Systems and methods for wave generation using transcutaneous vibration

Abstract

This invention relates to a system and method for generating waves using transcutaneous vibration. The system and method for assisting a subject in achieving a target state include: obtaining input of the subject's target state; and generating a transcutaneous vibration output to be applied to a part of the subject's body to assist the subject in achieving the target state. The transcutaneous vibration output has variable parameters including perceived pitch, perceived beat, and perceived intensity. The step of generating the transcutaneous vibration output further includes modifying the variable parameters to correspond to the target state.

Description

[0001] This application is a divisional application. The original application was filed on December 20, 2019, with application number 201980093597.X (PCT / US2019 / 067769) and the invention title "System and method for wave generation for transcutaneous vibration".

[0002] Priority requirements

[0003] This application claims the benefit of the following provisional applications, the entire contents of which are incorporated herein by reference: U.S. Serial No. 62 / 788,564 (APLO-0003-P01), filed January 4, 2019; U.S. Serial No. 62 / 788,605 (APLO-0004-P01), filed January 4, 2019; and U.S. Serial No. 62 / 867,591 (APLO-0006-P01), filed June 27, 2019. Technical Field

[0004] This disclosure provides systems and methods for promoting changes in neural or emotional states. Background Technology

[0005] The autonomic nervous system (ANS) is part of the peripheral and central nervous system and includes the nerves that communicate between the brainstem and the body's internal organs. The ANS comprises complementary branches or systems of the sympathetic and parasympathetic nervous systems. The sympathetic nervous system is often referred to as the body's "fight or flight" system because it prepares the body for intense physical activity to increase its chances of survival when dealing with threatening situations. The parasympathetic nervous system (sometimes called the "rest and digest" system), on the other hand, allows the body to relax and can reduce or inhibit many of the body's high-energy functions required for effective management of survival.

[0006] The sympathetic and parasympathetic nervous systems operate below the level of consciousness through complex interactions between their two branches, responding rapidly and continuously to disturbances that threaten the stability of the body's internal environment. Thus, the sympathetic and parasympathetic systems work together to maintain homeostasis. Activity within the sympathetic nervous system can be intentionally modulated through activities that enhance parasympathetic activity, such as meditation and deep breathing.

[0007] The autonomic nervous system can be manipulated through sensory pathways. For example, in the resonance method, periodic sensory stimulation can elicit physiological responses that peak at certain stimulus frequencies. This includes a resonance mechanism characterized by physiological responses peaking relative to frequency, causing periodic sensory signals to trigger oscillatory patterns in certain neural circuits. The most common example of this phenomenon is music. While music resonates slightly differently in each individual, it reliably induces significant shifts in consciousness, cognition, mood, and many other senses in a highly similar manner. Fast, loud music typically elicits physiological and subjective responses from the sympathetic nervous system, while slow, gentle, and soothing music tends to elicit the opposite parasympathetic response. This general rule regarding the relationship between the intensity and frequency of physiological and subjective responses is similar for touch and most other stimuli.

[0008] The responses to sympathetic and parasympathetic nerve stimulation are often antagonistic. For example, they have opposing or antagonistic effects on heart rate. While stimulation of sympathetic branches increases heart rate, stimulation of parasympathetic branches decreases it. Furthermore, the body's response to activity in one branch depends on the activity levels in other branches. Sympathetic and parasympathetic activity constitute a complex dynamic system that constantly adjusts to changes in the body and its external environment. The ANS (Autonomic Nervous System) strives to optimize activity in each branch and balances the two branches in real time according to internal and external conditions, thereby maintaining homeostasis.

[0009] In certain diseases and conditions, the balance between the activity of the sympathetic and parasympathetic nervous systems is involved, either causally or in attempts to remedy the condition.

[0010] Therefore, there is a need for methods to influence the health or condition of a subject by stimulating and improving the function of the sympathetic and / or parasympathetic branches of the autonomic nervous system (ANS) (both rapidly and gradually over time). This disclosure generally relates to methods and apparatus for influencing the health or condition of a subject by modulating and / or applying stimulation to the sympathetic and / or parasympathetic branches of the autonomic nervous system (e.g., as a function of heart rate) using information about the sympathetic and / or parasympathetic branches of the autonomic nervous system. Summary of the Invention

[0011] Throughout this disclosure, the methods and systems described herein relate to assisting subjects in achieving, maintaining, and / or preparing users to achieve a target state (e.g., calmness, focus, flow, presence, sleep, wakefulness, relaxation, arousal, euphoria, or performance state), maintaining the target state, and / or preparing users in advance to achieve the target state. Subjects may provide input about the desired target state to a processor associated with a transducer, which may generate a transcutaneous vibrational output to be applied to a part of the subject's body. Throughout this disclosure, the transcutaneous vibrational output may be described as having variable parameters including perceived pitch, perceived beat, and perceived intensity. Throughout this disclosure, the transcutaneous vibrational output may be generated using multiple perceived pitches and / or multiple perceived beats. Throughout this disclosure, the transcutaneous vibrational output may be generated by multiplicatively combining a sinusoidal waveform envelope with a waveform having a perceived pitch, for example, according to the formula: [sin(2.0*π*frequency_perceived_pitch*t)]*[sin(π*frequency_perceived_beat*t)]. Throughout this disclosure, the user's sensory thresholds (both lower and upper limits) can be used as boundaries for the generated transcutaneous vibrational output. Sensory thresholds can be determined through calibration procedures, by collecting active data through survey questions, or by collecting passive data through monitoring mobile device and application usage. Variable parameters can be modified based on the desired target state, for example, through the device's user interface or automatically, further avoiding habituation. The desired target state can be inferred based on the subject's current condition, which can be determined manually and actively through user input, or passively through the user's movement and environmental data, and biometric or physiological sensing. Throughout this disclosure, physiological sensing data can include any of the following: heart rate (HR), heart rate variability (HRV), skin conductance (GSR), movement, respiratory rate, temperature, SpO2, vital capacity measurement, EEG, ECG, EMG, CO2, exercise, blood pressure, or glucose. Achieving the target state may include generating a second transcutaneous vibrational output, for example, in the absence of a first transcutaneous vibrational output, or generating a transcutaneous vibrational output with multiple segments. As with any implementation herein, the transducer's processor may communicate with one or more sensors, other systems, devices or transducers and any of their processors, or a remote server.

[0012] The methods and systems disclosed herein relate to assisting a subject in achieving a target state using their feedback as an aid. A desired target state for the user is determined, and a transcutaneous vibrational output is generated, designed or programmed to aid in achieving, maintaining, or pre-preparing the user to achieve the target state. The transcutaneous vibrational output is applied to a part of the subject's body (e.g., using a transducer), and user input regarding state achievement is obtained as feedback to the system. Failure to achieve the target state may result in the generation of a second transcutaneous vibrational output for application. In any embodiment of this disclosure, the target state and / or user feedback may be selected using a user interface including a transducer, a second device communicating with the transducer, or an application executed on a mobile device communicating with the transducer. A processor may electronically communicate with the transducer and the user input device, wherein the processor causes the transducer to generate a transcutaneous vibrational output upon receiving input or instructions from the user input device.

[0013] The methods and systems disclosed herein relate to assisting subjects in achieving a target state using sensor-based measurements or third-party data sources as feedback. Sensor-based measurements may include, but are not limited to, heart rate, heart rate variability, respiratory rate, and skin conductance. Third-party data sources may include, but are not limited to, health informatics applications, electronic health records, hospital data systems, social media post content, metadata from mobile devices (smartphones), or communication content. The desired target state for the user is determined, and a transcutaneous vibrational output is generated, designed or programmed to help achieve, maintain, or prepare the user to achieve the target state. The transcutaneous vibrational output is applied to a part of the subject's body (e.g., using a transducer), and sensor-based measurements or third-party data regarding state achievement are obtained as feedback to the system. Failure to achieve the target state may result in the generation of a second transcutaneous vibrational output for application. Achieving the target state may cause interruption of stimulation or generate a maintenance stimulation protocol. The target state and user feedback can be selected using a user interface of a device including a transducer, a second device communicating with the transducer, or an application executed on a mobile device communicating with the transducer. The processor can electronically communicate with a transducer, a physiological sensor, and an optional user input device, wherein the processor causes the transducer to generate a transcutaneous vibration output when receiving input or instructions from the user input device, the sensor, or a third-party data source, and generates further transcutaneous vibration output in response to a determination of target achievement based on the sensor or third-party data source.

[0014] The methods and systems disclosed herein relate to calibrating methods and / or systems that help subjects achieve a target state. The calibration method may involve selecting a first transcutaneous vibrational output based on a target state determined by the user, applying the vibrational output, and measuring its effectiveness, for example, using a sensor or user feedback. Then, a second transcutaneous vibrational output is used to achieve the same target state, and its effectiveness is similarly measured. Based on the effectiveness determination, the processor calibrates the method for achieving the target state, selecting a vibrational output for subsequent attempts in achieving the target state, or generating a third transcutaneous vibrational output. Alternatively, the calibration method may utilize multiple transcutaneous vibrational outputs in a given session where effectiveness has been determined. Once a valid transcutaneous vibrational output is identified, it is stored in a database. The database is used for other valid transcutaneous vibrational outputs, and one of these other valid transcutaneous vibrational outputs is selected for emission using an electronic transducer.

[0015] As soon as the user begins using the stimulation device, another calibration process begins. Over a period of time, this calibration involves using sensors in conjunction with routine assessments of the mobile device user and metadata to determine the user's baseline, non-stress state through periodic measurements of physiological parameters such as heart rate (HR), heart rate variability (HRV), conductance of skin (GSR), movement, respiratory rate, temperature, SpO2, vital capacity, EEG, ECG, EMG, heart rate, CO2, exercise, blood pressure, or glucose. Then, when the device's processor, communicating with the sensors, identifies a deviation from the baseline, it responsively identifies a transcutaneous vibration output and transmits it to the processor for generation and application by the transducer. The user can help identify the baseline state during calibration by inputting information about their mood. The processor can also use correlated data periodically received from the mobile device to determine the baseline state, deviations from it, or mood. Correlated data, which can be used in any of the disclosed embodiments, may be derived from social media content, navigation apps, calendar apps, mobile trackers, mobile device usage, keystrokes entered on the mobile device, or project management apps. As with all implementations described herein, if the transcutaneous vibration output is ineffective in helping the user enter the target state, it can be modified (e.g., by changing one or more variable parameters), interrupted, or a second transcutaneous vibration output can be generated and started.

[0016] The methods and systems disclosed herein relate to predicting whether a user is leaving a target state or is not in or about to achieve a target state, and then assisting the user in reaching that target state. Prediction is made by electronically sensing at least one physiological state using wearable sensors / devices, or by collecting data from a separate device / database (e.g., smartphone, fitness tracker, smartwatch, smart speaker, smart glasses, connected vehicle, or smart headphones) or by association with the user, to determine emotional and / or physiological states. A transcutaneous vibrational output designed to resolve or avoid the predicted state is then generated and delivered as needed. The transcutaneous vibrational output may have multiple segments, each with variable parameters. As with all embodiments herein, if the transcutaneous vibrational output is ineffective in helping the user avoid the predicted state or enter the target state, it may be modified (e.g., by changing one or more variable parameters), interrupted, or a second transcutaneous vibrational output may be generated and initiated.

[0017] The methods and systems disclosed herein relate to assisting subjects in achieving a target state by using both their sensory thresholds (lower and upper limits) as boundaries for the generated transcutaneous vibratory output. When a state input is given to a processor communicating with the transducer, such as when a user has a specific symptom, the transducer generates a transcutaneous vibratory output in a selected mode, based on the identified symptom, at or above the sensory threshold used for the subject's sensory output. Various values ​​and ranges of perceived beat, perceived pitch, and sensory threshold limitations are disclosed in the treatment of various low-arousal and high-arousal symptoms associated with imbalances in the autonomic nervous system (ANS).

[0018] The methods and systems disclosed herein relate to assisting subjects in achieving a target state and storing at least one of the user's associative or biometric data as a baseline state while the user is in the target state. For example, a user may desire stimulation to achieve a "state of arousal" (optimal performance state) and may indicate this in a user interface, and a transcutaneous vibrational output may be generated to achieve said state. When the user achieves said state, for example by indicating it in the user interface or by turning it off, biometric and associative data are stored for future use. Associative data may include the user's location in a gym. If this location is sensed again by a processor communicating with the transducer, the transcutaneous vibrational output generated to achieve the "state of arousal" can be automatically initiated.

[0019] The system disclosed herein is configured to assist a subject in achieving a target state using a coordinated system of transducers. Each transducer in the system emits a transcutaneous vibrational output according to the user's desired target state, wherein each transducer emits one of a waveform for sensing pitch or for sensing beat, or each transducer in the system emits a different transcutaneous vibrational output in a certain pattern (e.g., simultaneously, sequentially, alternately, coordinated). Each transducer in the system can be worn on different parts of the body. As with all embodiments herein, if a transcutaneous vibrational output emitted by any transducer is ineffective in helping the user enter the target state, it can be modified (e.g., by changing one or more variable parameters), interrupted, or a new transcutaneous vibrational output from one or more transducers can be generated and started. In some embodiments, the processor of the first transducer is programmed to modify the first transcutaneous vibrational output pattern based on data received from a second transducer. As with any embodiment herein, the transducer processor can communicate with one or more sensors, with other systems, devices, or transducers and any of their processors, or with a remote server.

[0020] The methods and systems disclosed herein relate to assisting subjects in achieving a target state using transcutaneous vibrational output and another method (e.g., sensory stimulation (e.g., visual, olfactory, tactile, etc.) or therapy (e.g., psychotherapy, physical therapy, massage)). Based on the user's condition, transcutaneous vibrational output is automatically determined through sensing (e.g., physiological, biometrics) or user input to help resolve the condition. Furthermore, sensory stimulation can be selected based on the user's assessed condition or the selected vibrational output. Sensory stimulation can be further initiated via a processor communicating with a controller of the system delivering the sensory stimulation or the sensory output device. In some embodiments, sensory stimulation is applied using a stimulation device.

[0021] The methods and systems disclosed herein relate to using transcutaneous vibrational output to help subjects mitigate the side effects of medications (e.g., antidepressants, anxiolytics, antipsychotics, and psychoactive drugs) in the treatment of mental health conditions. The method may include administering the medication to the subject during a treatment session and identifying any adverse effects (e.g., anxiety, restlessness) that may affect the treatment session. If any adverse effect is identified, for example through therapist input, sensors (e.g., physiological or biometrics), or user input, a transcutaneous vibrational output and / or variable parameters used to generate that vibrational output may be selected to mitigate or reduce the adverse effect. The vibrational output may be generated and applied. Sensory stimuli may also be applied to the subject in response to the identification of any adverse effect.

[0022] The methods and systems disclosed herein relate to providing transcutaneous vibrational outputs for a therapeutic session based on events experienced by the user. Data about the events can be obtained by inputting on a user interface or by transmitting the events to a processor that creates parameters for the therapeutic session. Based on the events, the processor can assign a set of consecutive output segments to the events and instruct the transducers, or send instructions to a processor associated with the transducers, to generate segments, at which point the transducers generate the segments. The therapeutic session can be further modified based on the events. The events can be at least one of sporting events, recreational events, psychotherapy sessions, or stress-induced events, and data about the events can be received from a transportation application based on location, collected by physiological sensors, for changes in the event, changes in traffic patterns. The method may also include administering medication during the psychotherapy session.

[0023] The methods and systems disclosed herein relate to aiding sleep in subjects using transcutaneous vibrational output. During transcutaneous vibrational stimulation designed to prepare a user for sleep, physiological sensors worn or near the user provide data to a processor communicating with a transducer regarding whether the subject is in a pre-sleep state or asleep. Based on the data, the processor may alter one or more variable parameters of the stimulation pattern emitted by the transducer, or shut down the transducer. In embodiments, certain variable parameters may be decremented if the data indicates that the user is approaching or already asleep. Decrease may include reducing the frequency of the perceived pitch and / or increasing the interval of the perceived beat and / or decreasing the intensity, and optionally maintaining the decreased frequency and / or increased interval and / or decreased intensity for a period of time. In some embodiments, the therapeutic stimulation pattern comprises two or more oscillations, one in the range of about 1 to about 100 Hz, and another initially differing from the first frequency by about 0.0001 to about 1 Hz, which together form the beat output.

[0024] The methods and systems disclosed herein relate to assisting a subject in achieving a target state using transcutaneous vibrational output. A processor, at least one of which is located within or in electronic communication with a mobile device, is in electronic communication with a transducer and a sensor that senses the user's biometric data. The transducer receives the user's target state and generates a first transcutaneous vibrational output. Biometric data is received from the sensor and the processor determines whether the user has achieved or not achieved at least one of the target state, and if the user has not achieved the target state, the processor is further programmed to determine the user's current state. The mobile device is caused to (i) generate an output indicating whether the user has achieved the target state, and (ii) if the user has not achieved the target state, generate an output (e.g., visual, auditory, or tactile) guiding (e.g., a beating heart, a depicted breathing rhythm) the user to achieve the target state.

[0025] The methods and systems disclosed herein relate to assisting a subject in achieving a target state using transcutaneous vibrational output delivered via or by furniture. The system may include a housing containing a seat / seat backrest comprising a transducer. Physiological sensors may determine the alertness state of the seat occupant, and a processor may responsively control the transducer, for example, to generate stimuli relating to inducing the user to awaken. Vehicle sensors may sense vehicle operating parameters (e.g., vehicle motion, windshield wiper activation), wherein the processor may control the transducer using vehicle operating parameters.

[0026] The methods and systems disclosed herein relate to assisting a subject in achieving a target state using transcutaneous vibrational output delivered via or by a baby seat. The baby seat includes a transducer, at least partially located within a housing, and adapted to deliver vibrational stimulation to the seat's occupant (e.g., an infant). A microphone senses speech from the infant and transmits it to a processor via a data transmitter. The processor may be located remotely from or within the housing. An indicator may be adapted to provide output in response to signals from the processor, such as via a mobile device display or a display on the baby seat. The processor determines the initial volume and duration of speech, as well as the current volume and duration, and determines the magnitude of the difference between the values, and generates a signal indicating whether additional vibrational stimulation is needed, and the duration or intensity of any optional vibrational stimulation. The signal may be sent to one or more processors associated with the system. The processor may further cause the transducer to produce a transcutaneous vibrational output.

[0027] The methods, systems, and toolkits disclosed herein relate to inducing epigenetic changes using transcutaneous vibrational output. Epigenetic markers are measured in a user, wherein the epigenetic marker is at least one of the following: regulation of a protein or gene, or the methylation, acetylation, or phosphorylation state of a gene or histone. Transcutaneous vibrational output is provided to the user, optionally repeatedly, involving enabling the user to achieve a target state, followed by repeated measurement of the epigenetic marker to identify changes in epigenetic markers resulting from the user's exposure to the first transcutaneous vibrational output or a series of vibrational outputs over time. Achievement of the target state can be verified by physiological sensors and / or user input. Transcutaneous vibrational output can be continued, modified, or terminated in response to data regarding the epigenetic marker. Representatives of the epigenetic changes, such as stress indicators, can be measured instead of measuring the epigenetic marker. Stress indicators can be the presence, absence, or frequency of one or more positive or negative words in a communication or social media post. Stress indicators can be tone, pitch, and speech rate, the time to reach the target state after sustained use, or the duration of stay in the target state after sustained use. The toolkit may include stimulation devices, physiological sensors, and a user interface, and may also include a biological sample collection device, wherein, if the user is indicated to have achieved the target state, the user is prompted via the user interface to provide a biological sample for epigenetic change testing.

[0028] The methods and systems disclosed herein relate to using dynamic transcutaneous vibrational output to prevent habituation in assisting subjects to achieve a target state. Preventing habituation may include decreasing or increasing transcutaneous vibrational output, which is generated and applied to the user to help them achieve the target state. Any decreasing rate, increasing rate, maximum or minimum value can be modified using each subsequent execution session to prevent habituation. Furthermore, decreasing or increasing may involve decreasing or increasing one or more different variable parameters during subsequent execution sessions. In other embodiments, the initial transcutaneous vibrational output for subsequent execution sessions may include at least one variable parameter different from those used in previous sessions.

[0029] The methods and systems disclosed herein relate to determining a user's sensory threshold for transcutaneous vibrational output. A lower sensory threshold is established by delivering transcutaneous vibrational output to a part of the user's body and gradually decreasing the intensity of the output until the user indicates (e.g., on a user interface) that it is barely perceptible, and then delivering subsequent transcutaneous vibrational output within or at a desired standard deviation of the lower sensory threshold, for example, to help the user achieve a target state. An upper sensory threshold is established by delivering transcutaneous vibrational output to a part of the user's body and gradually increasing the intensity until the user indicates that it is distracting, and then delivering subsequent transcutaneous vibrational output within or at a desired standard deviation of the upper sensory threshold, for example, to help the user achieve a target state. In some embodiments, the sensory threshold is established by delivering transcutaneous vibrational output to the user and providing a user interface to adjust the perceived intensity, for example, to a point where it is barely perceptible or distracting. The user interface can provide prompts to guide the user through adjustment during the establishment of the sensory threshold. After the user has completed adjustment, a final value of the perceived intensity is stored, where the final value is the sensory threshold.

[0030] The methods and systems disclosed herein relate to using a decreasing or increasing transcutaneous vibrational output to assist a subject in achieving a target state. One or more values ​​of a first perceived pitch, a first perceived beat, and a first perceived intensity of the transcutaneous vibrational output are at an upper limit. One or more of the first perceived pitch, first perceived beat, and first perceived intensity are decreased to a lower limit over a first time period, and optionally held or interrupted upon reaching the lower limit. Decrease can be performed using a first deceleration rate to reach one or more intermediate values ​​between the highest and lowest values, wherein multiple rounds of decrease and holding can be performed between the highest and lowest values. Other deceleration rates can be used between intermediate values ​​and between intermediate and lowest values. In an increasing state, one or more values ​​of a first perceived pitch, first perceived beat, and first perceived intensity of the transcutaneous vibrational output are at a lower limit. One or more of the first perceived pitch, first perceived beat, and first perceived intensity are increased to an upper limit over a first time period, and optionally held or interrupted upon reaching the upper limit. Increase can be performed using a first increase rate to reach one or more intermediate values ​​between the lowest and highest values, wherein multiple rounds of increase and holding can be performed between the lowest and highest values. Other ramp rates can be used between intermediate values ​​and between intermediate and maximum values.

[0031] The methods and systems disclosed herein relate to assisting subjects in achieving a target state using transcutaneous vibrational output, including state-based achievement or control of external devices to achieve the state, said state achievement being determined, for example, by sensors, user input, or third-party data. The user's target state is determined, a transcutaneous vibrational output is generated and applied to the user. Actions associated with controlling external devices are generated to assist in entering the desired target state or to respond to achieve at least one of the desired target state. Actions may be adjusting parameters of the environment or device, such as turning lights on / off, changing room temperature, lowering / raising curtains, turning music on / off, triggering assistive stimulation devices in a mattress / pillow / seat, triggering aromatherapy, or triggering a specific color. Actions may be adjusting at least one of content delivery settings or content filtering for applications and communications, wherein content filtering determines the type of content delivered to the user. Actions may be adjusting social media settings, such as Do Not Disturb settings. Actions may be prompting the user to perform a task.

[0032] The methods and systems disclosed herein relate to using auditory vibration output to assist a subject in achieving a target state. Upon receiving input indicating a target state or determining the need to achieve a target state based on sensor or third-party data, an auditory output is generated and delivered to the subject to assist in achieving the target state. The auditory output has variable parameters including perceptual pitch, perceptual beat, and perceptual intensity. Similar to transcutaneous vibration output, a user or processor can adjust any of the variable parameters to make the output dynamic, decreasing, ramping, stopped, or held, calibrating, establishing a sensory threshold for the auditory output, and other methods and systems described herein. In embodiments, the auditory output may include multiple segments, each optionally having different values ​​for perceptual pitch, perceptual beat, and intensity. In some embodiments, the auditory output may be accompanied by transcutaneous vibration output.

[0033] These and other systems, methods, objects, features, and advantages of this disclosure will become apparent to those skilled in the art from the following detailed description and accompanying drawings of preferred embodiments.

[0034] All documents mentioned in this document are incorporated herein by reference in their entirety. References to singular items should be understood to include plural items, and vice versa, unless otherwise explicitly stated or clearly apparent from the text. Unless otherwise stated or clearly apparent from the text, grammatical conjunctions are intended to express any and all disjunctive and conjunctive combinations connecting clauses, sentences, words, etc. Attached Figure Description

[0035] This disclosure and the following detailed description of certain embodiments thereof may be understood with reference to the following figures:

[0036] Figure 1 A system for promoting neural state transitions is described.

[0037] Figure 2 depicts a block diagram of the stimulation device.

[0038] Figure 3 Various implementation schemes of the device for providing stimulation are described.

[0039] Figure 4A The waveform with perceived pitch was described.

[0040] Figure 4B The envelope of the sinusoidal waveform is depicted.

[0041] Figure 4C Depicting with Figure 4B The waveform of the envelope or beat shown.

[0042] Figure 5A It describes frequencies with perceived pitch. Figure 5B The envelope is described.

[0043] Figure 5C Depicting through Figure 5B Envelope modulation in Figure 5A The waveform generated by the wave in the middle.

[0044] Figure 6 The coordination group transducer for delivering stimuli described in this paper is depicted.

[0045] Figure 7 The waveform with the maximum intensity of variation is depicted.

[0046] Figure 8 A waveform with gradually increasing perceived pitch was depicted.

[0047] Figure 9 A waveform with a gradually increasing beat frequency is depicted.

[0048] Figure 10 It depicts waveforms with gradually increasing perceived pitch, perceived beat, and intensity.

[0049] Figure 11 A system for equalization and compression is described.

[0050] Figure 12 The different stages of vibration are described.

[0051] Figure 13 The calibration method is described.

[0052] Figure 14 The method of operating the stimulation device is described.

[0053] Figure 15 Methods to reduce the negative side effects of treatment are described.

[0054] Figure 16 Methods for promoting epigenetic changes are described. Detailed Implementation

[0055] Devices with transducers can deliver stimulation and / or therapy to a portion of a subject, such as in response to input, with the aim of enabling the subject to achieve a target state, such as a neural state. Such “stimulation” will be described more fully herein; however, it should be referred to here simply as transcutaneous vibrational stimulation. However, individuals inhabit an ecosystem with numerous inputs, devices, and stressors, making it difficult to achieve and maintain any state, recover from a state, or be resilient to certain states (e.g., stress). The devices, methods, and systems described herein offer solutions to certain problems, such as how to: mitigate the adverse effects of co-treatment with stimulation protocols; predict the onset of specific neural states and actively treat with specific waveforms; determine the subject’s state and / or achieve the target state after stimulation / therapy using data outside the device; learn the user’s stimulation preferences and needs to generate stimulation / therapy plans; determine the user’s sensory thresholds; develop protocols to avoid habituation to stimulation or stimulation patterns; decremental or ramp stimulation protocols; fine-tune the stimulation required to achieve the target state based on real-time or longitudinal data; program the device to provide stimulation patterns / sessions; assist in inducing a sleep state; provide visual feedback to the user of the state and / or treatment protocol to help inducing the state; and coordinate from… Stimulation from multiple transducers; control of external devices based on various aspects of stimulation therapy; provision of meditation / mindfulness applications; delivery of stimulation therapy to users via any connected hardware; provision of stimulation therapy in various products (e.g., seats / furniture, mobile seats, gaming seats, baby seats or other furniture, cradles / strollers / cribs, bedding, wearables / clothing, glasses, augmented reality glasses, wearable pet products, gaming / entertainment devices); provision of tactile schemes at multiple frequencies; provision of therapy using auditory frequencies; provision of transducers as components of another device (e.g., in a buckle / part of a smartwatch strap communicatively coupled to a smartwatch or other device); measurement and tracking of epigenetic changes due to therapy, etc. Some of the solutions described herein aim to address the aforementioned problems.

