumer / illegal vs. professional / legal detection (i.e., China FDA, USA - FDA, etc.).

[0251] The determination can include detection of actual survey criteria or regional laws by comparing or contrasting with actual sleep survey configuration details (i.e., health insurance reimbursement or government reimbursement or market approval bodies (i.e., USA, China FDA, etc.).

[0252] Provide indication, suggestion, and automatic prompting in any one or any combination of the following aspects: - Requirements for professional / legal compliance (i.e., China-FDA, USA-FDA, etc.); - Actual progress or process steps in terms of the necessary (pending) investigation status or the completed progress, professional supervision, and authority of the investigation institution / composition, compared with the supervision and authority of China-FDA, USA-FDA, etc.; - Determination of the completion of authorization by a qualified sleep specialist (BCSS) through evaluating the suspicion of obstructive sleep apnea (OSA) in the subject / patient; - BCSS determination of whether the subject / patient has symptoms or signs of comorbid medical diseases; - BCSS determination of whether the subject / patient has symptoms or signs of symptoms or comorbid sleep disorders; - Compliance with professional / legal (i.e., China-FDA, USA-FDA, etc.) requirements for sleep or other subject / patient health questionnaire(s).

[0253] (Sleep range) The predefined columns or monitoring protocols that can be classified include (but are not limited to) any one or any combination of sleep, cardiovascular, oximetry, position, respiratory effort, and / or respiratory measurements.

[0254] The sleep categorization 1 can include the monitoring of sleep parameters such as sleep by using (by way of example only and without limitation) three active EEG channels, at least one EOG channel, and a submental EMG channel.

[0255] The sleep categorization 2 can include the monitoring of sleep parameters such as sleep by using (by way of example only and without limitation) at least two active EEG channels (and an individual reference EEG channel) with or without an EOG channel or a submental EMG channel.

[0256] The sleep categorization 3 can include (by way of example and without limitation) monitoring of a sleep proxy channel such as actigraphy.

[0257] The sleep categorization 4 is based on other sleep measurement values other than those detailed in the sleep categorizations 1, 2, and 3 (by way of example).

[0258] Cardiovascular range The cardiovascular categorization 1 can include (by way of example and without limitation) monitoring of cardiovascular parameters such as two or more derived ECGs, along with optionally obtained events.

[0259] The cardiovascular categorization 2 can include (by way of example and without limitation) monitoring of cardiovascular parameters such as peripheral arterial pressure measurement (such as those described in FIGS. 37 and 38).

[0260] The cardiovascular categorization 3 can include (by way of example and without limitation) monitoring of cardiovascular parameters such as a standard (one exemplary) ECG measurement.

[0261] The cardiovascular categorization 4 can include (by way of example and without limitation) monitoring of cardiovascular parameters such as pulse derivation, oximetry.

[0262] The cardiovascular categorization 5 can include (by way of example and without limitation) monitoring of cardiovascular parameters based on other heart measurement values other than those detailed in the sleep categorizations 1, 2, 3, and 4.

[0263] Oximetry range The oximetry categorization 1 can include (by way of example and without limitation) monitoring of oximetry such as finger or ear detection, using three averaged samplings and a sampling rate of at least 10 Hz, preferably 25 Hz.

[0264] The oximetry categorization 1a can include, by way of example and without limitation, monitoring of oximetry such as detection of a finger or an ear, and uses three averaging sampling characteristics and a sampling rate of 10 Hz.

[0265] The oximetry categorization 2 can include, by way of example and without limitation, monitoring of oximetry at an alternative site such as the forehead.

[0266] The oximetry categorization 3 can include, by way of example, monitoring of other oximetry formats.

[0267] Position range The position categorization 1 can include, by way of example, monitoring of video or visual position measurements.

[0268] The position categorization 2 can include, by way of example, monitoring of non-visual position measurements.

[0269] Respiratory effort range The respiratory effort categorization 1 can include, by way of example, monitoring of measurements of two respiratory inductive plethysmogram measurements (abdominal and chest measurements).

[0270] The respiratory effort categorization 2 can include, by way of example, monitoring of measurements of one respiratory inductive plethysmogram measurement (either abdominal or chest measurement).

[0271] The respiratory effort categorization 3 can include, by way of example, monitoring of measurements of one respiratory inductive plethysmogram measurement such as frontal vein pressure (FVP), and derived respiratory effort measurements.

[0272] The respiratory effort categorization 4 can include, by way of example, monitoring of measurements of other respiratory efforts such as measurements of a pressure respiratory belt.

[0273] Respiratory range The respiratory effort categorization 1 can include, for example, monitoring of nasal pressure and a thermal sensor device.

[0274] The respiratory effort categorization 2 can include, for example, monitoring of a nasal pressure sensor device.

[0275] The respiratory effort categorization 3 can include, for example, monitoring of a thermal sensor.

[0276] The respiratory effort categorization 4 can include, for example, monitoring of an end-tidal CO2 (ETCO2) sensor.

[0277] The respiratory effort categorization 5 can include, for example, monitoring of another respiratory measurement.

[0278] Any or all combinations of the sleep categorization formats (including any of the types or levels of categorizations 1 through 5) and / or associated monitoring signal channels (including any or all combinations of sleep, cardiovascular, oximetry, position, respiratory effort, respiratory range, as described above) can include automatically coordinating one or more distributed wireless interconnected monitoring sensors by time synchronization (i.e., without limitation, as described in the named: Multi-point Time Synchronized Monitoring (MTM) system and as described in the associated "Description of the Invention").

[0279] The present invention provides a consumer- or professional-wearable mobile HMS that can be automatically connected and configured (including devices, corresponding online services, sensors, therapeutic interventions and controls, and optionally with a biofeedback function), and is relatedly activated according to any one or any combination of the following: (but not limited to) a) surveillance surveys or HMS target requirements, b) surveillance or HMS "categorization" formats, c) surveillance surveys or HMS "type or level" requirements, d) sensor kits, monitoring kits, e) safe opt-in medical providers authorized by experts, f) consumer service providers, g) professional service providers, h) personal care management platforms, i) applications, j) opt-in practitioners (legal - i.e., China FDA; USA FDA; CE, etc.), k) online purchase kits (i.e., Amazon, Apple Store, Samsung, Microsoft, Telco, MobileCo, Xiaomi, Baidu, Alibaba, Huawei, etc.), Chinese form, k) HMS eHealth online selection, l) HMS eLife online shop selection, k) selection or function of the HMS eHealth App, k) selection or function of the HMS eLife App, l) HMO, m) health insurance organizations, n) government health rebate-related systems) AMD, n) AICC, o) SQE, p) SQI&C.

[0280] The sleep surveillance survey type (level) 1 (the most comprehensive level) (by way of example only) includes the following surveillance channels: EEG, EOG, ECG / heart rate, submandibular EMG, limb EMG, respiratory effort in the chest and abdomen, airflow via nasal cannula, thermistor and / or respiratory effort (respiratory inductive plethysmography), pulse oximetry, additional channels for CPAP / BiPAP A levels, pressure, CO2, pH, etc.

[0281] The sleep surveillance survey type (level) 2 includes (by way of example only) the following surveillance channels: EEG, EOG, ECG / heart rate, airflow, respiratory effort, oxygen saturation.

[0282] The sleep monitoring survey type (level) 2 AU includes (by way of example only) the following monitoring channels: EEG, ECG, airflow, chest-abdominal movement, oxygen saturation, body position, and either EOG or submental EMG).

[0283] The sleep monitoring survey type (level) 3 includes (by way of example only) the following monitoring channels: 2 respiratory movement / airflow, 1 ECG / heart rate, 1 oxygen saturation.

[0284] The sleep monitoring survey type (level) 4 includes (by way of example only) the following monitoring channels: At a minimum, directly calculates the AHI or RDI measurement together with three channels including arterial oxygen saturation, airflow, and optional chest-abdominal movement.

[0285] The present invention further provides automatic mode determination (AMD) means. The AMD function operates together with the AICC, SQE, and SQI&C functions, enabling the setting of the system configuration according to the specific electrode configuration and quality state during system operation. The AICC, SQE, and SQI&C functions are detailed in the patient interface section. Specifically, the SQE system tracks the electrode connection and quality state. The corresponding control function is relayed to the AMD system by the SQI&C function. Next, the A&CD monitoring mode is adjusted according to the validity and connection state of the sensors and electrodes at any given time.

[0286] As shown in FIG. 83 (lower), when the automatic mode determination is activated (FIG. 83; [3:Y]), the A&CD system is prompted to configure the monitoring operation mode according to the ISA format and signal quality. However, when the AMD function is not activated (FIG. 83; [3:N]), the operator interface is configured according to the operator manual mode selection (FIG. 83; [4]). The integrated mounting sensor (FIG. 83; [6]) is connected to the patient interface module [7], and the patient interface module [7] detects and determines the ISA format together with the sensor mounting part and the quality state (FIG. 83; [8]). This information is input as part of a decision matrix related to the automatic identification and channel characterization (FIG. 83; [9]; AICC) system. Next, the mode determination (FIG. 5) enables various combined systems including a dynamically linked signal conditioning (FIG. 83;

[11] ) and a dynamically linked analysis conditioning (FIG. 83;

[12] ) system, and configures or adapts the A&CD system to the conditions of operation, environment, and signal quality. The combination of online signal quality tracking and AMD separates AEP click stimuli and enables special online adaptation in cases where the system can return from a hybrid (AEP and EEG based) to an EEG based monitoring mode, etc.

[0287] The present invention further provides automatic identification and channel characterization (AICC) means. The AICC system is designed to automatically detect the integrated sensor attachment (ISA) system configuration (i.e., FIG. 82), and other monitoring system examples (but not limited to, FIGS. 1; 28; 31; 38; 46; 55), i.e., the monitoring modes (hybrid, EEG based, etc.) and formats (standard or advanced) of wearable portable or other monitoring systems. Furthermore, the specific signal filtering and processing characteristics required for each channel can be automatically configured. In this way, a single quick snap ISA connection (for example) can automatically prepare the monitoring system.

[0288] The present invention further provides signal quality estimation (SQE) means, and the signal quality estimation (SQE) system enables continuous tracking of the integrity and overall quality of an input signal. Furthermore, such measurements can continuously compare a predetermined acceptable signal range, limits, and other important characteristics.

[0289] The SQE function operates together with the online impedance measurement function (OIM).

[0290] The present invention further provides sensor / electrode quality indicator and control (SQI&C) means. The SQI&C system can be integrated within a patient interface (i.e., a wearable device example in FIG. 1 without limitation) or a monitoring head box (i.e., for clinical or laboratory monitoring), providing several important functions including a visual user prompt that constantly displays the connection and sensor quality status.

[0291] Low-obstruction continuous online impedance measurement (LCOIM) system The LCOIM system generally refers to the use of active online impedance measurement values, which are taken to flag during the measurement period and excluded from downstream analysis results. Furthermore, the impedance measurement period can be minimized by a transient response signal measurement pair, a conventional steady-state waveform measurement method. The present invention enables a combination of passive signal quality tracking (i.e., investigation of a monitoring signal typical of typical expected signal characteristics versus interference and other artifact sources (i.e., power supply, artifacts caused by sweating, noise due to sudden movement of electrodes, etc.) at the point of signal characteristics).

[0292] The present invention further enables the active impedance measurement values to be interleaved with the monitoring signals, and makes it possible to limit the measurement period (which can cause monitoring signal disturbances) to a "non-important" or "less important" monitoring period (i.e., a period not important for the determination of sleep stage epochs (such as during transitional sleep stages, etc.)). The non-important period can be predefined as a period during which vital measurement values such as spindles or K-complexes marking sleep stage changes are not evident.

