Delivery of stochastic vibrotactile stimulation to improve sleep

Abstract

A system utilizes stochastic vibrotactile stimulation ("SV'S") to influence a user's autonomic nervous system by way of an SYS device that comprises a processor, operatively coupled to an SYS signal generator, operatively coupled to an emitter. The processor has a controller operatively coupled to it that controls the intensity of the SYS signal. The device may comprise sensor(s) operatively coupled to the processor. Components of the device may be enclosed in housing(s).

Description

DELIVERY OF STOCHASTIC VIBROTACTILE STIMULATION TO IMPROVE SLEEPCROSS REFERENCE TO RELATED APPLICATION

[0001] This application is a PCT application which claims the benefits of priority under the applicable US and PCT laws, rules, and regulations, of US provisional application USSN 63 / 625,740, filed 26 January 2024, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND

[0002] The autonomic nervous system (“ANS”), which is principally composed of the vagus and splanchnic nerves and ganglia, regulates a human body’s unconscious organ functions in the head, thorax, and gut. When the autonomic nervous system is out of balance, the body fails to react with sufficient sensitivity or in a timely manner to peripheral nervous system reports of deficiencies or toxicities present for uptake at proprioceptors. This peripheral autonomic neuropathy (“PAN”) is the earliest stage of advanced autonomic neuropathy and orthostatic dysfunction, deleteriously characterized by poor cardiac and cerebral perfusion, presenting as lightheadedness, dizziness, brain fog, cognitive and memory difficulties, sleep dysfunction, tension and migraine headache disorders and cranial sensory dysfunction.

[0003] It is known that potential neurological behavior disorders should be considered for differential diagnosis against a primary function breakdown in sleep. Notwithstanding the etiological ambiguity of PAN as potentially a contributor to and / or symptom of sleep dysfunction (e.g. due to the impracticality of direct measurement of autonomic tone with non- invasive sensors) the effectiveness of parasympathetic proprioception promotion in bringing about improvements in measurable metrics (e.g. heart rate variability, respiratory variability, pupillary hippus, and galvanic skin response) that are used to characterize PAN is more significant than conclusive semantic classification of proprioception promotion as a primarily prophylactic or therapeutic mechanism.

[0004] KR 102331184B1 (Lee) discloses a device for inducing sleep based on an optimal sleep cycle, stated to comprise: a ballistocardiogram sensor measuring the ballistocardiogram of a user; a vibrator applying vibration stimulation to the user; and a processor that monitors a sleepstate of a user based on the measured ballistocardiogram and induces a sleep cycle of the user to coincide with a pre-stored optimal sleep cycle using the vibrator.

[0005] US 11,648,413 (Kim) discloses a method and apparatus for simulating the vagus nerve, stated to include: a magnetic field generation unit generating a magnetic field in a form of pulse, which stimulates a preset area including the vagus nerve of a user by an electric current applied to a coil, and stated to be useful to enhance sleep quality, relieve stress, stabilize the heart rate and respiration.

[0006] “Study design and rationale for a randomized controlled trial to assess effectiveness of stochastic vibrotactile mattress stimulation versus standard non-oscillating crib mattress for treating hospitalized opioid-exposed newborns” (Bloch- Salisbury) discloses a specially- constructed SVS crib mattress stated to deliver gentle vibrations (30-60 Hz, 12 m RMS surface displacement) at 3 hour intervals, wherein the mattress contains a mechanical actuator that vibrates a soundboard embedded in the foam, and the stimulation is driven by a low voltage electric current from a stimulus controller.

[0007] There is a need to link stochastic vibrotacticle stimulation (“SVS”) technology with the potential to influence sleep and several conditions where the balance of the autonomic nervous system is disturbed. As a non-limiting example, stress may lead to issues with sleep and may also impact the quality of sleep. Applicants describe herein a system comprising a method and / or device to deliver SVS to a body.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order that the embodiments may be better understood, embodiments of the system comprising a method and / or device to deliver SVS to a body will now be described by way of examples. These embodiments are not to limit the scope of the claims as other embodiments of the system will become apparent to one having ordinary skill in the art upon reading the instant description. Non-limiting examples of the embodiments of the invention are shown in figures wherein:

[0009] Fig. 1 shows a schematic of a system utilizing an SVS device (100) with a user.

[0010] Figs. 2 and 3 show examples of suitable circuit boards for use with processor (200) and SVS signal generator (300).

[0011] Fig. 4 depicts the distribution of the lowest characteristic structural mode for the enclosure housing (600) the emitter (400).

