Apparatus for sleep therapy using vestibular nerve stimulation

Abstract

Methods, systems, and devices for stimulating the vestibular system are provided to excite nervous system components of the physiological rhythm system and induce sleep. A device having one or more electrodes placed on the subject's scalp provides vestibular nerve stimulation (VeNS) to the vestibular nerve, which is then carried into the vestibular nuclei of the brainstem, after which it is transmitted to nervous system components of the physiological rhythm system to excite areas that promote sleep, thereby putting the body into a sleep state. The characteristics of the stimulation signal and the duration of the treatment are configured to allow the treatment to be delivered prior to the subject's desired sleep time, thereby not requiring the device to be worn in bed.

Description

[0001] background

[0002] Inventive Technology

[0003] The systems, methods, and devices described in this article relate to vestibular stimulation, and more specifically to stimulating the vestibular nuclei to promote sleep.

[0004] Related technologies

[0005] With the growing link between sleep deprivation and poor health, sleep is becoming an increasingly prominent topic in human health. While some sleep disorders, such as insomnia or sleep apnea, are well-known and have various accepted treatments, much remains unknown about how the body typically regulates sleep or the external and internal factors that influence the body's ability to sleep. As the connection between sleep and overall health expands, there is a growing interest in understanding how the body, particularly the brain, regulates sleep.

[0006] The brainstem contains many areas that control unconscious bodily functions such as blood pressure, heart rate, kidney function, body fat, and sleep. Like many brain functions, sleep is a complex process influenced by various physiological and neurological factors. Key brain regions considered to affect sleep include the hypothalamus, the suprachiasmatic nucleus (SCN), and the intergenic lobule (IGL). These are thought to act as circadian rhythm clocks, telling the body when to sleep and when to wake. Therefore, attempts to regulate circadian rhythms through these key brain anatomical features could lead to methods that promote sleep.

[0007] The vestibular system can be a pathway for regulating circadian rhythms and influencing sleep. It is a major contributor to our sense of balance and spatial orientation, and in each inner ear consists of three semicircular canals (which detect rotational movements) and two otolithic organs (called the utricle and saccule, which detect linear acceleration and gravity) (Khan and Chang, 2013). These are called otolithic organs because they are fluid-filled sacs containing a large number of freely moving calcium carbonate crystals—called otoliths—that move under the influence of gravity or linear acceleration, acting on receptor cells to alter the activity of vestibular afferent nerves.

[0008] One pathway for regulating sleep via the circadian rhythm system is through the vestibular system, as the circadian rhythm system has been found to receive input from the vestibular nuclei. The vestibular nuclei (particularly the medial vestibular nucleus, or “MVe”) are located in the pons and medulla oblongata and receive input from the vestibular system via vestibular nerves. The MVE is considered a brainstem homeostatic site that protrudes (directly and indirectly via the parietosular vestibular cortex (PIVC)) into the parabrachial nucleus (PB) and periaqueductal gray (PAG) (see Chapter 1 and Section 8 of Chapter 3 of McGeoch’s doctoral dissertation, 2010). The PB appears to maintain homeostasis—that is, a stable internal physiological environment—by integrating this vestibular input with sympathetic input (via the thin layer 1 spinal cord and trigeminal-thalamic tract fibers) and parasympathetic input (via the nucleus tractus solitarius) (Balaban and Yates, 2004; Craig, 2007; Craig, 2009; McGeoch et al., 2008, 2009; McGeoch, 2010).

[0009] The PB (brain barrier) is thought to play a role in maintaining homeostasis through behavioral, neuroendocrine, and autonomic efferent (i.e., sympathetic and parasympathetic) responses (Balaban and Yates, 2004; McGeoch, 2010). Anatomically, the PB protrudes to the insula and anterior cingulate cortex, amygdala, and hypothalamus. The insula and anterior cingulate cortex are areas of the cerebral cortex involved in emotional influences and motivation, and therefore behavior (Craig, 2009). The hypothalamus plays a crucial role in coordinating the neuroendocrine system (Balaban and Yates, 2004; Fuller et al., 2004; Craig, 2007). Similarly, the amygdala (again, along with the hypothalamus and insula) is known to be important in autonomic control. The PB also outputs to the PAG (brain barrier) and basal forebrain, which are also involved in homeostasis (Balaban and Yates, 2004).

[0010] Vestibular nerve stimulation (“VeNS”) uses electrical current to simultaneously activate all five components of the vestibular apparatus (Fitzpatrick and Day, 2004; St. George and Fitzpatrick, 2011) and offers a practical option for home use and commercial production without expert supervision. VeNS involves stimulating the vestibular system by applying a small current (typically between 0.1 mA and 3 mA) percutaneously via two electrodes. The electrodes can be applied at various locations around the head, but typically one electrode is applied to the skin on each mastoid process, i.e., the skin behind each ear. Some authors refer to this as “biaural application.” If a cathode and an anode are used, with one placed on each mastoid process (this is the most common iteration), then this is called bipolar biaural application of VeNS. Current can be delivered in a variety of ways, including in a constant state, as a square wave, a sinusoidal (alternating) mode, and as a pulse sequence (Petersen et al., 1994; Carter and Ray, 2007; Fitzpatrick and Day, 2004; St. George and Fitzpatrick, 2011).