[0293] Artifact Compensation and Rejection (AC & R) System The AC and R system of the present invention incorporates a series of algorithms that can eliminate or minimize noise or artifacts. The automatic online artifact routine can identify specific severity levels, intervals, and classifications of artifacts. Reduction or removal of the effects of unwanted background physiological artifacts, including EMG signal intrusion, eye blinks, EOG intrusion, arousal (including various neural and autonomic categories), body movement, movement time, and unwanted PAMR signal intrusion, can be automatically and continuously tracked and performed online. The present invention enables signal monitoring with high tolerance and quality during severe interference by electrical, EMF, and other body movement artifacts and other signal interference sources. The present invention can incorporate a high-impedance environmental noise-sampling input channel configured to operate an antenna for noise and sample interference, and can monitor and / or store signal characteristics or environmental interference. In this way, the environmental noise can be characterized in terms of determining the filter processing type and characteristics necessary for minimizing or eliminating noise from the monitoring signal channel. For example, by using the environmental noise-sampling input channel, phase shift, amplitude adjustment, and ultimately eliminating unwanted environmental noise, it can be used to assist in noise cancellation within the input channel of interest. That is, a noise cancellation channel is generated and then phase-shifted by exactly 180 degrees out of phase with the noise present in the signal channel to null out or eliminate the unwanted noise.

[0294] The AC and R incorporation of the present invention of an unrestricted "noise - sampling channel" as a means for eliminating unwanted signals is shown in FIG. 29.

[0295] healthpal The present invention enables a health payment system which, in addition to means for enabling conventional online payment transactions, "appropriately" incorporates means for separating information of patients or consumers from health service or product providers (i.e., in compliance with relevant privacy, security, government, medical, patient care, safety aspects which can be linked or programmed according to location or patient - specific details and health information as a function of the present invention), while still enabling access to important information such as health insurance compliance or approval data, verification and / or adjustment of treatment types (i.e., PAP, NIPPV devices), etc., prescription data including.

[0296] A further aspect of the present invention includes the function of "appropriately" evaluating the confirmation of contradictions between contradictions, side - effects, a patient's medical history (i.e., allergies, reactions to specific drugs, etc.) and the prescribed drugs, and warning or notifying the subject / patient and related medical providers as necessary. A further aspect of the present invention includes the function of automatically handling government / insurance reimbursements through advice, guidance, simple steps, advice / steps to GPs, practicing physicians, HMOs, etc.

[0297] A further aspect of the present invention includes the function of using data access separated in two directions or buffered, which ensures separation between the subject / patient and the provider with respect to both the privacy and security of information, and conceals private illnesses, medical histories or privacy in general (i.e., private medication by "healthpal" with high sensitivity to health confidentiality and safety of health professionals).

[0298] Invention of Patent - Elife gait or movement neuron (including Parkinson's disease) processing or device The present invention provides means for characterizing motion characteristics including an individual's gait, or any criteria of the interrelationship of motion between a plurality of body extremities or limbs, and the present invention includes (but is not limited to) any one or any combination of the following:

[0299] (Motion characteristics of walking, running, stride) The present invention provides means for analyzing the motion characteristics of a subject / patient by analysis (i.e., spectral analysis such as FFT applicable to different components of the subject's motion and partitioning of specific frequency bands), and the analysis includes analysis of frequency band characteristics related to arm swing, and correlation between arm swing and leg steps in terms of the nature of the phase and signal synchronization. The said motion characterization can include decomposing motion characteristics such as linear length (i.e., millimeters), cycle time (i.e., seconds), regularity (i.e., certainty or regularity of arm swing or leg stride motion characteristics), or any combination thereof.

[0300] (Interrelationship of body extremity motions) The said synchronization and phase interrelationship between hand swing and the motion characteristics of the corresponding leg will change over time as the motion progresses and with neuropathy, especially when guiding the subject, such as angles, direction changes, etc., into more difficult motion control situations.

[0301] (NLDB motion analysis) Similarly, the analysis of motion sensor output (i.e., accelerometer) can include the development of non-linear dynamic-based (NLDB) analysis transformation, and as just an example, the regularity (i.e., certainty or regularity) of arm swing or limb stride motion characteristics can be measured in terms of non-linear dynamic characteristic indices such as (but not limited to) complexity or entropy.

[0302] (Motion pattern or signal form analysis) Similarly, the analysis of the motion sensor output (i.e., accelerometer) can include the development of pattern recognition analysis transformation, mapping and recording the leg stride and arm swing motion by signal characterization, and characterizing the pendulum motion, smoothness, flow of motion, and gradual changes in synchronization with other limbs or extremities as measures of minor or more significant decreases or improvements applicable to motion reversal / recovery or deterioration, "event of interest / EOI" (detailed in the glossary at the end of this document under "Definition of EOI").

[0303] (Motion Interrelationship with Location / GPS Analysis) The present invention further incorporates means for mapping an individual's motion characteristics by combining location tracking such as GPS information, and when related to different categories of motion (i.e., walking, jogging, ascending / descending stairs, sports or gym motion systems such as treadmills, running), a gradual decrease over a period of time, in terms of path determination or difficulty in pacing (i.e., mild, moderate or severe difficulty in movement, straight path, etc.), corresponding pacing or balance output measurements (i.e., but not limited to, can be analyzed with any one or any combination of the following: >>Degree of co-synchronization between the measurement values of the interrelationship (any two or more body limbs or extremities or main body motion detection locations). >>Circular and / or phase interrelationship between two or more signals or data outputs of two or more motion detection systems (i.e., wearable devices incorporating detection devices (i.e., uniaxial or multi-axial accelerometer measurement sensors) or part of or attachable to the subject's mobile phone or mobile phone case). >>The movement analysis or characterization of the limb or extremity and / or the main body part(s) can include, but is not limited to, the swing of the arm (linear or arcuate millimeters), the smoothness of walking; the movement of the arm during walking; the pattern of the arm swing; any or any combination of the movement of the arm swing (i.e., the synchronization of the arm during walking with the synchronization of the leg during walking in terms of the phase nature and the synchronization between signals, such as through a watch or bangle with a uniaxial or multi-axial accelerometer). The said movement characterization can include the linear length (i.e., millimeters), the cycle time (i.e., seconds), the regularity (i.e., the certainty or regularity of the movement characteristics of the arm swing or the leg stride; and the pendulum movement of each arm swing or step; the resolution of the movement characteristics such as any or any combination of the objectivity elements which are the interrelationship between the movement of the arm and the leg during walking), and the present invention further includes other means for associating, comparing or other phase or cycle analysis, or determining the interrelationship between the movements of multiple said extremities, limbs or body parts of the object / individual.

[0304] The present invention provides a measurement evaluation and characterization of a combination of SBD REM atony and movement analysis applicable to the prediction or diagnosis of movement or neuropathy including a "health event of interest" or "event of interest / EOI" (according to the "Definition of EOI" detailed in the abbreviation table at the rear of this document).

[0305] The present invention incorporates means for correlating SBD (according to Figure 75) and / or movement analysis such as those described elsewhere in this document with each other.

[0306] Description of the Drawings Description of the Diagram of Circadian HMS Figure 96. The present invention provides a process that can bring about circadian clock health management through an input such as any or any combination of the input functions, applications or systems dealt with in Figure 96 of this specification, as part of a microprocessor programmed in any one or any combination of, but not limited to, software application(s), portable device(s), wearable technology, or interconnected communication system(s) (i.e., SAAS including cloud computing services, LAN, WAN, NAS, etc.).

[0307] Processing / decision by block 1 and block 2 or block 3, or respective outputs from block 4 to 10, or other inputs, decisions or outputs handled elsewhere in this document.

[0308] [Block 1] Input of circadian clock (CC) health management system (HMS) >> Input for environmental information CC synchronization; Block 1 incorporates inputs containing information on new and current environmental time zones and / or solar daylight conditions, temperature changes, population studies, or health information such as typical sleep deprivation or sleep impulse / tendency related to various degrees of circadian clock asynchrony (as part of the incorporation, a self-learning algorithm process (i.e., including, but not limited to, an exemplary self-learning process)).

[0309] >> Input / information - When the questionnaire relates to the characterization of an individual's sleep / wake cycle and / or circadian clock cycle, the questionnaire is activated by interaction via the subject / patient / user and information or information obtained in relation thereto or related results. That is, exemplary (but not limited to) questionnaires include the Horne-Ostberg Morning-Eveningness Questionnaire (MEQ); Epworth Sleepiness Scale (ESS); Munich Chronotype Questionnaire (MCTQ), etc. (see also CC HMS processing / decision): - Endogenous circadian cycle; - Target / desired circadian clock synchronization result for the subject / patient / user; - Target (desired) circadian clock for the subject / patient / user; - Actual circadian clock vs. target circadian clock.

[0310] >> Input for environmental monitoring and tracking CC synchronization; That is, but not limited to, any one or any combination of the following: - Synchronization stimulus or environmental condition change (i.e., control input for phototherapy; control targeting and dosage and property adjustment input for magnetic stimulation; temperature control input, etc.; - Zeitgeber.

[0311] >> Environmental monitoring and tracking CC synchronization input; That is, without limitation, any one or any combination of the following: - Synchronization stimulus or environmental condition change (i.e., control input for phototherapy; control targeting, dosage, and characteristic adjustment input for magnetic stimulation; temperature control input, etc.).

[0312] >> Adjustment of sleep by circadian and homeostasis sleep / wake elements That is, without limitation, any one or any combination of the following: - Actual sleep-wake cycle (i.e., without limitation, the monitoring sleep parameters and / or related measured values including FIGS. 77, 78, and 79 dealt with elsewhere in this document; the times and compositions of sleep and wakefulness obtained therefrom); - Target / patient / user target (desirable) sleep-wake cycle; - Actual sleep-wake cycle - temperature measured value pair, target sleep-wake cycle - temperature measured value.

[0313] >> Physiological and / or psychological monitoring and tracking CC synchronization input; That is, without limitation, any one or any combination of the following: - EEG measured value; - Retinal light measured value; - GSR measured value; - Activity measured value; - Position measured value; - Pulse measured value; - Blood pressure measured value; - Brain activation measured value; - Sleep / wake measured value; - Light measured value; - Objective measurement of the rest-activity cycle time can be performed by actigraphy.

[0314] - Point-of-care body fluid measurement of melatonin, etc. (i.e., the rhythm of melatonin concentration provides an optimal circadian phase marker for humans), or the cortex (i.e., periodic examination of saliva, blood / plasma or urine samples, or related blood / plasma, saliva or urine sampling test trips and measurements by a related point-of-care test system, optionally with automatic integration or interface with a portable health monitoring or tracking system).

[0315] [Block 2] Circadian clock (CC) Health management system (HMS) Brain sleep / wake regulation input The present invention enables forward and / or reverse uniform EEG electrode minimization / monitoring (i.e., also refer to the minimization process in FIG. 45) and / or source location identification applicable to personal health management and related markers of consciousness, sleep / wake homeostasis, or circadian rhythm determination / monitoring, brain-centered regulation of wakefulness and sleep (including neuromodulators and neurotransmitters that bring about EEG activation, such as histamine, acetylcholine, norepinephrine, hypocretin, and glutamate), and further includes (but is not limited to) any one or any combination of the following brain regions: - Thalamus or related regions; - Posterior cingulate cortex or related regions; Medial parietal cortex or related regions; - Medial basal forebrain or related regions; - Occipital cerebral cortex region or related regions; - Cingulate gyrus or related regions; - Prefrontal cortex or related regions; - Reticular formation or related regions; - Pons or related regions; - Visual cortex (the visual cortex located in the occipital lobe of the cerebral cortex; or related regions; - Hypothalamus or related regions: anterior (ventrolateral preoptic area involved in promoting sleep) or related regions; - Posterior (tuberomammillary nucleus involved in the production of histamine; medulla oblongata; orexin [A / B] related to wake-promoting neural activity); - Midbrain and pons (locus coeruleus (norepinephrine; NE), raphe nucleus (serotonin; 5-HT) generation center point and - Pedunculopontine tegmental nucleus) or related regions; - Olfactory bulb or related area; - Cerebellum or related area; and / or - Suprachiasmatic nucleus (circadian clock) area or related area; - And dipoles that model related coherence, or connectivity interrelationships (including thalamus-cortex interrelationships).