[0012] Fig. 5 shows an example of a suitable housing (600), in a perspective view from a vantage point above.

[0013] Fig. 5a shows a perspective view, from a vantage point below, of the example of a suitable housing (600) in Fig. 5.

[0014] Fig. 5b shows a front view of the example of a suitable housing (600) in Fig. 5.

[0015] Fig. 5c shows a side view of the example of a suitable housing (600) in Fig. 5.

[0016] Fig. 5d shows a top view of the example of a suitable housing (600) in Fig. 5.DETAILED DESCRIPTION

[0017] Applicants describe herein a system comprising a method and / or device to deliver SVS to a body, such system including a system and method for influencing (and optionally assessing) autonomic tone via enhanced parasympathetic proprioception for improved health and lifestyle benefits, including improved sleep. Without being bound by theory, it is believed that the SVS described herein may be able to improve the balance of the autonomic nervous system, which in turn, may reduce the sympathetic system in favor of the parasympathetic nervous system and impact the more ventral part of the vagus nerve and influence several biologic factors, including heart rate variability (“HRV”).

[0018] In an embodiment, the system utilizes SVS for the influence of a user’s autonomic nervous system by way of an SVS device (100) that comprises a processor (200), operatively coupled to an SVS signal generator (300), operatively coupled to an emitter (400). The processor (200) will have a controller (250) operatively coupled to it, that controls the intensity of the SVS signal. The device (100) may further comprise one or more sensors (500) operatively coupled to the processor (200). Various components of the device (100) may be enclosed in one or more housings (600). Fig. 1 is schematic generally illustrating the system. As shown in Fig.1, a housing (600) may contain SVS device (100) and components processor (200), SVS signal generator (300), an emitter (400), and optional sensors (500), and a controller (250) which is wirelessly coupled to the processor (200). In Fig. 1, the housing (600) is placed under a user’s mattress that the user may lay on, and the emitter (400) may emit an SVS signal, providing stochastic vibrotactile stimulation to the user, and the controller (250) is a smart phone. The skilled person will appreciate that software will be used to instruct and execute the steps and tasks described herein which by their nature lend themselves to be so performed.

[0019] The processor (200) may comprise a processor or microprocessor which may be comprised within a circuit board or a chip or microchip within or associated with a circuit board. Examples of suitable circuit boards are shown in Figs. 2 and 3. Processor (200) may be comprised within a motherboard, and will operate to control the SVS device (100) and its components. The processor (200) will have a controller (250) that a user or another may use to provide direction to the processor (200); the controller (250) may be wired or wirelessly coupled to the processor (200).

[0020] In an embodiment, controller (250) is a mechanical control, such as a rotary dial, knob, sliding bar, switch, or the like, that is capable of providing direction to the processor. Such direction may be to increase, decrease, maintain, start, pause, or stop the SVS signal. In another embodiment, controller (250) is comprised within an app, which may be loaded onto a smart device or computer.

[0021] The SVS signal generator (300) may comprise a processor or microprocessor which may be comprised within a circuit board or a chip or microchip within or associated with a circuit board. Examples of suitable circuit boards are shown in Figs. 2 and 3. SVS signal generator (300) may be comprised within a motherboard, and will generate the signal to be delivered to a user via an emitter (400). SVS signal generator (300) may be comprised within the same circuit board as processor (200) or may be comprised on a separate circuit board.

[0022] The emitter (400) may comprise a device that conveys the SVS signal from the SVS signal generator (300) to a user of SVS device (100). Emitter (400) is preferably placed so that the user and the emitter (400) are separated by a substrate, e.g. mattress, and the signal is conveyed to the user through the substrate. In an embodiment, the emitter (400) delivers random or pseudo-random vibrations to the user’s body, without touching the skin or body of the user.Emitter (400) does not require direct contact with the user’s body (therefore not requiring an engaging element such as a gel to aide in conduction of the signal, like those used with many conventional ultrasound devices), and will preferably be placed under the user’s mattress, and will deliver the SVS signal through the substrate, e.g. mattress. It is preferred that the emitter (400) is placed outside of the mattress itself, and not within the mattress. Placement within the mattress may lead to discomfort for the user, inability for the emitter (400) to be portable for use wherever the user may sleep without having to transport the entire mattress, and / or difficulty providing maintenance to the emitter (400) if needed due to lack of accessibility. The intensity of the signal emitted may be modulated to account for the thickness of the mattress and any additional substrates, e.g. sheets, mattress pads, bed wetting covers, and egg-shell foam layers.