[0056] The terminology related to this document includes the following:

[0057] As used herein, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” include plural references. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As used herein, the term “comprising” (or “including”) means “including (or including) but not limited to.” When used in this document, the term “exemplary” is intended to mean “as an example” and is not intended to indicate that a particular example item is preferred or required.

[0058] In this document, when terms such as “first” and “second” are used to modify nouns, such use is simply intended to distinguish one item from another and is not intended to require a sequential order unless explicitly stated. When used in conjunction with numerical values, the term “about” is intended to include values ​​that are close to, but not exactly, that value. For example, in some embodiments, the term “about” may include values ​​within + / - 10% of said value.

[0059] When used in this document, terms such as “top” and “bottom,” “upper” and “lower”, or “front” and “rear” are not intended to have an absolute orientation, but rather to describe the relative positions of the various components with respect to each other. For example, when a device having components as part of it is oriented in a first direction, the first component may be an “upper” component and the second component may be a “lower” component. If the orientation of the structure comprising the components changes, the relative orientation of the components may be reversed, or the components may be in the same plane. The claims are intended to cover all orientations of a device comprising such components.

[0060] "Electronic device" or "computing device" refers to a device or system that includes a processor and memory. Each device may have its own processor and / or memory, or the processor and / or memory may be shared with other devices, as in a virtual machine or container arrangement. The memory will contain or receive programming instructions that, when executed by the processor, cause the electronic device to perform one or more operations according to the programming instructions. Examples of electronic devices include personal computers, servers, mainframes, virtual machines, containers, gaming systems, televisions, digital home assistants and mobile electronic devices (such as smartphones), fitness trackers, and wearable virtual reality devices. Electronic devices may also include internet-connected wearable devices, such as smartwatches, smart clothing, and smart glasses. Electronic devices may also be embedded in products designed for use while sleeping, such as pillows, mattresses, mattress covers, or bedding (sheets, pillowcases, blankets, etc.). In a client-server arrangement, both the client device and the server are electronic devices, where the server contains instructions and / or data accessed by the client device through one or more communication links in one or more communication networks. In a virtual machine arrangement, the server can be an electronic device, and each virtual machine or container can also be considered an electronic device. In the following discussion, for the sake of brevity, client devices, server devices, virtual machines, or containers will simply be referred to as "devices." The following will... Figure 1 In the context of 2, we discuss additional components that can be included in electronic devices.

[0061] The terms “processor” and “processing device” refer to the hardware components of an electronic device configured to execute programmed instructions. Unless otherwise expressly stated, the singular terms “processor” and “processing device” are intended to include both implementations of a single processing device and implementations in which multiple processing devices together or jointly perform a process.

[0062] The terms “memory,” “memory device,” “data storage,” “data storage apparatus,” etc., each refer to a non-transitory means thereon storing computer-readable data, programming instructions, or both. Unless otherwise expressly stated, the terms “memory,” “memory device,” “data storage,” “data storage apparatus,” etc., are intended to include single-device embodiments, embodiments in which multiple memory devices together or jointly store a set of data or instructions, and a single sector within such a device.

[0063] As used in this article, the terms "treatment," "management," or "stimulation" refer to improving a subject's mood and / or physical and / or symptoms, including enhancing a person's positive outlook on life or suppressing a person's negative outlook on life. This can refer to a person's mental health, including but not limited to their emotional, cognitive, and motivational states.

[0064] The term “depression” refers to a pathological sadness, depression, or melancholy, and includes general physical conditions in which a person exhibits symptoms such as sleep problems, appetite problems, loss of pleasure or lack of energy, feelings of worthlessness or hopelessness, difficulty concentrating, and suicidal thoughts.

[0065] As used in this article, the term "side effect" refers to undesirable physiological and / or psychological effects of medical treatment on the subject. Side effects can be reduced by lessening their severity, decreasing their frequency, or both. Side effects from various medical treatments, including but not limited to medications, drugs, psychotherapy, and surgery, can be reduced by applying vibrational stimulation (as discussed herein) to the autonomic nervous system.

[0066] Throughout this specification, the stimulus is referred to as a transcutaneous vibrational stimulus or transcutaneous vibrational output. One form of such a transcutaneous vibrational stimulus or transcutaneous vibrational output may be a tactile or tactile stimulus, wherein “tactile” and “tactile” may be used interchangeably. In other embodiments, the stimulus (transcutaneous or not) may be auditory (and therefore audible to the subject). Such auditory embodiments are designed to achieve the target state through the subject’s hearing or sense of hearing. All such stimuli may be referred to as “therapeutic” or “therapeutic output.”

[0067] The “subject” may be referred to as the “user” or “wearer” of the device. In some cases, there is a “subject” (i.e., a person or organism to which the vibrational stimulation is applied) and a “user” who may be separate from the subject. Thus, the user may or may not be the subject, depending on the context of the description or accompanying claims.

[0068] Throughout embodiments of this disclosure and as further described herein, a system for treating a subject may include a stimulation device comprising a tactile transducer configured to communicate with a processor to emit a transcutaneous vibrational output to a portion of the subject's body. The system may optionally include a sensory output device also communicating with the processor. The processor may communicate with a memory having instructions stored thereon, which, when executed, cause the processor to determine the transcutaneous vibrational output and optionally sensor outputs, wherein the processor causes the tactile transducer to emit the transcutaneous vibrational output determined by the processor, the transcutaneous vibrational output including perceived pitch and perceived beat. An application communicating with the processor may receive data from the stimulation device and embedded or associated sensors and devices, and may further control the stimulation device and embedded or associated sensors and devices. In embodiments, the processor may optionally cause the sensory output device to output at least one of visual, olfactory, or auditory outputs. The system may also include one or more sensors, such as physiological sensors or biometric sensors, that generate data indicative of a user's condition, wherein the processor is further configured to determine the transcutaneous vibrational output or sensory output based on the data indicative of the user's condition.

[0069] The system may include controllers, processors, network infrastructure, cloud-based storage, input / output devices, servers, client devices (e.g., laptops, desktops, terminals, mobile devices, and / or dedicated devices), sensors, actuators, data storage or subscriptions, and / or components configured to cause the processor to perform one or more functions when executed by the processor. The system may be distributed across many devices, including wearable devices, and / or the system's functions may be performed collaboratively by one or more devices.

[0070] The system may include application programming interfaces (APIs) that facilitate connectivity between system components and between the system and external entities, and assist users in operating, programming, and using the system. Any component or interface of the system may be controlled by a controller or a controller-controller. In some embodiments, a mobile device operated by a user may form part of the system described herein.

[0071] Certain considerations for those skilled in the art in determining the configuration of components, circuits, controllers, and / or devices to perform the system described herein include, but are not limited to: the availability of sensed or collected data; the state of communication with one or more sensors; knowledge of one or more sensory thresholds; the proximity of a suitable transducer to a part of the user's body; the availability of a suitable transducer; whether the user will provide direct instructions or whether the system will be triggered; and whether another therapeutic modality (e.g., pharmacological, sensory, or therapeutic) will be used simultaneously.

[0072] While specific examples of systems and considerations are described herein for illustrative purposes, any system that benefits from the disclosure herein and any considerations that are understood by one of those skilled in the art as a result of the disclosure herein are expressly covered within the scope of this disclosure.

[0073] Now for reference Figure 1 This paper describes an implementation scheme for a system used to facilitate a transition in a neural state. In the system, a stimulation device 102 can be programmed to provide acoustic and / or vibrational energy, such as tactile, sensory, or transcutaneous vibrational energy, which can be delivered to a subject 114 wearing a therapeutic device. The stimulation device 102 can be a device with a transducer adapted to deliver stimulation to a portion of the subject, intended to enable the subject to achieve a state. In some implementations, the stimulation may include oscillations of different frequencies, such as sinusoidal oscillations, which generate a beat frequency output to the subject. In one implementation, the stimulation device can be configured via a processor to generate a transcutaneous vibrational output to help the user achieve a target state, the transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity. The stimulation device 102 can be directly controlled via a user interface of the stimulation device 102, for example, via a controller 212, or via an application running on a mobile device or computing device. In implementations, a remote server or application running in a cloud 104 can be used to control, configure, or otherwise communicate with the processor of the stimulation device 102. Data can be provided by I / O device 110 (e.g., a third-party device or software) for processing by stimulation device 102 and / or associated applications or systems. Similarly, stimulation device 102 can provide and / or transmit data to I / O device 110. Mathematical analysis can be performed on collected data from all available sources via the processor of stimulation device 102 or an application / remote server communicating with the stimulation device to, among other things, generate predictions of state transitions. External devices / systems 108, such as mobile phones or applications (e.g., care provider applications), can be used to control stimulation device 102, or conversely, can be controlled by stimulation device 102 or its outputs. Any system components can communicate with each other directly via the cloud or via some other relay. The system may include remote server 112, with which stimulation device 102 can communicate to receive data, instructions, programming, or firmware updates, etc.

[0074] Sensor 118 may be external to or integrated with stimulation device 102 and may be used to obtain feedback from a user before, during, or after operation of stimulation device 102. It may be configured to collect biometric, physiological, mobility, and / or contextual data from subject 114, or the subject's environment to determine subject status, provide data that can be used to modify vibrational output, establish a baseline state of the subject, predict the user's future state, establish sensory thresholds, and any other implementations described herein. Sensor 118 readings may be used as feedback by the device and / or related applications, potentially altering the pattern, frequency, intensity, and / or duration of the transcutaneous vibrational output (or auditory output, as appropriate), which will be further described herein. Physiological sensors can measure ECG, temperature, heart rate, heart rate variability (e.g., representative of autonomic nervous system tone and mood regulation), respiratory rate, blood volume pulse, blood pressure, transcortisol, blood glucose, tone / pitch / speech rate (e.g., using a microphone), skin conductance response, gamma band EEG, pupil size / responsiveness, brain activity (whole-brain EEG), muscle activity, facial expression, temperature, sweat volume, sweat composition, earwax composition, etc. Environmental sensors for further assessment of the user's status may include calendar activity, social media posts, screen time / phone usage, texting frequency, screen touch pressure, or gaming frequency. Digital image frames can be received from imaging sensors (e.g., cameras) capable of capturing video and / or still images, wherein the camera may be associated with the stimulation device or a separate device. The system may also include a position sensor 560 and / or a motion sensor 570 to detect the position, movement, activity, or location of the user or the stimulation device. The position sensor 560 and / or motion sensor 570 may be worn by the user or in a device carried by the user. In one embodiment, motion sensor 570 may include a gyroscope or accelerometer. In another embodiment, location sensor 560 may include a Global Positioning System (GPS) sensor device that receives location data from an external GPS network. Associated data, which may be used in any of the disclosed embodiments, may be obtained from social media content, navigation applications, calendar applications, motion trackers, location trackers, direction of travel, mobile device usage, keystrokes input to a mobile device, or project management applications. Data collected by any of the sensor devices described herein may be used to modify an aspect of a stimulus, interrupt the stimulus, or otherwise use it for feedback loops. The sensor device may be embedded in a sensing wearable device, such as a watch, wristband, bracelet, shirt, medical device (e.g., blood pressure cuff, pulse oximeter, thermometer, light stimulation, sound stimulation), exercise / activity monitor, or other wearable items. Alternatively or supplementally, the sensor device may be embedded in a separate device that contacts or is close to the user, such as a pillow, mattress, blanket, or other bedding.

[0075] Stimulation device 102 may be configured to provide acoustic and / or transcutaneous vibrational stimulation to subject 114 and may be configured to modulate the autonomic nervous system. In various embodiments, stimulation device 102 may be configured to apply stimulation to one or more body parts of subject 114, by means of wear or proximal placement, but not limited to, a person's wrist, ear, neck, ankle, hip, knee, foot, sternum, chest, back, whole body, etc. In some embodiments, stimulation device 102 is adapted to deliver stimulation, for example, by implantation into a part of the subject, such as by implantation device 102, or when device 102 is integrated with another implantable device, such as an insulin pump, pacemaker, etc. Therefore, components of the vibrating stimulation device 102 may be in the form of wearable devices, such as a strap wrapped around a suitable body part (wrist, ankle, head, foot, etc.), a pair of headphones or earplugs, a hat or top hat, a watch, a shirt, or other wearable or implantable devices. In some embodiments, stimulation device 102 must contact the body to be effective, while in other embodiments, stimulation device 102 is effective without actual contact with the body.

[0076] In one implementation scheme and now referenced Figure 3The stimulation device 102 may be embodied in the following items: wearables (which are internet-connected), watches, smartwatches, smartphones, computing devices, anklets, braces, smart clothing / apparel (hats / shirts, scarves, earmuffs, headbands), shoes / soles / insoles, headphones / earplugs / phones (e.g., audio stimulation via the phone), smart glasses, eye masks, seats, baby seats / cradles / furniture, vehicle seats with sensors in dashboards / seats / wheels, pillows, beds, mattresses, mattress covers or bedding (e.g., sheets, pillowcases, blankets, weighted blankets, animal blankets, etc.), yoga mats, pet products, dog beds, pet collars, off-the-shelf pods or other clothing or furniture, where sensors and transducers / stimulators can be arranged or embedded. For example, a system for soothing an infant may include a seat (e.g., a cushion, mattress, mattress cover, bedding, pillow, stuffed toy animal) with at least one strategically placed transducer adapted to emit vibrations including perceived pitch, perceived beat and perceived intensity, which are selected to induce a soothing state. For example, the system may be incorporated into bedding such as mattress linings or pillows, where it delivers therapeutic stimulation to aid sleep, including a decay function and / or a sleep detection off function. Sensors may also be embedded in the bedding to track entry into and / or exit from sleep, provide feedback on the effectiveness of the stimulation (e.g., changes in breathing, decrease in crying), or provide signals to initiate stimulation (e.g., a microphone that detects crying). Speakers may be included to play lullabies, heartbeat sounds, white noise, or other soothing outputs. In another example, the system may include a transducer located in a seat or seat back, such as a fixed seat or a seat in a transportation environment, where the transducer is configured to deliver transcutaneous vibrational stimulation to the seat occupant. Physiological sensors may be used to determine the seat occupant's alertness state, and a processor may control the transducer responsively. When the seat is in a vehicle, vehicle sensors may sense vehicle operating parameters, where the processor also uses these parameters to control the transducer. For example, if the vehicle sensors indicate that the user is closing their eyes while the vehicle is still moving, the processor communicating with the transducer in the seat may activate it and deliver stimulation for wakefulness. In another example, a pet or animal collar may have an embedded transducer and processor, wherein the processor can be remotely controlled via a separate device or an application running on a smartphone, mobile device, computer, etc., to deliver stimuli through the transducer (as described herein) to the animal wearing the collar. Sensors, such as physiological sensors, microphones, cameras, etc., may be integrated with or associated with the collar to provide feedback (as described herein) to the processor. In any implementation, control over the generation and delivery of stimuli may be achieved by the implementation itself using firmware embedded in the integrated or associated processor, or by software or an API running on a computing device.

[0077] In one example, when the stimulation device 102 is embodied in a smartphone, it can be controlled by an application on the smartphone computing device to emit stimulation as a transcutaneous vibration output, auditory output, or both. Stimulation can be generated via one or more of the smartphone's vibration motor or speaker. In embodiments, additional content can be delivered via the smartphone, or other apps can be used to generate additional actions or control other devices during therapeutic output. In another example, the stimulation device 102 embodied in an off-the-shelf pod may include modular components or kits or parts sold to other product manufacturers, such as seats, sleep PODS, baby seats, pet collars, etc., which will be incorporated into the design / product. APIs and wireless connectivity can be components of off-the-shelf pods sold to manufacturers to provide control options. In one embodiment, the stimulation device 102 may be embodied in augmented reality or virtual reality glasses or other devices associated with these embodiments. For example, a transducer may be incorporated into the glasses arm to deliver tactile stimulation and optional auditory stimulation to the user. The tactile and auditory stimulation can be synergistic or complementary. In embodiments, the augmented reality glasses can be programmed to combine stimulation with content delivery.

[0078] Figure 2A and Figure 2B A block diagram of an example stimulation device 102 is shown. As shown in FIG. 2, the stimulation device 102 may include one or more transducers 201, a controller 212, and a processor 202 within a housing 210. The stimulation device 210 may communicate with a communication interface 203, a power supply 204, an optional user interface 205, and a memory 206 (e.g., ...). Figure 2A (as shown), or optionally include them (such as) Figure 2B middle).

[0079] One or more transducers 201 can be any device capable of transmitting vibrational and / or acoustic energy from an energy source to a subject in the form of stimulation. Examples of transducers may include, but are not limited to, bone conductors (e.g., bone conductors in smart or augmented reality glasses), tactile transducers, transcutaneous vibration transducers, linear resonant actuators, rotary motors, bass vibrators, or audio transducers (e.g., speakers). Although not shown here, transducer 201 may receive it from a driver that amplifies and filters the desired stimulation signal in order to apply appropriate voltage and current signals to transducer 201.

[0080] Processor 202 may be configured to control one or more functions of stimulation device 102, such as, but not limited to, applying appropriate stimulation to a subject, controlling the frequency of the applied stimulation, processing feedback received from sensor devices, and communicating with a user or external system. In some embodiments, processor 202 may be configured to control the applied stimulation (e.g., frequency, duration, intensity, etc.) based on, but not limited to, readings from stimulation device 102, sensors 118, 208, 570, 560, user input, or any other information or combinations thereof. Processor 202 may communicate with each other component of stimulation device 102 via, for example, a communication bus or any other suitable mechanism. Processor 202 may be controlled by an application executing on a mobile device, computing device, or remote server 112.

[0081] In some embodiments, the stimulation device 102 may be configured to apply the desired stimulation as a transcutaneous vibration to the subject at discrete time intervals. In some embodiments, it may be a continuous application of a frequency sound. The duration of stimulation application may vary depending on various factors, such as the nature and severity of the condition being treated, the subject's body size, age, sex, and overall condition (physical and psychological). Alternatively and / or supplementally, the duration may be defined based on input received from sensors, user, or third-party data. Typically, the duration of application may range from 1 minute to 2 hours, and optionally within the range of 5-15 minutes or 1-5 minutes. Alternatively, the duty cycle of the stimulation delivery may be in an oscillatory or pulsed manner, for example, by employing a repetitive sequence of on and off cycles lasting several seconds or minutes, which produces intermittent (e.g., paroxysmal: 30 seconds on - 30 seconds off) or (e.g., non-paroxysmal: 30 seconds on - 10 seconds off) alternating delivery and cessation of the therapeutic stimulation. In embodiments, the signal may be a series of discrete pulses with additional vibrations between the pulses. The duty cycle can be programmed to produce intermittent vibrations.

[0082] In one or more embodiments, the communication interface 203 may be configured to facilitate data input and output from the stimulation device 102. In some embodiments, the communication interface 203 may include, but is not limited to, a WiFi transceiver, a Bluetooth transceiver, an RFID transceiver, an Ethernet port, a USB port, and / or any other type of wired and / or wireless communication interface. The communication interface 203 may be configured to transmit data to and receive data from computing devices, mobile devices, and / or networks not included in the stimulation device 102. For example, the communication interface may couple the stimulation device 102 to an application running on a user device, such as a mobile device.

[0083] In some embodiments, the user interface 205 may include any type of input and / or output device that allows the user to input commands to or receive information from the stimulation device 102. Optional user interface 205 may include elements configured to receive commands or input parameters or to be used for checking or changing settings. Examples include tactile input (e.g., a keypad or touchscreen), a microphone, dedicated buttons, dials, switches, or other devices. In embodiments, the user interface 205 may be adapted to receive gesture input or verbal input.

[0084] User interface 205 may also include elements configured to output data, such as a display, light-emitting diode (LED), transcutaneous vibration / tactile device, or audio speaker. Output from stimulation device 102 may be displayed on device 102 itself, on a mobile device, on a third-party device, or in an application, such as a care provider application. In embodiments, the output may provide visual feedback to the user in conjunction with the delivered therapy. The processor may also communicate with the mobile device and sensors that sense the user's biometric data. During the delivery of the transcutaneous vibration output to the user, the sensors may collect the user's biometric data. The processor may use the biometric data to determine whether the user has achieved or not achieved at least one of the target states, and if the user has not achieved the target state, to further program the processor to determine the user's current state relative to the target state. Based on these determinations, the processor then causes the mobile device to (i) generate an output indicating whether the user has achieved the target state, and (ii) if the user has not achieved the target state, generate an output guiding the user to achieve the target state.

[0085] In other embodiments, visual feedback on the user's status can be provided on a display within the stimulation device itself. For example, a processor, either within or separate from the stimulation device, can communicate with the transducer, as well as the device's display and sensors. The processor causes the transducer to generate a first transcutaneous vibration output, then determines, based on biometric data from the sensors, whether the user has achieved or failed to achieve at least one of the target states, and if the user has failed to achieve the target state, further programs the processor to determine the user's current state relative to the target state. The processor can cause the display to show an indication of whether the user has achieved the target state, and if the user has failed to achieve the target state, display information guiding the user to achieve the target state. In other embodiments, visual feedback on the user's status can be provided in an application running on a smartphone, mobile device, computer, etc.

[0086] In any implementation, the output can be at least one of visual, auditory, or tactile. For example, visual output can be an image of a beating heart that roughly reflects an individual's actual heartbeat. In implementations, the beating heart can be configured to slow down or speed up based on the sensed heart rate. Output guiding the user can be generated based on the user's current state relative to a target state. The output guiding the user can convey a recommended breathing rhythm. If the processor determines that the user has not yet achieved the desired target state, the processor decides that the output needs to be modified and causes the transducer to generate another percutaneous vibration output that can change one or more variable parameters relative to the first vibration output.

[0087] User interface 205 allows users to control the operation of stimulation device 102, limit the settings of stimulation device (e.g., frequency, intensity, duration, etc.), receive information about the operation of stimulation device, troubleshoot problems with stimulation device, etc.

[0088] The system's user interface may include inputs that enable users to activate and / or deactivate the transducers to modify stimulation patterns, including modifying parameters of the outputs described herein, and / or indicating whether a particular pattern is acceptable or unacceptable. The system may determine a user's usage patterns, such as the most frequently used patterns and typical usage durations, and save this data to a user profile so that the system can automatically adjust to user preferences. For example, if a particular treatment has a default duration, and the user typically does not turn off the treatment before that duration ends, the system may retain that duration when the treatment is reapplied. However, if the user typically turns off stimulation before the default duration ends, the system may adjust the user's default duration to match the user's average or mean duration of actual treatment applications, optionally considering only the values ​​before a threshold or the number of applications when calculating the mean or average. The system may also use other functions to determine durations based on actual usage data. Similarly, a particular treatment may have a default intensity level, the user interface may allow the user to change the intensity level, and the system may automatically adjust the default value to match the user's mean or average selected intensity level.

[0089] In some implementations, power source 204 may be configured to provide power to stimulation device 102. Power source 204 may include one or more of a rechargeable battery, a non-rechargeable battery, a solar cell, a chemical reactor generator, a power input port connected to an external power supply, or any other device configured to provide power to stimulation device 102 and its components.

[0090] The housing 210 can be configured to attach the sensor 201 to the site where stimulation is applied to the subject. For example, if the stimulation will be applied to the subject's wrist, the housing can be in the form of a wristband. Similarly, if the stimulation will be applied to various points on the subject's back, the housing can be a mattress, mattress cover, sheet or blanket, a wearable shirt, seat or cushion, wrap, or other item that contacts the subject's back. Some components of the device, such as the transducer 201, may be on or outside the housing, or a sound-guiding wire may extend from the transducer 201 out of the housing.

[0091] In some implementations, auditory frequencies can be delivered via the stimulation device itself, via a connected audio device, or in combination with tactile vibrations. The emission of auditory and / or vibrational frequencies on the stimulation device or peripheral devices can be controlled or induced by an application or other software.

[0092] Figure 1 Various components that may be included in the system are also depicted, either within the stimulation device or in a mobile or computing device communicating with the stimulation device. In some embodiments, an electrical bus may provide electronic communication between the various components, and the controller 120 may control such communication. The processor 505 may be configured to perform computational and logical operations required to execute programmed instructions. As used herein and in the claims, the terms “processor” and “processing device” may refer to any number of processors, such as a central processing unit (CPU), a graphics processing unit (GPU), a remote server, or a combination thereof, in a single processor or a group of processors that collectively perform a set of operations. Read-only memory (ROM), random access memory (RAM), flash memory, hard disk drives, and other devices capable of storing electronic data constitute examples of memory device 525. A memory device may comprise a single device or a collection of devices storing data and / or instructions. The processor may be embedded in the stimulation device or may be in a separate device.

[0093] Optional display interface 530 allows information to be displayed on display device 535 in visual, graphical, or alphanumeric form. An audio interface and audio output (e.g., a speaker) may also be provided. Communication with external devices can occur using various communication devices 540, such as wireless antennas, RFID tags, and / or short-range or near-field transceivers, each optionally connected to other components of the device via one or more communication systems. Communication devices 540 can be configured to communicate with a communication network, such as the Internet, a local area network, or a cellular data network.

[0094] In one implementation, the user interface 545 enables the reception of data from an input device 550, such as a keyboard, keypad, mouse, joystick, touchscreen, touchpad, remote control, pointing device, dedicated button, dial, switch, and / or microphone.

[0095] In one embodiment, one or more transducers 201 may be configured to provide acoustic and / or vibrational energy as a waveform that can be transmitted to a subject, including the stimuli described herein, configured to enable the user to achieve a target state or maintain a current state. The waveform may be generated using a phase accumulator or a digitally controlled oscillator. Data storage 580 may include data related to parameters generated by the fundamental vibration, data related to treatment protocols (including associated treatments and stimuli), data on how to interpret physiological and / or correlated data, data on endpoints used to trigger stimuli, user profile data including known physiological parameters, sensory thresholds, baseline states, performance states, typical locations, etc., manually collected data from the user, epigenetic data using data partially collected from the biosample collection device 590, and data from monitoring mobile devices and application usage, etc. The parameters generated by the fundamental vibration are the frequency of the perceived pitch, the frequency and intensity (or maximum intensity) of the perceived beat. The frequency of the perceived pitch defines the fundamental (carrier) tone. The frequency of the perceived beat defines an envelope that modulates the amplitude of the fundamental tone of the fundamental vibration. This modulation involves multiplicative combination, as described herein. The intensity is then used when scaling the fundamental vibration for delivery via the transducer. In the implementation, the envelope is a sine wave with a frequency half that of the perceived beat. The intensity is related to the user's awareness of the stimulus, with the minimum necessary intensity being the point at which the user becomes aware of the wave / vibration, and the maximum intensity being the point at which the user no longer tolerates the stimulus. Developing the fundamental vibration in this way has the benefit of enhancing the user experience by facilitating access to a variety of stimulus patterns. This approach also makes the generation of certain stimulus patterns, such as (i.e., decreasing, increasing, and / or intensity variations), far more efficient than using interference patterns, including, for example, by reducing the processing required to generate those stimulus patterns. Compared to using interference patterns, the multiplicative approach to waveform generation improves the efficiency of additional frequency layering in practice. For example, the most basic form of a waveform is a perceived pitch and a perceived beat; however, as discussed herein, waveforms can be generated with more than one perceived pitch and / or more than one perceived beat. Compared to the approach using interference patterns (also described herein), the multiplicative approach described herein provides an improvement by making layering more efficient, for example, by including more than one perceived pitch and / or more than one perceived beat. Compared to methods utilizing interferometric modes, the efficiency improvement of the multiplicative method stems from the fact that using more than two interferometric modes leads to a high level of unpredictability due to the physical properties of combined frequencies. Complex interferometric modes are unpredictable and computationally inefficient, a concern alleviated by the multiplicative method described in this paper. By providing enhanced means of adjusting or selecting multiple variables and segments of the vibrational stimulus, the multiplicative method also offers enhanced user control over waveform generation and ultimately improves the user experience.