[0316] [Block 3] Circadian clock (CC) health management system (HMS) processing / decision >>- Synchronization of the CC with the environmental clock or cycle (i.e., social, travel, time zone, sun, work shift, required schedule, required calendar, required journey clock, etc.) - Determination of optimal synchronization or tuning with the environment. It can be mediated by controlling steady-state or periodic stimuli (also called zeitgebers) that stimulate or act on the circadian clock of the subject / patient / user; (see also CC HMS input); - Interaction and interrelationship between the biological clock (or circadian clock (pacemaker)) and the sleep homeostasis process of the subject / patient / user (i.e., depending on previous sleep / wake and related characteristics); - Modeling / calculating interaction and interrelationship determination between the biological clock (or circadian pacemaker) and the sleep homeostasis process of the subject / patient / user, and determination and recommendation of related frameworks and / or control of related treatment through biofeedback and / or drug treatment and / or regulation of related circadian rhythms, as a means of determining a series of sleep disorders or sleep disturbances such as the possibility of circadian clock abnormalities indicating involvement in (but not limited to) depression; - Determination of temporal variations between the circadian rhythm phase of the subject / patient / user such as sleep onset and the zeitgeber phase such as the solar clock cycle (i.e., dusk or dawn); - Sleep period information such as the midpoint of sleep (i.e., between sleep start time and wake-up time); - Objective analysis of the rest-activity cycle, actigraphy, i.e., FFT and frequency analysis of accelerometer output, followed by differentiation of the possible source or cause of activity, and then association of the categorized movement with sleep, sleep, and other activities as a means of deriving the final sleep / wake / activity cycle of the subject / patient / user; - When the present invention is related to the characterization of an individual's sleep / wake cycle and / or circadian clock cycle, activation of a sleep / behavior questionnaire involving an interaction via a subject / patient / user and information or information obtained in relation thereto or related results. That is, exemplary (but not limited to) questionnaires include the Horne-Ostberg Morning-Eveningness Questionnaire (MEQ); the Epworth Sleepiness Scale (ESS); the Munich Chronotype Questionnaire (MCTQ), etc. (see also CC HMS output); - Determination by melatonin samples of the "dim light melatonin onset" (DLMO). Melatonin is a marker of body clock time and can be measured in sleep saliva or urine or blood / plasma before human sleep. Further, during 24-hour rhythm measurements, points including peaks, midline intersections, secretion shifts, and other points can be determined as derivatives of the subject / patient / user circadian clock.

[0317] The present invention can provide a point-of-care testing system that automatically interfaces with a portable or wearable device or, by means of interconnectivity, automatically interfaces with a communication network or system, enabling saliva, blood / plasma, urine sampling (i.e., a melatonin assay method, which includes impregnating a test strip designed to react according to the presence or concentration of melatonin, among other things, with a chemical substance, and then, optionally, automatically scanning, analyzing the test strip, and displaying or communicating the results).

[0318] The incorporation of algorithms results in clinically useful or personalized subject / patient / user health monitoring or tracking functions, including (but not limited to) the use of sleep midpoints (by the sleep / wake monitoring function of the present invention detailed elsewhere in this document and provided that sleep is not overly disrupted), and can be developed as an ideal means, albeit as a proxy, to approximate the determination of the circadian phase cycle.

[0319] The incorporation of algorithms can result in the calculation of therapeutic dosages (i.e., high-intensity light therapy) to be applied according to the internal circadian rhythm of the subject / patient / user and the external environmental clock time conditions. In this way, automated, patient-wearable technologies and / or integrated portable device systems can contribute to the incorporation of circadian principles and enable important drug treatment decisions (i.e., align or regulate between the circadian (internal) and environmental (external) clock cycles to minimize optimal health, safety, and occupational risks). The said therapy can be extended to the optimization of the subject / patient / user's room, alarm clock settings, or other environmental or temperature conditions, personalized conditions versus general conditions.

[0320] The determination of the sleep midpoint on a single occasion or routine basis is based on the analysis of sleep midpoint calculations based on the sleep / awake monitoring of the present invention and / or the MEQ, MCTQ questionnaires and / or the subject / patient / user sleep diary (i.e., start sleep period time, bedtime for sleep, time awakened from sleep), to determine an approximation of the internal circadian cycle clock time.

[0321] A treatment decision or adjustment / conformance strategy to advance the light therapy stage based on the requirements of correlation and interrelationship, which shifts the internal circadian clock and synchronizes it with the external environment (time zone and / or solar clock elements and / or required sleep / awake cycle), and automatically matches the light therapy (i.e., activation of bright room lighting) with the time the alarm clock wakes up (i.e., activation of wirelessly linked lighting or deployment of lighting controllers), etc., to advance the circadian clock cycle time. Such steps can be deployed to address disorders such as "anxiety" or winter "depression" in winter or areas trapped by snow, or the onset of non-seasonal depression.

[0322] In this way, the present invention incorporates an alarm and / or sleep guidance determination function together with an algorithm designed to assist or guide a person by notifying an optimal rest time (i.e., a nap or recovery sleep) that the user can set their preferences for (i.e., for the purpose of, for example, a driver or pilot avoiding or reducing occupational risks due to drowsiness), thereby improving the waking state or performance ability. The present invention enables the subject / user to input a desired sleep period and allows for the selection of "the best sleep recovery strategy" (said means may involve any CC determination and / or waking, sleeping, REM or waking state determination by an awakening function (i.e., an alarm by sound, vibration) including a vibration function within a monitor-wearable device (i.e., a forehead Somfit / forehead strip, etc.)).

[0323] Determination of sleep / wake (i.e., monitoring function and / or sleep diary entry) applicable to the cause and / or treatment of long-term activity (i.e., actigraphy) and / or guidance applicable to depression; - Determination of an unstable rest-activity cycle as a marker that may potentially have an insufficient circadian synchronization and may adversely affect the physical or mental health status; - Determination of any one or any combination of the following sleep / wake monitoring data or related results and / or sleep / wake parameters such as actigraphy (i.e., accelerometer result measurements) based on (but not limited to) sleep onset, wake-up time, wake period, sleep efficiency, intermediate sleep time, etc.; - Determination of circadian variables such as circadian relative amplitude vs. period time and / or CC maximum amplitude and / or CC minimum amplitude, CC stability per day (daily stability or related fragmentation elements) and / or CC stability per day (stability within a day or related fragmentation elements); - Determination of circadian variables such as the coupling strength or correlation between an external CC environmental stimulus factor (zeitgeber) and the CC cycle - Determination of the objective verification and / or characterization of a chronotype (the time until the subject / patient / user goes to bed and wakes up and / or the time optimally required for the subject / patient / user to go to bed and wake up); - When the present invention is related to treatment, drug therapy; tests after depression, etc., celebration parties, special periods such as illness, etc., determination of objective verification and / or characterization of the chronotype (the time until the subject / patient / user goes to bed and wakes up and / or the time optimally required until the subject / patient / user goes to bed and wakes up); - Determination of any or any combination of CC processing / determination based on long-term scale or trend (i.e., but not limited to, summary or overview on a weekly, monthly, or annual basis) and / or short-term scale or trend (such as per hour) and / or the mutual relationship with working hours, leisure time, relaxation time, etc., optionally with display, guidance synchronization determination, etc., to stabilize the CC clock cycle and / or synchronize the internal CC cycle with external environmental clock elements (time zone; solar clock; Zeitgeber element); - Synchronization stability (i.e., the start time of melatonin secretion; DLMO (a marker of the body clock time based on saliva measurement before the subject / patient / user goes to bed over consecutive days, weeks, months, etc.)) by any or any combination of environmental environment / indoor lighting, sunlight, temperature and / or physiological subject / patient / user light, temperature, actigraphy, EEG measurement values; - Log of environmental / indoor lighting and / or sunlight; - Social Zeitgeber by a social rhythm questionnaire; - Sleep log by any or any combination of related questionnaires and / or sleep / wake monitoring and / or actigraphy; - Determination of CC amplitude by any or any combination of core body temperature, melatonin sample test, EEG measurement values, surrogate or derived or estimated body temperature measurement values; - Determination of light input frequency / color composition and / or intensity; - When the present invention is related to slow-wave sleep (i.e., NREM such as 0.75 Hz to 4.5 Hz, etc.), determination of sleep homeostasis characteristics including short-term or long-term increase or decrease; - When the present invention is related to REM sleep, determination of sleep homeostasis characteristics including short-term or long-term increase or decrease; - When the present invention is related to wake EEG, determination of sleep homeostasis characteristics including short-term or long-term increase or decrease; -Determination of sleep homeostasis characteristics including short-term or long-term increases or decreases, if the present invention is related to faster beta waves during active walking and / or slower alpha waves during quiet walking; -Determination of external zeitgebers applicable to sleep and wakefulness compositional aspects and / or variations; -Determination of zeitgeber intensity based on the luminous intensity received by the subject / patient / user along with the relevant time, if the present invention is related to synchronization requirements and / or current synchronization determination.

[0324] The present invention can be mounted within a single application or automatically incorporated as part of a portable device all CC synchronization elements, display aspects, alarm clock functions, light detection functions, guidance and / or messaging and / or warning functions.

[0325] The present invention can determine the circadian clock nadir element (i.e., the interval from body temperature and / or body temperature nadir to sleep deviation), and the circadian clock nadir element includes the subject / patient / user's Delayed Sleep Phase Syndrome (DSPS), optimize CC synchronization (i.e., light therapy including glasses that project blue light as a stimulus towards the subject / patient / user's retina - the blue light can be blocked from forward projection based on the shaded or blocked section above the glasses, minimizing the intrusive or intense nature of such treatment).

[0326] The present invention can track the sleep-wake rhythm and characterize the absence of an clearly distinguishable circadian pattern of sleep-wake times as a marker or potential prediction.

[0327] The present invention can track the sleep-wake rhythm and characterize the absence of an clearly distinguishable circadian pattern of sleep-wake times as a marker or potential prediction of Shift Work Disorder (SWD), and / or questionnaire results related to excessive sleepiness, non-refreshing sleep and / or insomnia that vary according to the work schedule.

[0328] [Block 3A]-Optional integrated or adjustable special wearing monitoring technology, portable or other systems Multi-point Time Synchronization Monitoring (MTM) System: Figure 30 - IR Reflection Eye Movement Recording and / or Video Imaging (with IR function) and / or Integrated Phototherapy and / or Portable CC HMS Application - Interface - System (i.e., glasses): Figure 43 - Automatic Diagnosis and Predictive EEG Monitoring and Analysis System incorporates minimization processes and enables expert and consumer level monitoring and automatic analysis decisions (minimization system according to the example of Figure 45); - HMS with Automatic Tracking of EOI, according to Figure 75; - HMS Sensor or Monitor Device / System (SOMDI) Interface; - Driver / Subject Wearable Glasses incorporate any of the following, either binocular or monocular or any combination; - Self - learning and Personalized Self - adaptation System AI; ES; according to Figures 77; 78; 79; and / or - Personalized Target / Patient - Health Management System (HMS) incorporating any or any combination of monitoring targets according to Example Figure 80[1].