[0023] In some embodiments, various types of emitters may be utilized to stimulate the user. Non-limiting examples of these may include: vibrotactile, vibroacoustic, electromagnetic, electrogenic, ultrasonic, magnetohydrodynamic, preferably vibrotactile, vibroacoustic, or ultrasonic. For example, vibrotactile emitters may interact with the user’s autonomic nervous system balancing it in favor of the parasympathetic subsystem over the sympathetic system. This vibro-acoustic stimulation may lead to improved physical and mental well-being, stress reduction, reduced pain sensation, improved sleep, muscle relaxation, enhanced mood, and cognitive benefits. In another example, electromagnetic and ultrasonic stimulation may help to reach both superficial and deeper muscles with the right amount of heat to reduce pain / spasm. In still another example, the electrogenic stimulation of muscles may prevent or minimize muscle atrophy.

[0024] In an embodiment, the emitter (400) may comprise a loudspeaker. The skilled person will appreciate that the physical characteristics of the loudspeaker, including excursion of the cone (how far the top can move during excitation), comer frequency (the naturally comfortable frequency of the loudspeaker), and Qts (a measurement of how efficiently the driver moves at low frequencies), may be manipulated to produce an SVS signal that delivers low-amplitude, stochastic (randomized) vibrations to the skin, preferably in the range of about 60dB to about 70dB. In an embodiment, the SVS signal generator (300) may comprise a signal generator that is fed into a smart amplifier, which can filter the signal into a low-frequency stimulation. In an embodiment, Qts may preferably be maintained at about 0.707. Enclosures, including a housing (600) and substrates between the emitter (400) and the user, and even the user’s body weight(which may compress a mattress to different degrees) are expected to modify the alignment of the loudspeaker, and thus, must be accounted for when attempting to achieve an effective Qts.

[0025] Fig. 4 depicts the distribution of the lowest characteristic structural mode for the enclosure housing (600) the emitter (400). Based on both finite element modeling and validation via measurement in free space with a laser interferometer (Keyence LB-11), the lowest structural mode at 137 Hz provides that the functional range of the emitter does not excite undesired or standing modes within the enclosure (600). This provides that the targeted therapy is effective for users without restrictions in weight or height, as well as maintaining functionality across differing densities of mattresses. In an embodiment, the cut-off frequency of the SVS signal may be about 118 Hz.

[0026] The SVS signal will preferably provide mechanical or substantially mechanical excitation to the user’s ANS, rather than chemical, electrical, or electromagnetic excitation. Chemical excitation is typically delivered via medicines, which may carry negative side effects. Electrical excitation and electromagnetic excitation alone may not provide sufficient stimulation to the user to achieve the desired results without being delivered at a level that also carry with it negative side effects. It is desired that the signal affects the ANS, but does not directly affect brain waves or other parts of the nervous system that are biologically proximate to the brain and its function.

[0027] The SVS signal may be manifest to the user in sound and / or vibration generated by the emitter, and its intensity may be modulated by adjusting the crest factor and / or amplitude of the signal. The intensity needed to effect the desired benefit, e.g. improved sleep quality, may be at a degree that the user does or does not hear the sound, and / or does or does not feel the vibration. Importantly, the intensity should be at the level that produces the desired effect, regardless of the user’s ability to appreciate the intensity through hearing and / or feeling the signal. In some embodiments, the intensity may be adjusted by the user; in other embodiments, it may be provided by the emitter (400) using pre-programmed settings; in yet other embodiments, it may be provided by the emitter (400) as (or after) the system collects (or has collected) data about the user from static input about the user provided by the user prior to user of the system, and / or from dynamic input about the user being gathered by sensors (500) during use of the system.

[0028] In some embodiments, it is preferred that the SVS signal induce vibration in at least the torso of the user, preferably an area of the user greater than the torso, also preferably amajority of the user’s body. In some embodiments, the targeted range of vibration is an average stimulus of about 12 to about 18 microns RMS across the user’s whole bodies' surface area, which may correspond to a desirable intensity of stimulus to encourage surfactant mixing of acetylcholine along the spinal column of the user.