[0096] For example, Figure 4AThe graph shown depicts a 1-second waveform with a perceived pitch of 402 at 10 Hz, meaning the waveform oscillates 10 times per second. Figure 4B The graph shown depicts the envelope 404 of a sinusoidal waveform with a frequency of 1 Hz. The perceived beat frequency is always twice the envelope frequency. Therefore, in this example, the perceived beat frequency is 2 Hz. When Figure 4A The basic pitch shown is through Figure 4B When the envelope 404 is modulated as shown, Figure 4C The resulting waveform / fundamental vibration shown indicates a perceived beat frequency of 2 Hz (i.e., the user perceives the waveform repeating twice per second). The waveform shape for the perceived pitch at a given frequency is found using Equation 1:

[0097] Signal_Basic_Pitch = sin(2.0 * π * Frequency_Perceived_Pitch * t). [Formula 1]

[0098] This formula seeks to find the signal or amplitude of the fundamental pitch at each point in time. In Formula 1, Frequency_Perceived_Pitch is the frequency of the fundamental pitch, expressed in Hz. For Figure 4A In the example shown, the frequency of the basic tone is 10 Hz, and time varies along the X-axis. In this example, the wave reaches its maximum positive signal (1.0) between 0.02 and 0.03 seconds, then turns back to zero between 0.05 and 0.06 seconds, reaches its maximum negative signal (-1.0) between 0.07 and 0.08 seconds, and then turns back to zero around 0.1 seconds. The value of Equation 1 is established. Figure 4A The numerical range and shape of the waveform shown are illustrated.

[0099] Formula 2 is used to discover the shape of the envelope for a given perceived beat frequency:

[0100] Signal_Envelope = sin(π * Frequency_Sensing_Beat * t) [Formula 2]

[0101] In Formula 2, Frequency_Sensation_Beat is the frequency of the sensed beat, denoted by Hz. For Figure 4B In the example shown, the perceived beat frequency is 2Hz, and time varies along the X-axis. In this example, the wave reaches its maximum positive signal (1.0) at 0.25 seconds, then turns back to zero at approximately 0.5 seconds, reaches its maximum negative signal (-1.0) at 0.75 seconds, and then turns back to zero at approximately 1 second. In this example, the waveform is a sine wave generated at 1Hz, as shown... Figure 4B The drawing is in the middle.

[0102] Combining these two waveforms produces the basic tone based on envelope modulation of a sine wave. To obtain... Figure 4C The wave pattern shown can be combined using formula 3 via multiplication. Figure 4A and4B The wave pattern drawn in the image:

[0103] Signal_fundamental_vibration = Signal_fundamental_pitch * Signal_envelope. [Formula 3]

[0104] In Equation 3, the results of Equations 1 and 2 are multiplied with respect to each time point to determine the signal's fundamental oscillation at that specific time. For example, at 0.23 seconds, the signal's fundamental pitch is 1.0, the signal envelope is 1.0, and their product, or signal's fundamental oscillation, is 1.0, which is the maximum positive signal of the combined waveform. This maximum signal is reached again at 0.77 seconds during the second part of the 2Hz envelope.

[0105] Ultimately, the fundamental vibration is converted into a signal that is sent to the transducer, where the signal is constrained to a range of values ​​suitable for the transducer being used and for a given intensity.

[0106] In this implementation, the intensity is a scalar value between 0 and 1, which causes the amplitude of the fundamental vibration to decay.

[0107] Signal output = signal fundamental vibration * intensity [Formula 4];

[0108] The signal_output is defined as the signal output by the transducer.

[0109] In some implementations, intensity is not interpreted as amplitude attenuation, but rather as the power of the signal (expressed as g-force) measured at the transducer. The signal sent to the transducer or speaker is an electrical signal measured via voltage. The conversion from voltage to signal power may not be linear. To maintain a consistent power level, the amplitude can be adjusted relative to the physical properties of the transducer. As an example, for a fundamental signal whose frequency is close to the transducer's resonant frequency, the output signal may need to be attenuated.

[0110] In the implementation scheme, the fundamental vibration can be further modulated. In another example, Figure 5A It depicts the basic tones. Figure 5B The envelope is described. Figure 5C To pass Figure 5B Envelope modulation in Figure 5A The fundamental vibration produced by waves in the middle. Now refer to Figure 7The graph depicts a waveform with a perceived pitch of 20 Hz that remains unchanged over the plotted time period, and a perceived beat frequency of 1 Hz that also remains unchanged over the plotted time period. However, the maximum intensity varies over the displayed time period. A line drawn from the peak of the first beat to the peak of the last beat indicates that this variation has a negative slope, which translates to a rate of approximately 0.009%. In this example, the programmer may have set the perceived pitch and perceived beat frequency of the waveform and the initial intensity, specifying that the intensity should slope down over time at a rate of 0.009%, without changing the perceived pitch or perceived beat. Therefore, the sloping down changes the maximum intensity without changing the envelope.

[0111] exist Figure 8 In the wave shown (e.g., a scan (perceived pitch)), the perceived pitch starts low and increases linearly to maximum intensity, while the perceived beat remains unchanged. Figure 9 In the wave shown (e.g., a sweep (envelope)), pitch and intensity remain constant over time, but the beat frequency increases over time. Figure 10 In the wave shown, perceived pitch, perceived beat, and intensity all increase with time.

[0112] The waveform depicted above is output through the transducer described in this article. Modifying the resulting waveform parameters—pitch, tempo, and intensity—can achieve different basic pitch / envelopes and therapeutic purposes.

[0113] In the implementation, transducer 201 may provide stimulation in the form of a fundamental tone or wave with a perceptible pitch ranging from 1 to 500 Hz, and an envelope with a perceptible beat frequency modulating the fundamental tone in the range of 0.0001 to 20 Hz, and a perceptible intensity determined based on the sensory threshold of each individual user. The lower sensory threshold is the minimum intensity level at which the user becomes aware of the wave / vibration. The upper sensory threshold can be the intensity level of the stimulus at which the user finds the vibration difficult to ignore or finds it distracting. As described elsewhere herein, the sensory threshold of an individual user can be determined by at least one of three methods: a) calibration; b) active data collection (via brief survey questions in the app); and c) passive data collection (via monitoring mobile device and app usage).

[0114] In settings where users have different sensitivities to the frequency of the fundamental signal, intensity can be applied to modulate the power of the transducer output signal, ensuring that the perceived intensity for the user is consistent across the fundamental frequency.

[0115] In some embodiments, the stimulation provided by device 102 may be a combination of sinusoidal oscillations of different frequencies, which produce a beat frequency output to the subject. The combination of the dominant frequency and the modulation frequency produces a beat output that, at frequencies determined to be arousing or calming based on the applied therapy (as described elsewhere herein) and / or the subject's physiology, provides the user with a sensation of slow-wave or fast-wave stimulation. The applied stimulation may include a single modulation frequency or multiple modulation frequencies. Generating the fundamental vibration using an interference pattern is an alternative embodiment, distinct from the embodiment described with respect to a fundamental tone modulated by an envelope in intensity. In this alternative embodiment, the frequency of the perceived pitch and the "beat" of the signal is derived from the two frequencies of the beat interference pattern according to the following formula.

[0116] Frequency_Perception_Pitch = (Frequency_Interference1 + Frequency_Interference2) / 2 [Formula 5]

[0117] Frequency_Perception_Beat = Frequency_Interference1 - Frequency_Interference2 [Formula 6]

[0118] In this alternative implementation, the beat interference pattern can be generated from a pre-generated sine wave using signal data extracted from a WAV audio file.

[0119] For example, transducer 201 may provide a simulation in the following forms: (i) a dominant frequency of 1–500 Hz modulated by a modulation frequency differing from the dominant frequency by about 0.0001–10 Hz; (ii) a dominant frequency of 1–100 Hz modulated by a modulation frequency differing from the dominant frequency by about 0.0001–1 Hz; or (iii) other frequency values ​​within the range listed above. The combination of the dominant frequency and the modulation frequency produces an interference waveform and a beat output. At frequencies determined to be arousing or calming based on the applied treatment and / or the physiology of the subject, the interference waveform and beat output can provide the user with a sensation of slow-wave stimulation. The applied stimulation may include a single modulation frequency or multiple modulation frequencies. In an embodiment, one transducer 201 may deliver the dominant frequency, while another transducer 201 delivers the modulation frequency or a perceived beat. The acoustic or vibrational energy used in this disclosure may be low-frequency sound (acoustic energy) or vibration (mechanical energy). For example, the delivered acoustic vibration may be in the form of a dominant frequency of about 1–100 Hz. In some implementations, the primary frequency can be about 1-40 Hz, about 1-30 Hz, about 1-33 Hz, or other values ​​within those ranges. In some implementations that generate interference patterns, the primary frequency can be combined with one or more modulation frequencies, the modulation frequencies differing from the primary frequency by about 0.0001-1 Hz. The two frequencies can together form a beat frequency output. For example, in applications designed to keep a subject asleep, the primary frequency can be in the range of 1-40 Hz, while the modulation frequency can differ from the primary frequency by about 0.0001-0.1 Hz. In one example, the stimulation device 102 delivers a vibrational output in the form of a primary oscillation between 20-300 Hz and a modulated oscillation between 0.05-10 Hz that together form the beat output. The stimulation device 102 can be designed to deliver the output in the form of vibration, electrical output (e.g., voltage, such as a PWM waveform), audio output, or a combination thereof. In instances where the outputs are combined, the selected frequencies can be chosen to be complementary or synergistic.

[0120] Now for reference Figure 12Waves can have three phase types: synchronization, transition, and stabilization. These segments are a series of fundamental vibrations that gradually transition from an initial vibration to a target fundamental frequency. In the synchronization phase, the stimulation device can emit a fundamental vibration corresponding to the user's reported physical / emotional state when defining the wave. This initial vibration constitutes a portion of the overall application, after which the wave switches to a transition / stabilization phase pair of 0 or greater. During the transition phase, the parameters of the fundamental vibration are gradually modified until they match those of the target fundamental vibration. In stabilization, vibrations are played until a state of synchronization is achieved, where there are no anticipated mood or energy changes and this can be maintained. By utilizing these phases, stimulation therapy can first align with the user's current state, then gradually transition to an intermediate state, and then to the target state. In the boundary case, the wave is equivalent to the fundamental vibration. In the boundary case, the initial and target fundamental vibrations are the same, and the length of the wave is infinite. In implementations, the phase parameter for the initial or target vibration can be frequency. 音调 =1-300Hz, frequency 包络 =0.001-10Hz, intensity is a number between 0 and 100, and duration is in seconds.

[0121] In some implementations, the transformation from initial vibration parameters to target vibration parameters can be linear. The stage parameters for the synchronization and stabilization phases can have the same initial and target vibrations. A gradual increase / decrease effect can be achieved by using initial and target vibrations with the same frequency but different intensities (0 initial for gradual increase, 0 target for gradual decrease). Sudden changes can be achieved by using zero segments with zero duration.

[0122] In applications where the frequency varies over time, the system can dynamically adjust the intensity of the vibration to maintain a constant intensity level. That is, and with reference to... Figure 11 Because the frequency generated by wave generator 1102 (e.g., phase accumulator or digitally controlled oscillator) changes over time, the intensity level perceptible to the user may not show a significant perceptible change. Equalization refers to adjustments that can be made by equalizer 1104, up to the maximum amplitude of the signal to produce a signal with the same subjective intensity level across all frequencies. Adjustments can be made via scaling factors between 0 and 1. Signal compression can also be performed. Compression, which can be performed by compressor 1108, refers to adjusting the signal after equalization so that the signal value maps to the intensity range identified by the user during calibration, with a lower threshold labeled "just perceptible" and an upper threshold labeled "the highest tolerable value." After compression, the signal is sent to digital-to-analog converter 1110. The compression step includes checks to ensure that the output voltage to speaker 1112 does not exceed a certain range, such as ±0.8 volts.

[0123] In an implementation, system 100 may employ a coordinated system of multiple transducers 201. Each transducer in the system emits a transcutaneous vibrational output according to the user's desired target state, wherein each transducer emits one of a waveform for sensing pitch or for sensing beat, or each transducer in the system emits a different transcutaneous vibrational output in a certain mode (e.g., simultaneously, sequentially, alternately, coordinated). For example, a first transducer may be disposed in a wearable device applied to the user's wrist to deliver a first stimulation pattern in a manner as described herein. A second transducer may be applied to a different part of the user's body, such as the neck, and may deliver a second stimulation pattern. The second stimulation pattern may be the same or may be different. In an implementation, the first transducer may be disposed in a stimulation device, and the second transducer may be disposed in a third-party device, such as a mobile device. Note that the transducer in the mobile device may be of the type already incorporated into the mobile device to emit vibrations or sounds. The third-party device may also be a wearable device. In one implementation, a first transducer may be disposed in a third-party wearable, and a second transducer may be disposed in a device associated with said wearable, such as a watch strap or buckle of the third-party wearable. In another implementation, the transducer is disposed in a buckle / portion of a smartwatch strap communicatively coupled to a smartwatch or smart device, wherein the buckle or strap includes at least one transducer for delivering oscillatory / vibrational stimulation to the subject's wrist, including the ventral side of the wrist. The timing, intensity, beat output, and pitch output of the two devices can be selected to achieve specific coordination patterns, such as specific slicing or rhythms across the transducers. Stimulation can be coordinated between the two transducers to deliver stimulation in an implementation that has a similar effect to stimulation delivered by a single device with two transducers. Coordination can be performed by a processor associated with the stimulation device, third-party device, mobile device, etc. Whether a single transducer or a coordinated group of transducers, stimulation therapy is effective when the transducer is placed on or near the user's body. In alternative methods for generating transcutaneous vibration output, one transducer delivers the master frequency while another transducer delivers the modulation frequency.

[0124] Now for reference Figure 6A system for delivering vibration therapy to a user may include a first transducer 1302 adapted to emit a first transcutaneous vibration output 1308, and a second transducer 1304 adapted to emit a second transcutaneous vibration output 1310. The first transducer may be worn on a first part of the user's body, while the second transducer may be worn on a second part of the user's body. The user can select a target state desired for vibration therapy using a user interface that communicates with the first and / or second transducers, wherein the transcutaneous vibration output pattern may be based on the target state. In an embodiment, the user interface operates on a mobile device application. A processor may communicate electronically with the user interface, the first transducer, and the second transducer. The processor may be a component of the first or second transducer, or may be in a separate device. In one embodiment, the first transducer may communicate electronically with the second transducer. The processor may be programmed to cause the transducer to generate transcutaneous vibration output patterns and emit transcutaneous vibration outputs according to those patterns, each transcutaneous vibration output including a sensed pitch, a sensed beat, and a sensed intensity, which may be the same or different.

[0125] In implementations, the first transcutaneous vibration output mode and the second transcutaneous vibration output mode may be emitted simultaneously, sequentially, or alternately. In implementations, the first transcutaneous vibration output mode and the second transcutaneous vibration output mode may be independent of each other or coordinated with each other. In some implementations, the second transcutaneous vibration output is interrupted when the first transcutaneous vibration output is emitted, and vice versa. In one implementation, the processor may be programmed to modify the first transcutaneous vibration output mode by changing the first perceived pitch, and further by changing the second perceived pitch. In one implementation, the processor may be programmed to modify the first transcutaneous vibration output mode by changing the first perceived beat, and further by changing the second perceived beat. In one implementation, the processor may be programmed to modify the vibration mode by changing the perceived intensity. In one implementation, the processor of the first transducer may be programmed to modify the first transcutaneous vibration output mode based on data received from the second transducer.

[0126] A fundamental vibration, with variable parameters including the frequency of the perceived pitch or fundamental (carrier) tone, the frequency of the perceived beat, and the maximum intensity (referred to as intensity), can be used in methods and systems to help subjects achieve a target state. A transcutaneous vibrational output can be applied to a part of the subject's body, as described herein, to help the subject achieve the target state. Based on the subject's input of the desired target state, a transcutaneous vibrational output with variable parameters including perceived pitch, perceived beat, and perceived intensity can be generated.

[0127] The stimulation device 102 and / or related applications can be applicable to deliver stimulation, the parameters of which are selected to induce a user to a target state (e.g., arousal, relaxation, sleep, lower heart rate, lower blood pressure, calmness, focus, flow, presence, sleep, wakefulness, relaxation, arousal, euphoria, etc.), promote entry into the target state, or treat conditions (e.g., anxiety, insomnia, chronic pain, chronic stress, autism, depression, psychosis, headache, migraine, autoimmune diseases, hypertension, conditions associated with low arousal (e.g., narcolepsy, fatigue, excessive daytime sleepiness, chronic fatigue syndrome, constipation, tension, metabolic syndrome). Eating disorders, obesity, hypotension, familial autonomic dysfunction, attention deficit disorder (ADHD), attention deficit disorder characterized by a decrease or imbalance in sympathetic nervous system activity over time (e.g., treatment induced increased attention to internal bodily functions by increasing parasympathetic nervous system activity relative to sympathetic nervous system activity, or increased attention to external bodily stimuli by increasing sympathetic nervous system activity relative to parasympathetic nervous system activity), motion sickness, vertigo, vasovagal response, metabolic disorders (including insulin insensitivity (type 2 diabetes) and metabolic syndrome), autonomic dysfunction, autoimmune disorders, or anemia), and mitigation of treatment side effects are all possible targets. Each target state can be defined by certain parameters, such as physiological or biometric parameters. For example, a calm state can be identified based on a heart rate below 60 bpm, a heart rate velocities (HRV) above 80, high frequency of positive words in social media posts and texts, and low speaking volume. In another instance, an agitated state can be identified based on a heart rate above 100 bpm, an HRV below 40, high speaking volume, and increased use of negative words.

[0128] Configuring stimulation to achieve a target state or maintain the current state may include adjusting one or more variable parameters. Any stimulation parameter may be modified individually or in combination of two or more. Modification may include increasing or decreasing one or more of perceived pitch, perceived beat, or intensity. For example, when assisting a target to achieve a flow state (peak performance), the transcutaneous vibrational output parameters used to achieve the flow state may be obtained from a lookup table, may be based on transcutaneous vibrational outputs that have previously successfully assisted a subject into a flow state, may be performed in real time based on sensor feedback, or may be performed manually, etc. For example, the variable parameters may be modified using the stimulation device or a user interface of the related device controlling the stimulation device. In an implementation, during the application of transcutaneous vibrational output, at least one variable parameter may be changed to generate a second transcutaneous vibrational output, which is then applied to a part of the subject's body to assist the subject in achieving the target state.

[0129] In implementations, parameters of the transcutaneous vibration output can be dynamically adjusted to prevent habituation. In some implementations, the beat frequency output is dynamic rather than constant to prevent subject habituation. Dynamic properties can be induced based on data collected by sensor device 118, user feedback, and / or automatically. For example, if data collected by the sensor device indicates that the balance between the sympathetic and parasympathetic nervous systems has improved over time but is not yet at its optimal level, the dominant frequency can be gradually decreased rather than abruptly cut off. When subsequently attempting to reach the same target state, one of the variable parameters (e.g., pitch, beat, intensity) or the rate of decrease or ramp can be changed from those used in previous sessions to prevent habituation. As an alternative and / or supplement, the system's user interface may include an input area where the user can select a pattern for increasing or decreasing the rate of frequency decrease from a higher starting point to a lower ending point. In another implementation, dynamic properties can be induced automatically. As mentioned above, if data from one or more of these sensors exceeds a threshold, the system can be programmed to resume stimulation (or prevent its shutdown).

[0130] In implementation schemes, the system can be programmed to receive user input and feedback to manually initiate, terminate, or adjust stimulation, for example, in the user interface of a stimulation device, in a user input device where a verbal indication of state is given to a microphone, in applications controlling the stimulation device, such as applications running on mobile devices (e.g., smartphones, smartwatches, smart glasses, etc.), and so on. For example, the user can input the current state and / or a desired target state. The user's current state or condition can be indicated by the user (e.g., "I feel stressed"). The stimulation scheme or transcutaneous vibrational output can be selected based on the desired target state, based on the current state indicated by the user, and optionally based on the current state relative to the desired target state. Based on the input, the transducer of the stimulation device generates a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity. Determining whether the user has achieved the desired target state can also be done subjectively, for example by receiving input from the user indicating goal achievement (e.g., "I feel good"), as described herein, or by the user manually interrupting the stimulation. Throughout the stimulation process, if the user still feels they haven't reached the target state, if they remain in the initial state, or if they feel they are in between, they can still input or be prompted to input. If the user does not achieve the desired target state, a second transcutaneous vibrational output can be generated, for example using a stimulation device, and delivered to the user in achieving the desired target state. The second transcutaneous vibrational output may have variable parameters different from the first transcutaneous vibrational output (e.g., perceived pitch, perceived beat, and perceived intensity).

[0131] Determining the current state or condition, or the achievement of a target state, can also be done using biometric data, sensed physiological data (e.g., HRV, GSR, heart rate, respiratory rate, etc.), sensor readings compared to the target physiological characteristic, based on usage patterns, third-party data, social media, etc. In various implementations, the target state can be indicated, for example, in a user interface, or using data collected by a sensing device indicating the need for a target state. In implementations, the target state can be a specific health index. A health index can be a set of various health-related measurements, such as blood pressure, heart rate, HRV, HR / HRV ratio, etc.

[0132] In one implementation, data collected by the sensor device can be used as feedback to initiate and / or control the application of stimulation or a first transcutaneous vibrational output to the subject via stimulation device 102. As a supplement and / or alternative, data collected by the sensor device can be used to select and personalize stimulation applied to the subject 114. For example, frequency ranges, stimulation patterns, number of stimulation applications, duration of stimulation application, etc., can be personalized for the user. Continuous or periodic monitoring can be performed using sensors, optionally compared to parameters of a known / stored state. For example, if a user is attempting to reach a target state of sleep, the sensing parameters associated with that state could be high HRV, low motion, and low audible sound. In this case, one or more of a motion sensor, biometric or physiological sensor, or microphone can be used to monitor the user's potential entry into sleep state based on a set or part of the set of sensing parameters, comparing them to a known range of sensing parameters. In another instance, if the target state is wakefulness and the sensor indicates low HRV, stimulation can be initiated to address low arousal. In another implementation, sensors indicating high HR and low HRV in the absence of physical activity can trigger therapeutic stimulation for hyperarousal. If the sensors indicate that the user has not reached the target or expected state, the sensor device can continue operating with this sensor feedback (e.g., typically, a fast, high-intensity vibration pattern increases heart rate (HR), respiration, blood pressure, and perspiration, while decreasing heart rate velocity (HRV). Typically, a slow, mild, low-intensity vibration pattern decreases HR, respiration, blood pressure, and perspiration, while increasing HRV); if the user has reached the target state, operation terminates; if the sensors indicate that the user is approaching the target state, the stimulation begins to decrease, generating a second transcutaneous vibration output, and so on. The second transcutaneous vibration output may have variable parameters different from the first transcutaneous vibration output (e.g., perceived pitch, perceived beat, and perceived intensity).

[0133] In one implementation, the system for altering a user's mood may include a user input device, a stimulation device including a transducer adapted to emit transcutaneous vibrational output, a physiological sensor sensing the user's physiological parameters, and a processor electronically communicating with the user input device, the transducer, and the physiological sensor. The system can accept input of a desired state from the user and responsively cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state. In this implementation, the first transcutaneous vibrational output may include parameters including a first perceived pitch, a first perceived beat, and a perceived intensity. The user's physiological parameters can be used to determine whether the user has achieved the desired target state. If the user has not achieved the desired target state, the transducer may generate a second transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state; the second transcutaneous vibrational output has parameters including a second perceived pitch, a second perceived beat, and a perceived intensity (which may be a second perceived intensity).

[0134] In one implementation, stimulation can be terminated once a state is indicated by passive sensing (e.g., from other information sources) or active sensing (e.g., accelerometer indicating no movement, respiratory rate indicating sleep, location, sensor indicating health index / level) that a state has been reached. In one implementation, stimulation can be resumed when a sensor indicates a change in state. The system can be programmed to resume stimulation (or prevent its shutdown, or extend the decrementing time) if data from one or more of these sensors exceeds a threshold, or based on elapsed time. The system can be programmed to initiate a procedure upon receiving a specific sensor reading.

[0135] In some respects, the sensors can determine the user's current association or physiological state and can initiate, terminate, or modulate stimulation based on one or more detected states. For example, if the sensors indicate stress (e.g., based on a health index), other data can be used to modulate the on / off of stimulation. In one instance, if an accelerometer indicates that the user is moving at an exercise rate, the sensor readings may not indicate stress but rather reflect exercise. In one embodiment, if the sensors indicate that movement slows down at a specific time, this can be interpreted as preparation for sleep, and the stimulation device's sleep routine can be initiated. In one embodiment, if the sensors indicate that the user is in a car but is experiencing drowsiness, the stimulation device 102 can be caused to begin delivering stimulation configured to promote wakefulness.

[0136] In one implementation, determining whether a user has achieved a purpose or target state due to stimulation can be done through user input, using system data, passive user data, or sensing wearables (e.g., smartwatches, medical devices (e.g., blood pressure cuffs, pulse oximeters, thermometers)), exercise / activity monitors, or other wearable items, or can be done using external and / or third-party sources, such as third-party data, third-party devices, SaaS applications, health and fitness information applications, health and fitness APIs, hospital data systems, social media posts, communications, etc. For example, the processor of the stimulation device or a processor associated with the stimulation device can be programmed to receive the user's social media posts and comments and assess the tone and emotion of the language used. In some implementations, determining whether a user has achieved a target state can be done using any combination of user input, internal sensing, or external data or sources. External and / or third-party sources can provide data on physiological parameters (e.g., blood pressure, HRV, GSR, respiratory rate, etc.). In some implementations, based on the determination from external and / or third-party sources that a target state has been achieved, a second stimulus can be generated and delivered / applied to the subject to help achieve or maintain the target state. In some implementations, stimulation may be interrupted or prolonged based on whether a target state has been reached, determined from external and / or third-party sources.