[0329] [Block 4] Circadian Clock (CC) Health Management System (HMS) Input / Output - Control of the environment and / or other stimulating factors that enables or can transition to an optimal synchronization with the environment or entrainment. This is mediated by the control of a steady - state or periodic stimulus (also called zeitgeber) that can stimulate or act on the circadian clock of the subject / patient / user (see also CC HMS input); - Circadian sleep - wake cycle - Neurobehavioral capabilities, - Mood, - Cortisol, - Melatonin, - Temperature, - Heart rate, etc. - Calculation of a circadian clock that generates a cycle matching the solar day

[0330] Control or measurement to maintain or modify the correlation between the subject / patient / user's circadian clock cycle (i.e., shift the circadian and sleep-wake clocks to synchronize them closer) (i.e., before the sleep / wake cycle) and the current environmental clock cycle (i.e., solar clock, time zone of the subject / patient / individual or schedule requirements) and / or a target clock (i.e., the desired subject / patient / user and / or the clock or schedule desired or preferred by the subject / patient / user (i.e., including any or all combinations of considerations such as wake cycle, sleep cycle, work cycle, leisure cycle, fitness cycle, relaxation cycle, travel cycle, work shift cycle, study cycle, test peak performance cycle, jet lag cycle, current time zone cycle, one or more new time zone cycles, etc.); That is, without limitation, any of the following or any combination:

[0331] Circadian clock synchronization output or result. That is, without limitation, a circadian clock bi-directional (or uni-directional information access) option (CCIO); The CCIO includes (without limitation) any of the following combinations - a map display or application by a mapping function, or a display or related comment or information by an automatic and / or dynamic data exchange or update option; - A clock or clock display by an automatic and / or dynamic data exchange or update option; - A clock or clock alarm display or setting by an automatic and / or dynamic data exchange or update option.

[0332] As part of circadian clock synchronization, a stimulus or environmental regulation determination matrix or environmental control or treatment deployment by an automatic and / or dynamic data exchange or update option (i.e., without limitation, any of light therapy); - A change in temperature or environment by an automatic and / or dynamic data exchange or update option; - A vibration or other stimulus, magnetic stimulus, steady state or "light flashing stimulus" by an automatic and / or dynamic data exchange or update option.

[0333] Said "light stimulus" can include, without limitation, a room or glasses or other head-mounted / applied system, which system includes hidden steady-state light therapy means using means to block forward light and / or less obvious object / patient steady-state light and light color selection or light color control characteristics.

[0334] The present invention includes any combination or any one of motion tracking (such as actigraphy or acceleration measurements), body temperature, GSR measurements, pulse measurements, light measurements as means for approximating or determining and / or displaying the subject / patient / user circadian clock cycle.

[0335] [Block 5] - Circadian clock (CC) Health Management System (HMS) output - Map - Link function Function to automatically access travel schedules - Integrated mapping application (i.e., geographical or road map) display or comments, options, additional notes or related information or symbolization related to various travel scenario displays;

[0336] [Block 6] Circadian clock (CC) Health Management System (HMS) output - Application or function linked to social / professional / geographical The present invention enables a series of clocks or clock face programmable functions including a clock display sequence, and the functions can be switched by selection as required.

[0337] For example, any combination of solar - cycle, sleep - wake cycle, time zone, social - clock and phase shift related to the circadian clock can be programmed by the user presenting as the default library of displays and / or programming the display format among different users.

[0338] The CC HMS of the present invention enables a shared or dedicated selection grouping function, allowing medical professionals to guide, advise, support, and intervene when tracking, diagnosing, and supporting an individual's expert safety aspects, sports performance aspects, overall health aspects, depression, and other psychological disorders significantly affected by appropriate CC management (FIG. 96; FIG. 97).

[0339] [Block 7] - Circadian Clock (CC) Health Management System (HMS) Treatment / Control / Feedback / Biofeedback The control of related treatments by related frameworks and recommendations and / or determination of biofeedback and / or drug treatment or related circadian rhythm regulation includes transcranial magnetic stimulation targeting and dosing and / or phototherapy stimulation targeting and dosing and / or room temperature targeting and dosing.

[0340] Provide interventions by wearable devices for the subject, or some entrainment scenarios such as environmental lighting as a means of advancing or delaying the phase response curves of various subjects (i.e., an integrated circadian curve phase relationship for the subject with external clock elements due to social, time zone, work, work shift, study requirements, etc.), and be applicable to minimize Delayed Sleep Phase Disorder (DSPD) or Advanced Sleep-Wake Phase Disorder (ASPD) according to the medical supervision or intervention of the subject and / or personal preferences or requirements and / or occupational risk / safety considerations.

[0341] Activate the intensity and type of light through automatic or manual assistance (i.e., for longer wavelength light, visible blue light with a shorter wavelength, and a higher intensity melatonin suppression effect can be developed as part of an automatically calculated CC entrainment treatment plan) and the time adjustment function of such phototherapy (i.e., evening phototherapy can delay the CC phase while midday phototherapy can bring about an advancement of the CC phase).

[0342] Automatically (or with manual intervention option) control synchronization elements (i.e., lighting time adjustment and / or lux intensity and / or melatonin dosage and administration time adjustment or recommendation), and optionally, recommendations or settings for bedtime or wake-up clock settings according to the social, work, travel requirements or environmental elements of the subject / patient (or medical advisor).

[0343] The present invention can advise / guide and / or automatically adjust the CC synchronization according to the preferences, selections or personal scenario selections of the subject / patient / user (i.e., more aggressive adjustment over a shorter number of days, or more gentle CC adjustment over a longer number of days).

[0344] [Block 8] Circadian clock (CC) health management system (HMS) output - Function to link personalized health management and guidance Can measure environmental lighting conditions, applicable to the subject / patient / user (i.e., via a wearable device such as a clock, mobile device, etc.), provide guidance or advice, treat winter depression or other forms of depression or delayed sleep phase disorder (DSPD), or compensate for the deviation between the CC and the environment (i.e., time zone or social clock elements or behavioral clock characteristics (i.e., social clock, work clock, work shift, travel / jet lag clock, clock and related requirements or preferences of the schedule / planner)), and the guidance can include CC deviation therapy (i.e., light therapy, melatonin drug therapy, adaptation of homeostatic sleep elements (i.e., optimally increase the waking time of the subject / patient / user, enable high-quality sleep, and the alignment of the CC by the sleep pattern (and vice versa)).

[0345] [Block 9] Circadian clock (CC) health management system (HMS) integrated (interconnected) applications and notifications - Decision-making, prediction and display (i.e., optional calendar application comments; - Monitoring of scheduled or hypothetical schedules, journeys, natural circadian clock cycles, homeostatic sleep / wakefulness;

[0346] Determination of accuracy or confidence level in terms of the calculation accuracy of an individual's previous and latest circadian clock cycle states, and other factors affecting the determination of the individual's current circadian clock state (i.e., based on the quality and availability of previous sleep / wake survey data, and actigraphy and other circadian clock-related measurements).

[0347] Automatic synchronization (i.e., according to FIGS. 96[1], [7]) programming of a CC processing system (i.e., high-intensity light therapy including glasses or sunglasses (i.e., as an example, glasses that cover half, or glasses with the upper part of the lens thinly colored)) by incorporating CC calculation parameters as part of the programming, the glasses can include recording of reflex eye movements (i.e., according to FIG. 43), and the recording of reflex eye movements can be used as a sleepiness marker to detect synchronization of light therapy and / or movement and / or opening of the eyelids, enabling a biofeedback synchronization function that adjusts CC cycle deviation elements and / or sleep tendency and / or sleep impulse elements.

[0348] Determination of a -CC confidence level factor (i.e., accuracy - i.e., error factor) in terms of the determination accuracy of an individual's previous and latest circadian clock cycle states, and other factors affecting the determination of the individual's current circadian clock state. The present invention enables incorporation of all these functions and capabilities into one or more wearable or portable devices (i.e., smart watches, mobile phones, Somfit sleep monitoring headbands and / or others (FIG. 1) addressed elsewhere in any of the terms of this patent application document).

[0349] Automatic link (i.e., wireless or other interconnectivity communication and information access means) to a messaging system (mobile phone SM, email, calendar, application, etc.) to enable tracking and / or commenting / health guidance and / or sleep scheduling.

[0350] Integrated calendar or scheduling / planning application(s) (i.e., geographical or roadmap) display or comment. Optionally, display or symbolization of further notes or related information related to various travel scenarios.

[0351] [Block 10] Circadian Clock (CC) Health Management System (HMS) Display Index The gist of the personal health management system of the present invention is to automatically determine and display guidance, warnings, messages, and CC synchronization stimuli applicable to the subject / patient / user. The CC synchronization stimuli are based on a series of scenarios including input elements, correlations, or the quality and length of sleep related to the manner in which the subject copes with the natural CC. The present invention provides a synchronization adaptation monitoring (EAM) system including the following four stages: Stage 1 of providing the initial monitoring and analysis objectives (i.e., personalization of the work and lifestyle of the subject / patient / user - preferences (W and LP; see also the monitoring objectives by the minimization process in FIG. 45), and personalization of any applicable treatment / biological feedback - preferences (TP)), determination of the objectives of the sleep / wake process (SWP) for the circadian process (CP), including wearable technology customization / minimization in Stage 2, customization / adaptation of the wearable technology in Stage 3 (see also the EEG monitoring sensor adaptation according to FIG. 52), and Stage 4 of incorporating the analysis and consideration decision (see FIGS. 77; 78; 79; see also the self - learning algorithm by the artificial intelligence or expert system analysis process) for synchronization or treatment decision.

[0352] The sleep / wake / circadian synchronization adaptation monitoring (SEAM) system includes the following four stages: Stage 1 of providing the determination of the objectives of the sleep / wake process (SWP) for the circadian process (CP) applicable to the initial monitoring and analysis objectives (i.e., personalization of the work and lifestyle of the subject / patient / user - preferences (W and LP), and personalization of any applicable treatment / biological feedback - preferences (TP)), Stage 2 including wearable technology customization / minimization, Stage 3 of wearable technology customization / adaptation, Stage 4 of incorporating the analysis and consideration decision, and 5) synchronization or treatment decision.

[0353] The upper section represents the circadian and homeostasis integrated sleep / wake / work / leisure / relaxation management (CHASM) system, the middle section represents the fitness health management system, and the lower section represents the neurological health management system.

[0354] The basic Entrainment Adaptation Monitoring (BEAM) system includes the following: 1) Initial monitoring and analysis goal determination (i.e., the goal and the first stage according to FIG. 45), and then; 2) Establishment of monitoring and analysis parameter configuration (i.e., self-learning by the expert system and AI according to FIGS. 77; 78; 79) through wearable technology customization / minimization (i.e., according to FIG. 45), and then; 3) Conformity determination (i.e., according to FIG. 45 showing an example of a conforming wearable technology EEG electrode system), and then; 4) Analytical consideration determination (i.e., self-learning by the expert system and AI according to FIGS. 77; 78; 79), and then; 5) Entrainment or treatment decision (treatment / biofeedback examples in FIGS. 96; 97); 6) Based on the effectiveness of the process result (i.e., statistical evaluation according to FIG. 45), return to step 1) or step 2), and so on.

[0355] In this example, the display can be programmed to display the sleep / wake element, for example, on the left side of the display panel (i.e., typically within the 6 o'clock to 12 o'clock panel range), while on the right side of the 6 to 12 o'clock range, it can be programmed to display daytime fitness and other health parameters.

[0356] In one example, the system can be programmed to display the overall sleep quality based on, for example, at least about 20% of the total REM sleep time and non-REM deep sleep time (i.e., the total of N2 and N3) achieved by the subject / user compared to the normal quality sleep requirement (i.e., it can be based on any or any combination of a) normalized set average and related comparison, 2) specific results for the subject using a sleep quality tracking survey / questionnaire, 3) monitoring sleep / wake parameters, 4) monitoring circadian rhythm, 5) time zone or related deviation, circadian deviation elements, local environmental elements, etc.). Further, the user can switch between sleep / wake targets (i.e., sleep / wake targets for high-quality sleep tracking) or actual results (i.e., actual sleep / wake results including sleep deprivation, circadian delay elements, etc.) vs. targets through the display mode. Similarly, the user / subject can switch fitness goals (i.e., pace, exercise, activity, etc.) and related goals, etc. through the display mode. The switching or replacement by the display mode can be activated via gesture or tap / shake means (i.e., detected by the accelerometer mounted on the Somfit module). Similarly, all these functions can be integrated as part of a smart or computer-based clock system. A high-level user interface graphic drag-and-click type application enables the user to program the Somfit module display system and / or the compatible computer-based clock-face display functions, or enables them to include these and other measurements.