[0029] In an embodiment, the SVS device (100) may further comprise one or more sensors (500) operatively coupled to processor (200). In this embodiment, processor (200) may receive one or more inputs regarding a user and / or the user’s environment from one or more sensors (500). The processor (200) may then collect, store, and / or process the data received from the one or more sensors (500), locally, e.g. on the processor (200), or remotely, e.g. via the cloud, an app on a smart device or computer. The processor (200) may then respond to the user by directing the SVS signal generator (300) to, e.g. increase, decrease, or maintain the intensity of the signal.The processor (200) may also store the user’s data for further analysis or provide recommendations for future SVS signal modifications, based on the user’s data, or use the data for external computation along with additional information collected from other sensors native to a user’s smart device.

[0030] The sensors (500) may be used to gather input on one or more biological parameters that may be useful for influencing the human autonomic nervous system. Sensors (500) may be used to collect data from a user and the user’s environment. Non-limiting examples of sensors (500) may include: accelerometer, barometric pressure sensors, Ag / AgCl electrode, EEG sensor, MRI / fMRI, microphones, SpO2 sensors, motion detectors, IR microbolometers, and olfactory sensors. The sensors (500) maybe provided in a wearable smart device, e.g. phone, watch, ring, wrist band, provided that the sensors (500) are operatively coupled to the processor (200).

[0031] One or more housings (600) may enclose various components of SVS device (100). In Figs. 5 to 5d, a suitable housing (600) that encloses processor (200), SVS signal generator (300), and emitter (400), is shown. The skilled person will appreciate that the housing (600) will be designed taking into consideration such factors as how many components of SVS device (100) are being enclosed, the comfort of the user when the housing (600) is placed, e.g. under the user’s mattress, providing a slim substantially flat vertical profile, providing adequate protection for the emitter (400), access points including those for replacing or charging batteries, supplying power, connecting to data ports, and performing maintenance. In embodiments where thehousing (600) encloses the processor (200), SVS signal generator (300), and emitter (400), acrylonitrile butadiene styrene (or ABS) or other suitable material known in the art, may be molded to protect the circuitry and / or emitter (400), e.g. loudspeaker, while also providing backing in order that the SVS signal from the loudspeaker is directed in the appropriate direction, namely towards the user. The skilled person will appreciate that the design of housing (600) will take into account meeting the needs of structural strength of the apparatus without unduly negatively affecting the delivery of the SVS signal.

[0032] A system according to the present invention was tested, where the subjects, who reported no particular sleep disorders but did indicate a desire to improve their sleep quality, were 4 males (ages 48, 56, 65 and 67 years) and 6 females (ages 20, 21, 23, 23, 63 and 64 years). To minimize variation in daily activities over the week (including weekends), data was collected from the subjects for 7 consecutive days without the use of the system, and then for the next 7 consecutive weekdays using the system. The data collected compares within the same people, 7 of the same days of the week without the device versus 7 of the same days of the week, with the device. To minimize the subjectivity of the data, only the more objective data which is least influenced by the subject, was collected. The 5 objective data points collected were disturbances / hour, total REM sleep (in minutes), total SWS deep sleep (in minutes), total restorative sleep (REM sleep plus SWS sleep, in minutes), and HRV (heart rate variability, in milliseconds). To minimize the effect of disturbances and unnatural sleep environment, e.g. that which may be caused by a subject wearing removably adhesive leads affixed to their head and / or body, the data was collected with a WHOOP device (wrist band), a wearable for sleep known have a high correlation with systems used in sleep labs (e.g. polysomnography).

[0033] During the first week of testing, the subjects were instructed to wear the WHOOP wrist band as they slept overnight, and the test administrator collected the data via the WHOOP app. During the second week of testing, the subjects were instructed wear the WHOOP wrist band as they slept overnight, and further, they were provided with an SVS device (100) according to the present invention, and instructed to place it under their mattress and to dial up the intensity of the signal to a level that they were just able to hear the sound of the signal and / or feel the vibration of the signal, and then reduce the setting of the intensity by one measure, so that they no longer heard or felt the signal, and the test administrator collected the data via the WHOOP app.

[0034] Outcome: The data collected was then analyzed. Use of the SVS device (100) as compared to not using the SVS device (100) resulted in: (1) Disturbances / hour were reduced by 8%; (2) REM sleep minutes increased by 21%; (3) SWS sleep minutes increased by 22%; (4) total restorative sleep increased by 22%$; and (5) HRV improved 7.4%.