[0011] Efforts to influence sleep using vestibular stimulation have been limited. One effort is described in U.S. Patent No. 6,314,324 to Lattner et al., which relies on known vestibular treatments to combat vertigo by rhythmically stimulating the semicircular canals, saccule, utricle, and / or ampulla. This stimulation produces an artificial rocking sensation that mimics the feeling of the body rocking back and forth, like a baby in a cradle. However, this therapy is designed to be performed while the person is lying in bed so that the rocking sensation gently induces sleep, and is designed to be worn during sleep to provide additional stimulation if the user's sleep pattern is disrupted.

[0012] Therefore, there is a need to further develop methods and devices for providing vestibular stimulation to promote sleep in a more effective and efficient manner. Summary of the Invention

[0013] The embodiments described herein provide systems, devices, and methods for promoting sleep by utilizing vestibular stimulation to stimulate areas of the brain responsible for regulating circadian rhythms, thereby promoting sleep and reducing wakefulness. Stimulation for a period of time can be delivered before bedtime using customized signal shapes and durations. This stimulation is delivered to the vestibular nerve via a head-mounted portable electronic device that does not require the user to be in bed, as it avoids creating a swaying sensation that could affect the user's balance. This stimulation essentially tells the brain it's time to sleep, providing an effective method for promoting sleep that does not require the user to wear the device or lie in bed.

[0014] In one embodiment, a method for promoting sleep in a human subject by delivering vestibular nerve stimulation (VeNS) includes: positioning at least one electrode in electrical contact with and near the vestibular system of the human subject; and delivering the VeNS to the human subject from a current source connected to the at least one electrode, wherein the VeNS is delivered prior to the subject's desired sleep time.

[0015] In another embodiment, a method of treating insomnia using vestibular nerve stimulation includes: positioning at least one electrode in electrical contact with and near the vestibular system of a human subject; and delivering VeNS to the human subject from a current source connected to the at least one electrode, wherein the VeNS is delivered before the subject's desired sleep time.

[0016] In another embodiment, a device for promoting sleep in a human subject includes: electrodes arranged to electrically contact the subject's scalp at locations corresponding to the subject's vestibular system; and an electric current source electrically connected to the electrodes for delivering vestibular nerve stimulation (VeNS) to the subject, wherein the electric current source delivers VeNS for approximately 30 minutes to approximately 60 minutes during approximately 1 to several hours of the subject's desired sleep time.

[0017] Other features and advantages of the present invention will become more apparent to those skilled in the art upon viewing the following detailed description and accompanying drawings. Attached Figure Description

[0018] The structure and operation of the present invention will be understood by referring to the following detailed description and accompanying drawings, wherein the same reference numerals refer to the same parts, and in the drawings:

[0019] Figure 1 This is a diagram showing the vestibular system of the left inner ear;

[0020] Figure 2 It is a model that demonstrates the anatomical features connecting the vestibular system and the physiological rhythm timing system (CTS);

[0021] Figure 3 This is a flowchart illustrating an example method for influencing sleep using VeNS, according to an embodiment of the present invention;

[0022] Figure 4 This is a diagram illustrating an exemplary waveform for delivering VeNS according to an embodiment of the present invention;

[0023] Figure 5A This is a graphical representation of sleep data of a subject before using the VeNS device, according to an embodiment of the present invention.

[0024] Figure 5B This is a graphical representation of sleep data of a subject after using the VeNS device, according to an embodiment of the present invention.

[0025] Figure 6A This is a graphical representation of the sleep stages of a subject before using the VeNS device, according to an embodiment of the present invention.

[0026] Figure 6B This is a graphical representation of the sleep stages of a subject after using a VeNS device, according to an embodiment of the present invention.

[0027] Figure 7 It is a graph showing the average Insomnia Severity Index (ISI) scores of a group of subjects before and after a period of VeNS therapy according to an embodiment of the present invention;

[0028] Figure 8 It is a graph showing the distribution of ISI categories of the group of subjects before and after a period of time of VeNS therapy according to an embodiment of the present invention;

[0029] Figure 9 It is a graph showing the average calm subjective score of the group of subjects over time before and after treatment according to an embodiment of the present invention;

[0030] Figure 10 This is a schematic diagram of an exemplary stimulator circuit for a vestibular nerve stimulation (VeNS) device according to an embodiment of the present invention;

[0031] Figure 11 This is a schematic diagram of an alternative embodiment of a stimulator circuit with a gain control component according to an embodiment of the present invention;