[0357] Claims - Somfit: See the abstract, specification, drawings, the claims of the applicable patent claims section, or subsequent divisional applications. Name: eLifeWATCH Description of the Invention Patient-wearable smart health watch device incorporating all combinations: Specifications of the standard eLifeWATCH model · Integrated ambient light detection sensor · Integrated microphone sensor (right hand side: Figure 7), optionally combines the sound dish function and improves the watch lens; · Integrated pulse pressure sensor; · Photoplethysmography measurement system with an oximetry photoplethysmography measurement option Integrated temperature sensor; (Figure 1; Figure 7) · Motion / vibration detection system with fall detection function and patient posture detection function; · GSR sensor with the option of a second wristband (for GSR function from wrist to wrist); · A modular rear watch panel that supports a wide range of embedded monitoring smart watch sensors and systems, a uniquely configurable monitoring sensor platform.

[0358] Specifications of Other eLifeWATCH Models · Configurable display parameters · Waterproof rating · One-week charging function in standard smart watch mode · Three 24-hour - 7-day - sleep eLifeWATCH all-channel acquisition modes Specifications of the eLifeWATCH Platform · Regionally sharable eHealthMEDICS application, available for free or purchasable through the application shop display option and reporting program · eHealthMEDICS application sharable among scientific developers' SDKs and technology communities, available for free or purchasable through the application shop display and reporting program purchase · Personalized "opt-in" health community application for Android, Apple, PC, or mobile wireless devices Sleep 360 SAAS including SAAS with cloud computing services or NAS · Neuro 360 SAAS including SAAS with cloud computing services or NAS · Ultrasonic Doppler blood flow (Figure 9) · 360 SAAS including cloud computing services or NAS · Cardio 360 SAAS including cloud computing services or NAS Patient-wearable smart health watch device incorporating any combination of other specifications: · Interface to wireless networks such as SAAS including (but not limited to) network application services (NAS), cloud computing services, or other networks or point-to-point interconnections; · Temporary and / or removable memory function; · Wireless gateway / interconnection function with wearable chest or abdominal band · Wireless gateway / interconnection function with a wearable device (not limited, such as a band or a watch, etc.); · One or more motion or movement detection sensors or systems incorporating linear (i.e., spectral analysis) and non-linear (i.e., spectral entropy or related complexity analysis) functions to improve the distinction and classification of the "footprint" of neurological, nervous system and / or muscular system disorders and related symptomatic vibrations or movements; · Psychological state-related tremors and / or vibrations and / or movement analysis to enable improved diagnostic classification of sleep, wakefulness, cardiac, respiratory, neurological, nerve and / or muscular system disorders and related symptomatic vibrations or movements "footprint"; · Integrated function (by the above motion detection) or individual posture detection and / or fall detection and / or gait or running state and / or other gait parameters; · Options specific to gyroscopes to improve posture / position / fall detection; / gait tracking function; · Options for a positioning system (GPS) that can assist in determining geographical locations; · Options for one or more integrated electrocardiogram (ECG) sensors (such as carbon rubber sensors, etc.); · One or more light sensors with options for smart watches combined with a light analysis function to improve environmental light determination (i.e., sleep statistical analysis results); · One or more respiratory inductive plethysmography and / or piezoelectric and / or PVD respiration sensors or sensor bands; · Options for body EMG sensors and monitoring by ECG or individual sensors, optionally providing effort measurement values related to respiratory effort and drawing a line for monitoring and event determination that interferes with central monitoring and event determination; · Photoplethysmography oximeter module and related analysis options (Figure 6; Figure 7; Figure 9; Figure 13) enabling cardiac functions including PTT, pulse wave amplitude, arterial pulse tension, transient pulse wave amplitude, oximetry.

[0359] Acquisition, analysis and increased complexity without the drawbacks of conventional data and analysis; The present invention incorporates processing functions and can undertake extensive or further processing requirements by a distributed or parallel processing system (including, but not limited to, an accompanying processing system, an interface to a wireless network (including, but not limited to, a network application service (NAS)), cloud computing services, or other networks or point-to-point interconnections, etc.) (Figure 13).

[0360] Developing the inherent processing and keeping it synchronized with other relevant simultaneous monitoring information (i.e., the physiological parameters of the subject; the voice and video of the subject), it is possible to automatically construct and stamp the monitoring data with critical time synchronization or time of interruption or inconsistency, so that the reconstructed state of the complete release of the data is always clear to the user, and incomplete records or inconsistent data can be guaranteed to be avoided along with the associated diagnostic ambiguities and risks of misinterpretation.

[0361] Essential supervision and health-community involvement guarantee the accuracy of such processing and the risk diagnosis of misdiagnosis.

[0362] The present invention incorporates a medical provider "opt-in" function. "Opt-in" refers to the function of the present invention that enables access by other parties upon receiving special medical permission. That is, the "special medical permission" involves, for example, online verification or permission and confirmation of the proper registration of a practicing doctor, and confirmation of the current and eligible registration status, legitimacy, and qualifications, etc. of the practicing doctor by a formal relevant register (s).

[0363] In this way, the present invention enables the system user to opt in (enabling the system user to specify and permit an approved medical practitioner), and only the user can select who can access which data, thus ensuring privacy and data security. That is, the user can request a medical "opt-in" or "link-in" status to a personalized "health network" (i.e., general practitioners, dentists, chiropractors, osteopaths, podiatrists, etc.).

[0364] After the subject / patient / user has "opted" into the personalized health network group, the user can "opt" on who should receive health warnings and messages, which calendar appointments should be automatically configured in the personalized calendar, which scheduling should be automatically configured in the personalized schedule, which medical record systems should be interfaced or data accessed (i.e., permitted for a personally controlled electronic health record (PCEHR)), and which other management systems (mobile phones, smart watches, etc.) should have access or be configured as part of the interconnectivity options of the present invention.

[0365] The wearable band (for the head, body, any body extremity, etc.) has an integrated fitness exercise and true sleep diagnostic monitoring function.

[0366] An example of the display screen of an embodiment of the present invention includes a watch mode display screen with a single eLifeWATCH menu button activation, and the screen includes four application display screens and a home sleep test (HST) setting display screen (FIG. 6; FIG. 10).

[0367] An exemplary embodiment of a body module type sensor platform system clock incorporates a photoplethysmography and / or oximeter plethysmography and / or temperature and / or spring type pressure or fixed electrophysiological (i.e., conductive rubber) or skin galvanic sensor (GSR) monitoring electrodes and / or Doppler ultrasound monitoring and / or pressure measurement monitoring (vascular monitoring) sensor system and / or light detection sensor and / or microphone sensor (Figure 7).

[0368] Example of the 3-step eLifeWATCH HST investigation process (Figure 8): · Step 1: Go to the AMAZON or eHealth shop cart, click and purchase eLifeWATCH for temperature; pulse; activity / position; skin / GSR; plethysmography oximeter; sound; light built-in personalized healthcare "everywhere". The modular rear cover provides specialized eLifeWATCH options including Doppler / ultrasound vascular function (patent pending), plethysmography oximeter (patent pending), vascular pulse pressure detection system (patent pending), glucose in interstitial fluid (patent pending), blood pressure analyzer, etc. eLifeWATCH includes eHealthMEDICS which are current and future generation applications and services. · Step 2: Go to the AMAZON or eHealth shop cart, eHealth sensor or eHealth data PLAN, click and purchase an eLifeWATCH sensor kit or special eHealthMEDICS service requirements. · That is, US home sleep examination types i), ll), iii) and / or iv) or AU level 2 · Option: While in the online shop, or alternatively, go to the eHealth data PLAN. · Step 3: Go to eHealthYOU or eHealthMEDICS and "opt-in" to the personalized health community. · Step 4: Charge the eLifeWATCH and sensor kit with the eLifeWATCH POD (lasts for 1 week in normal or standby use) (Figure 8).

[0369] Embodiments of the present invention: Clock-based sleep monitoring system · Automatically detect the survey type and configure the eLifeWATCH system for the user. · For various sleep, heart, and nerve surveys, a simple translucent sensor kit with a disposable self-adhesive electrode (like a "magic tape" band-aid) kit is available (i.e., click and buy on AMAZON) (Figure 8). · Electrode pairs with 2CM, 4CM, and 8CM intervals, sold in wide (6mm), medium (4mm), and narrow (3mm) options, allow the magnetic alignment sensor electronic module to be easily aligned and snap-connected without a problem, being almost invisible and hardly noticeable. · Peel the backing paper from the sensor and attach the fully charged and blinking-stopped magnetic alignment (patent pending) sensor module and the clock eLifeWATCH display. · The green circle around the eLifeWATCH sensor display is charged for more than 24 hours, and in the case of red, it is not charged. · Use a digital or color-coded position guidance system to uniquely use the eLifeWATCH display (or select an animated video guidance). · The unique eLifeWATCH automatically detects the sensor type and configures the system (patent pending) so that the survey type and system screen are automatically presented. · The unique eLifeWATCH display setting mode (Figure 11; left) is displayed, and the sensor blinks until all sensors and signal quality are acceptable, and then the OK mode is displayed (see Figure 8). · Scroll the screen (Figure 12) for animated video guidance, helpful tips, troubleshooting, diagnosis, more detailed status, etc.

[0370] The rear clock module - sensor platform of the present invention The wearable device or application of the present invention for attachment to the body, head, limb or end part of the body includes, but is not limited to, a wristband, a watch or a portable monitoring, detection or communication device, and has an interface function for monitoring the subject and / or between the wearable device and the "watch-case module type sensor platform" and / or the "watch-face module type sensor platform" and / or the "watch-body module type sensor platform" (Figure 13).

[0371] In one embodiment of the present invention, a detachable or removable modular sensor platform system for the "watch / wristband body" and / or the "watch / wristband face" and / or the "watch / wristband-back" and / or the "watch / wristband strap" and / or the "watch / wristband buckle" includes a watch device that houses a processing function, and the interface between the "watch-body module type sensor platform" enables any or any combination of analog, power, digital or wireless interfaces, enabling a series of configurable smartwatch devices having a range of environmental or health monitoring characteristics, and the device includes (but is not limited to) embedded, attached and / or integrated sensors (through the watch-back), and optionally has an automatic processing function (sound monitoring detailed in the subheadings listed in this document including health monitoring aspects; stethoscope auscultation sensor, monitoring and automatic analysis, classification, tracking and detection functions; acoustic noise cancellation system; motion detection; REM sleep behavior disorder (RBD); pulse wave analysis (PWA) and pulse wave velocity (PWV) monitoring and analysis functions; PWA and PWV sensors; PWA sensor measurement; electrocardiography; position, location and motion detection and monitoring; motion and position information; ECG sensor(s) and monitoring; optical sensor(s) and monitoring; respiratory band sensor and monitoring; EMG sensor and monitoring; GSR; heart function; sleep training system; photoplethysmography (PPG) (Figure 7); plethysmographic oximetry; transient pulse wave amplitude measurement; temperature (Figure 7), energy effort / metabolism monitoring (EM) as proxy calorie burn measurement; physiological and / or sleep and / or wakefulness scale or marker; and other mental states (i.e., sleep, wakefulness), etc.).