[0035] Conclusion: It is noted that disturbed sleep deleteriously interferes with a person experiencing the benefits of REM, SWS, and total restorative sleep. REM sleep is important for "brain rest" and allows the brain to store data / memories, improving cognition and memory.SWS sleep is important to the physical recovery of the body. With better / more SWS sleep the body is able to take on more physical activity the next day. Restorative sleep is a metric used as a sleep efficacy measure. HRV is an important measure for fitness, especially cardiovascular fitness. It also can be a measure of stress and / or relaxation. Given that the subject experienced improvement in these factors with the use of SVS device (100) as compared to sleep without using it, we conclude that SVS device (100) is consistent in improving the reduction of the sleep disturbances, the quality of sleep, and / or an improved HRV.

[0036] By delivering SVS signals to a user, the system of the present invention may be useful to provide health and lifestyle benefits to the user via several modes.

[0037] (1) Neurophysiological Modulation - SVS introduces low-amplitude, stochastic (randomized) vibrations to the skin, which are believed to stimulate mechanoreceptors such as Pacinian corpuscles and Merkel cells. These receptors relay signals to the central nervous system (CNS), potentially modulating neural activity in regions associated with arousal and relaxation. By influencing afferent sensory input, delivering SVS signals to a user may reduce hyperarousal or restlessness, which are common barriers to sleep onset and maintenance.

[0038] (2) Entraining the Nervous System - The random nature of the SVS signal may help regulate neural circuits through a phenomenon known as stochastic resonance. This process enhances the signal-to-noise ratio in the nervous system, making it easier for weak neural signals to be detected and processed. This improved signal clarity may promote synchronization of neural oscillations, including those associated with relaxation and slow-wave sleep SWS.

[0039] (3) Autonomic Nervous System (ANS) Regulation - SVS signals have been suggested to influence the balance of the autonomic nervous system by reducing sympathetic nervous system activity (associated with stress and alertness) and enhancing parasympathetic activity (associatedwith rest and recovery). This shift can lower heart rate, reduce blood pressure, and promote a state conducive to falling and staying asleep.

[0040] (4) Stress and Anxiety Reduction - Vibrotactile stimulation may have a calming effect on a user by reducing perceived stress and anxiety levels. This could be mediated through direct neural pathways or indirectly via relaxation of muscles and a decrease in cortisol levels.

[0041] (5) Sleep Architecture Support - Preliminary studies suggest that SVS might enhance slow-wave activity (SWA) and REM during sleep, a hallmark of deep, restorative sleep. This could occur through modulation of thalamocortical circuits that govern the transition to and maintenance of deep sleep stages.

[0042] (6) Impact on heart rate variability - Research has indicated that interventions involving stochastic vibrotactile stimulation may enhance HRV, particularly when the body is in a relaxed state. The sensory input can help regulate autonomic functions, potentially reducing sympathetic dominance (which typically decreases HRV) and increasing parasympathetic activity.

[0043] In an embodiment, a system for influencing and / or assessing autonomic tone is provided, the system comprising: a user interface for data collection via qualitative reports from the user and / or via various quantitative biological or environmental sensors; an information database which holds by data about the user’s activities, physiological disposition, and / or environmental factors affecting the user during the day and / or while the user is sleeping; an assessment module for the evaluation of the user and / or environment; a mechanism for the determination of appropriate stimulus; a signal generator for the synthesis and output of the signal for stimulus; a transducer for the delivery of parasympathetic nervous stimulation to the user via proprioception promotion; wherein: (a) the user interface is a physical interface for device control, or alternatively an application on a smart phone, tablet, laptop computer, desktop computer, or alternatively integrated as a part of a digital device typically found in a bedroom, or alternatively via voice assistant; and / or (b) the qualitative reports about the user are subjective self-reports or professional medical assessments of the user’s relative activity levels, stress levels, exhaustion levels, and physical comfort levels with and / or without consideration to the contribution to these levels due to environmental factors; and / or (c) the biological sensors are sensors of autonomic nervous system tone and / or co-occurring biological indexes; and / or (d) the environmental sensors are sensors of sub-haptic, haptic, acoustic, electromagnetic, and optical field levels;and / or (e) wherein the data collections occurs at periodic intervals or continuously, reporting periodically, continuously, or on detection of a predetermined threshold or button press, wired or wireless, or via integration with loT connected sensors from other manufacturers; and / or (f) the information database and assessment module may operate within the background of the user interface, via a cloud service, or as integrated with licensed professional health services; (g) and / or the assessment module may rely on computation resources provided via the user interface, the information database, or via dedicated computation resources; and / or (h) the assessment module may rely on the concurrence of biological or environmental sensors to produce assessments in the absence of timely data from one or more sensors; and / or (i) the determination of appropriate stimulus may rely on realtime outputs from the assessment module, or on historical outputs from the assessment module, or on speculative outputs from the assessment module; and / or (j) the determination of appropriate stimulus may draw upon anonymous impulse-normalized results from the collective group of other users for optimization; and / or (k) the signal generator may produce one or more unique digital signals for amplification via an active transducers; and / or (1) the signal generator may optionally provide analog conversion of the digital signals for driving of passive transducers; and / or (m) the transducers may be mass coupled electromagnetic linear solenoids or servos, mass coupled rotary reciprocating electronic motors or servos, acoustic coupled electromagnetic motors or servos, ultrasonic intermodulation boundary effect motors, beamformed acoustic arrays, electromagnetic excitation, or any combination of these transducers and topologies.