[0137] Configuring stimuli to achieve a target state or maintain the current state may include generating stimuli in more than one segment, such as a stimulus session with a series or sequence of stimulus patterns to achieve the desired state. In some implementations, the session may be associated with an event, such as a recreational event, a sporting event, a stress-induced event, a psychotherapy session, etc., and each segment may be selected to produce an “overall” experience that is beneficial to the event or session. For example, a session for alleviating air travel anxiety may have multiple segments, such as a segment performed while the subject is waiting to board the plane, another segment on the plane but waiting to take off, a segment during takeoff, a segment during flight, etc. The user can manually indicate when the air travel status has changed in order to perform the next segment. Data such as third-party data may be used to indicate when the air travel status has changed in order to perform the next segment, for example, air traffic control and route status data. Sensors may be used to indicate the air travel status in order to move from one segment to another, such as a microphone for listening to notifications, a connected camera in smart glasses, an altimeter indicating altitude, etc. In implementation schemes, data about events experienced or currently experienced by a user can be obtained through user interfaces, correlations, biometric or physiological sensors, third-party data, or applications. Physiological sensors may include respiration, temperature, GSR, SpO2, vital capacity measurement, EEG, ECG, EMG, heart rate, HRV, CO2, exercise, blood pressure, glucose, etc. Biometric sensors may capture data about fingerprints, visual / facial cues, voice tone, pitch, iris, etc. Correlation sensors may capture data about geospatial environment, location, meteorology and weather, air pollution / quality monitoring, flood monitoring, etc. In some implementation schemes, the data about events is changes in events, such as changes in traffic patterns, flight delays, significant changes in weather, etc.

[0138] Other examples of events where stimulating sessions might be useful include during sporting events, public speaking sessions, lectures or performances, commutes, treatment of specific conditions (e.g., PTSD), and for desired feelings or outcomes for the day. For instance, in the case of commuting, data from traffic, GPS, or navigation apps can be used to determine speed, location, and surrounding traffic volume. This data can be used to establish therapeutic session parameters and to move the session between segments, such as one segment when traffic is moving and another segment when traffic is slowing down.

[0139] In the implementation scheme, each stimulation segment may be defined by one or more parameters, including perceived pitch, perceived beat, and intensity. When generating each segment, values ​​for these variable parameters can be assigned to each segment. Data about the events experienced by the user can be transmitted to a computer processor configured to establish treatment session parameters. Treatment session parameters are established by assigning a set of consecutive output segments to the event and assigning perceived pitch and perceived beat of the transcutaneous vibrational output to each output segment based on the event. The transducer generates transcutaneous vibrational outputs for the treatment session based on the treatment session parameters, for example, upon receiving the treatment session parameters from the computer processor. Treatment session parameters can be generated through machine learning of past responses and past stimuli to past events that have been used to achieve the target state during the event or regardless of the event.

[0140] In the implementation scheme, these segments can begin immediately after the previous segment has ended, or the stimulation can be sloping up or down between segments in terms of at least one parameter. In the implementation scheme, one or more variable parameters for each segment can be programmed according to the target state, wherein programming can be performed using lookup tables, based on transcutaneous vibrational outputs that have previously successfully helped the subject enter the target state, in real time based on sensor feedback, or manually, etc.

[0141] In some implementations, the treatment session may be accompanied by other treatments or related interventions, such as delivery of compounds (e.g., drugs, psychoactive agents, etc.), playing music, back massage, releasing certain fragrances, dimming the lights, etc.

[0142] To effectively deliver stimulation, device 102 and / or the associated algorithm can first be calibrated. Calibration can be performed in several ways, as described below. In one aspect, calibration may include establishing a baseline, characteristics of a non-stressed state and health index, or characteristics of various non-baseline states. For example, by initially using the stimulation device and continuously recording various parameters relevant to the user, via embedded or associated sensors, the user can indicate when they are stressed and not stressed, so that the algorithm associates the stored parameters with the identified states for future recall. Based on the health index, a range of frequencies can be delivered responsively. For example, one range may be used to treat depression, while another range may be used to aid sleep. In one embodiment, periodic or continuous monitoring of the baseline state and health index allows for fine-tuning of the calibration to individually and temporarily customize the range of frequencies delivered responsively.

[0143] Another approach to detecting stress-related shifts and calibration for unwanted stress could be to actively encourage entry into a specific state (e.g., rest, stress, fatigue, or other user-specified state) by delivering specific stimuli known to induce that state, and then storing the user's characteristics for future reference after the delivery of the stimulus and entry into the specific state. Entry into the state can be confirmed by the user or through sensor input. In another embodiment, the user can be encouraged into a relaxed state, for example, through the use of a mindfulness application, meditation application, and / or stimuli, and then different stimuli known to induce the state can be delivered, along with learning user characteristics and associating them with that state. For example, the user can be exposed to stimuli known to increase sympathetic and decrease parasympathetic tension to induce a stress state, and in this device 102, the characteristics of the stress state can be learned.

[0144] In one passive calibration method, a user is exposed to a range of stimulation patterns, and then the sensed parameters are used to determine whether the user has reached a target state. After repeated attempts, the optimal calming mode and the optimal arousal therapy mode can be selected. In another passive calibration method, a first transcutaneous vibrational output is delivered to the user with parameters including a first perceived pitch, a first perceived beat, and a perceived intensity. After determining the user's desired target state, the parameters of the first transcutaneous vibrational output can be selected, for example, from a database or by prediction. After or during the delivery of the first transcutaneous vibrational output, data such as physiological sensing data or user input are used to determine whether the user has reached the target state. The transcutaneous vibrational output in this passive calibration process can be modified to produce a second transcutaneous vibrational output. The second transcutaneous vibrational output is then delivered to the user with parameters including a second perceived pitch, a second perceived beat, and a perceived intensity, and the data is again used to determine whether the user has reached the target state. Based on the effectiveness of the first and second transcutaneous vibrational outputs, a processor can select one of the first or second vibrational outputs to continue using to help the user achieve the target state. In the implementation scheme, the processor may choose neither the first transcutaneous vibration output nor the second transcutaneous vibration output. This allows for iterative modification of the transcutaneous vibration output to find a set of transcutaneous vibration output parameters that effectively help the user achieve the target state.

[0145] In one implementation, multiple transcutaneous vibration outputs can be selected based on a desired target state to be used for a calibration session. Each transcutaneous vibration output can be based on parameters, including perceived pitch, perceived beat, and perceived intensity, and can be selected from a database or by prediction. During or after the emission of each of the multiple transcutaneous vibration outputs in a given session, data regarding whether the user has achieved the desired target state in each of the given sessions can be obtained, for example using an electronic transducer in partial contact with the user's body (e.g., using a physiological sensor or from user input). When determining the effectiveness of each of the multiple transcutaneous vibration outputs based on the data, one of the multiple transcutaneous vibration outputs can be selected as effective for helping the user enter the desired target state. The selected transcutaneous vibration output can then be transmitted to a database that includes other transcutaneous vibration outputs determined to be effective for the desired target state. The database can be accessed to identify other effective transcutaneous vibration outputs. One or more other effective transcutaneous vibration outputs can be selected from the database and emitted by an electronic transducer. The multiple vibration outputs may originate from a single user, while in other implementations, the database may store these vibration outputs (and those considered effective for multiple users) and thus be used to improve effectiveness for multiple users.

[0146] In personalized passive calibration, after the user begins using device 102, periodic measurements can be taken over a period of time at different times of the day. Measurements can be performed by one or more sensors (e.g., physiological sensors), cameras, microphones, etc., along with data collected from the user's manual adjustments to the device's operation. For example, physiological parameters sensed by the sensors could include movement, heart rate, GSR, temperature, etc. The user's baseline status can be determined through evaluation over a period of time (e.g., the first week of use).

[0147] In any of the embodiments described herein, a user's baseline state can be calculated based on readings from one or more sensors, which are described herein. The baseline state can be determined for a user over a period of time during the day, such as a morning baseline compared to an evening baseline. In some embodiments, in addition to establishing a baseline state using sensor readings, the user may be prompted for information or a rating about their mood, for example, through the user interface of a mobile device. Mood information can be used to confirm the establishment of a sensor-based baseline or as another data point in establishing the baseline state. In still other embodiments, the user's baseline state can be additionally based on correlated data received from the user's mobile device. Correlated data can indicate the amount of mobile device usage. Correlated data can be keystrokes input into the mobile device. Correlated data can indicate the user's mood (e.g., negative, positive, frustrated, angry, anxious, distracted, etc.). Correlated data can be the content of social media posts, where the content is used to indicate the user's mood (e.g., negative, positive, frustrated, angry, anxious, distracted, etc.). In still other embodiments, the user's baseline state can be established using physiological data, user input, facial recognition data, correlated data, or any combination thereof. In this way, one person's baseline state can differ from another person's baseline state.

[0148] The system can save baseline state data to a user profile, which can be accessed in the future to set parameters (such as duration and timing, frequency and / or intensity) when stimuli are applied to the user. As the user uses the device, the system can continuously collect new data, which can be used to supplement the user profile, and / or replace the oldest data with new data as new data is received.

[0149] Continuous measurements using sensors can be used to determine deviations from a baseline state. Deviations from the baseline state can indicate that the user is experiencing a stressor. Deviations from the baseline state can be detected by changes in sensor readings or changes in a set of sensor readings. For example, a deviation could be a shift of one standard deviation from the user's baseline. In response, downstream actions can be triggered, such as the initiation of therapeutic stimulation, selection of a specific transcutaneous vibrational output for delivery, or triggering a request to begin therapeutic stimulation.

[0150] Depending on the magnitude of the deviation from the baseline, an appropriate transcutaneous vibrational output can be selected based on the user's current state. For example, if the user experiences only a one standard deviation shift from the user's baseline, the selected transcutaneous vibrational output can begin at a lower intensity to reach the target state compared to a larger shift from the baseline. In another instance, a smaller shift from the baseline may require a shorter duration of stimulation compared to a user moving further away from the baseline. Knowing where the baseline is and how far the user is currently from it allows for dynamic selection of the transcutaneous vibrational output to help the user reach the target state from whatever state they are currently in. If the user does not reach the target state with the first transcutaneous vibrational output selected based on personalized passive calibration, a second transcutaneous vibrational output can be selected and generated to be applied to the user in an effort to help them reach the target state. Transcutaneous vibrational output can also be dynamically selected to avoid habituation.

[0151] Personalized passive calibration can be embodied in a system comprising the stimulation device described herein, a physiological sensor of the stimulation device that periodically measures data of at least one physiological parameter of the user, and a processor that communicates electronically with the mobile device and the stimulation device. (Reference) Figure 13 The processor can be programmed to (i) determine a user's baseline state 1320 based on periodic measurements from sensors of at least one physiological parameter of the individual; (ii) determine a deviation from the baseline 1322 based on data from the sensors of at least one physiological parameter of the user; (iii) determine, based on the deviation, a transcutaneous vibrational output 1324 for application to a portion of the user's body to achieve a target state; and (iv) transmit the determined transcutaneous vibrational output to a stimulation device 1328. Based on the transmitted determined transcutaneous vibrational output, a transducer of the stimulation device generates a transcutaneous vibrational output to be applied to a portion of the user's body, wherein the transcutaneous vibrational output includes a first perceived pitch, a first perceived beat, and a first perceived intensity. The processor can be further programmed to determine the user's baseline state by prompting the user to input data about the user's mood into a mobile device or by using the associated data or a combination thereof described herein. In any of the embodiments described herein, the processor may be further programmed to determine whether the user has achieved the target state (e.g., via sensors or user input), and if the user has not achieved the target state, to cause the transducer to generate a second transcutaneous vibration output to be applied to a part of the user's body to help the user achieve the target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a second perceived intensity.

[0152] Continuously collected baseline data can be stored to form a longitudinal dataset. The delivered frequencies can be iteratively tuned and optimized in real time based on the longitudinal data. For example, if a user's baseline changes over time, therapeutic stimulation is triggered precisely only when there is a deviation from the new baseline. Continuing this example, as the user progresses with device 102 and the baseline changes, perhaps reaching a more tranquil baseline state, the therapeutic stimulation protocol used when a deviation from the baseline is detected may need to be changed in one aspect (e.g., frequency, intensity, and / or duration) to affect the user's state.

[0153] As previously described, the sensory threshold for an individual user can be determined through: a) calibration, as described herein; b) active data collection (by conducting brief surveys in the app); c) passive data collection (by monitoring mobile device and app usage to determine the extent to which the user reduces or increases stimulation); and so on. In implementation, the sensory threshold can be determined for the user, for example, via calibration testing. The sensory threshold can be manually adjusted by the user. The intensity of the treatment frequency can be provided within one standard deviation of the sensory threshold. The lower sensory threshold can be a level where the vibration is barely perceptible when the user pays attention to it, but does not distract the user when their attention is diverted, gradually blending into the environment. The upper sensory threshold is where the stimulus might be distracting. The lower sensory threshold can be established by delivering a transcutaneous vibrational output to a part of the user's body and gradually decreasing the intensity of the transcutaneous vibrational output until the user indicates that it is barely perceptible, for example, through a user interface of the stimulation device or an application controlling the stimulation device. The upper sensory threshold can be established by delivering a transcutaneous vibrational output to a part of the user's body and gradually increasing the intensity of the transcutaneous vibrational output until the user indicates that it is distracting, for example, through the user interface of the stimulation device or by using an application that controls the stimulation device. Alternatively, the user can establish the lower and upper sensory thresholds themselves by manually adjusting the intensity of the stimulus until it is barely perceptible at the lower end or distracting at the upper end, where the final value of the adjustment is stored as the sensory threshold.

[0154] The delivery of the stimulus can be configured such that it does not exceed the sensory threshold, is within or at one standard deviation of the self-sensory threshold, or at some other point relative to the sensory threshold, such that it is not perceptible or is less distracting or uncomfortable. If the parameters of the stimulus are changed to produce a second stimulus, as described in the various embodiments herein, the second stimulus can also be configured such that it does not exceed the sensory threshold, is within or at one standard deviation of the self-sensory threshold, or at some other point relative to the sensory threshold, such that it is not perceptible or is less distracting or uncomfortable.

[0155] The delivery of therapeutic stimulation can utilize sensory thresholds, for example, by delivering a decreasing stimulus. The intensity of the decreasing stimulus can begin at the upper end of the sensory threshold and decrease at a rate (e.g., about 10% per minute) over an initial time period (e.g., about 2 to 15 minutes) to a barely perceptible level. In an implementation, the intensity can be maintained at the final level for the remaining stimulation duration (e.g., an additional 15-25 minutes).

[0156] After tapering, the stimulus may automatically turn off after a period of time (e.g., after the primary frequency has been applied at its lowest level for some time). After tapering, the stimulus may automatically turn off after a total period (from the initial value to the lowest level) has been applied for some time (e.g., at least 30 minutes). The intensity of the stimulus may be maintained at or within one standard deviation of the median of the user's sensory threshold to provide the desired result.

[0157] In some therapeutic applications involving stimulation patterns, the perceived pitch can be approximately 1-200 Hz or begin at approximately 1-200 Hz, and the perceived beat can be between 0.0001-4 Hz. This is used, for example, to treat conditions associated with hyperarousal, such as sleep disorders, chronic pain, post-traumatic stress disorder, chronic stress, autism, autoimmune diseases, anxiety, hypertension, tachycardia, arrhythmia, or similar conditions characterized by increased sympathetic nervous system activity over time. More than one perceived pitch and more than one perceived beat may also be used.

[0158] Treatment of conditions associated with autonomic nervous system hyperarousalgia may include obtaining input for the hyperarousal condition and a subject's sensory threshold for transcutaneous vibratory output. Input for the hyperarousal condition may be obtained through a user interface communicating with a processor. Alternatively, input for the hyperarousal condition may be obtained through sensed data or third-party data. The user's sensory threshold may be determined as described herein. Based on the hyperarousal condition, the processor may select a stimulation model for transcutaneous vibratory output, to be emitted by a transducer of a stimulation device, the stimulation pattern being based on parameters including perceived pitch, perceived beat, and perceived intensity. The computer processor may cause the transducer to generate transcutaneous vibratory output at or above the subject's sensory threshold for transcutaneous vibratory output using the selected stimulation model.

[0159] This article provides examples of perceptual pitch and perceptual beat used to treat certain hyperarousal disorders:

[0160] Treatment of chronic pain may include applying a perceived pitch of about 200 Hz or less, and a perceived beat of about 0.25 Hz or less, with an optional intensity within 1.5 standard deviations of the user’s sensory threshold.

[0161] Treatment of chronic stress may include applying a perceived pitch of 200 Hz or less and a perceived beat of about 4 Hz or less, with an optional intensity at one standard deviation from the user’s sensory threshold.

[0162] Treatment for autism may include applying a perceived pitch of about 200 Hz or less, and a perceived beat of about 10 Hz or less, with the optional intensity within two standard deviations of the user’s sensory threshold.

[0163] Treatment of autoimmune diseases may include applying a perceived pitch of about 200 Hz or less, and a perceived beat of about 10 Hz or less, with the optional intensity within two standard deviations of the user’s sensory threshold.

[0164] Treatment of anxiety may include applying a perceived pitch of about 200 Hz or less and a perceived beat of 4 Hz or less, with the intensity optionally within one standard deviation of the user’s sensory threshold.

[0165] Treatment of hypertension may include applying a perceived pitch of about 200 Hz or less and a perceived beat of 4 Hz or less, with the optional intensity within one standard deviation of the user’s sensory threshold.

[0166] In some other applications, the perceived pitch can be approximately 40-500 Hz, and the perceived tempo can be approximately 0.1-20 Hz (e.g., for treating conditions associated with low arousal, such as depression, narcolepsy, fatigue, constipation, tension, metabolic syndrome, eating disorders, hypotension, and attention deficit disorder characterized by a decrease or imbalance in sympathetic nervous system activity over time). In some implementations, the treatment of conditions associated with low arousal can use a perceived pitch at (or starting at) a level between 40 Hz and 500 Hz, and a perceived tempo of 0.1-10 Hz.

[0167] Treatment of conditions associated with low arousal of the autonomic nervous system may include obtaining input for the low arousal condition and a subject's sensory threshold for transcutaneous vibratory output. Input for the low arousal condition can be obtained through a user interface communicating with a processor. Alternatively, input for the low arousal condition can be obtained through sensed data or third-party data. The user's sensory threshold can be determined as described herein. Based on the low arousal condition, the processor can select a stimulation model for transcutaneous vibratory output, emitted by a transducer of a stimulation device, the stimulation model having parameters including perceived pitch, perceived beat, and perceived intensity. The computer processor can cause the transducer to generate transcutaneous vibratory output in the selected stimulation model at or above the subject's sensory threshold for transcutaneous vibratory output.

[0168] This article provides examples of perceptual pitch and perceptual beat used to treat certain low-arousal symptoms:

[0169] Treatment of depression may include applying a perceived pitch of approximately 10 Hz or higher, and a perceived beat equal to or greater than 0.05 Hz, optionally with an intensity within two standard deviations of the user's sensory threshold. In an implementation, an antidepressant compound and / or mindfulness activity may be combined with stimulation to treat depression.

[0170] Treatment of fatigue, narcolepsy, excessive daytime sleepiness, chronic fatigue syndrome, etc. may include applying a perceived pitch of 40 Hz or higher and a perceived beat equal to or greater than about 0.1 Hz, with the intensity optionally within two standard deviations above the user’s sensory threshold.

[0171] Treatment of tension disorder may include applying a perceived pitch of about 10 Hz or higher, and a perceived beat equal to or greater than 0.01 Hz, with the optional intensity within one standard deviation of the user’s sensory threshold.

[0172] Treatment of constipation may include applying a perceived pitch of about 20 Hz or greater, and a perceived beat equal to or greater than about 0.05 Hz, with the optional intensity within two standard deviations above the user’s sensory threshold.

[0173] Treatment of attention deficit disorder and other attention and concentration problems may include applying a perceived pitch of about 40 Hz or greater, and a perceived beat equal to or greater than about 0.1 Hz, with an optional intensity within one standard deviation of the user’s sensory threshold.

[0174] Treatment of metabolic disorders (including insulin insensitivity (i.e., type 2 diabetes) and metabolic syndrome may include applying a perceived pitch of about 10 Hz or greater, and a perceived beat equal to or greater than 0.001 Hz, with the optional intensity within two standard deviations of the user’s sensory threshold.

[0175] Treatment of hypotension and familial autonomic dysfunction may include applying a perceived pitch of about 20 Hz or greater, and a perceived beat equal to or greater than 0.001 Hz, with the optional intensity within two standard deviations above the user’s sensory threshold.

[0176] To reduce the symptoms of over-arousal, these layered oscillations can begin at a higher frequency corresponding to the user's current energy level and decrease to a slower oscillation corresponding to an upper threshold energy level associated with deep relaxation and / or sleepiness (the target state in this case). For example, the perceived pitch can begin at an initial value (e.g., 100 Hz), established in any suitable manner, such as by default, or based on user-selectable input, or based on the user's answers to certain questions, such as "How are you feeling?", or based on data collected from the user's mobile electronics and / or wearable devices with sensors (e.g., accelerometers). Different inputs can be associated with different initial values, for example, through a lookup table, or through an algorithm that takes into account combinations of input details. Typically, for sleep applications, in some implementations, the initial value of the perceived pitch will not exceed 200 Hz.

[0177] In one implementation, the perceived pitch can then be decreased from an initial value (e.g., 200 Hz) at a rate of approximately 5-10 Hz every 10-20 seconds (approximately) until an upper threshold level (e.g., approximately 40 Hz) is reached. The perceived pitch can be held at the upper threshold for a certain duration (stabilization phase), e.g., approximately 60 seconds. The perceived pitch can then be decreased at a rate of approximately 1 Hz every 10 seconds (approximately) until a second threshold (stabilization phase) is reached below the first threshold (e.g., approximately 30 Hz, or approximately 75% of the first threshold) is reached. The perceived pitch can be held at the second threshold for a duration. After that, the perceived pitch can be decreased at a rate of approximately 1 Hz every 10 seconds (approximately) until a third threshold (e.g., 20 Hz, or approximately 50% of the upper threshold) is reached below the second threshold and held at 20 Hz for a valid duration (e.g., approximately 20 minutes). This valid duration can be determined partly by software time limits (minimum: 5 minutes / maximum: 60 minutes) and / or partly by the user.

[0178] During this process, the perceived beat can begin at a first level (e.g., 0.2 Hz) and decrease at a rate of approximately 0.025 Hz every 15 seconds until it reaches approximately 0.1 Hz. The perceived beat can be held at approximately 0.1 Hz for approximately 120 seconds. Then, the perceived beat can be decreased by approximately 0.01 Hz every 30 seconds until the desired frequency is reached to obtain the desired result (e.g., approximately 0.05 Hz). The perceived beat can be held at 0.05 Hz for an effective time (e.g., up to 20 minutes), or until a change in perceived pitch is achieved.

[0179] As an example, a perceived pitch starting at approximately 100 Hz can be used as an option for the longest / slowest decrease (e.g., a 60-minute cycle), approximately 40 Hz can be considered as the average starting point for the perceived pitch (e.g., a 30-minute cycle), and approximately 33 Hz can be considered as the starting point for the perceived pitch for the shortest / fastest decrease (e.g., a 10-minute cycle). Similarly, the perceived pitch and perceived beat can be decreased independently or in series. One iteration of such rapid relaxation could have a perceived pitch starting at 200 Hz, decreasing to 40 Hz over a 5-minute process, and then stabilizing at 40 Hz for another 10 minutes, while the perceived beat starts at 2 Hz and gradually decreases to 0.1 Hz over 15 minutes. In each case, the difference can decrease over time such that the primary and secondary oscillations are very close, for example, with a difference of approximately 0.0001 Hz before each frequency reaches zero. Optionally, the decrease in perceived beat can take longer than the decrease in perceived pitch because they allow the user to experience a longer arousal state before finally achieving the desired effect, especially if the user was more symptom-heavy before using the device. Generally, the faster the decrease (the less time spent in each frequency state) for each frequency, the faster the user may transition from symptom-free to symptom-free. Specific combinations may include, for example: (A) sensing pitch starting at approximately 100 Hz and decreasing to 20 Hz until off, with the initial sensing beat differing from the main frequency by approximately 1 Hz, which decreases over time to 0.01 Hz; (B) sensing pitch starting at approximately 40 Hz and decreasing to 10 Hz until off, with the initial sensing beat differing from the main frequency by approximately 0.2 Hz, which decreases over time to 0.001 Hz until off; and (C) sensing pitch starting at approximately 33 Hz and decreasing to 1 Hz until off, with the initial sensing beat differing from the main frequency by approximately 0.1 Hz, which decreases over time to 0.0001 Hz until off.

[0180] Similarly, in some applications that utilize alternative implementations of layered sine waves to generate interference patterns, the primary frequency can be approximately 1-200 Hz, and the modulation frequency can differ from the primary frequency by approximately 0.0001-4 Hz (e.g., for treating conditions associated with hyperarousal, such as sleep disorders, chronic pain, post-traumatic stress disorder, chronic stress, autism, autoimmune diseases, anxiety, hypertension, or similar conditions characterized by increased sympathetic nervous system activity over time). In some implementations, the perceived beat is partially generated by a primary frequency at (or beginning at) the 10-200 Hz level, and the secondary frequency differs from the primary frequency by 0.0001 Hz or more.

[0181] Examples may include, but are not limited to:

[0182] Treatment of chronic pain may include applying a dominant frequency of about 100 Hz or less, and a modulation frequency that differs from the dominant frequency by about 0.2 Hz, with the optional intensity within one standard deviation of the median of the user’s sensory threshold.

[0183] Treatment of chronic stress may include applying a dominant frequency of 200 Hz or less, and a modulation frequency that differs from the dominant frequency by about 4 Hz, optionally with an intensity of one standard deviation of the median of the user’s sensory threshold.

[0184] Treatment for autism may include applying a dominant frequency of about 200 Hz or less, and a modulation frequency that differs from the dominant frequency by about 4 Hz, with the optional intensity within two standard deviations of the median of the user’s sensory threshold.

[0185] Treatment of autoimmune diseases may include applying a main frequency of about 200 Hz or less, and a modulation frequency that differs from the main frequency by about 1 Hz, with the optional intensity within one standard deviation of the median of the user's sensory threshold.

[0186] Treatment of anxiety may include applying a main frequency of about 200 Hz or less, and a modulation frequency that differs from the main frequency by 4 Hz or less, with the optional intensity within one standard deviation of the median of the user’s sensory threshold.

[0187] Treatment of hypertension may include applying a dominant frequency of about 100 Hz or less, and a modulation frequency that differs from the dominant frequency by 4 Hz or less, with the optional intensity within one standard deviation of the median of the user’s sensory threshold.

[0188] In some other applications, the dominant frequency can be approximately 40-500 Hz, and the modulation frequency can differ from the dominant frequency by approximately 0.1-10 Hz (e.g., for treating conditions associated with low arousal, such as depression, narcolepsy, fatigue, constipation, tension, metabolic syndrome, eating disorders, hypotension, and attention deficit disorder characterized by a decrease or imbalance in sympathetic nervous system activity over time). In some embodiments, treatment of conditions associated with low arousal may use a dominant frequency at (or starting at) a level between 40 Hz and 200 Hz, with secondary frequencies differing from the dominant frequency by 0.1-10 Hz. The perceived beat of the stimulus is partly generated by the difference between the dominant and secondary frequencies.