[0372] Environmental sensing (interface to alarm or warning or display or associated portable device or messaging, email, telephone automated voice message and other information or communication systems, ionization monitoring, ionization smoke alarm, methane monitoring, toxic gas monitoring, toxic chemical monitoring and / or CO2 gas monitoring, methane gas monitoring and / or by thermometer).

[0373] The multivariate analysis function enables the generation of indicator, alarm, and messaging functions based on analyzing any combination of environmental or health variables and exceeding a normal baseline or safe operating range or any predetermined combination or cluster of events or health or environmental conditions of concern or interest.

[0374] Name: eLifeBUDS Description of the Invention The present invention provides for incorporating one or more integrated (embedded or attached) sensors (Figure 14) capable of monitoring one or more physiological parameters into a patient-wearable device such as earphones (plural), enabling the present invention to function as a physiological monitor and a portable wireless device holder.

[0375] The present invention provides a sensor capable of detecting from fine tremor movements from a cardiovalistogram to coarser vibrations or movements.

[0376] Such a sensor can include a membrane or sensor (such as an accelerometer) capable of detecting movement or motion and generating a signal or measurement related to the "movement or motion".

[0377] The present invention enables access to the information related to "signals or measured values related to said movement or motion", directly accesses further "conversion or transposition (linear or non-linear)" of said "information", associates such "information" with a sleep state including a REM sleep state, and is intended to identify the possibility of tremors physiologically generated in relation to the occurrence of REM behavior disorder.

[0378] The present invention provides for incorporating the information or RBD related to "signals or measured values related to said movement or motion" into a decision-making or control process applicable to the optimization of the administration of optimal drug treatment, so as to achieve a predetermined result in terms of minimizing any or any combination of RBD and / or tremor states during a pre-specified sleep or wake state.

[0379] EMG by the carbon rubber section of the earphone insert. The conductive carbon section of the small earphone can be placed at a location between two or more carbon conductive regions that enable skin contact and conduction of a slight electrical signal (i.e., galvanic skin resistance can be determined from the measured value of a constant current transmitted as a means of determining the impedance / resistance between two sensors that vary with various sleep states, sweating of the subject, and other physiological changes between the two conductive sensors).

[0380] EEG includes vestibular signals via the carbon rubber section earphone insert. In the insert, conductive electrodes such as carbon rubber or other conductive materials can detect signals around the cochlear region of the brain. (That is, PAMR as a measure of the auditory muscle in response to the sound level, which can be developed as a measure of excessive volume and the possibility of damaging the subject's hearing). · PAMR by the carbon rubber section of the earphone insert (as described above); · Galvanic skin resistance by the carbon rubber section of the earphone insert (as described above).

[0381] ECG by the rubber section of the earphone insert (i.e., as a marker of heart function and heart rate variability, a means for determining a slightly but detectable signal measurement value that is clear throughout the skin surface, as a conductive sensor).

[0382] The auditory acoustic examination function includes any or all combinations of hearing evaluations (i.e., the use of earplugs is useful when using continuous high volumes, and in particular, the sensitive hearing physiological functions among children or adults may cause lifelong hearing damage without being examined or diagnosed (i.e., the present invention provides means for enabling automatic hearing diagnosis examinations and auditory tracking within a portable device, and when a hearing loss or the possibility thereof is suggested, it is possible to recommend further medical support to parents or individuals).

[0383] The present invention enables the inclusion of a hearing examination in a mobile phone or music or hearing aid or any combination of the above systems (plural possible), and as a means of reducing the more serious possibility of hearing damage if left unexamined among children and adults, etc., it brings about automatic hearing diagnosis examinations, guidance, and enhanced awareness.

[0384] The present invention also has means for utilizing such hearing examination results as criteria for auditory volume sensitivity, spectral auditory sensitivity, auditory conductivity characteristics, and auditory directional hearing characteristics (i.e., by changing a plurality of speakers spatially distributed within a small earphone, it is possible to compensate for spatial directivity disorders, and according to the user's preferred mode (i.e., speech intelligibility, listening to music, concentration on conversations in noisy rooms, audibility in classrooms, etc.), automatically compensate the subject / patient for specific optimal auditory processing requirements).

[0385] The present invention can provide an audiometer function as part of a portable device and earplugs or headphones, and the headphones or earplugs can generate a series of sounds including frequency bursts, frequency tones such as pips, MMN, oddball responses, and auditory steady-state responses (ASSR) of other AEP test paradigms, which can be used to evaluate an individual's hearing or attention / awareness (i.e., calmness, vigilance, concentration, etc. applicable to the diagnosis of autism spectrum disorder, ADHD, etc.).

[0386] Using an accompanying frontal system or other EEG head monitoring system (i.e., including, but not limited to, any of the following or any combination example presented in FIG. 2; FIG. 3; FIG. 4; FIG. 16; FIG. 21; FIG. 23; FIG. 24; FIG. 25; FIG. 27; FIG. 28; FIG. 45; FIG. 46; FIG. 47; FIG. 48; FIG. 49; FIG. 50; FIG. 51; FIG. 52; FIG. 53; FIG. 54; FIG. 55), as an evaluation means for the auditory evoked potential (AEP) hearing of a subject (i.e., sound conduction rate, directivity determination, sensitivity, spectral response, etc.), myogenic (i.e., PAMR) or neurogenic responses to auditory sounds or stimuli (i.e., including, but not limited to, the presence of a beep sound, or the frequency of other beep sounds, frequency bursts, or frequencies generated by the test sequence) can be monitored.

[0387] The present invention can provide an audiometer function as part of a portable device and earplugs or headphones, and the headphones or earplugs can generate a series of test sequence sounds including frequency bursts or the frequencies of beep sounds.

[0388] The present invention can include an electrophysiological sensor (i.e., a conductive material) attached or embedded in or as part of an earplug, and can monitor neurogenic and myogenic signals near the earplug or cortical region of a subject as part of an AEP test paradigm.

[0389] The present invention can include one or more vibration (i.e., speaker) vibration sensors capable of vibrating a series of frequencies, emulating tuning fork characteristics, and enabling an individual to test the sound conduction rate (i.e., measurement or diagnostic evaluation of conductive hearing loss) of a subject's auditory physiological function detection function.

[0390] The present invention can include one or more vibration probes (plural possible) (i.e., speakers or other vibration elements embedded in or attached to earplugs), and the probes can be vibrated in the same manner as tuning forks used to evaluate sound conduction rate (hearing impairment), the sensor can vibrate a series of frequencies, emulate tuning fork characteristics, and an individual can examine the sound conduction rate (i.e., measurement or diagnostic evaluation of sound conduction hearing impairment) with respect to the detection function of the target's auditory physiological function.

[0391] The present invention can include one or more individual and / or standard speaker transducers (plural possible) used for sound generation (i.e., embedded in or attached to earplugs or headphones), and evaluate sensorineural (i.e., problems caused by the auditory nerve or auditory pathway / cerebral cortex) hearing impairment by any combination of AEP tests and spontaneous responses (i.e., the subject taps or indicates when a certain sound is heard or not heard using a user interface).

[0392] The small earphone or headphone system of the present invention can include means for deploying a speech hearing test (HINT) within the system, and the means can include incorporating individual and / or standard speaker transducers (plural possible) used for sound generation (i.e., embedded in or attached to earplugs or headphones), and a test paradigm including any of the sound sequences generated in quiet and noisy ambient sound situations (i.e., competing sounds or sound sequences) can be simulated as part of the current system.

[0393] Furthermore, the present invention includes a plurality of speakers strategically arranged within the earplugs or headphones of the present invention to be able to simulate directional sound, and evaluates the ability to distinguish sounds from different directions of the subject (i.e., the location of the speakers at different positions with respect to the ear canal through the small earphones or the structure of the ear with respect to the headphones (i.e., above, left, front, back, below, etc. of the speakers) tends to simulate changes in the direction of sound, and the neurological processing of the subject's perception of the direction of sound can be evaluated (i.e., using the user interface, based on the activation of different speakers at different locations at the point of the subject's auditory space direction, prompting the user to indicate the perceived change in the direction of sound).

[0394] The present invention enables the HINT test and evaluates the subject's hearing ability under several conditions, including (but not limited to) the generation of text or sound sequences without competing background noise, the generation of text or sound sequences with competing background noise, the generation of text or sound sequences with competing background noise and directivity (i.e., simulation by a plurality of speakers strategically positioned or arranged within the earplug or headphone system) (i.e., the sound perceived as originating from in front of the subject with the same sound and speaker direction in the left and right ears of the subject (i.e., activation arranged in front of the same sound and speaker) simulates the "central" sound from the subject's perspective), the generation of text or sound sequences with a directivity of 90 degrees to the left or 90 degrees to the right (i.e., simulation by a plurality of speakers strategically positioned or arranged within the earplug or headphone system) (i.e., by adjusting which speaker and generating what level of sound, the sound can be directed from left to right), including any or all combinations thereof.

[0395] The present invention provides means for calculating the signal-to-noise ratio under various conditions based on determining the sound magnitude level required to reproduce text above background noise, giving priority above all else to the subject's ability to accurately repeat the text at least 50% of the time.

[0396] The present invention can record and analyze the correctness of repeating a target sentence (eliminating or differentiating from competing background noise generation) using a microphone such as a standard built-in or small microphone.

[0397] The small earphone of the present invention or the headphone system of the present invention can include means for incorporating tympanogram hearing evaluation within the system, and the means can include incorporating one or more pressure sensors on one or both sides of the small earphone or headphone (i.e., embedding or attaching into the small earphone(s), or being part of the small earphone(s)), and can generate pressure within the ear canal, change it, measure the corresponding pressure or pressure leakage, and determine the ear canal volume and (for example) the eardrum function (i.e., eardrum perforation). The means can include a speaker or other device (i.e., a calibrated speaker transducer and / or part of a small valve configuration) (i.e., the calibrated pressure sensor can measure the ear canal pressure, and the generated pressure and / or corresponding air volume versus the obtained pressure and / or obtained ear canal air volume and / or pressure can help explain the eardrum characteristics (such as eardrum perforation), the desired pressure and pressure fluctuations).

[0398] The small earphone of the present invention or the headphone system of the present invention can include means for incorporating the following

[0399] The acoustic reflection inspection function within the said system. The means includes one main element (i.e., it can be embedded into or be part of or attached to a small earphone(s)), and each element can include an individual tube facing the ear canal of the subject, and the small earphone can form a tight seal against the ear canal of the subject. The small earphone of the present invention can accommodate any or any combination of air-connected tubes (by way of example only and not limitation), the said tubes can transmit sound through a speaker, other tubes can connect the ear canal to a microphone, and other tubes can be a pressure generation pump (i.e., a small pump within the small earphone) that can generate a series of pressures typically ranging from -200 daPa to +400 daPa (1 Pascal is equal to 0.1 decapascals (daPa)), and / or another of the said tubes can connect the ear canal pressure to a pressure measurement transducer (the said tubes can be a combination of one or more tubes). A series of sounds can be generated through a speaker, and the impedance obtained (by acoustic reflectivity measurement) can be measured by a microphone. Using the obtained values, a graph called a tympanogram can be generated that includes compliance or acoustic impedance in response to a series of pressure values. In this way, the present invention can include one or more individual and / or standard speaker transducers (s) for use in sound generation (i.e., embedding or attaching to earplugs or headphones), calibrate one or more of the said speaker transducers to generate a known sound pressure level, present a sound (i.e., by way of example only and not limitation, a tone exceeding 70 decibel sound pressure level (DBSPL)) to the subject, and measure the subject's stapedius muscle (the stapedius muscle protects the ear from loud noises including, for example, the subject's own voice which can reach 90 DBSPL or more at the subject's eardrum).

[0400] The present invention includes any or any combination of sensorineural (i.e., caused by problems with the cochlea, sensory organs or hearing), conductive (i.e., caused by problems with the outer or middle ear), hearing loss, speech audiometry (HINT), tympanogram (determining how the eardrum and other structures within the middle ear are functioning), acoustic reflex testing (evaluating the subject's hearing threshold and providing information about vestibular and facial nerve function).