[0044] While several embodiments have been described and illustrated herein, those of ordinary skill in the art (“the skilled person”) will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachings is / are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of exampleonly and that, within the scope of the appended claims and equivalents thereto, embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, and / or methods, if such features, systems, articles, materials, and / or methods are not mutually inconsistent, is included within the scope of the present disclosure.

[0045] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0046] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

[0047] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0048] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms ofexclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0049] As used herein, the term “about,” when referring to a value or to an amount of mass, weight, time, volume, concentration or percentage is meant to encompass variations of in some embodiments ±20%, in some embodiments ±10%, in some embodiments ±5%, in some embodiments ±1%, in some embodiments ±0.5%, and in some embodiments ±0.1% from the specified amount, as such variations are appropriate to perform the disclosed method.

[0050] As used herein, ranges can be expressed as from “about” one particular value, and / or to “about” another particular value. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “about 10” is also disclosed. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0051] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and / or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0052] It should also be understood that, unless clearly indicated to the contrary, in any methods claimed herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.

[0053] In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0054] It is to be understood that the embodiments are not limited in its application to the details of construction and the arrangement of components set forth in the description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Unless limited otherwise, the terms “connected,” “coupled,” “in communication with,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not restricted to physical or mechanical connections or couplings.

Claims

CLAIMS1. A device to deliver stochastic vibrotactile stimulation (SVS) to a human, for influencing the human’s autonomic tone via enhanced parasympathetic proprioception for improving health and / or lifestyle benefit of the human, the SVS device (100) comprising: (a) a processor (200), operatively coupled to an SVS signal generator (300), operatively coupled to an emitter (400), the processor (200) having a controller (250) operatively coupled to it, that controls the intensity of the SVS signal.

2. A device according to any of the preceding claims, further comprising one or more sensors (500) operatively coupled to the processor (200).

3. A device according to any one of the preceding claims, wherein at least two components of device (100) are enclosed in one or more housings (600).

4. A device according to any one of the preceding claims, wherein the emitter (400) is placed under a user’s mattress that the user may lay on.

5. A device according to any one of the preceding claims, wherein the emitter (400) is selected from vibrotactile, vibroacoustic, electromagnetic, electrogenic, ultrasonic, and / or magnetohydrodynamic, preferably selected from vibrotactile, vibroacoustic, and / or ultrasonic.

6. A device according to any one of the preceding claims, wherein the emitter (400) comprises a loudspeaker, preferably wherein the loudspeaker, when in use meets at least one of the following: (a) it may be manipulated to produce an SVS signal that delivers low-amplitude, stochastic (randomized) vibrations to the skin of a user, preferably in the range of about 60dB to about 70dB; (b) the Qts of the loudspeaker may be maintained at about 0.707; and (c) the cut-off frequency of the SVS signal is about 118 Hz.

7. A device according to any one of the preceding claims, wherein the sensors (500) are used to collect data from a user and the user’s environment, and are preferably selected from: accelerometer, barometric pressure sensors, Ag / AgCl electrode, EEG sensor, MRI / fMRI, microphones, SpO2 sensors, motion detectors, IR microbolometers, and olfactory sensors.

8. A method of improving health and / or lifestyle benefit of a human, comprising delivering an SVS signal to the human via an SYS device (100) according to any one of the preceding claims.

9. A method according to the preceding claim, wherein the improvement in health and / or lifestyle benefit is one or more of: (a) reduction in disturbances / hour during sleep; (b) increase in REM sleep minutes; (c) increase in SWS sleep minutes; (d) increase in total restorative sleep; and / or (e) improvement in heart rate variability.

10. A method according to any one of Claims 8 or 9, wherein the human using the SVS device (100) experiences improvement in their quality of sleep.

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