[0189] Continuing with examples, these examples may include, but are not limited to:

[0190] Treatment of depression may include applying a dominant frequency of about 40 Hz or greater, and a modulation frequency that differs from the dominant frequency by about 0.1 Hz to 4 Hz, with the optional intensity within two standard deviations above the median of the user’s sensory threshold.

[0191] Treatment of fatigue, narcolepsy, excessive daytime sleepiness, chronic fatigue syndrome, etc. may include applying a dominant frequency of 89 Hz or higher, and a modulation frequency that differs from the dominant frequency by about 0.1 Hz, with the optional intensity within two standard deviations above the median of the user's sensory threshold.

[0192] Treatment of tension disorder may include applying a dominant frequency of about 10 Hz or greater, and a modulation frequency that differs from the dominant frequency by about 0.1 Hz, optionally with an intensity within one standard deviation of the median of the user’s sensory threshold.

[0193] Treatment of constipation may include applying a main frequency of about 20 Hz or greater, and a modulation frequency that differs from the main frequency by about 0.1 Hz, with the optional intensity within two standard deviations above the median of the user’s sensory threshold.

[0194] Treatment of attention deficit disorder and other attention and concentration problems may include applying a dominant frequency of about 40 Hz or greater, and a modulation frequency that differs from the dominant frequency by about 0.1 Hz, with the optional intensity within one standard deviation of the median of the user’s sensory threshold.

[0195] Treatment of metabolic disorders (including insulin insensitivity (type 2 diabetes) and metabolic syndrome) involves applying a dominant frequency of about 40 Hz or greater, and a modulation frequency that differs from the dominant frequency by 0.1 Hz or greater, with the optional intensity within two standard deviations of the median of the user’s sensory threshold.

[0196] Treatment of hypotension and familial autonomic dysfunction may include applying a dominant frequency of about 60 Hz or greater, and a modulation frequency that differs from the dominant frequency by 0.1 Hz or greater, with the optional intensity within two standard deviations above the median of the user’s sensory threshold.

[0197] To reduce the symptoms of over-arousal, the oscillation can begin at a higher frequency corresponding to the user's current energy level and decrease to a frequency corresponding to an upper threshold energy level associated with deep relaxation and / or sleepiness. For example, the primary frequency can begin at a starting value (e.g., 100 Hz), which can be established in any suitable manner, such as by default, or based on user-selectable input, or based on the user's answers to certain questions, such as "How are you feeling?", or based on data collected from the user's mobile electronics and / or wearable devices with sensors (e.g., accelerometers). Different inputs can be associated with different starting values, for example, through a lookup table, or through an algorithm that takes into account combinations of input details. Typically, for sleep applications, in some implementations, the starting value of the primary frequency will not exceed 100 Hz.

[0198] The primary frequency can then be decreased from the initial value at a rate of approximately 5-10 Hz every 20 seconds (approximately) until it reaches an upper threshold level (e.g., approximately 40 Hz). The primary frequency can be held at the upper threshold for a certain period of time, e.g., approximately 60 seconds. The primary frequency can then be decreased at a rate of approximately 1 Hz every 10 seconds (approximately) until it reaches a second threshold below the first threshold (e.g., approximately 30 Hz, or approximately 75% of the first threshold). The primary frequency can be held at the second threshold for a certain period of time. After that, the primary frequency can be decreased at a rate of approximately 1 Hz every 10 seconds (approximately) until it reaches a third threshold below the second threshold (e.g., 20 Hz, or approximately 50% of the upper threshold) and held at 20 Hz for a valid period of time (e.g., approximately 20 minutes). This valid period of time can be determined partly by software time limits (minimum: 5 minutes / maximum: 60 minutes) and / or partly by the user.

[0199] During this process, the secondary frequency may begin at a first level (e.g., 0.2 Hz) and decrease at a rate of approximately 0.025 Hz every 15 seconds until it reaches approximately 0.1 Hz. The secondary frequency may be maintained at approximately 0.1 Hz for approximately 120 seconds. Then, the secondary frequency may be decreased by approximately 0.01 Hz every 30 seconds until the desired frequency is reached to relieve symptoms (e.g., approximately 0.05 Hz). The secondary frequency may be maintained at 0.01 Hz for an effective period (e.g., up to 20 minutes) or until the primary frequency changes.

[0200] As an example, a primary frequency starting at approximately 100 Hz can be used as an option for the longest / slowest decay (e.g., a 60-minute cycle), approximately 40 Hz can be considered as the average starting point for the primary frequency (e.g., a 30-minute cycle), and approximately 33 Hz can be considered as the starting point for the primary frequency for the shortest / fastest decay (e.g., a 10-minute cycle). Similarly, the difference between the primary and secondary frequencies (i.e., the modulation frequency) can also decrease, for example, starting at a difference of approximately >2 Hz from the primary frequency = the longest decay; starting at a difference of approximately 0.2-2 Hz = a moderate decay; and starting at a difference of approximately <0.2 Hz = the shortest decay. In each case, the difference can decrease over time such that the primary and secondary oscillations are very close, for example, the difference is approximately 0.0001 Hz before each frequency reaches zero. Optionally, the decay of the secondary frequencies can have a longer duration than the decay of the primary frequency, because they allow the user to experience a longer arousal state before finally achieving the desired effect, especially if the user was more symptomatic before using the device. Generally, for each frequency, the greater the rate of decline (the less time spent in each frequency state), the faster the user may transition from symptomatic to asymptomatic. Specific combinations may include, for example: (A) a primary frequency starting at approximately 100 Hz and declining to 20 Hz until it is off, with the secondary frequency initially differing from the primary frequency by approximately 1 Hz, decreasing over time to 0.01 Hz; (B) a primary frequency starting at approximately 40 Hz and declining to 10 Hz until it is off, with the secondary frequency initially differing from the primary frequency by approximately 0.2 Hz, decreasing over time to 0.001 Hz until it is off; and (C) a primary frequency starting at approximately 33 Hz and declining to 1 Hz until it is off, with the secondary frequency initially differing from the primary frequency by approximately 0.1 Hz, decreasing over time to 0.0001 Hz until it is off.

[0201] Similarly, to reduce symptoms of low arousal, oscillations can begin at a lower frequency corresponding to the user's current energy level and increase to a frequency corresponding to a threshold energy level associated with energizing the user. For example, the primary frequency can begin at an initial value (e.g., 40 Hz), established in any suitable manner, such as by default, or based on user-selectable input, or based on the user's answers to certain questions, such as "How are you feeling?", or based on data collected from the user's mobile electronics and / or wearable devices with sensors (e.g., accelerometers). Different inputs can be associated with different initial values, for example, through a lookup table, or through an algorithm that considers combinations of input details.

[0202] The primary frequency can then be increased from the initial value at a rate of approximately 5-10 Hz every 20 seconds (approximately) until an upper threshold level (e.g., approximately 40 Hz) is reached. The primary frequency can be held at the upper threshold for a certain period of time, e.g., approximately 60 seconds. The primary frequency can then be increased at a rate of approximately 1 Hz every 10 seconds (approximately) until a second threshold (e.g., approximately 600 Hz) is reached, which is greater than the first threshold. The primary frequency can be held at the second threshold for a certain period of time. After that, the primary frequency can be increased at a rate of approximately 1 Hz every 10 seconds (approximately) until a third threshold (e.g., 100 Hz) is reached, which is held at 100 Hz for a valid period of time (e.g., approximately 20 minutes). This valid period of time can be determined partly by software time limits (minimum: 5 minutes / maximum: 60 minutes) and / or partly by the user.

[0203] During this process, the secondary frequency may begin at a first level (e.g., 0.2 Hz) and increase at a rate of approximately 0.025 Hz every 15 seconds until it reaches approximately 1 Hz. The secondary frequency may be maintained at approximately 1 Hz for approximately 120 seconds. Then, the secondary frequency may be decreased by approximately 0.01 Hz every 30 seconds until the desired frequency is reached to relieve symptoms (e.g., approximately 5 Hz). The secondary frequency may be maintained at 5 Hz for an effective period (e.g., up to 20 minutes) or until the primary frequency changes.

[0204] Stimulation works by increasing the balance between the sympathetic and parasympathetic components of the autonomic nervous system, which is necessary for optimal bodily function. One way the stimulation device 102 can deliver therapeutic therapy is by increasing parasympathetic activity, inhibiting sympathetic activity, or increasing / inhibiting parasympathetic activity through acoustically and / or vibrationally induced stimulation—collectively referred to as autonomic nervous system modulation. The frequency ranges described above are provided for illustrative purposes only and can be adjusted or tuned for the subject using feedback loops based on the subject's physiological responses, as described below. Specifically, the frequencies can be personalized for the subject based on biometric data collected by the sensor device 118 (e.g., heart rate, heart rate variability, blood pressure, respiration, perspiration, resting pulse rate, brain activity, etc.) and / or based on user feedback.

[0205] Typically, the increase in the balance of the parasympathetic and sympathetic nervous systems caused by the application of low-frequency sounds (or vibrations) is perceptible and can be monitored in real time, allowing for careful monitoring of the results and modulation, control, or withdrawal of the stimulation as needed. In some implementations, the results can be presented to the subject, for example, through a user interface and / or via an application on the user's device. Furthermore, a treatment plan can be designed in which the continuous or pulsed delivery of low-frequency sounds is carried out over days, weeks, months, or even years, depending on the specific circumstances of the subject being treated.

[0206] Therapeutic stimulation can promote sleep. Most people experience difficulty falling asleep and / or staying asleep at some point in their lives. Insomnia can occur in response to stressful life events, during travel when normal bodily rhythms are disrupted, in response to engaging in stimulating activities before bedtime, or for other reasons. Many people experience recurring insomnia multiple nights a week; this condition can be considered acute insomnia. If this pattern persists for several months, it can be considered chronic insomnia.

[0207] It is estimated that 25% to 30% of people experience acute insomnia each year. Therefore, many treatments are available to help manage insomnia. These treatments range from medication (such as benzodiazepines) to other medications. Non-benzodiazepine Sedatives and natural interventions are both options. Many drug treatments can cause harmful side effects, require monitoring for interactions with other medications, and may cause drowsiness to persist beyond the desired sleep duration. Non-pharmacological treatments, such as light therapy and cognitive behavioral therapy, can be time-consuming and require a considerable amount of self-discipline to continue the treatment process. Therefore, better ways to treat insomnia and other forms of insomnia are needed.

[0208] This disclosure provides a method and system for treating insomnia by applying and removing vibrational or auditory stimulation to the human body in a pattern that increases the balance between the sympathetic and parasympathetic components of the autonomic nervous system. Stimulation improves parasympathetic activity by activating afferent sensory nerve fibers in the skin and deep tissues that are networked with the parasympathetic nervous system in the spinal cord and brain, and whose main components include the vagus nerve and its collateral branches. This improvement in parasympathetic activity leads to a reduction in abnormal or harmful activity within the sympathetic nervous system.

[0209] Terminology related to this disclosure includes the term "insomnia." Insomnia includes a general physical condition in which a person is unable to fall asleep and / or remain asleep for more than a short period of time (e.g., only one to three hours). "Insomnia disorder" refers to a condition in which a person experiences insomnia multiple nights per week. Chronic insomnia is defined as insomnia that occurs at least three nights per week and lasts for at least three months. Insomnia that lasts for a shorter period of time may be considered acute insomnia.

[0210] To induce deep relaxation and / or sleepiness in awake subjects, the transcutaneous vibrational output can begin at a higher frequency / pitch / beat / intensity corresponding to the user's current energy level and decrease to a frequency / pitch / beat / intensity corresponding to an upper limit threshold energy level associated with deep relaxation and / or sleepiness. For example, the dominant frequency or perceived pitch can begin at a starting value established in any suitable manner, such as by setting a default value, based on user-selectable input, or based on the user's answers to certain questions, such as "How do you feel?", or based on data collected from the user's mobile electronics and / or wearable devices with sensors (e.g., accelerometers). Different inputs can be associated with different starting values, for example, through a lookup table, or through an algorithm that considers combinations of input details.

[0211] In some implementations, transcutaneous vibration output can be initiated automatically, for example at a certain time or in response to sensors worn by or near the user. These sensors provide data to a processor indicating that the user is in a pre-sleep state. For example, an accelerometer can indicate slowing or no movement, suggesting readiness for sleep.

[0212] refer to Figure 14 Upon receiving data 1402, the processor may provide a stimulation pattern 1404 to the transducer for transcutaneous vibrational output to be emitted by the transducer. The stimulation pattern may have parameters including perceived pitch, perceived beat, and perceived intensity. In some embodiments, the stimulation pattern may include a perceived pitch between 1 and 100 Hz and a perceived beat at a second frequency between 0.0001 and 1.5 Hz. In other embodiments, the perceived beat is generated in part by a first oscillation at a first frequency in the 1-100 Hz range and a second oscillation at a second frequency differing from the first frequency by 0.0001 to 1.5 Hz. The sensor continuously collects data 1408 to determine the user's sleep state (e.g., before sleep, almost asleep, asleep). Based on the sleep state determined by the sensor, the processor may modify the stimulation pattern 1410, for example, by starting to decrease 1412, accelerating the decrease 1414, interrupting the stimulation pattern 1418 or turning off the device 1420 when the user falls asleep, extending the duration of the stimulation pattern 1422, etc. Altering the stimulation pattern may also include at least one of the following: (i) decreasing the frequency of perceived pitch 1424, (ii) increasing the interval of perceived beat 1428, or (iii) decreasing the intensity 1430. In some embodiments, the stimulation pattern may be matched to a sleep state. For example, if an accelerometer indicates a slowing of activity, but other indicators suggest the user is ready to sleep but has not fallen asleep, a specific relaxation frequency may be initiated to facilitate an eventual transition to sleep.

[0213] When the frequency of the perceived pitch decreases to a first decreased perceived pitch, the first decreased perceived pitch can be maintained for a selected period of time, or until the sensor indicates a change in the user's sleep state, which may require another change in the stimulation pattern. For example, if the sensor indicates that the user has reached a near-sleep state, a second change in the stimulation pattern can be triggered, and the first decreased perceived pitch can decrease to a second decreased perceived pitch, which can be maintained for a selected period of time, or until the sensor indicates a change in the user's sleep state, which may require another change in the stimulation pattern. For example, during sleep, an accelerometer can sense motion during a nightmare and can trigger a stimulation pattern to encourage re-entry into sleep.

[0214] When the interval of the sensing beat decreases to the first increased sensing beat, the first decreased sensing beat can be maintained for a selected period of time, or until the sensor indicates a change in the user's sleep state, which may require another change in the stimulation pattern. For example, if the sensor indicates that the user has reached a state of near sleep, a second change in the stimulation pattern can be triggered, and the first decreased sensing beat can be reduced to the second decreased sensing beat, which can be maintained for a selected period of time, or until the sensor indicates a change in the user's sleep state, which may require another change in the stimulation pattern.

[0215] When the intensity decreases to a first reduced intensity, the first reduced intensity may remain for a selected period of time, or until the sensor indicates a change in the user's sleep state, which may require another change in the stimulation pattern. For example, if the sensor indicates that the user has reached a state of near sleep, a second change in the stimulation pattern may be triggered, and the first reduced intensity may decrease to a second reduced intensity, which may remain for a selected period of time, or until the sensor indicates a change in the user's sleep state, which may require another change in the stimulation pattern.

[0216] For example, a perceived pitch starting at approximately 100 Hz could be used as an option for the longest / slowest decay (e.g., a 30-minute cycle), approximately 40 Hz could be considered as the average starting point for the perceived pitch (e.g., a 20-minute cycle), and approximately 30 Hz or approximately 33 Hz could be considered as the starting point for the shortest / fastest decay (e.g., a 10-minute cycle). Similarly, the perceived beat could also decay independently of the perceived pitch decay, for example, starting at approximately 0.2–1 Hz for the longest decay; at approximately 0.1–0.2 Hz for the medium decay; and at 0.05–0.1 Hz for the shortest decay. In each case, the frequency of the perceived pitch and / or the perceived beat could decay over time. Optionally, the decay of the perceived beat could last longer than the decay of the perceived pitch, as they allow the user to experience more arousal before finally falling asleep, especially if the user was more alert / awake before using the device. Generally, for each frequency, the greater the rate of decrease (the less time spent in each frequency state), the faster the user may transition from wakefulness to sleep. Specific combinations may include, for example: (A) perceived pitch starting at approximately 100 Hz and decreasing to 1 Hz until off, and perceived beat starting at 1 Hz and decreasing to 0.0001 Hz over time; (B) perceived pitch starting at approximately 40 Hz and decreasing to 1 Hz until off, and perceived beat starting at approximately 0.2 Hz and decreasing to 0.0001 Hz over time until off; and (C) perceived pitch starting at approximately 33 Hz and decreasing to 1 Hz until off, and perceived beat at approximately 0.1 Hz and decreasing to 0.0001 Hz over time until off.

[0217] In an alternative implementation of the layered sine wave that generates the interference pattern, the dominant frequency can be decreased from an initial value (e.g., 100 Hz) until an upper threshold level (e.g., about 40 Hz) is reached. The rate of stimulus deceleration can be programmed. For example, the deceleration rate can be a rate of about 5-10 Hz every 20 seconds. The dominant frequency can be maintained at the upper threshold for a certain duration, for example, about 60 seconds. The dominant frequency can then be decreased (e.g., at a rate of about 1 Hz every 10 seconds) until a second threshold (e.g., about 30 Hz, or about 75% of the first threshold) is reached, which is less than the first threshold. The dominant frequency can be maintained at the second threshold for a certain duration. After that, the dominant frequency can be decreased (e.g., at a rate of about 1 Hz every 10 seconds) until a third threshold (e.g., 10 Hz, or about 25% of the upper threshold) is reached, which is less than the second threshold, and maintained at the third threshold for a sleep duration (e.g., about 20 minutes).

[0218] Continuing with the implementation of the layered sine wave that generates the interference pattern, during this process, a secondary frequency may begin at a first level (e.g., 0.2 Hz) and decrease (e.g., at a rate of approximately 0.025 Hz every 15 seconds) until it reaches a second level, e.g., approximately 0.1 Hz in this example. The secondary frequency may be maintained at the second level for a certain duration (e.g., approximately 240 seconds). The secondary frequency may then be decreased (e.g., at a rate of approximately 0.01 Hz every 30 seconds) until it reaches the desired frequency for sleep (e.g., approximately 0.01 Hz). The secondary frequency may be maintained at the desired frequency for sleep duration (e.g., up to 20 minutes) or until the primary frequency changes.

[0219] For example, and continuing with this implementation of a layered sine wave that generates interference modes, a primary frequency starting at approximately 100 Hz can be used as an option for utilizing the longest / slowest decrease (e.g., a 30-minute period), approximately 40 Hz can be considered as the average starting point for the primary frequency (e.g., a 20-minute period), and approximately 30 Hz or approximately 33 Hz can be considered as the starting point for the primary frequency for the shortest / fastest decrease (e.g., a 10-minute period). Similarly, the difference between the primary and secondary frequencies (i.e., the modulation frequency) can also decrease, for example, for the longest decrease starting at a difference of approximately 0.2-1 Hz from the primary frequency; for the medium decrease starting at a difference of approximately 0.1-0.2 Hz; and for the shortest decrease starting at a difference of approximately 0.05 Hz. In each case, the difference can decrease over time such that the primary and secondary oscillations can be very close, for example, with a difference of approximately 0.0001 Hz before each frequency reaches zero. Optionally, the decrease in secondary frequencies may take longer than the decrease in primary frequencies because they allow the user to experience more arousal before finally reaching sleep, especially if the user was more alert / awake before using the device. Generally, the faster the decrease (the less time spent in each frequency state) for each frequency, the faster the user may transition from wakefulness to sleep. Specific combinations may include, for example: (A) a primary frequency starting at approximately 100 Hz and decreasing to 1 until off, with secondary frequencies initially differing from the primary frequency by approximately 1 Hz, the difference decreasing over time to 0.0001 Hz; (B) a primary frequency starting at approximately 40 Hz and decreasing to 1 until off, with secondary frequencies initially differing from the primary frequency by approximately 0.2 Hz, the difference decreasing over time to 0.0001 Hz until off; and (C) a primary frequency starting at approximately 33 Hz and decreasing to 1 until off, with secondary frequencies initially differing from the primary frequency by approximately 0.1 Hz, the difference decreasing over time to 0.0001 Hz until off. In one embodiment, the first oscillation of two or more oscillations may exhibit a first frequency having an initial value in the range of about 1 to about 100 Hz, and the second oscillation of two or more oscillations may exhibit a second frequency that differs from the first frequency by about 0.0001 to about 1 Hz initially. The two or more oscillations together form a beat output.

[0220] In some implementations, the system's user interface may include an input area where the user can select a mode that increases or decreases the rate at which the frequency decreases from a higher starting point to a lower endpoint. For example, a user who wants to fall asleep very quickly can choose a mode where the frequency decreases at a faster end of the spectrum, while those who relax (gradually decrease) more slowly or are more energetic before bed can choose a mode with a frequency decrease at a slower end of the spectrum. The user can make this selection via a slider or dial, by entering a numerical value, or by selecting from a variety of modes (each mode will have various numbers and thresholds assigned to it).

[0221] In some implementations, as the vibration frequency decreases, the intensity of the vibration also decreases from a stronger value to a weaker value, or vice versa. That is, each frequency, perceived pitch, perceived beat, and perceived intensity can be modulated independently of each other. The device can do this by reducing the current applied to the transducer coil, as the device also reduces the frequency at which the sound is emitted. The intensity of the oscillation can begin at the upper end of the sensory threshold (where the user will find it more difficult to ignore the vibration). The intensity can then decrease at a certain rate (e.g., about 10% per minute) over a first time period (e.g., about 15 minutes) to a level that is almost imperceptible (at the lower end of the sensory threshold). This rate can be measured from the level present during the previous minute. The intensity can be maintained at the final level for the remaining stimulation duration (e.g., an additional 15-25 minutes). If a smaller threshold is used, a shorter time period can be used. In other implementations, the intensity of the stimulus can be maintained at or within one standard deviation of the median of the user's sensory threshold to provide the desired result.

[0222] After a period of time, the stimulation may automatically turn off, for example, after the primary frequency has been applied at its lowest level, or after a total cycle (from the initial value to the lowest level) has been applied for a period of time (e.g., at least 30 minutes). Automatic shutdown can be triggered by other time values. The acoustic vibration may continue for a longer period of time associated with the desired rest or treatment period (e.g., 6, 7, or 8 hours), or may continue until the user wakes up and turns off the vibration. Optionally, unless a sensor device communicating with the stimulation device 102 or its controller provides data indicating that the user has not yet reached the desired measurable biometric state (e.g., target respiratory rate, heart rate, pulse, movement, etc.), the system may default to turning off after the initial cycle (e.g., 20-30 minutes). Such data may include data from a body motion sensor worn by the user, indicating that the user is moving or has moved above a threshold level during a specified period of time just before the end of the sleep cycle (e.g., 1 minute before the end of the sleep cycle, 3 minutes before the end of the sleep cycle, etc.). The body motion sensor may also indicate that the user has stopped moving, which may be an indication that the user has fallen asleep, and may cause the stimulation to be interrupted, decreased at a faster rate, or immediately switched to a sleep-maintaining level.

[0223] Optionally, the sound vibrations can be initiated up to one hour before the user wishes to fall asleep. However, the stimulation may begin to induce relaxation and drowsiness within as little as three minutes. The stimulation may be effective when the dominant frequency is combined with the modulation frequency and applied for a certain duration, such as at least 15 minutes. In some embodiments, the sleep mode may apply stimulation for a predetermined duration (e.g., 30-40 minutes). In some embodiments, the system allows the user to select the duration of the program.

[0224] In one aspect, a method for delivering and reducing user stimuli may include reducing a first oscillation (also referred to as the dominant frequency or fundamental tone) from an upper threshold frequency to a lower threshold frequency over a first time period, and maintaining the first oscillation / fundamental tone at the lower threshold frequency during a second time period (e.g., 5 minutes). The reduction may utilize a first deceleration rate to reduce the first oscillation / fundamental tone to a target frequency (e.g., 100 Hz, 40 Hz, 33 Hz, 30 Hz, 1 Hz, etc.), and when the first oscillation / fundamental tone reaches the target frequency, changing the deceleration rate to a second deceleration rate, at which point the first oscillation / fundamental tone is reduced from the target frequency to the lower threshold frequency (e.g., 40 Hz, 33 Hz, 30 Hz, 1 Hz, etc.). In embodiments, the target frequency of the first oscillation / fundamental tone can be any frequency, for example, a frequency selected from 0.1 Hz to 100 Hz (e.g., 100 Hz, 40 Hz, 33 Hz, 30 Hz, 1 Hz, etc.). The stimulation device 102 can emit a beat output as a vibration corresponding to a therapeutic stimulation pattern. This may include initiating a second oscillation (also referred to as a modulation frequency or perceived beat frequency) at a first threshold frequency, decreasing the second oscillation to a second threshold frequency over a first time period, and maintaining the second oscillation at the second threshold frequency during a second time period. The deceleration rate can be user-customizable and adjustable. The upper threshold frequency can be set by the user based on current activity, currently indicated sensation, desired sensation, lookup table, or an algorithm that takes into account a combination of input details.

[0225] In one implementation, the duration of the decay period can vary with the onset of the oscillation. For example, the decay period can be 30 min, 20 min, 10 min, etc. In one implementation, the modulation frequency can also decay, as described herein with respect to the primary frequency. For example, the modulation frequency or sensing beat may begin at approximately 1 Hz for the longest decay; at approximately 0.1–0.2 Hz for a medium decay; or at approximately 0.05 Hz for the shortest decay.

[0226] In one implementation, the difference between the primary frequency and the modulation frequency may decrease over time, making them very close before each frequency reaches zero. In some implementations, the decrease in the secondary frequency or modulation frequency may take longer than the decrease in the primary frequency. In one implementation, shutdown may be triggered after a specific time period or after the primary frequency has been applied at its lowest level for a period of time.

[0227] In one implementation, a first transcutaneous vibrational output is generated for application to a part of the user's body based on the user's desired target state. This first transcutaneous vibrational output includes parameters including a first perceived pitch, a first perceived beat, and a first perceived intensity. The values ​​of one or more of the first perceived pitch, first perceived beat, and first perceived intensity begin at an upper limit value, and the first transcutaneous vibrational output can be decreased by decreasing one or more of the first perceived pitch, first perceived beat, and first perceived intensity to a lower limit value over a first time period, depending on the stimulation protocol required to achieve the desired target state. The lower limit value can be maintained during a second time period. A target frequency prior to the first perceived pitch or first perceived beat value can be decreased using a first deceleration rate. After the target frequency is reached, for example, if a sensor indicates that the target state has been reached, the deceleration or stimulation can be interrupted, or a second deceleration rate can be used to decrease the output from the target frequency to the lower limit value. The lower limit value can be reached using as many segments as possible, decreasing to progressively lower values ​​at the same or different deceleration rates.