[0401] Pulse volume plethysmography (PPG) and output (see A&CD patents); Pulse oximeters based on ear reflectance are useful for non-invasive measurement of oxygen saturation (SpO2) and pulse rate (PR), and their output is useful for measurements including pulse wave amplitude, arterial pulse tension, transient pulse wave amplitude, PTT arousal, surrogate or qualitative blood pressure measurement, vascular tone, and sleep stage confidence level or probability based on autonomic neuropathy. · Pressure pulse signal · Temperature measurement · Monitoring of an individual's metabolism, effort or energy expenditure (see also armband-mounted metabolism monitoring devices)

[0402] The present invention provides for the incorporation of a gyroscope system, which can determine an individual's inclination or angular position relative to gravity or a horizontal position as a health metric (i.e., gait, onset of Parkinson's disease, fall detection), or as a fitness (optimal ability exercise, ability, behavioral physiological mechanisms, efficiency, improvement, etc.) (more details are also provided in the subheadings, health status or monitoring of this document).

[0403] GPS-based or position information derived from a communication system including, but not limited to, any or any combination of CDMA / code division multiple access, GSM / Global System for Mobile, Wifi, satellite, LAN, WAN, and / or Bluetooth systems.

[0404] The present invention provides a position sensor system (such as a "metal ball in a switch cage" device that can determine an individual's posture).

[0405] The present invention provides for the incorporation of a photoplethysmography pulse sensor.

[0406] The present invention provides, as part of a small earphone body (such as a wireless-linked music or communication earphone), (but not limited to) a cardiobalistogram monitoring sensor (i.e., a sensitive film sensor system such as an accelerometer), temperature (i.e., any sensor incorporating a thermistor, thermocouple, PVDF, infrared LDR, infrared LDR and interface infrared LED (including LED switches for three-dimensional thermal image characterization or mapping functions)), and can develop near-infrared energy thermal characterization related to an individual's effort or energy effort or related metabolism or calorie burn rate (detailed elsewhere in this document).

[0407] The present invention provides a means for notifying an individual wearing a small earphone of precursors to health conditions or events of interest such as heart events or thresholds, and can prioritize an automated voice over music or the sound during a call as a guarantee in situations where the respiratory rate or oxygen saturation, body temperature or other factors may be harmful to safety and proper physiological conditions.

[0408] The present invention provides a means for notifying an individual wearing a small earphone of precursors to health or safety conditions, which includes determining and detecting a crossing, a railway, and an oncoming vehicle (which may not be detectable otherwise due to reduced perception related to calls or music, etc.), and the present invention can prioritize the sound during music or a call as a guarantee for notifying an individual of an imminent danger or the possibility thereof.

[0409] Such a process or device can be used in combination with glasses or other wearable or portable cameras or voice monitoring devices.

[0410] The present invention provides a wireless-linked stereo or monaural small earphone incorporating an eHealth management system capable of any of the following combinations: · Audible sound · Integrated glasses with a voice-synchronized video function · Integrated temperature sensor(s) ·Integrated oximeter ·Integrated plethysmographic oximeter ·Integrated plethysmographic oximeter having the following information output: ·Pulse wave amplitude ·Pulse transit time ·Arterial pulse tension ·Pulse oximeter having a plethysmographic measurement waveform ·One or more ECG signals ·Barogram motion detection ·Motion detection ·GPS system ·Gyro position detection ·Patient position detection ·Electrophysiological sensors including any of the following combinations: ·EEG sensor ·EEG including vestibular detection ·EMG sensor ·PAMR sensor ·Optical pulse reflectance detection oximeter · system ·Optical reflectance oximeter · system ·Voice noise cancellation system ·Auditory echo monitoring system ·ER stimulation function ·ER auditory response measurement function ·ER auditory examination echo measurement system ·IP wireless · interface function ·IP wireless · interface function having a video glasses mounting function ·Wireless data · modem function ·Wireless mobile phone function ·Wireless video and mobile phone function having a synchronous video mounted glasses function.

[0411] The present invention provides a telephone holder that combines the telephone, entertainment, health - tracking and / or hearing aid of the present invention with small earphones or headphones.

[0412] The present invention is incorporated into a small earphone worn by a subject or one or two microphones or earphones, and the microphone can measure ambient sound including speech in various directions, and the phase, amplitude level, spectral composition, and comparison characteristics between two or more of the microphones from the earphones at one or both ears of the subject (and optionally other locations) are analyzed.

[0413] This enables means for reconstructing sound, processing the speech of interest, removing noise (including elimination of unwanted or background noise), and manipulating the focus of the received sound (i.e., weighting different microphone sound sources based on the manipulation of the final "sound source of interest" that operates the earphone speaker).

[0414] The operation of the earphone speaker of interest can include the operation of a plurality of speakers within each earphone and both earphones together, and according to the specific hearing requirements of the subject and personalized voice options (i.e., speech focus, enjoying music, adjusting speech in a crowded or noisy environment, etc.), the subject and / or speech sound focus and / or spectral filtering and / or spatial information for background or unwanted background noise are maximized.

[0415] The present invention further provides means for enhancing conventional entertainment and / or health detection small earphones or earphones regardless of whether they are wireless or wired connection versions, enabling enhancement for conventional mobile phones or entertainment voice or visual applications.

[0416] The invention can be calibrated, compensated for a subject's specific hearing, or calibrated and compensated in a specialized acoustic environment by using an online application.

[0417] The present invention provides small earphone health monitoring including a PAMR hearing function - The present invention describes a wearable audio earphone or headphones (plural possible) method or device, the method or device incorporating a health monitoring function and comprising one or more electrophysiological sensors (electrodes) enabling a neural and / or myogenic monitoring function.

[0418] Said neural monitoring can include monitoring of electroencephalogram (EEG) signals by electrodes embedded or attached as part of an earphone or headphone device, the function including the function of monitoring EEG signals in the cochlear or vestibular brain regions. Other EEG monitoring can include monitoring in the vicinity of the head or scalp region by further wired-connected electrodes.

[0419] Said myogenic monitoring can include monitoring of postauricular muscle response (PAMR) by electrodes embedded or attached as part of an earphone or headphone device, the function including the function of monitoring electromyogram (EMG) signals in the cochlear or vestibular brain regions. Other EMG monitoring can include monitoring in the vicinity of the head or scalp region by further wired-connected electrodes.

[0420] The present invention records, analyzes the postauricular muscle response (PAMR) as a biometric signal applicable to a large sound level response, and adjusts or minimizes the relevant dangerous sound levels for children or adults in earphones or small earphones or headphones, thus reducing the hearing damage that might otherwise be suffered (especially for young children with a more sensitive auditory perception system).

[0421] The present invention further incorporates a series of audiological examinations and audiological examination paradigms via application software as part of a portable or wireless portable processing device or telephone. Said "audiological examination" can include any one or any combination of the following: · Pure tone audiometry; - Air conduction; - Bone conduction; - High frequency; - It may be necessary to use modified pure tones (e.g., tremolo, pulse) in the vicinity of the frequencies affected by tinnitus - Masking may exacerbate tinnitus and should not be performed until after tinnitus. Nevertheless, perceptual evaluation; · Tinnitus match; - Pitch; - Loudness; · Minimum masking level; · Total / partial residual inhibition; · Speech audiometry that may be required; - Detection; - Recognition; - Identification; - Discrimination; - Masking if necessary (judgment is required if tinnitus may be exacerbated); · Tympanometry; · Otoacoustic emissions; - Evoked transient; - Distortion component; and / or · Auditory brainstem response (ABR) 7 。

[0422] Background of earphone PAMR monitoring: Problem: Long-term use of high-level audio through earphones may have an adverse effect on hearing, especially among infants and children, resulting in lifelong hearing dysfunction. Solution: Health monitoring in the form of continuous auditory measurements incorporated into wires, attachment straps, or actual earphones, small earphones, or headphones can provide useful tracking information and avoid tension damage due to specific excessive volume or excessive amplitude to individual hearing responses and hearing functions. The present invention provides several auditory measurements that can minimize the risk of hearing damage by incorporating a microphone into a hearing device (earphone(s), small earphone(s), headphone(s)) capable of performing dB sound pressure level (SPL) or various said "hearing tests" or related surrogate measurements.

[0423] When a continuous click sound is presented to a subject (i.e., via earphones), a PAM response is induced and can be measured using an electrophysiological sensor. Conventionally, this signal has been discarded as an unwanted artifact. The PAM response can almost certainly be monitored as a measure of muscle tension. For example, in the case of a procedure on a subject in a deep sleep or anesthetized state, the muscle activity of the whole body is relaxed, so the EMG response is suppressed. By "inducing" the muscle signal at the back of the ear (i.e., a loud click sound to the ear) and then monitoring the resulting "evoked response", the depth of sleep or anesthesia of the subject can be further measured. For example, when the subject transitions to a deeper sleep stage such as REM sleep or an anesthetized state, the muscle tension of the subject is gradually suppressed, and similarly, the PAM response also gradually decreases. Therefore, by inducing PAM with an auditory click and then measuring the amplitude of the resulting PAM response ("evoked posterior auricular response"), a useful measure of sleep or anesthesia depth can be provided. Therefore, the PAMR response and the related amplitude can be used as a marker of the sound pressure level that appears in the subject.

[0424] See the summary, specification, drawings, claims of the applicable patent claims, or subsequent divisional applications for the claims of the patent. Name: eLifeKIT Background Importance of Sleep · High-quality sleep is essential for health, well-being, all aspects of lifestyle, and even the passion for living. · The most affected by sleep deprivation is due to insufficient deep sleep. · During deep sleep, the body repairs itself and restores energy for the next day. · It is not the time spent in bed that matters most, but the quality of sleep. · Sleep is composed of different stages, and each stage of the sleep cycle brings different benefits. · Deep sleep (stage N3) and REM sleep are the most important sleep stages. · In the case of a normal adult, about 50% of the total sleep time is spent in stage 2 sleep, 20% is spent in REM sleep, and 30% is spent in the remaining stages including deep sleep. · Sleep debt is the difference between the amount and quality of sleep actually obtained and the amount and quality of sleep required. · Sacrificing sleep adds to the sleep debt. · Ultimately, the sleep debt must be "paid back" to rebalance the "sleep account". · Sleep debt contributes to daytime sleepiness, leading to lapses in attention and reduced daytime performance, including traffic accidents, medical errors, lighting, other mistakes, disasters, and safety hazards. · Reliable or effective sleep monitoring cannot be achieved with the use of conventional wrist monitoring systems, and monitoring of the brain, muscle tension, and eyes is required. · Inadequate deep sleep has an adverse effect on the immune system, including metabolism, weight, memory recall, energy levels, occupational risks, suppression of dangerous cells in the body, and even the ability to fight cancer, as well as overall health and quality of life. · Among children, poor-quality sleep is associated with low IQ and behavioral disorders, while among women with sleep disorders, the health of the fetus is at risk, and there are life-threatening complications such as hypertension or preeclampsia. · Sleep deprivation leads to depression, anxiety, irritability, lack of concentration and emotion, or fatigue and overall emotional blunting. · Sleep disorders are also associated with cardiovascular health, such as elevated stress hormone levels, hypertension, arrhythmia, and congestive heart failure.

[0425] In terms of comorbid sleep disorders, the majority of patients with drug-resistant hypertension [1], obesity [2], congestive heart failure [3], type 2 diabetes [4], stroke, and transient ischemic attack [5] also have sleep-disordered breathing.