[0228] In the implementation, the therapeutic stimulus can be increased from a starting value and ramped up to a target value. For example, one or more of perceived pitch, perceived beat frequency, or intensity can ramp up from a starting value to a target value. The starting value can be a lower threshold frequency. The target value can be selected to correspond to a treatment goal, such as an upper threshold frequency, etc. The ramping can be performed over a period of time at a certain rate, where the rate itself can be variable or speed-based. The maximum value can be reached by using as many segments as possible to ramp up to progressively higher values ​​at the same or different ramp rates. In the implementation, once the target value is reached, a second time period can be maintained, or it can be terminated or decremented, for example, in response to sensor feedback or by manual input.

[0229] In one implementation, the system may be able to predict the onset of a user's state, such as an emotional state. Various emotional states include anger, fear, annoyance, sadness, anxiety, apathy, frustration, distraction, etc. Predicting the onset of a state allows the system to resolve the user's current state or avoid the predicted state. Resolving or avoiding a state may involve triggering a stimulus program, for example, a stimulus involving mitigating the onset of the state or treating the state. The predicted state of the user can be determined by at least one of electronically sensing the user's physiological state or the user's associated data. In some implementations, the predicted state can be determined by electronically sensing the user's physiological state and collecting the user's associated data. Physiological states can be sensed using sensors on wearable devices. Information from sensing wearables and / or third-party sources (e.g., social media) can be used to determine the user's condition and coordinate the delivery of appropriate stimulus therapy.

[0230] In one instance, a sensor can determine HRV (Human Resonance Value). In another instance, the sensor can be a sound sensor that senses sound data such as yawns, sighs, shouts, pitch, tone, speech rate, volume, acoustic characteristics, etc. Correlated data can be sensed or collected from devices separate from the wearable device (e.g., smartphones, fitness trackers, smartwatches, smart speakers, smart glasses, connected vehicles, smart headphones, etc.), social media platforms, environmental sensors, third-party data, etc. For example, social media posts can be analyzed to derive indications of a user's mood (e.g., negative, positive, frustrated, angry, anxious, distracted, etc.). In another instance of related data, user movement or location data can be sensed or collected, for example, from the user's mobile device. The system can determine whether the user's location is an indication or prediction of their mood. Other related user data may include calendar entries, project management entries, social media content, screen time, or currently sensed activity (e.g., flying, commuting, in transit) to modify an aspect of a stimulus, triggering or interrupting the stimulus. In the implementation scheme, various indicators of user activity can be inferred from associated user data, optionally in conjunction with other data, to obtain characteristics of user-related data regarding when a user feels good about their life (which could be a user's goal or target state), when they feel bad, or any state in between. These life characteristics, which could be personalized target states, can be monitored by the system to predict when a user's overall mood or well-being begins to decline, for example, when their life characteristics begin to move away from good and towards bad. Upon detecting a predicted or actual decline, the system can trigger stimuli that can be designed to mitigate further decline and / or support positive feelings. One such example of a detectable pattern helpful for declining life characteristics is when persistent poor sleep is detected via a wearable activity tracker.

[0231] Various other characteristics of personalized target states can be developed using the sensed or collected data described herein (e.g., physiological, associative, environmental, etc.), such as running target states / characteristics, sleep target states / characteristics, work target states / characteristics, performance states, relaxation states, focus states, etc. In one method of establishing a personalized target state while simultaneously receiving a first transcutaneous vibrational output to achieve the desired target state, the user can provide feedback on whether they have achieved the target state. The user can select the target state using a user interface or input data regarding whether the user has achieved the desired target state. If the user has achieved the desired target state, at least one of the user's associative or biometric data can be obtained while the user is in the target state. Biometric data can be obtained using optional wearable electronic sensors. Obtaining associative data may include receiving data from third-party applications. At least one of the user's associative or biometric data can be stored while the user is in the target state, for example, in a user profile, as a baseline or personalized target state. The personalized target state can be stored in the user profile along with any other supplementary data, such as state-related identification data and stimulus parameters. Specific stimulus patterns and their delivery parameters can be associated with maintaining or encouraging entry into the personalized target state. Continuing this approach, the user's association and / or biometric data can be collected again, periodically, or continuously, and used to determine whether the user is not in a baseline state. If it is determined that the user is not in a baseline state, a transcutaneous vibrational output designed to help the user achieve that state is generated and applied to a part of the user's body. The first or second transcutaneous vibrational output can be emitted using or via an electronic sensor.

[0232] When a predicted state is identified, the delivery of the therapeutic stimulus pattern can be triggered, interrupted, modified, decremented, or ramped up. The system can generate or trigger a transcutaneous vibrational output to be applied to a part of the user's body, such as using a wearable device, to help the user resolve or avoid at least one of the predicted states. As described herein, the transcutaneous vibrational output may have variable parameters, including perceived pitch, perceived beat, and perceived intensity, wherein each variable parameter can be dynamically modified based on, for example, predicted emotional state, physiological state, or associated data. In some embodiments, the transcutaneous vibrational output may have multiple segments, wherein each segment may have at least one of perceived pitch, perceived beat, and perceived intensity assigned to it, and wherein each of these variables may be different or the same between segments. Assigning perceived pitch can be done by increasing or decreasing at least one of the perceived pitch. Assigning perceived beat can be done by increasing or decreasing at least one of the perceived beat.

[0233] Triggering can occur sufficiently ahead of the actual onset of the predicted state, allowing the stimulus to avoid the predicted state. In an implementation, a notification can be triggered to the user upon determining the estimated state. The notification may include a suggestion to begin a treatment stimulation protocol, where the user can choose to manually begin the protocol. Responses to the stimulus (e.g., from sensors in the wearable), movement data, and / or manual / behavioral responses to the treatment stimulus (e.g., turning off the stimulus, increasing the intensity, changing settings) can be used as feedback to the system. Feedback can be used to identify the user's current physiological state and can be used to dynamically modify variable parameters. For example, any of the perceived pitch, perceived beat, and perceived intensity can be modified based on feedback during the application of a first transcutaneous vibrational output, for example, to result in the generation and application of a second transcutaneous vibrational output.

[0234] In some implementations, based on collected biometric data, user manual adjustments in response to stimuli applied to the user (for training the system and / or in real-time), the system can use any now- or later-known machine learning algorithms to define new stimulus patterns and / or update existing stimulus patterns for the user. In some implementations, the system can utilize machine learning using sensor data to predict estimated states and can elicit or trigger actions in response to new predicted states. Machine learning can utilize training data from the user, including sensor data, including point, trend, and longitudinal data related to known states. The algorithm can use the training data to learn the correlation between sensor data and states and be able to predict what the user's state is or what state is imminent. For example, sensor data used for training, validation, or use can include any sensor data type described herein, including GSR, heart rate, HF-HRV, HRV interval, other HRV parameters (LF, IBI, total power, LF / HF ratio, RMSSD, etc.), blood pressure, EEG, facial recognition, vocal cues, mobile device usage data, and more. Machine learning can be used to learn a user's baseline state and predict whether the state is changing or has already changed, and in an implementation, what the new state is, such as anxiety, drowsiness, wakefulness, etc. In an implementation, a therapeutic stimulation protocol can be triggered when the estimated state is predicted. The triggering can be sufficiently early so that the stimulus avoids causing the predicted state. In an implementation, when the estimated state is determined, a notification can be triggered to the user in that state. The notification may include a suggestion to start a therapeutic stimulation protocol. Biometric responses to therapeutic stimuli (e.g., from sensors in wearables), motion data, and / or manual / behavioral responses to therapeutic stimuli (e.g., turning off the stimulus, increasing the intensity, changing settings) can also be used as seeds for machine learning.

[0235] In one embodiment, the delivery of the stimulus described herein may be paired, coordinated, and / or synchronized with one or more other sensory stimuli 122, such as tactile, visual / visual, auditory, olfactory / odorous, gustatory, electrical, etc. For example, using a stimulation device, a first transcutaneous vibrational output may be generated to be applied to a part of the user's body. In some embodiments, the sensory stimulus 122 may be applied using a stimulation device or may be in a separate device. The stimulation device may include both a transducer and a sensory output device. In embodiments, the user's condition may be assessed. Based on the condition, one or more aspects of the stimulus and / or paired sensory stimuli may be selected or modified. In one embodiment, the sensory stimulus may be based on at least one of the user's assessed condition or a selected beat output pattern.

[0236] In any of the above embodiments, transcutaneous vibrational output may be applied in conjunction with a therapeutic modality (e.g., psychotherapy, physical therapy, mindfulness practice), wherein the modality is based on the subject's condition or a target state. In these embodiments, transcutaneous vibrational output may synergize with or enhance the therapeutic modality to achieve positive outcomes or increase engagement within the modality. Applications for guiding mindfulness may include devices that deliver programmed and / or evoked stimulation therapy and guide the user during delivery through a series of mindfulness cues (e.g., guided auditory sessions). The application may periodically prompt the user about the delivery of evoked stimulation therapy as part of the guidance. The application user interface may visually depict biometric changes in the user experience during guidance.

[0237] Medical treatments, such as prescription drug therapy, are widely used to treat a wide range of medical conditions and illnesses. Many prescription drugs produce side effects and adverse reactions in patients, which can lead to considerable discomfort and a poor quality of life. While such drugs may alleviate one condition, they may exacerbate others. For example, side effects of various medications may include sleep disturbances, loss of appetite or other eating disorders, depression, stress, high blood pressure, digestive problems, pain, cognitive impairment, etc. Similarly, other medical treatments (e.g., hospitalization, surgery, hospital procedures, psychotherapy) may also produce side effects such as stress, depression, sleep disturbances, high blood pressure, etc.

[0238] At least some of these side effects may be caused by an imbalance between the sympathetic and parasympathetic branches of the autonomic nervous system (ANS). Therefore, methods are needed to monitor and alleviate the side effects of medical treatments by stimulating the sympathetic and / or parasympathetic branches of the ANS.

[0239] In one or more embodiments, system 100 may address physiological and / or psychological aspects of a subject's function that may be attributable to medical treatment (e.g., drug side effects, the effects of psychotherapy, hospitalization procedures, etc.). This may include determining which aspects of the subject's function are affected by the applied medical treatment by collecting physiological data from the subject using sensing devices, analyzing and comparing the physiological data with the subject's baseline state, and applying vibrational energy to the subject at appropriate frequency, intensity, duration, etc.

[0240] In one or more embodiments and reference Figure 15 The subject's baseline status may correspond to the subject's status before the start of medical treatment (e.g., before starting drug treatment, before hospitalization, etc.) and may include physiological data (corresponding to measurable physiological attributes) collected from the subject before the start of medical treatment 1502. Such physiological data may include, for example, but not limited to, heart rate, blood metabolite concentration, respiratory rate, blood pressure, or other quantifiable data that may be related to potential side effects of medical treatment. For example, some stress indicators include a higher resting pulse rate, frequent rapid increases in heart rate; shallow breathing, reduced movement during threshold periods; hypertension; high heart rate with low heart rate variability (in the absence of physical activity); sudden increase in sweating (in the absence of physical activity), or combinations thereof. Therefore, if the potential side effect of medical treatment is stress, the baseline status may include physiological data such as resting pulse rate, heart rate, respiratory rate, blood pressure, etc. Medical treatment may be initiated 1504, and after the start of medical treatment, the system may continuously and / or periodically collect physiological data from the subject 1508 and analyze it to determine the presence of one or more indicators of stress 1510. If one or more data collected by the sensing device are related to a stress condition, vibrational energy 1512 at a beat frequency used to alleviate stress can be applied to the subject.

[0241] As an alternative and / or supplement, some side effects are acceptable during medical treatment, and / or the baseline may differ (i.e., they may be acceptable up to a certain level), and the user or medical practitioner may define the baseline status accordingly.

[0242] Subjects can be monitored to identify potential side effects or harmful effects of medical treatment during administration and / or at a predetermined time after completion of medical treatment. The indicators of side effects during medical treatment may differ from those after completion of medical treatment, and / or the baseline may differ.

[0243] In some embodiments, the delivery of the stimulus described herein may be administered in conjunction with a compound, such as a pharmaceutical compound, a psychoactive compound, an antidepressant, anxiolytic, a drug, a therapeutic agent, etc. In some embodiments, the stimulus may mitigate the negative side effects of the compound, for example, by reducing unease or anxiety associated with the compound and / or the treatment experience. In this embodiment, the stimulus device or associated device may interpret parameter changes attributable to the user's state of being attributable to the compound, and then apply the stimulus to enhance or amplify the benefits of the compound by mitigating its negative side effects and / or synergizing with or enhancing its beneficial or positive effects. In some embodiments, the administration of the compound and the stimulus may take place in a controlled session, such as a psychotherapy session. Reducing the side effects of certain medications, such as the unease often associated with many psychoactive drugs, may facilitate their use in the psychotherapy of certain conditions (e.g., PTSD or depression) and may enable patients to participate more effectively in treatment.

[0244] In practice, during a therapeutic session, a drug or other compound may be administered to the subject, wherein the drug is a psychoactive compound, a therapeutic agent, or one of some other herbal or pharmaceutical compounds or therapeutic agents. The subject may be monitored to determine whether the effects of the drug have a negative impact on the therapeutic session (e.g., anxiety, restlessness). Monitoring may be performed using sensors to generate biometric data of the subject, or it may be performed by another participant during the therapeutic session. The sensor may be part of a stimulation device or may be part of another device or environment. For example, a sensor may be used to determine HRV, which can be associated with anxiety. In another instance, the sensor may be a sound sensor that senses sound data such as shouting, crying, or increased pitch.

[0245] Once a negative side effect of the drug is identified, the stimulation device can be triggered to provide tactile stimulation to the subject during a treatment session, wherein the transcutaneous vibrational output and / or any fundamental variable parameter 1514 are selected to reduce the adverse or harmful effects of the drug, and in some embodiments, this can be based on the type of effect experienced. In cases where another participant is monitoring the subject's negative side effects, the stimulation device can be manually triggered to select and / or deliver the transcutaneous vibrational output. The transcutaneous vibrational output can be a combination of oscillations described herein (e.g., a perceived pitch or master oscillation at a first frequency and a perceived beat or modulated oscillation at a second frequency, which together form a beat output; a selected envelope defined by a fundamental tone; perceived pitch and perceived beat). In one embodiment, the beat and / or pitch can be selected based on the effect of the drug. In one embodiment, the perceived pitch and / or perceived beat can be modified based on the effect of the drug.

[0246] In addition to applying stimulation to alleviate the negative side effects of certain medications, sensory stimulation may also be applied to the subject. Sensory stimulation can be one or more of visual, olfactory, gustatory, tactile, or auditory stimulation, and can be selected based on the effects of the medication. Furthermore, treatment may be combined with one or more other devices used for treatment or measurement (e.g., blood pressure cuff, pulse oximeter, auditory stimulation, light stimulation, music).

[0247] In this embodiment and in any of the embodiments disclosed herein, parameters of the applied transcutaneous vibrational energy (e.g., frequency, intensity, duration, etc.) can be determined based on physiological data collected by the sensor device 118. Generally, rapid and high-intensity vibrations can lead to increased heart rate, respiration, blood pressure, and sweating, while reducing heart rate variability. On the other hand, slow, gentle, low-intensity vibrations can lead to decreased heart rate, respiration, blood pressure, and sweating, while increasing heart rate variability.

[0248] Furthermore, the parameter values ​​and examples in this disclosure are provided for illustrative purposes only and can be adjusted or tuned for the subject using feedback loops based on the subject's physiological responses and data, as described herein. Specifically, parameters can be personalized for the subject based on physiological data (e.g., heart rate, heart rate variability, blood pressure, respiration, perspiration, resting pulse rate, brain activity, etc.) collected by sensor device 118 and / or based on user feedback. Specifically, in various embodiments, the data collected by sensor device 118 can be used in feedback loops to initiate and / or control the application of stimulation to the subject via stimulation device 102. As a supplement and / or alternative, data collected by the sensor device to select and personalize the application of stimulation to the subject 114 can be based on the data collected by sensor device 118. For example, frequency range, stimulation pattern, number of stimulation applications, stimulation application duration, etc., can be personalized to the user.

[0249] Furthermore, the base frequency of the stimulus can be adjusted in real time based on the subject's response to the applied beat frequency. For example, if data collected by sensor device 118 indicates that the initial stimulus does not alleviate stress symptoms (e.g., the resting pulse rate does not decrease to a non-stress level), the applied frequency can be gradually increased until the desired effect is achieved. Alternatively and / or supplementarily, if data collected by sensor device 118 indicates that the stimulus is reducing the subject's stress (e.g., the resting pulse rate decreases slowly), the applied frequency can be gradually decreased to an off level.

[0250] In addition to controlling the beat frequency in real time based on data collected by sensor device 118, user feedback can also be used to control the application of stimuli (e.g., turn off, increase intensity, change settings, etc.).

[0251] In some implementations, the baseline status of the subject may also correspond to the status of an ordinary person with similar physical attributes to the subject undergoing medical treatment (e.g., same sex, weight, height, BMI, etc.). For example, some stress indicators include, but are not limited to, a resting pulse of approximately 60 beats per minute (bpm) for healthy men and greater than approximately 70 bpm for healthy women; frequent rapid increases in heart rate; shallow breathing at a rate greater than approximately 12 breaths per minute; reduced movement during threshold periods; blood pressure greater than 120 / 80 mmHg in healthy men (without physical activity); high heart rate with low heart rate variability (without physical activity); sudden and dramatic increase in sweating (without physical activity); or combinations thereof.

[0252] In implementations, external or auxiliary devices and services can be controlled based on the realization of the current or target state, such as realization determined by sensors, external data sources, or user input. Controlling the operation of third-party devices can be based on a predicted or actual state of the delivered stimulation therapy. For example, when a user has reached a state, a stimulation device can be triggered to deliver a stimulation mode and / or generate environmental adjustments, such as turning lights on / off, changing light color, changing room temperature, starting / interrupting aromatherapy, lowering / raising curtains, turning music on / off, triggering auxiliary stimulation devices in the mattress / pillow, etc. In another implementation, a vibrating massage chair can be triggered when a user reaches a state (e.g., more alert) after stimulation has been applied. In another implementation, red light can be irradiated at an increased frequency to help the user emerge from drowsiness when a user has reached a state where drowsiness has occurred. In another implementation, when a user has reached a state, at least one of content delivery settings or content filtering for applications and communications can be adjusted. Content filtering determines the type of content delivered to the user. The setting can be a do-not-disturb setting. In another implementation, when a user has reached a state, social media settings, such as do-not-disturb settings or content delivery settings, can be adjusted. In another implementation, when a user has reached a certain state, they may be prompted to perform a task. In any of the above instances, control operations and services may be initiated by the stimulating device or associated sensors or processors sending instructions or triggers to another device / server or system controller. Alternatively, other devices or servers may periodically check the stimulating device, associated sensors / processors, or remote locations from which they collect data and determine if a triggering event or data point has occurred. In implementations, the stimulating device may send data to remote servers or cloud locations, accessible to third-party devices or controllers, to trigger actions.

[0253] In the implementation scheme, based on the delivery of stimulation therapy, the system can control the operation of third-party devices to achieve a certain state. For example, when a calming transcutaneous vibration output is initiated, the system can instruct nearby lights to dim. Conversely, if awakening therapy is initiated, instructions can be sent to brighten the lights and raise the curtains.

[0254] In one implementation, another solution described herein is how to induce and track epigenetic changes as a result of employing the methods and apparatus described herein. Growing evidence suggests that epigenetic regulation of gene expression is associated with trauma exposure, can be involved in the pathophysiology and treatment response of PTSD patients, and that epigenetic regulation and modifications of the epigenome can be persistent and potentially inherited by subsequent generations. Some of this evidence relates to methylation and acetylation patterns of certain genes, which are associated with regulating the expression levels of different portions of these genes that are ultimately transcribed and translated into proteins. In some implementations and referenced... Figure 16According to this disclosure, applying therapeutic stimulation, either once, intermittently, or repeatedly over a period of time, to achieve a target state 1604 (e.g., mental presence, flow, optimal performance, relaxation, non-depression, etc.) can result in measurable epigenetic changes that cause or induce the following: state-, disease-, symptom-, trauma-, or stress-related regulation of certain proteins (e.g., stress hormones, receptors, receptor ligands, growth factors, etc.); methylation / acetylation / phosphorylation patterns of genes or histones; or the occurrence of regulation of reward-response genes or proteins (e.g., neurotransmitters, neurotransmitter receptors, ion channels, etc.), wherein regulation can be any of the following: increased levels, decreased levels, silence, etc. To assess the epigenetic effects of the stimulation, epigenetic markers can be measured before 1602 and after 1608 transcutaneous vibrational stimulation. The cause or trigger of epigenetic changes may be the therapeutic stimulus itself, the achievement of the target state and its associated physical manifestations (e.g., achieving a resonant frequency or resonant state, improved balance between the parasympathetic and sympathetic nervous systems, increased HRV, etc.), changes in the mechanosensitivity of receptors or receptor affinity, downstream effects of changes in the mechanosensitivity of receptors or receptor affinity, or some combination thereof. Where direct measurements of epigenetic changes as described herein (e.g., measuring the methylation or acetylation characteristics of certain genes before and after treatment, measuring the expression levels of reward-response proteins or stress-related proteins, etc.) are not available, certain surrogate measurements may be used to infer epigenetic changes. One surrogate could be stress indicators in communication such as social media posts, mobile device use, text, calls, etc., such as the presence, absence, or frequency of positive or negative words used, or tone / pitch / speed of speech related to life characteristics. Another surrogate could be a faster time to reach the target state after sustained use. Yet another surrogate could be a longer duration of stay in the target state. In the implementation plan, stimulation therapy targeting epigenetic changes may be delivered in conjunction with sensory stimulation, physical therapy / massage, and / or pharmacological therapy.

[0255] Supplemental Statements to this Disclosure

[0256] In some implementations, systems and methods for passively determining the upper and lower sensory thresholds may be described in the following items or elsewhere herein.

[0257] Item Group A

[0258] Item 1. A computer-implemented method for assisting a user in achieving a target state, the method comprising the steps of: establishing a sensory threshold by delivering a transcutaneous vibrational output including a perceived pitch, a perceived beat, and a perceived intensity to a part of the user's body; providing a user interface for the user to adjust the perceived intensity; and storing a final value of the perceived intensity, wherein the final value is the sensory threshold, after the user has completed the adjustment; determining the user's desired target state; and generating a first transcutaneous vibrational output to be applied to a part of the user's body to assist the user in achieving the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a first perceived intensity, wherein the first perceived intensity of the first transcutaneous vibrational output is at or within one standard deviation of the sensory threshold.

[0259] Item 2. The method of Item 1, wherein the adjustment is to increase the intensity of perception until it distracts the user.

[0260] Item 3. The method of Item 1, wherein the sensory threshold is the upper sensory threshold.

[0261] Item 4. The method of Item 1, wherein the adjustment is to reduce the perceived intensity until the user can hardly perceive it.

[0262] Item 5.1 method, wherein the sensory threshold is the lower limit sensory threshold.

[0263] Item 6.1's method, the method further comprising obtaining data on whether the user has achieved a desired target state; and if the user has not achieved the desired target state, generating a second transcutaneous vibration output to be applied to a part of the user's body to help the user achieve the desired target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a second perceived intensity, wherein the second perceived intensity is within one standard deviation of a sensory threshold.

[0264] Item 7.1's method, the method further comprising emitting the generated first transcutaneous vibration output and transcutaneous vibration output using an electronic transducer.

[0265] Item 8.1's method, the method further comprising providing a user interface for a user to select a target state.

[0266] The method of item 9.6, the method further comprising providing a user interface for inputting data about whether the user has achieved the desired target state.

[0267] The method in item 10.6, where the data is user input.

[0268] Item 11.6's method, wherein data is obtained from a sensor that measures the user's physiological parameters to determine whether the user has achieved the desired target state.

[0269] Item 12. The method of Item 11, wherein the user's physiological parameters are at least heart rate variability, heart rate, respiration or skin conductance response.

[0270] Item 13. The method of Item 1, the method further comprising multiplying a sinusoidal waveform envelope generated by a first sensed beat with a waveform generated by a first sensed pitch to generate a first transcutaneous vibration output.

[0271] Item 14. The method of Item 13, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0272] Item 15. The method of Item 1, wherein the first transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0273] Item 16. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including: a transducer adapted to emit a transcutaneous vibrational output; a processor in electronic communication with the user input device and the transducer, the processor being programmed to – (i) establish a sensory threshold by delivering a transcutaneous vibrational output including a perceived pitch, a perceived beat, and a perceived intensity to a part of the user's body; provide a user interface for adjusting the perceived intensity; and store a final value of the perceived intensity after the user has completed the adjustment, wherein the final value is the sensory threshold; (ii) receive input from the user input device of a desired target state from the user; and (iii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a first perceived intensity, wherein the first perceived intensity of the first transcutaneous vibrational output is at or within one standard deviation of the sensory threshold.

[0274] Item 17. The system of Item 16, wherein the processor is further programmed to: (i) receive data about whether the user has achieved the desired target state; and (ii) if the user has not achieved the desired target state, cause the transducer to generate a second transcutaneous vibration output to be applied to a part of the user's body to help the user achieve the desired target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a second perceived intensity, wherein the second perceived intensity is within one standard deviation of the sensory threshold.

[0275] The system of item 18.16, wherein the adjustment is to increase the intensity of perception until it distracts the user.

[0276] The system of item 19.16, wherein the sensory threshold is the upper sensory threshold.

[0277] The system of item 20.16, wherein the adjustment is to reduce the perceived intensity until the user can hardly detect it.

[0278] The system of item 21.16, wherein the sensory threshold is the lower limit sensory threshold.

[0279] The system of item 22.16, the system further comprising obtaining data on whether the user has achieved a desired target state; and if the user has not achieved the desired target state, generating a second transcutaneous vibration output to be applied to a part of the user's body to help the user achieve the desired target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a second perceived intensity, wherein the second perceived intensity is within one standard deviation of the sensory threshold.

[0280] The system of item 23.16, the system further comprising a first transcutaneous vibration output and a transcutaneous vibration output generated by an electronic transducer.

[0281] The system of item 24.16, wherein the input device includes a user interface for a user to select a target state.

[0282] The system of item 25.17, wherein the input device includes a user interface for the user to input data about whether the user has achieved the desired target state.

[0283] The system described in items 26 and 17, where the data is user input.

[0284] Item 27. The system of Item 17, wherein data is obtained from sensors that measure the user’s physiological parameters to determine whether the user has achieved the desired target state.

[0285] The system of item 28. Item 27, wherein the user’s physiological parameters are at least heart rate variability, heart rate, respiration or skin conductance response.

[0286] In some implementations, systems and methods for decremental and ascending transcutaneous vibration stimulation may be described in the following items or elsewhere herein.

[0287] Item group B

[0288] Item 29. A method comprising: determining a desired target state of a user; generating a first transcutaneous vibrational output to be applied to a portion of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a first perceived intensity, wherein one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity are at an upper limit; decreasing one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity to a lower limit over a first time period; and maintaining one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity at the lower limit over a second time period.

[0289] The method of Item 30.29, wherein reducing one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity to a lower limit value over a first time period comprises: reducing the first perceived pitch or the first perceived beat to a target frequency using a first deceleration rate; and when the first perceived pitch or the first perceived beat reaches the target frequency, modifying the first deceleration rate to a second deceleration rate, at which point reducing the first perceived pitch or the first perceived beat from the target frequency to the lower limit value.

[0290] The method of item 31.29, the method further comprising: decreasing one or more of a first perceived pitch, a first perceived beat, and a first perceived intensity to a second lower limit value over a third time period; and maintaining one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity at the second lower limit value during a fourth time period.

[0291] The method of item 32.31, wherein the decrease over the third time period is accomplished by using a second deceleration rate.

[0292] The method of item 33.29, the method further comprising: repeating the decreasing and holding steps until a minimum value is reached or at least one of the first transcutaneous vibration output is terminated.

[0293] The method of item 34.29, the method further comprising multiplying the envelope of a sinusoidal waveform generated by the first sense beat with the waveform generated by the first sense pitch to generate a first transcutaneous vibration output.

[0294] The method of item 35.34, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0295] The method of item 36.29, wherein the first transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0296] Item 37. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including: a transducer adapted to emit a transcutaneous vibrational output; a processor in electronic communication with the user input device and the transducer, the processor being programmed to – (i) receive input from the user input device of a desired target state of the user; (ii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a first perceived intensity, wherein one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity are at an upper limit value; (iii) cause the transducer to decrease one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity to a lower limit value over a first time period; and (iv) maintain one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity at the lower limit value during a second time period.

[0297] The system of item 38. Item 37, wherein the transducer causes one or more of a first sensed pitch, a first sensed beat, and a first sensed intensity to decrease to a target frequency over a first time period using a first deceleration rate; and when the first sensed pitch or the first sensed beat reaches the target frequency, the first deceleration rate is modified to a second deceleration rate, at which point the first sensed pitch or the first sensed beat decreases from the target frequency to a lower limit value.

[0298] The system of item 39. Item 37, wherein the processor is further programmed to: decrease one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity to a second lower limit value over a third time period; and maintain one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity at the second lower limit value during a fourth time period.

[0299] The system of item 40 and item 39, wherein the decrease over the third time period is accomplished by using a second deceleration rate.

[0300] The system of item 41.37, wherein the processor is further programmed to repeat the decreasing and holding steps until a minimum value is reached or the first transcutaneous vibration output terminates at least one of them.

[0301] Item 42. A method comprising: determining a desired target state of a user; generating a first transcutaneous vibrational output to be applied to a portion of the user's body to assist the user in achieving the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a first perceived intensity, wherein one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity are at a lower limit; ramping one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity to an upper limit over a first time period; and maintaining one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity at the upper limit over a second time period.

[0302] Item 43. The method of Item 42, wherein raising one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity to an upper limit value over a first time period comprises: raising the first perceived pitch or the first perceived beat to a target frequency using a first raising rate; and when the first perceived pitch or the first perceived beat reaches the target frequency, modifying the first raising rate to a second raising rate, at which point raising the first perceived pitch or the first perceived beat from the target frequency to an upper limit value.

[0303] Item 44. The method of Item 42, the method further comprising: ramping one or more of a first perceived pitch, a first perceived beat, and a first perceived intensity to a second upper limit value over a third time period; and maintaining one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity at the second upper limit value during a fourth time period.

[0304] The method of item 45.44, wherein the ascent over the third time period is accomplished by using a second ascent rate.

[0305] The method of item 46.42, the method further comprising: repeating the steps of ramping and holding until at least one of the maximum value is reached or the first transcutaneous vibration output terminates.

[0306] The method of item 47.42, the method further comprising multiplying the envelope of a sinusoidal waveform generated by the first sense beat with the waveform generated by the first sense pitch to generate a first transcutaneous vibration output.

[0307] The method of item 48.47, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0308] Item 49. The method of Item 42, wherein the first transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0309] Item 50. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including: a transducer adapted to emit a transcutaneous vibrational output; a processor in electronic communication with the user input device and the transducer, the processor being programmed to – (i) receive input from the user input device of a desired target state of the user; (ii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a first perceived intensity, wherein one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity are at a lower limit; (iii) cause the transducer to ramp one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity to an upper limit over a first time period; and (iv) maintain one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity at the upper limit during a second time period.

[0310] Item 51. The system of Item 50, wherein the transducer causes one or more of a first sensed pitch, a first sensed beat, and a first sensed intensity to ramp to a target frequency over a first time period using a first ramp rate; and when the first sensed pitch or the first sensed beat reaches the target frequency, the first ramp rate is modified to a second ramp rate, at which point the first sensed pitch or the first sensed beat ramps from the target frequency to an upper limit value.

[0311] Item 52. The system of Item 50, wherein the processor is further programmed to: cause one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity to ramp up to a second upper limit value over a third time period; and to maintain one or more of the first perceived pitch, the first perceived beat, and the first perceived intensity at the second upper limit value during a fourth time period.

[0312] The system of item 53.52, wherein the ramp is completed over a third time period by using a second ramp rate.

[0313] Item 54. The system of Item 50, wherein the processor is further programmed to repeat the ramp and hold steps until the maximum value is reached or the first transcutaneous vibration output terminates at least one of them.

[0314] In some implementations, systems and methods for controlling external devices based on state realization and / or target state realization may be described in the following items or otherwise herein.

[0315] Item group C

[0316] Item 55. A computer-implemented method for assisting a user in achieving a target state, the method comprising the steps of: determining a desired target state for the user; generating a first transcutaneous vibrational output to be applied to a part of the user's body to assist the user in achieving the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity; and generating an action to facilitate entry into the desired target state or a response to achieve at least one of the desired target state.

[0317] Item 56. The method of Item 55, the method further comprising determining whether the user has achieved the desired target state.

[0318] Item 57. The method of Item 55, wherein determining includes measuring the user's physiological parameters using physiological sensors.

[0319] The method of item 58 and item 57, wherein the user's physiological parameter is at least one of heart rate or heart rate variability.

[0320] The method in item 59 and item 57, wherein the user's physiological parameter is respiratory rate.

[0321] The methods in items 60 and 57, wherein the user's physiological parameter is the skin conductance response.

[0322] The method in item 61.55, wherein it is determined to be based on a third-party data source.

[0323] Item 62. The method of Item 61, wherein the third-party data source is at least one of health information applications, electronic health records, hospital data systems, social media post content, or communication content.

[0324] The method of item 63.55, wherein the action is to adjust the parameters of the environment or device.

[0325] Item 64. The method of Item 63, wherein adjusting parameters of the environment or device includes turning lights on / off, changing room temperature, lowering / raising curtains, turning music on / off, triggering an auxiliary stimulation device in a mattress / pillow / seat, triggering aromatherapy, or triggering at least one of a specific color.

[0326] Item 65. The method of Item 55, wherein the action is to adjust at least one of content delivery settings or content filtering for application and communication.

[0327] Item 66. The method of Item 65, wherein content filtering determines the type of content delivered to the user.

[0328] The method in item 67.55, where the action is to adjust social media settings.

[0329] The method in items 68 and 67, where Do Not Disturb settings are configured.

[0330] The method in item 69 and item 55, where the action is to prompt the user to perform a certain task.

[0331] The method of item 70.55, the method further comprising multiplying a sinusoidal waveform envelope generated by a first sensed beat with a waveform generated by a first sensed pitch to generate a first transcutaneous vibration output.

[0332] Item 71. The method of Item 70, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0333] Item 72. The method of Item 55, wherein the first transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency that differs from the first frequency by less than 10 Hz.

[0334] Item 73. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including a transducer adapted to emit a transcutaneous vibrational output; a processor in electronic communication with the user input device, the transducer, and an external data source or device, the processor being programmed to – (i) receive input of a desired target state from the user; (ii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity; (iii) determine, based on data obtained from the external data source or device, whether the user has achieved the desired target state; and (iv) generate an action to facilitate entry into the desired target state or a response to achieve at least one of the desired target state.

[0335] The system described in item 74.73, where the action is to prompt the user to perform a certain task.

[0336] The system of item 75. Item 73, wherein determining whether a user has achieved a desired target state includes measuring the user's physiological parameters using physiological sensors.

[0337] The system of item 76. Item 75, wherein the user’s physiological parameter is at least one of heart rate or heart rate variability.

[0338] The system described in items 77 and 75, in which the user's physiological parameter is respiratory rate.

[0339] The system described in items 78 and 75, in which the user's physiological parameter is the skin conductance response.

[0340] The system described in item 79.73, in which the determination of whether a user has achieved the desired target state is based on a third-party data source.

[0341] The system of items 80 and 79, wherein the third-party data source is at least one of health information applications, electronic health records, hospital data systems, social media post content, or communication content.

[0342] The system of item 81. item 73, wherein the action is to adjust the parameters of the environment or device.

[0343] Item 82. The system of Item 81, wherein adjusting parameters of the environment or device includes turning lights on / off, changing room temperature, lowering / raising curtains, turning music on / off, triggering auxiliary stimulation devices in a mattress / pillow / seat, triggering aromatherapy, or triggering at least one of a specific color.

[0344] The system of item 83. Item 73, wherein the action is to adjust at least one of content delivery settings or content filtering for application and communication.

[0345] Item 84. The system of Item 83, wherein content filtering determines the type of content delivered to the user.

[0346] The system in item 85 and item 73, where the action is to adjust social media settings.

[0347] Item 86. The system of Item 85, in which Do Not Disturb settings are configured.

[0348] In some implementations, systems and methods for generating auditory frequencies using perceived pitch and perceived beat may be described in the following items or elsewhere herein.

[0349] Item group D

[0350] Item 87. A method for assisting a subject to achieve a target state, the method comprising the steps of: obtaining input of the subject's target state; and generating an auditory output to deliver to the subject to assist the subject in achieving the target state, the auditory output having variable parameters including perceived pitch, perceived beat, and perceived intensity, wherein the step of generating the auditory output further comprises the step of: modifying the variable parameters to correspond to the target state.

[0351] The method of item 88.87, the method further comprising providing an interface for a user to modify variable parameters to correspond to a target state.

[0352] The method in item 89.87, wherein modifying variable parameters to correspond to the target state also includes adjusting the perceived pitch.

[0353] The methods in items 90 and 87, which modify variable parameters to correspond to the target state, also include adjusting the sensing beat.

[0354] The method in item 91 and item 87, wherein modifying variable parameters to correspond to the target state also includes adjusting the perception intensity.

[0355] The method of item 92.91, wherein the perceived intensity is based on the user's sensory threshold.

[0356] The methods in items 93 and 87, wherein the target state is selected from calm, focused, flow, presence, asleep, awake, relaxed, aroused, or euphoric.

[0357] The method of item 94.87, wherein the step of obtaining the target state input of the subject further includes obtaining the current state input of the subject.

[0358] The method of item 95.94, wherein the step of obtaining input of the subject's current status further includes collecting the subject's biometric data.

[0359] The method of item 96.95, wherein the step of collecting biometric data of a subject further includes collecting biometric data using a sensor.

[0360] The method of item 97.87, the method further comprising multiplying a sinusoidal waveform envelope generated by a first perceived beat with a waveform generated by a first perceived pitch to produce an auditory output.

[0361] The method of item 98.97, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0362] The method of item 99.87, wherein the auditory output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0363] Item 100. A method for assisting a subject to achieve a target state, the method comprising the steps of: generating a first auditory output to be delivered to the subject to assist the subject in achieving the target state, the auditory output having variable parameters including perceived pitch, perceived beat, and perceived intensity; and during the delivery of the first auditory output, changing at least one parameter to generate a second auditory output to be delivered to the subject to assist the subject in achieving the target state.

[0364] Item 101. The method of Item 100, the method further comprising providing an interface for a user to change at least one parameter.

[0365] Item 102. The method of Item 100, wherein changing at least one parameter further includes changing the perceived pitch.

[0366] Item 103. The method of Item 100, wherein changing at least one parameter further includes changing the perceived beat.

[0367] Item 104. The method of Item 100, wherein changing at least one parameter further includes changing the perceived intensity.

[0368] The method of item 105.Item 104, wherein the perceived intensity is based on the user's sensory threshold.

[0369] The method in item 106 and item 100, wherein the target state is selected from calm, focused, flow, presence, asleep, awake, relaxed, aroused, or euphoric.

[0370] Item 107. The method of Item 100, the method further comprising multiplying a sinusoidal waveform envelope generated by a sensed beat and a waveform generated by a sensed pitch to produce a first auditory output.

[0371] The method of item 108.107, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0372] Item 109. The method of Item 100, wherein a first auditory output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency that differs from the first frequency by less than 10 Hz.

[0373] Item 110. A method for generating an auditory output signal for a user to achieve a target state using a stimulation device, the auditory output signal including a perceived pitch and a perceived beat, the method comprising the steps of: adjusting the perceived pitch and the perceived beat based on the target state; and generating an auditory output signal including the perceived pitch and the perceived beat for the user by selecting at least two frequency waveforms and combining them.

[0374] Item 111. The method of Item 110, the method further comprising providing an interface for a user to adjust the perceived pitch and perceived beat.

[0375] Item 112. The method of Item 110, wherein changing at least one parameter further includes increasing or decreasing at least one of the perceived pitch.

[0376] Item 113. The method of Item 110, wherein changing at least one parameter further includes increasing or decreasing at least one of the perceived beats.

[0377] Item 114. The method of Item 110, wherein changing at least one parameter further includes changing the perceived intensity.

[0378] The method in item 115.110, wherein the target state is selected from calm, focused, flow, presence, asleep, awake, relaxed, aroused or euphoric.

[0379] Item 116. A method for generating an auditory output signal for a user to achieve a target state using a stimulation device, the auditory output signal comprising a first segment and a second segment, the method comprising the steps of: assigning a perceived pitch and a perceived beat to the first segment; assigning a perceived pitch and a perceived beat to the second segment; and generating an auditory output signal, wherein the auditory output signal comprises the first segment and the second segment.

[0380] Item 117. The method of Item 116, the method further comprising providing a stimulation device for delivering an auditory output signal to a subject.

[0381] Item 118. The method of Item 116, the method further comprising providing an interface for a user to assign perceived pitch and perceived beat to a first segment and a second segment.

[0382] The method of item 119.116, the method further comprising allocating the perceived pitch by increasing or decreasing at least one of the perceived pitch.

[0383] The method of item 120 and item 116, the method further comprising allocating a sensing beat by increasing or decreasing at least one of the sensing beats.

[0384] The methods in items 121 and 116, wherein the target state is selected from calm, focused, flow, presence, asleep, awake, relaxed, aroused, or euphoric.

[0385] The method of item 122.116, the method further comprising multiplying a sinusoidal waveform envelope generated by a sensed beat and a waveform generated by a sensed pitch to generate an auditory output signal.

[0386] Item 123. The method of Item 122, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0387] Item 124. The method of Item 116, wherein the auditory output signal is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0388] Item 125. A method for assisting a subject to achieve a target state, the method comprising the steps of: generating a first auditory output to be delivered to the subject to assist the subject in achieving the target state, the auditory output having variable parameters including perceived pitch, perceived beat, and perceived intensity; and during the delivery of the first auditory output, changing at least one parameter to generate a second transcutaneous vibrational output to be delivered to the subject to assist the subject in achieving the target state.

[0389] The methods in items 126 and 125, wherein the target state is selected from calm, focused, flow, presence, asleep, awake, relaxed, aroused, or euphoric.

[0390] Item 127. The method of Item 125, the method further comprising multiplying a sinusoidal waveform envelope generated by a sensed beat and a waveform generated by a sensed pitch to produce a first auditory output.

[0391] Item 128a. The method of Item 127, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0392] Item 128b. The method of Item 127, wherein a first auditory output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0393] In some implementations, systems that utilize user feedback on a state to apply stimulation therapy in order to achieve a target state may be described in the following items or elsewhere herein.

[0394] Item group E

[0395] Item 129. A computer-implemented method for assisting a user in achieving a target state, the method comprising the steps of: determining a desired target state for the user; generating a first transcutaneous vibration output to be applied to a part of the user's body to assist the user in achieving the desired target state, the first transcutaneous vibration output including a first perceived pitch, a first perceived beat, and a perceived intensity; obtaining user input regarding whether the user has achieved the desired target state; and if the user has not achieved the desired target state, generating a second transcutaneous vibration output to be applied to a part of the user's body to assist the user in achieving the desired target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0396] The computer-implemented method of Items 130 and 129, the method further comprising emitting the generated first transcutaneous vibration output using an electronic transducer.

[0397] Item 131. The computer-implemented method of Item 130, the method further comprising emitting a second transcutaneous vibration output generated by an electronic transducer.

[0398] Item 132. Item 129 The computer-implemented method wherein a first transdermal vibration output is emitted via an electronic transducer.

[0399] Item 133. Item 129 The computer-implemented method wherein the perceived intensity is based on the user’s sensory threshold.

[0400] The computer-implemented method of item 134.129, the method further comprising providing a user interface to a user to select a target state.

[0401] The computer-implemented method of item 135.129, the method further comprising providing a user interface for inputting data about whether the user has achieved a desired target state.

[0402] The computer-implemented method of item 136.129, the method further comprising multiplying a sinusoidal waveform envelope generated by a first sensed beat with a waveform generated by a first sensed pitch to generate a first transcutaneous vibration output.

[0403] Item 137. The computer-implemented method of Item 136, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0404] The computer-implemented method of items 138 and 129, wherein a first transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0405] Item 139. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including: a transducer adapted to emit a transcutaneous vibrational output; a processor in electronic communication with the user input device and the transducer, the processor being programmed to – (i) receive input from the user input device of a desired target state of the user; (ii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity; (iii) receive data from the user input device regarding whether the user has achieved the desired target state; (iv) if the user has not achieved the desired target state, cause the transducer to generate a second transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the second transcutaneous vibrational output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0406] The system of items 140 and 139, wherein the first transcutaneous vibration output generated is emitted by an electronic transducer.

[0407] Item 141. The system of Item 140, wherein the generated second transcutaneous vibration output is emitted by an electronic transducer.

[0408] The system described in items 142 and 139, wherein the transcutaneous vibration output is emitted via an electronic transducer.

[0409] The system of item 143 and item 139, wherein the perceived intensity is based on the user’s sensory threshold.

[0410] The system of item 144.139, wherein the user input device includes a user interface for the user to select a target state.

[0411] The system of item 145. Item 139, wherein the user input device includes a user interface for the user to input data about whether the user has achieved a desired target state.

[0412] In some implementations, a system that utilizes sensor feedback of state to apply stimulation therapy to achieve a target state and determines whether the target state has been achieved from external devices and systems may be described in the following items or elsewhere herein.

[0413] Item group F

[0414] Item 146. A computer-implemented method for assisting a user in achieving a target state, the method comprising the steps of: determining a desired target state for the user; generating a first transcutaneous vibration output to be applied to a part of the user's body to assist the user in achieving the desired target state, the first transcutaneous vibration output including a first perceived pitch, a first perceived beat, and a perceived intensity; determining whether the user has achieved the desired target state; and if the user has not achieved the desired target state, generating a second transcutaneous vibration output to be applied to a part of the user's body to assist the user in achieving the desired target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0415] The computer-implemented method of item 147.146, the method further comprising emitting the generated first transcutaneous vibration output using an electronic transducer.

[0416] The computer-implemented method of item 148.146, the method further comprising emitting a second transcutaneous vibration output generated by an electronic transducer.

[0417] Item 149. Item 146 of the computer-implemented method, wherein the perceived intensity is based on the user’s sensory threshold.

[0418] The computer-implemented method of items 150 and 146, the method further comprising providing a user interface to a user to select a target state.

[0419] Item 151. Item 146 The computer-implemented method, wherein determining includes measuring a user's physiological parameters using physiological sensors.

[0420] Item 152. The computer-implemented method of Item 151, wherein the user's physiological parameters are at least one of heart rate and heart rate variability.

[0421] Item 153. Item 151's computer-implemented method, wherein the user's physiological parameter is respiratory rate.

[0422] Item 154. The computer-implemented method of Item 151, wherein the user's physiological parameter is the skin conductance response.

[0423] The computer-implemented methods of items 155 and 146, wherein the determination is based on a third-party data source.

[0424] Item 156. The computer-implemented method of Item 155, wherein the third-party data source is at least one of a health information application, electronic health record, hospital data system, social media post content, or communication content.

[0425] The computer-implemented method of item 157.146, the method further comprising multiplying a sinusoidal waveform envelope generated by a first sensed beat with a waveform generated by a first sensed pitch to generate a first transcutaneous vibration output.

[0426] Item 158. The computer-implemented method of Item 157, wherein the multiplicative combination conforms to the relation:

[0427] [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0428] The computer-implemented method of Items 159 and 146, wherein a first transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0429] Item 160. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including: a transducer adapted to emit a transcutaneous vibrational output; and a physiological sensor for sensing physiological parameters of the user; and a processor in electronic communication with the user input device, the transducer, and the physiological sensor, the processor being programmed to – (i) receive input of a desired target state from the user; (ii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity; (iii) determine, based on the user's physiological parameters, whether the user has achieved the desired target state; and (iv) if the user has not achieved the desired target state, cause the transducer to generate a second transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the second transcutaneous vibrational output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0430] The system of item 161 and item 160, wherein the perceived intensity is based on the user’s sensory threshold.

[0431] Item 162. The system of Item 160, wherein the user’s physiological parameters are at least one of heart rate variability, heart rate, respiratory rate or skin conductance response.

[0432] Item 163. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including a transducer adapted to emit a transcutaneous vibrational output; and a processor electronically communicating with the user input device, the transducer, and an external data source or device, the processor being programmed to – (i) receive input of a desired target state from the user; (ii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity; (iii) determine, based on data obtained from the external data source or device, whether the user has achieved the desired target state; and (iv) if the user has not achieved the desired target state, cause the transducer to generate a second transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the second transcutaneous vibrational output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0433] The system of item 164. Item 163, wherein the external data source is at least one of health information applications, electronic health records, hospital data systems, social media post content or communication content.

[0434] Item 165. Item 164: A system in which the processor determines a user's mood from the content of a social media post.

[0435] Item 166. A computer-implemented method for assisting a user in achieving a target state, the method comprising the steps of: determining a desired target state for the user; generating a first transcutaneous vibration output to be applied to a part of the user's body to assist the user in achieving the desired target state, the first transcutaneous vibration output including a first perceived pitch, a first perceived beat, and a perceived intensity; determining whether the user has achieved the desired target state; and if the user has achieved the desired target state, performing at least one of the following: interrupting the first transcutaneous vibration output, or generating a second transcutaneous vibration output to be applied to a part of the user's body to assist the user in maintaining the desired target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0436] Item 167. The computer-implemented method of Item 166, the method further comprising multiplying a sinusoidal waveform envelope generated by a first sensed beat with a waveform generated by a first sensed pitch to generate a first percutaneous vibration output.

[0437] Item 168. The computer-implemented method of Item 167, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0438] Item 169. The computer-implemented method of Item 166, wherein a first transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency that differs from the first frequency by less than 10 Hz.

[0439] Item 170. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including: a transducer adapted to emit a transcutaneous vibrational output; and a physiological sensor for sensing physiological parameters of the user; and a processor in electronic communication with the user input device, the transducer, and the physiological sensor, the processor being programmed to – (i) receive input of a desired target state from the user; (ii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity; (iii) determine, based on the user's physiological parameters, whether the user has achieved the desired target state; and (iv) if the user has achieved the desired target state, cause the transducer to perform at least one of: interrupting the first transcutaneous vibrational output, or generating a second transcutaneous vibrational output to be applied to a part of the user's body to help the user maintain the desired target state, the second transcutaneous vibrational output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0440] Item 171. A system for altering a user's mood, the system comprising: a user input device; a stimulation device including a transducer adapted to emit a transcutaneous vibrational output; and a processor electronically communicating with the user input device, the transducer, and an external data source or device, the processor being programmed to – (i) receive input of a desired target state from the user; (ii) cause the transducer to generate a first transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the first transcutaneous vibrational output including a first perceived pitch, a first perceived beat, and a perceived intensity; (iii) determine, based on data obtained from the external data source or device, whether the user has achieved the desired target state; and (iv) if the user has not achieved the desired target state, cause the transducer to generate a second transcutaneous vibrational output to be applied to a part of the user's body to help the user achieve the desired target state, the second transcutaneous vibrational output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0441] In some implementations, systems and methods for passive or subjective treatment calibration may be described in the following items or elsewhere herein.

[0442] Item group G

[0443] Item 172. A computer-implemented method for assisting a user in achieving a target state, the method comprising the steps of: determining a desired target state for the user; selecting a first transcutaneous vibration output using a processor to apply to a part of the user's body to assist the user in achieving the desired target state, the first transcutaneous vibration having parameters including a first perceived pitch, a first perceived beat, and a perceived intensity; emitting the first transcutaneous vibration output using an electronic transducer in contact with said part of the user's body; obtaining data regarding whether the user has achieved the desired target state; determining the validity of the first transcutaneous vibration output based on the data regarding whether the user has achieved the desired target state; and selecting a second transcutaneous vibration output using the processor to apply to the user. A part of the body, to help the user achieve a desired target state, the second transcutaneous vibration output has parameters including a second perceived pitch, a second perceived beat, and a perceived intensity; the second transcutaneous vibration output is emitted by an electronic transducer in contact with said part of the user's body; using a processor, the validity of the second transcutaneous vibration output is determined based on data regarding whether the user has achieved the desired target state; and using the processor, based on the validity of the first and second transcutaneous vibration outputs, at least one of a first, second, or third transcutaneous vibration output is selected to be applied to a part of the user's body to help the user achieve the desired target state, the second transcutaneous vibration output having parameters including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0444] Item 173. The computer-implemented method of Item 172, wherein data regarding whether a user has achieved a desired target state is obtained from a physiological sensor.

[0445] Item 174. The computer-implemented method of Item 172, wherein data regarding whether a user has achieved a desired target state is obtained from user input.

[0446] The computer-implemented method of item 175.172, the method further comprising multiplying a sinusoidal waveform envelope generated by a first sensed beat with a waveform generated by a first sensed pitch to generate a first transcutaneous vibration output.

[0447] Item 176. The computer-implemented method of Item 175, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0448] Item 177. The computer-implemented method of Item 172, wherein a first transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0449] Item 178. A computer-implemented method for assisting a user in achieving a target state, the method comprising the steps of: determining a desired target state for the user; selecting, using a processor, a plurality of transcutaneous vibration outputs to be applied to a part of the user's body to assist the user in achieving the desired target state, the plurality of transcutaneous vibration outputs having parameters including a first perceived pitch, a first perceived beat, and a perceived intensity; emitting each of the plurality of transcutaneous vibration outputs in a corresponding session using an electronic transducer in contact with said part of the user's body; obtaining data regarding whether the user has achieved the desired target state in each corresponding session; determining the validity of each of the plurality of transcutaneous vibration outputs based on the data regarding whether the user has achieved the desired target state; and, using the processor, selecting a transcutaneous vibration output effective for the user's desired target state based on the validity of the plurality of transcutaneous vibration outputs.

[0450] Item 179. Item 178 The computer-implemented method wherein data regarding whether a user has achieved a desired target state is obtained from a physiological sensor.

[0451] Items 180 and 178 describe computer-implemented methods in which data regarding whether a user has achieved a desired target state is obtained from user input.

[0452] Item 181. The computer-implemented method of Item 180, the method further comprising transmitting transcutaneous vibration outputs effective for a desired target state of a user to a database, the database including other transcutaneous vibration outputs determined to be effective for the desired target state.