[0426] Problems with conventional consumer-level health monitors · High-quality or healthy sleep depends on sufficient deep sleep and rapid eye movement (REM) sleep (also known as dream sleep), not just the amount of time spent sleeping. · Other consumer monitoring devices such as Fitbit "are not reliable devices for estimating sleep-wake patterns and the quality of sleep and significantly overestimate wakefulness and sleep efficiency."8 ·Previous attempts such as ZEO rely on unreliable, uncomfortable head pressure fitting sensors and unvalidated metrics. ·Conventional health trackers claim to monitor sleep and track sleep quality, but cannot be achieved in a simple state without monitoring brain, muscle, and eye measurements. ·Without routinely tracking deep sleep and REM sleep, the consistency or lasting effects of sleep quality cannot be tracked. ·Furthermore, without user-friendly, consumer-accessible simple sleep tracking, the average consumer cannot reliably access or manage their personalized sleep and almost certainly overall quality of life. ·Without effective sleep quality monitoring, it goes without saying that the impact of sleep quality on daytime ability, mood, occupational risks, and overall lifestyle and health status cannot be determined, and there can be no concept of sleep quality. ·Without effective sleep quality monitoring, it goes without saying that the understanding of risks related to oneself and others cannot be determined, and personalized sleep debt or depth or daytime sleep drive cannot be effectively tracked. ·Without effective sleep quality monitoring, the causes and effects of preventive sleep disorders such as environmental noise or other conditions cannot be tracked. ·Without effective sleep quality monitoring, there is a risk of missing early signs of sleep disorders that can be reported to a doctor and intervened early to avoid more serious health conditions. ·Without effective sleep quality monitoring, one risks not tracking the causes and effects of changes in sleep quality associated with age, sleep environment, health status, and stress.

[0427] Description of the Invention · The eHealthMEDICS solution incorporates the eLifeCHEST chest-worn band, the "companion" eLifeWATCH smart health watch, its own Network Application Service (NAS), a High Dependency Data Management (HDCM) system 9 (RFM14935), and a special eLife sleep patch - attached self-adhesive wireless electrode array, enabling conventional fitness or activity tracking and expert-level sleep monitoring, etc. · Daytime activity and respiration, as well as nocturnal diagnostic sleep and respiration monitoring, are now possible via a single integrated platform suitable for both consumer-level and expert-level health management. · Nighttime, daytime, and sleep respiration can be continuously and seamlessly monitored via a single eHealthMEDICS chest-worn fitness / sleep system.

[0428] eLife Sleep · By enabling routine deep sleep and REM sleep monitoring, ongoing tracking and investigation of the permanent effects on sleep quality become possible. · New integration of wrist-based online tracking of sleep quality and sleep debt index (from 1 to 10) with conventional fitness levels and goal measurement. · Sleep quality and sleep debt are based on the validation of "optimal criteria" sleep metrics and indices. · Simple yet highly consumer-friendly consumer and expert-level monitoring is made possible, which is suitable not only for tracking the amount of time spent sleeping but, importantly, also for tracking sleep quality, i.e., sufficient deep sleep and rapid eye movement (REM) sleep (also known as dream sleep). · Expert-level ("optimal criteria") medically proven format of monitoring techniques and the use of related self-adhesive disposable sensors (minimizing the risk of cross-infection). · The sensor system enables continuous monitoring of "optimal criteria" sleep parameters including brain, muscle, and eye measurements. (i.e., EEG, EMG, EOG), enabling automatic online determination and display of deep sleep and REM sleep, along with related sleep components and validated indices such as sleep efficiency. ·Enable the achievement of optimal levels of ability during the day, mood control, reduction of occupational risks, and determination of sleep quality applicable to an overall high-quality lifestyle and health status. ·The ability to monitor sleep quality involves incorporating relevant personalized sleep logs by an automatic sleep debt tracker, assisting in the management of the depth of sleep impulses during the day, and contributing to related occupational safety aspects. ·Incorporate new means to track the causes and consequences of preventive sleep disorders such as environmental noise or other conditions, including the analysis of the causes, impacts, and preventive actions (CAPA) of online automatic sleep disorder events. ·Enable effective monitoring of sleep quality, assist in personalized health management, support early intervention by physicians or health experts, and avoid the possibility of a more serious health condition. ·Enable effective routine monitoring of sleep quality, assist in personalized health management, and support physicians or health experts in associating with sleep quality fluctuations due to changing factors such as age, weight, fitness, sleep position, alcohol consumption, sleep environment, health status, and stress. ·With a unique biologically synchronized sound discrimination function, it can automatically analyze, classify respiratory and sleep disorders online, and present them as simple "sleep progress" CAPA personalized sleep tracking. The sleep disorder log is completed with suggestions of causes or possibilities and informative suggestions for improving sleep. That is, it can track the disturbing effects of an individual's snoring and a partner's snoring, enable online CPAP tracking (i.e., online playback of sound disorders), and identify the source of the disorder (i.e., abnormal events such as external noises including personal disturbances such as the sound of a car, a door slam, street noise, or a partner's snoring or cough). 9 (RFM14935).

[0429] Invention: CAPA Decision and Countermeasures The present invention enables a user to view a sleep pattern, hypnogram, profile, or other sleep summary, and provides for the incorporation or association of event markers indicative of sleep or breathing disorders, whereby the user can activate the event markers, establish corrective and preventive action (CAPA) information, and assist in the management and ultimate reduction of sleep disruptions or disorders or the improvement of sleep quality. Said "activation" includes (but is not limited to) playback for sound differentiation (i.e., corresponding to a sleep disorder), presenting to the individual being monitored or the healthcare provider whether the sound was of biological nature (i.e., synchronized biologically with the subject's monitoring signal or of biological nature but related to another individual such as a snoring partner) or other (street or house noise, etc.).

[0430] CAPA includes means for automatic or manual deployment, optimizing or adapting the settings of a treatment device or changes in environmental conditions (i.e., automatically adjusting temperature, room curtains or blinds, and blocking or reducing sound noise interference, etc.), and improving sleep or treatment conditions (automatically controlling at a later time or online or by remote intervention of a healthcare provider).

[0431] The present invention (Somfit bracelet) incorporates measurements, targets (i.e., target or normal functional ranges) and / or displays any or any combination of the onset or occurrence of sleep (i.e., sleep debt, sleep efficiency, sleep profile, REM sleep, deep sleep, incidence of mid-sleep awakenings) and / or fitness (gait, exercise, mapped routes, etc.) and / or health events or event clusters (i.e., idiopathic RBD, Parkinson's disease, epilepsy, epileptic seizures, Alzheimer's disease, autism and other noted nervous system and muscle or sleep disorders). a) The same band is interchangeable as a head or wrist-mounted system. b) An individual attachable system can be deployed. c) Automatically and dynamically synchronize data between the head and / or other body monitoring physiological processes or sleep parameters, enabling a clock, wrist, portable device or other related information access system to continuously update the entire cluster / group of physiological monitoring systems and related data.

[0432] The modified operation and preventive operation eCAPA function of the present invention provides means for adapting or adjusting any one or any combination of the following:

[0433] CPAP results - that is, based on the determination of the deviation between the natural circadian clock / rhythm pair of the subject / patient, the current or required circadian clock / rhythm pair of the subject / patient, and the different circadian clock / rhythms, means for advising or recommending drug therapy, together with means guidance and / or recommendation / advice and / or an alarm clock or other wake-up / arousal stimulus and / or light therapy / indoor lighting adjustment / curtain adjustment of the room (i.e., an increase in light can suppress the natural secretion of melatonin in the pineal gland in the brain, while darkness can stimulate the release of melatonin).

[0434] Using drugs that can suppress or stimulate melatonin, the natural circadian clock / rhythm can be resynchronized or adapted to the required wake / sleep or local time zone requirements.

[0435] The present invention enables any one or any combination of adjustments or adaptations according to the following, related to the circadian clock (i.e., based on the determination of the adjustment of the natural circadian clock when the circadian clock deviates from synchronization in a new environment).

[0436] Drug guidance, recommendation and / or administration / dispensing, appropriate (i.e., without limitation, any one or any combination of medical, legal, health insurance, prescription and / or advice requirements / recommendations) drug therapy options are conditional on the adaptation to the new environmental time and schedule requirements.

[0437] The drug online information or educational access and / or ordering / supply management functions of the present invention are subject to legal requirements (i.e., without limitation to any or all combinations, data security, data privacy, medical, legal, health insurance, prescription and / or advice requirements / recommendations), and incorporate these functions according to the subject / patient options for drug therapy options (i.e., treatment for modifying melatonin production or suppressing sleep impulses or promoting sleep functions), and compensate for jet lag and other offset causes such as natural circadian rhythms / clocks, new environments, or sleep / wake / work requirements. The online drug therapy or tumon or supply configuration functions of the present invention include, without limitation, modification of the circadian clock / rhythm by drugs. For example, by guiding or recommending dosage and / or type and / or controlling administration (i.e., an automatic drug dispensing system), it promotes sleep with sleeping pills,...

Claims

1. An apparatus for determining and monitoring neurological or muscular disorders, comprising: a forehead-mounted device comprising a sensor for acquiring an electromyogram (EMG) signal of a subject and a sensor for detecting fine tremor movements; a processor and means configured to detect REM sleep behavior disorder (RBD) defined by the incidence of REM sleep without atonia, in combination with a stepwise measurement from fine tremors to coarser vibrations during REM sleep, from the electromyogram (EMG) signal; a wrist-mounted device for acquiring a signal for measuring or monitoring the subject's gait; means for automatically or with computer assistance adjusting the range or threshold level of fine tremors relative to coarser or more prominent motor activity obtained from the sensor for detecting the fine tremor movements, and for detecting basic signs of potential neurological or muscular disorders or signs indistinguishable by other means from the data of the REM sleep behavior disorder (RBD); wherein the gait includes gait symmetry; The apparatus is characterized in that it is configured to identify a correlation between the REM sleep behavior disorder (RBD) and the gait of the subject.

2. The apparatus according to claim 1, wherein the pattern of the electromyogram (EMG) signal and / or the signal for measuring or monitoring the subject's gait is related to a signal characteristic of a movement disorder.

3. The apparatus according to claim 2, wherein the movement disorder is related to bradykinesia or abnormal movement.

4. The movement disorder is Parkinson's disease, restless legs syndrome, dystonia, Wilson's disease, or Huntington's disease, The apparatus according to claim 2 or 3, which is any one of them.

5. The apparatus according to any one of claims 1 to 4, wherein the signal for measuring or monitoring the subject's gait is analyzed by a motion signal dynamics technique, and the motion signal dynamics technique is an analysis technique of signal characteristics in terms of the dynamics of the motion signal, and is non-linear dynamics analysis, complexity analysis, entropy analysis.

6. The apparatus according to any one of claims 1 to 5, wherein the data indicating the electromyogram (EMG) signal and the signal for measuring or monitoring the subject's gait are stored in the cloud.

7. The apparatus according to any one of claims 1 to 6, further comprising a sensor for determining an electroencephalogram (EEG) signal of the subject.

8. The apparatus according to any one of claims 1 to 7, further comprising a sensor for determining an electrooculogram (EOG) signal. **Claim 9** The apparatus according to any one of claims 1 to 8, wherein any one of a sensor for acquiring an electromyogram (EMG) signal of a subject, a sensor for acquiring a signal for measuring or monitoring the gait of the subject, a sensor for determining an electroencephalogram (EEG) signal of the subject, and the sensor for determining an electrooculogram (EOG) signal is disposed within the forehead-mounted device. **Claim 10** The apparatus according to any one of claims 1 to 9, wherein determination of the electromyogram (EMG) signal and the signal for measuring or monitoring the gait of the subject is performed in real time. **Claim 11** The apparatus according to claim 7, wherein determination of the electroencephalogram (EEG) signal is performed in real time. **Claim 12** The apparatus according to claim 8, wherein determination of the electrooculogram (EOG) signal is performed in real time. **Claim 13** The apparatus according to any one of claims 1 to 12, further comprising storage means for storing signals acquired over a plurality of days.

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