[0453] Item 182. The computer-implemented method of Item 181, the method further comprising accessing a database of other effective transcutaneous vibration outputs and selecting one of the other effective transcutaneous vibration outputs for emission by an electronic transducer.

[0454] The computer-implemented method of item 183.178, the method further comprising multiplying a sinusoidal waveform envelope generated by a first sensed beat with a waveform generated by a first sensed pitch to generate at least one of a plurality of transcutaneous vibration outputs.

[0455] Item 184. The computer-implemented method of Item 183, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0456] The computer-implemented method of Items 185 and 178, wherein a plurality of transcutaneous vibration outputs are generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0457] In some implementations, systems and methods for personalized passive calibration may be described in the following items or elsewhere herein.

[0458] Item group H

[0459] Item 186. A system for delivering treatment to a user, the system comprising: a stimulation device including a transducer adapted to emit a transcutaneous vibrational output; a physiological sensor periodically measuring data of at least one physiological parameter of the user; and a processor electronically communicating with a mobile device and the stimulation device, the processor being programmed to – (i) determine a baseline state of the user based on periodic measurements from the physiological sensor of at least one physiological parameter of the individual; (ii) determine a deviation from the baseline based on data from the physiological sensor of at least one physiological parameter of the user; (iii) determine a transcutaneous vibrational output based on the deviation to be applied to a portion of the user's body to achieve a target state; and (iv) transmit the determined transcutaneous vibrational output to the stimulation device, wherein based on the transmitted determined transcutaneous vibrational output, the transducer generates a transcutaneous vibrational output to be applied to a portion of the user's body to assist the user in achieving the target state, the transcutaneous vibrational output including perceived pitch, perceived beat, and perceived intensity.

[0460] The system of item 187. Item 186, wherein the processor is further programmed to determine the user’s baseline state by prompting the user to input the user’s mood data into the mobile device.

[0461] The system of item 188 and item 186, wherein at least one physiological parameter of the user is movement.

[0462] The system of Item 189. Item 186, wherein the processor is further programmed based on at least one physiological parameter of the user to determine whether the user has achieved a target state; and if the user has not achieved the target state, the transducer generates a second transcutaneous vibration output to be applied to a part of the user's body to help the user achieve the target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0463] The system of items 190 and 186, wherein the processor is further programmed to determine the user’s baseline state based on associated data received from the mobile device.

[0464] Item 191. Item 190's system, wherein the associated data indicates the usage of mobile devices.

[0465] The system of item 192.Item 190, wherein the associated data is the keystrokes input to the mobile device.

[0466] The system described in items 193 and 190, where associated data indicates the user's mood.

[0467] The system in items 194 and 193, where the user's mood is negative.

[0468] The system in items 195 and 194, where the user's negative mood is one of frustration, anxiety, or anger.

[0469] The system in items 196 and 193, where the user's mood is positive.

[0470] The system in items 197 and 193, where the user's mood is distracted.

[0471] The system in items 198 and 186, where the associated data is the content of social media posts.

[0472] Item 199. Item 198's system, in which the processor determines whether the content of a social media post indicates a user's mood.

[0473] The system in items 200 and 199 has a negative user mood.

[0474] The system of item 201 and item 200, in which the user's negative mood is one of frustration, anxiety or anger.

[0475] The system in items 202 and 199 has a positive user mood.

[0476] The system in items 203 and 199, where the user's mood is distracted.

[0477] Item 204. A computer-implemented method for delivering vibration therapy to an individual to alter the individual's physiological or mental state, the method comprising: (i) periodically measuring at least one physiological parameter of the individual using sensors of a wearable device having a transducer configured to deliver a transcutaneous vibration output to a portion of the individual's body, the sensors generating data of at least one physiological parameter of the individual; (ii) transmitting the data of at least one physiological parameter of the individual to a computer processor; (iii) obtaining associated data of the individual, the associated data indicating the individual's mood; (iv) transmitting the associated data of the individual to the computer processor; (v) utilizing the computer processor, based on... (a) data of at least one physiological parameter of the individual and (b) associated data indicating the individual's mood to determine the user's baseline state; (vi) based on data of at least one physiological parameter of the individual or associated data indicating the individual's mood to determine the deviation from the baseline; (vii) based on the deviation, determining a transcutaneous vibrational output to be applied to a part of the individual's body to achieve the target state; and (viii) transmitting the determined transcutaneous vibrational output to a stimulation device, wherein based on the transmitted determined transcutaneous vibrational output, a transducer generates a transcutaneous vibrational output to be applied to a part of the individual's body to help the individual achieve the target state, the transcutaneous vibrational output including perceived pitch, perceived beat and perceived intensity.

[0478] Item 205. The computer-implemented method of Item 204, the method further comprising determining a user’s baseline state by prompting the user to input the user’s mood data into a mobile device.

[0479] Item 206. Item 204's computer-implemented method, wherein at least one physiological parameter of the user is movement.

[0480] Item 207. The computer-implemented method of Item 204, the method further comprising determining, based on the user's physiological parameters, whether the user has achieved a target state; and if the user has not achieved the target state, causing a transducer to generate a second transcutaneous vibration output to be applied to a part of the user's body to help the user achieve the target state, the second transcutaneous vibration output including a second perceived pitch, a second perceived beat, and a perceived intensity.

[0481] Item 208. The computer-implemented method of Item 204, the method further comprising determining a user’s baseline state based on associated data received from a mobile device.

[0482] Item 209. The computer-implemented method of Item 208, wherein associated data indicates the usage of a mobile device.

[0483] Item 210. Item 208 The computer-implemented method, wherein the associated data is keystrokes input into a mobile device.

[0484] Item 211. Item 208: A computer-implemented method wherein associated data indicates the user's mood.

[0485] Item 212. Item 211's computer-implemented method, wherein the user's mood is negative.

[0486] Item 213. The computer-implemented method of Item 212, wherein the user’s negative mood is one of frustration, anxiety or anger.

[0487] Item 214. The computer-implemented method of Item 211, wherein the user's mood is positive.

[0488] Item 215. Item 211's computer-implemented method, wherein the user's mood is distracted.

[0489] Item 216. Item 204, a computer-implemented method wherein the associated data is the content of a social media post.

[0490] Item 217. A computer-implemented method of Item 216, wherein a processor determines whether the content of a social media post indicates a user's mood.

[0491] Item 218. The computer-implemented method of Item 217, wherein the user's mood is negative.

[0492] Item 219. The computer-implemented method of Item 218, wherein the user’s negative mood is one of frustration, anxiety or anger.

[0493] Items 220 and 217 describe computer-implemented methods in which the user's mood is positive.

[0494] Item 221. Item 217 The computer-implemented method, wherein the user's mood is distracted.

[0495] Item 222. Item 204, a computer-implemented method, the method further comprising multiplying a sinusoidal waveform envelope generated by a first sensed beat with a waveform generated by a first sensed pitch to generate a transcutaneous vibration output.

[0496] Item 223. The computer-implemented method of Item 222, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0497] Item 224. Item 204's computer-implemented method, wherein the transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency less than 10 Hz different from the first frequency.

[0498] In some implementations, systems and methods for predicting and resolving emotional episodes may be described in the following items or elsewhere herein.

[0499] Item Group I

[0500] Item 225. A method for altering a user's mood, the method comprising the steps of: electronically sensing at least one of the user's physiological state or associated data; predicting the onset of an emotional state based on at least one of the user's physiological state or associated data; and generating a transcutaneous vibrational output to be applied to a part of the user's body to help the subject resolve or avoid at least one of the predicted emotional states, the transcutaneous vibrational output having variable parameters including perceived pitch, perceived beat, and perceived intensity, wherein the step of generating the transcutaneous vibrational output further comprises the step of dynamically modifying at least one variable parameter.

[0501] Item 226. The method of Item 225, wherein the step of dynamically modifying at least one variable parameter is based on a predicted emotional state or at least one physiological state or related data.

[0502] The method of Item 227. Item 225, wherein the step of generating a transcutaneous vibrational output to be applied to a part of a user’s body to help the subject resolve or avoid at least one of a predicted emotional state, further includes generating a first transcutaneous vibrational output.

[0503] The method of Item 228 and Item 227, wherein the step of dynamically modifying at least one variable parameter generates a second transcutaneous vibrational output to be applied to a part of the user’s body to help the subject resolve or avoid at least one of the predicted emotional states, wherein the second transcutaneous vibrational output is generated.

[0504] Item 229. Item 225 method, wherein a wearable device is used to generate transdermal vibration output.

[0505] The method of Items 230 and 229, wherein the wearable device includes a physiological sensor to perform the step of sensing the user's physiological state.

[0506] The method of item 231.229, wherein the wearable device includes a physiological sensor to perform the step of sensing the user's physiological state.

[0507] The method of item 232.229, wherein the step of sensing associated data of a user further includes sensing data from at least one device separate from the wearable device.

[0508] Item 233. The method of Item 232, wherein at least one device separate from the wearable device is selected from smartphones, fitness trackers, smartwatches, smart speakers, smart glasses, connected vehicles, and smart headphones.

[0509] The method of Items 234 and 225, wherein the step of sensing the user’s associated data further includes sensing data from at least one of a social media platform, a navigation application, a calendar application, or a project management application.

[0510] Item 235. The method of Item 225, wherein the emotional state is selected from anger, fear, annoyance, sadness, anxiety, indifference, frustration and distraction.

[0511] The method of item 236.225, the method further comprising multiplying a sinusoidal waveform envelope generated by a sensed beat and a waveform generated by a sensed pitch to generate a transcutaneous vibration output.

[0512] The method of item 237.Item 236, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0513] The method of Item 238.Item 225, wherein the transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency that differs from the first frequency by less than 10 Hz.

[0514] Item 239. A system for altering a user's mood, the system comprising: a stimulation device including a transducer adapted to emit a tactile transcutaneous vibrational output; a physiological sensor for sensing physiological parameters of the user; and a processor in electronic communication with the transducer and the physiological sensor, the processor being programmed to – (i) predict the onset of an emotional state based on the user's physiological state, (ii) generate a transcutaneous vibrational output pattern having variable parameters including perceived pitch, perceived beat, and perceived intensity, (iii) cause the transducer to emit a transcutaneous vibrational output based on the transcutaneous vibrational output pattern, and (iv) modify the pattern based on the user's predicted emotional or physiological state.

[0515] Systems of items 240 and 239, wherein the stimulation device is wearable.

[0516] The system of item 241 and item 239, wherein the processor is further programmed to modify the mode by changing the perceived pitch.

[0517] The system of item 242 and item 239, wherein the processor is further programmed to modify the mode by changing the perceptual beat.

[0518] The system of item 243 and item 239, wherein the processor is further programmed to modify the pattern by changing the intensity of perception.

[0519] The system of items 244 and 239, in which emotional states are selected from anger, fear, annoyance, sadness, anxiety, indifference, frustration, and distraction.

[0520] The systems of items 245 and 239, wherein transcutaneous vibration output is generated by multiplying a sinusoidal waveform envelope based on perceived beat and a waveform based on perceived pitch.

[0521] The system of item 246.245, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0522] Item 247. A method for altering a user's mood, the method comprising the steps of: electronically sensing the user's physiological state or collecting the user's associated data; determining an emotional state based on the user's physiological or associated data; generating a first transcutaneous vibrational output to be applied to a part of the subject's body to help the subject resolve or avoid at least one of the determined emotional states, the first transcutaneous vibrational output having variable parameters including perceived pitch, perceived beat, and perceived intensity; and changing at least one variable parameter during the application of the first transcutaneous vibrational output to a part of the subject's body to generate a second transcutaneous vibrational output to be applied to a part of the subject's body to help the subject resolve or avoid the determined emotional state.

[0523] The method of item 248. Item 247, wherein changing at least one variable parameter to generate a second transcutaneous vibration output is based on at least one of the user's physiological data or the user's associated data.

[0524] The method of Items 249 and 247, wherein a wearable device is used to generate transdermal vibration output.

[0525] The method of Items 250 and 249, wherein the wearable device includes a physiological sensor to perform the step of sensing the user's physiological state.

[0526] The method of item 251.249, wherein the step of collecting the user’s associated data further includes collecting data from at least one device separate from the wearable device.

[0527] Item 252. The method of Item 251, wherein at least one device separate from the wearable device is selected from smartphones, fitness trackers, smartwatches, smart speakers, smart glasses, connected vehicles, and smart headphones.

[0528] The method of item 253.247, wherein the step of collecting user-related data further includes collecting data from social media platforms, navigation apps, calendar apps or project management apps.

[0529] The method of item 254.Item 253, the method further includes analyzing the content of social media posts.

[0530] The method in item 255 and item 254, wherein the step of analyzing the content of social media posts determines whether the content indicates the user's mood.

[0531] The method in item 256 and item 255, where the user's mood is negative.

[0532] The methods in items 257 and 256, where the user's negative mood is one of frustration, anxiety, or anger.

[0533] The method in item 258 and item 255, where the user's mood is positive.

[0534] The method in item 259 and item 255, where the user's mood is distraction.

[0535] The methods in items 260 and 247, wherein the step of collecting associated data includes collecting data on user movement.

[0536] Item 261. The method of Item 260, wherein the step of collecting mobile data further includes collecting mobile data from the user's mobile device.

[0537] The method of item 262 and item 247, wherein the step of collecting associated data further includes collecting user location data.

[0538] Item 263. The method of Item 262, the method further comprising determining whether the user's location indicates the user's mood.

[0539] The method in item 264 and item 263, where the user's mood is negative.

[0540] The methods in items 265 and 264, where the user's negative mood is one of frustration, anxiety, or anger.

[0541] The method in item 266 and item 263, where the user's mood is positive.

[0542] The method in item 267 and item 263, where the user's mood is distraction.

[0543] The method of item 268 and item 247, wherein changing at least one parameter further includes changing the perceived pitch.

[0544] The methods of Items 269 and 247, wherein changing at least one parameter further includes changing the perceived beat.

[0545] The methods of Items 270 and 247, wherein changing at least one parameter further includes changing the perceived intensity.

[0546] The method of item 271 and item 270, wherein the perceived intensity is based on the user’s sensory threshold.

[0547] The methods in items 272 and 247, wherein the emotions are selected from anger, fear, annoyance, sadness, anxiety, indifference, frustration, and distraction.

[0548] The method of Items 273 and 247, wherein a transcutaneous vibration output is generated by multiplying a sinusoidal waveform envelope based on a perceived beat and a waveform based on a perceived pitch.

[0549] Item 274. The method of Item 273, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0550] The method of Item 275 and Item 247, wherein the transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency that differs from the first frequency by less than 10 Hz.

[0551] Item 276. A method for generating a tactile transcutaneous vibrational output signal for a stimulation device, the stimulation device being used to apply the tactile transcutaneous vibrational output to a subject to resolve or avoid an emotional state of the subject, the tactile transcutaneous vibrational output signal comprising a first segment and a second segment, the method comprising the steps of: electronically sensing physiological data of a user or collecting associated data of a user; determining an emotional state based on the user's physiological or associated data; assigning perceived pitch and perceived beat to a first segment based on the user's determined emotional state; assigning perceived pitch and perceived beat to a second segment based on the user's emotional state; and generating a tactile transcutaneous vibrational output signal, wherein the tactile transcutaneous vibrational output signal comprises a first segment and a second segment.

[0552] The method of item 277.276, the method further comprising providing a stimulation device for applying a tactile transcutaneous vibration output signal to a subject.

[0553] The method of item 278. Item 276, the method further comprising allocating the perceived pitch by increasing or decreasing at least one of the perceived pitch.

[0554] The method of item 279. Item 276, the method further comprising allocating a sensing beat by increasing or decreasing at least one of the sensing beats.

[0555] The methods in items 280 and 276, where the emotions are selected from anger, fear, annoyance, sadness, anxiety, indifference, frustration, and distraction.

[0556] The methods in items 281 and 276, wherein the target state is selected from calm, focused, flow, presence, asleep, awake, relaxed, aroused, or euphoric.

[0557] The method of Item 282.276, the method further comprising multiplying a sinusoidal waveform envelope generated by a sensed beat and a waveform generated by a sensed pitch to generate a tactile transcutaneous vibration output.

[0558] Item 283. The method of Item 282, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0559] The method of Items 284 and 276, wherein the tactile transcutaneous vibration output is generated in part by a first oscillation at a first frequency and a second oscillation at a second frequency that differs from the first frequency by less than 10 Hz.

[0560] In some implementations, systems and methods for applying stimulation therapy to achieve a target state may be described in the following items or additionally herein, wherein the state is X and the frequency is Y.

[0561] Item group J

[0562] Item 285. A computer-implemented method for treating a condition associated with low arousal of the autonomic nervous system, the method comprising the steps of: providing a therapeutic stimulation device including a transducer configured to emit a transcutaneous vibrational output to a body part of a subject; using a computer processor, obtaining input of the subject's low arousal condition; using the computer processor, obtaining input of the subject's sensory threshold for the transcutaneous vibrational output; using the computer processor and based on the input of the subject's low arousal condition, selecting a stimulation pattern for the transcutaneous vibrational output to be emitted by the transducer, the stimulation pattern including perceived pitch, perceived beat, and perceived intensity; and using the computer processor to cause the transducer to generate the transcutaneous vibrational output in the selected pattern at or above the sensory threshold for the subject's sensory threshold for the transcutaneous vibrational output.

[0563] The method of Item 286.285, wherein a sensory threshold is determined by one of a calibration procedure, by collecting active data through a survey question, and by collecting passive data through monitoring the use of mobile devices and applications.

[0564] Item 287. The method of Item 285, wherein the stimulation pattern is generated in part by a first oscillation at a first frequency in the range of 40-500 Hz and a second oscillation at a second frequency that differs from the first frequency by 0.1 Hz or greater.

[0565] The method of Item 288 and Item 285, wherein the stimulation pattern is generated in part by a first oscillation at a first frequency in the range of 40-500 Hz and a second oscillation at a second frequency in the range of 0.1-20 Hz.

[0566] The method of item 289 and item 288, wherein the perceived pitch is equal to or greater than 10 Hz and the perceived beat is equal to or greater than 0.05 Hz.

[0567] The methods in items 290 and 289, wherein the sensory threshold is within two standard deviations above the subject's sensory threshold.

[0568] The methods in items 291 and 290, where low arousal symptoms are depression.

[0569] The methods of Items 292 and 288, wherein the perceived pitch is equal to or greater than 40 Hz and the perceived beat is equal to or greater than 0.1 Hz.

[0570] The method of item 293.Item 292, wherein the sensory threshold is within two standard deviations above the sensory threshold of the subject.

[0571] The methods of items 294 and 293, wherein the low arousal symptom is at least one of fatigue, narcolepsy, excessive daytime sleepiness, or chronic fatigue syndrome.

[0572] The methods of items 295 and 288, wherein the perceived pitch is equal to or greater than 20 Hz and the perceived beat is equal to or greater than 0.05 Hz.

[0573] The method of item 296 and item 295, wherein the sensory threshold is within two standard deviations above the subject's sensory threshold.

[0574] The methods in items 297 and 296, in which low-level arousal symptoms include constipation.

[0575] The method of item 298 and item 288, wherein the perceived pitch is equal to or greater than 30 Hz and the perceived beat is equal to or greater than 0.01 Hz.

[0576] The methods in items 299 and 298, wherein the sensory threshold is within one standard deviation of the subject's sensory threshold.

[0577] The methods in items 300 and 299, wherein the low arousal condition is at least one of catatonia, attention deficit disorder, or insulin insensitivity.

[0578] The method of item 301 and item 288, wherein the perceived pitch is equal to or greater than 20 Hz and the perceived beat is equal to or greater than 0.001 Hz.

[0579] Item 302. The method of Item 301, wherein the sensory threshold is within two standard deviations above the subject's sensory threshold.

[0580] The method of item 303 and item 302, wherein the low-arousal symptom is at least one of hypotension or familial autonomic dysfunction.

[0581] The method of item 304 and item 285, the method further comprising multiplying a sinusoidal waveform envelope generated by a sensed beat and a waveform generated by a sensed pitch to generate a first transcutaneous vibration output.

[0582] The method of item 305.Item 304, wherein the multiplicative combination conforms to the relation: [sin(2.0*π*frequency_perception_pitch*t)]*[sin(π*frequency_perception_beat*t)].

[0583] The method of item 306 and item 287, the method further comprising increasing a first frequency from its initial value until it reaches an upper limit threshold level.

[0584] The method of item 307.306, the method further comprising increasing a first frequency from an upper threshold level to a second threshold level.

[0585] The method of item 308.307, the method further comprising increasing the first frequency from a second upper threshold level to a third threshold level.

[0586] Item 309. A system for treating a subject’s low arousal symptoms, the system comprising: a user interface; a stimulation device including a transducer adapted to emit a transcutaneous vibrational output; a processor in electronic communication with the user interface and the transducer, the processor receiving input of a subject’s low arousal symptoms from the user interface and programming it to: (i) establish a subject sensory threshold for the transcutaneous vibrational output; (ii) select a stimulation pattern for the transcutaneous vibrational output to be emitted by the transducer based on the subject’s low arousal symptoms input, the stimulation pattern including perceived pitch, perceived beat, and perceived intensity; and (iii) cause the transducer to generate the transcutaneous vibrational output in the selected pattern at or above the subject sensory threshold for the transcutaneous vibrational output.

[0587] The system of Items 310 and 309, wherein a sensory threshold is determined by one of a calibration procedure, by collecting active data through survey questions, and by collecting passive data through monitoring mobile device and application usage.

[0588] The system of Item 311. Item 309, wherein the stimulation pattern is generated in part by a first oscillation at a first frequency in the range of 40-500 Hz and a second oscillation at a second frequency that differs from the first frequency by 0.1 Hz or more.

[0589] The system of Item 312 and Item 309, wherein the stimulation pattern is generated in part by a first oscillation at a first frequency in the range of 40-500 Hz and a second oscillation at a second frequency in the range of 0.1-20 Hz.

[0590] The system of item 313.Item 312, wherein the perceived pitch is equal to or greater than 10 Hz and the perceived beat is equal to or greater than 0.05 Hz.

[0591] Item 314. The system of Item 313, wherein the sensory threshold is within two standard deviations above the sensory threshold of the subject.

[0592] The system of items 315 and 314, in which low arousal symptoms are depression.

[0593] The system of item 316. Item 312, wherein the perceived pitch is equal to or greater than 40 Hz and the perceived beat is equal to or greater than 0.1 Hz.

[0594] The system of item 317. Item 316, wherein the sensory threshold is within two standard deviations above the sensory threshold of the subject.

[0595] The system of item 318 and item 317, wherein the low arousal symptom is at least one of fatigue, narcolepsy, excessive daytime sleepiness or chronic fatigue syndrome.

[0596] The system of item 319. Item 312, wherein the perceived pitch is equal to or greater than 20 Hz and the perceived beat is equal to or greater than 0.05 Hz.

[0597] The systems in items 320 and 319, wherein the sensory threshold is within two standard deviations above the subject's sensory threshold.

[0598] The system of item 321 and item 320, in which low-level arousal symptoms include constipation.

[0599] The system of item 322.Item 312, wherein the perceived pitch is equal to or greater than 30 Hz and the perceived beat is equal to or greater than 0.01 Hz.

[0600] Item 323. Item 322's system, wherein...

Claims

1. A system for treating a sleep disorder in a subject, said system include: A stimulation device, the stimulation device comprising: A transducer suitable for emitting transcutaneous vibration output; Physiological sensors that generate physiological data from subjects; and A processor that communicates electronically with transducers and physiological sensors, the processor receiving and programming physiological data from the subject to: The transducer emits a stimulus, wherein the stimulus includes a transcutaneous vibration output having parameters including perceived pitch, perceived beat and intensity, wherein the transcutaneous vibration output is generated by multiplicatively combining the sine wave envelope generated by the perceived beat with the waveform generated by the perceived pitch. Based on physiological data, determine whether the subject is in a pre-sleep state or a sleep state; and Based on determining that the subject is in at least one of a pre-sleep state or a sleep state, the transcutaneous vibration output is altered. The alterations include at least one of the following: (i) decreasing the frequency of perceived pitch, (ii) increasing the interval of perceived beat, or (iii) decreasing the intensity of transcutaneous vibration output.

2. The system of claim 1, wherein the processor is further programmed to turn off the stimulation device based on determining that the subject is in a sleep state.

3. The system of claim 1, wherein reducing the frequency of perceived pitch further includes reducing the frequency of perceived pitch to a first reduced frequency and maintaining the first reduced frequency for a first selected time period.

4. The system of claim 3, wherein the processor is programmed to reduce the first reduction frequency to a second reduction frequency and maintain the second reduction frequency for a second selected time period.

5. The system of claim 1, wherein increasing the interval of the sensing beat further includes increasing the interval of the sensing beat to a first increasing interval and maintaining the first increasing interval for a first selected time period.

6. The system of claim 5, wherein the processor is further programmed to increase the first increment interval to a second increment interval and maintain the second increment interval for a second selected time period.

7. The system of claim 1, wherein reducing the intensity further includes reducing the intensity to a first reduced intensity and maintaining the first reduced intensity for a selected first time period.

8. The system of claim 7, wherein the processor is further programmed to reduce the first reduction intensity to a second reduction intensity and maintain the second reduction intensity for a selected second time period.

9. A system for treating insomnia or sleep disorder in humans using a therapeutic stimulation device, said stimulation device comprising: A transducer suitable for emitting a transcutaneous vibration output, the transcutaneous vibration output having variable parameters including perceived pitch, perceived beat and perceived intensity; and A processor that communicates electronically with the transducer receives input of the subject's target state and processes it in a programmed manner: Select a therapeutic stimulation mode, wherein the therapeutic stimulation mode comprises two or more oscillations with different frequencies, wherein: The first oscillation of the two or more oscillations exhibits a first frequency with an initial value in the range of 1 to 100 Hz. The second oscillation of the two or more oscillations exhibits a second frequency that initially differs from the first frequency by 0.0001 to 1 Hz, and The two or more oscillations together form a beat output; and A transducer emits a beat output as a vibration corresponding to a selected therapeutic stimulation pattern, wherein emitting the beat output includes: The first oscillation begins at the upper threshold frequency; The first oscillation decreases to the lower threshold frequency over the first time period; and During the second time period, the first oscillation is kept at the lower threshold frequency.

10. The system of claim 9, wherein reducing the first oscillation to the lower threshold frequency over a first time period further comprises: The first oscillation is reduced to the target frequency using a first deceleration rate; and When the first oscillation reaches the target frequency, the first deceleration rate is reduced to the second deceleration rate, at which point the first oscillation is reduced from the target frequency to the lower threshold frequency.

11. The system of claim 10, wherein the target frequency is about 100 Hz, and the lower threshold frequency is about 40 Hz, about 33 Hz, about 30 Hz, or about 1 Hz.

12. The system of claim 9, wherein emitting the beat output further comprises: The second oscillation begins at the first threshold frequency; The second oscillation is reduced to the second threshold frequency; and The second oscillation is maintained at the second threshold frequency.

13. The system of claim 9, wherein the initial value of the first frequency is about 100 Hz, about 40 Hz, about 33 Hz, about 30 Hz, or about 1 Hz.

14. The system of claim 9, wherein the second time period is at least 5 minutes.

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