[0032] Figure 12 This is a schematic diagram of a second alternative embodiment of a stimulator device according to one embodiment of the present invention;

[0033] Figure 13A and Figure 13B An exemplary waveform generated by the device according to an embodiment of the present invention is shown;

[0034] Figure 14 This is a diagram illustrating the placement of an exemplary VeNS electrode according to an embodiment of the present invention;

[0035] Figure 15 This is a block diagram illustrating an example wired or wireless device with a processor that can be used in conjunction with the various embodiments described herein. Detailed Implementation

[0036] Certain embodiments disclosed herein provide stimulation of the vestibular system to activate neural components of the circadian rhythm system and induce sleep. For example, one method disclosed herein allows a device placing one or more electrodes on a subject's scalp to deliver vestibular nerve stimulation (VeNS) to the vestibular nerves, then carries it to the vestibular nuclei in the brainstem, and subsequently transmits it to neural components of the circadian rhythm system to activate sleep-promoting areas, thereby inducing a sleep state. The characteristics of the stimulation signal and the duration of treatment are configured to allow delivery of treatment before the subject's desired sleep time, thus eliminating the need to wear the device in bed.

[0037] Upon reading this specification, those skilled in the art will understand how the invention can be practiced in various alternative embodiments and applications. However, while various embodiments of the invention will be described herein, it should be understood that these embodiments are presented by way of example only and not limitation. Therefore, the detailed description of various alternative embodiments should not be construed as limiting the scope or breadth of the invention as set forth in the appended claims.

[0038] Approaches to sleep therapy

[0039] Figure 1 The vestibular system of the left inner ear is shown. The cochlea 68, the peripheral organ of hearing, is also shown. It displays the anterior semicircular canals 62, posterior semicircular canals 67, and horizontal semicircular canals 63, which convert rotational movements; and the otolith organs (utricle 66 and saccule 65), which convert linear acceleration and gravity. The vestibulocochlear nerve 64 (also known as the eighth cranial nerve) is composed of the cochlear nerve (which carries signals from the cochlea) and the vestibular nerve (which carries signals from the vestibular system).

[0040] Figure 2 This model outlines the potential anatomical features connecting the vestibular and chronochronous timing systems (CTS). Light is the primary synchronizer of the CTS, transmitted via the retinohypothalamic tract (RHT) to the suprachiasmatic nucleus (SCN). Non-optical stimuli, such as voluntary movements (running wheel), are transmitted to the SCN via the intergenic lobule (IGL) and the genu hypothalamic tract (GHT). There is also evidence supporting the involvement of serotonergic mesencephalic raphes (dorsolateral and medial, dRN and mRN, respectively) in transmitting activity information to the SCN and IGL. Morphological data also suggest that the vestibular nuclei (VNs) may influence the raphe nuclei, particularly the dRN. The MGR is the macular gravity receptor, T is the chronochronous timing system, and T... b Body temperature.

[0041] Vestibular stimulation indirectly activates key brain regions associated with sleep by using the vestibular nuclei as relays to transmit vestibular system stimuli from the vestibular nuclei to the SCN, IGL, and hypothalamus. These neural components act as circadian rhythm systems and influence human sleep; therefore, the application of VeNS essentially re-regulates circadian rhythms and stimulates sleep-promoting areas (while reducing arousal), allowing the body to enter a sleep state at the right time.

[0042] Treatment

[0043] Figure 3 An embodiment of a method for influencing sleep in human subjects using VeNS is illustrated. In step 302, one or more electrodes are positioned on the subject's scalp near the vestibular system. The electrodes may be placed on one or both sides of the scalp, near approximate locations where vestibular nerve stimulation can be achieved. In step 304, parameters for VeNS treatment are configured on the VeNS device based on one or more factors related to the treatment or the subject, such as signal shape, pulse, frequency, treatment duration, and desired sleep time relative to the treatment time. Once the parameters are selected, the treatment session can be initiated in step 306 before the subject's desired sleep time. In step 308, the treatment is terminated at the end of the desired treatment duration, before the subject's desired sleep time.

[0044] While not part of the primary approach, the effectiveness of treatment can be determined by monitoring, for example, the subject's response to treatment via remote or wearable sensors, the subject's own observations of their sleep quality and duration, and other physiological and psychological factors that can be measured over a longer period after multiple treatment sessions. The subject's response to treatment can be used to adjust the overall treatment plan, VeNS parameters, or other observed factors that may affect the subject's sleep.

[0045] Treatment methods may include delivering vestibular stimulation at frequencies within the effective range for readjusting physiological rhythms. Figure 4 In one embodiment shown, the parameters for VeNS treatment include delivering a square wave with a frequency of approximately 0.25 Hz and a current range of approximately 0.01 mA to 1 mA at a duty cycle of approximately 50%. Electrodes can be placed bilaterally to deliver stimulation to both sides of the user's head. The treatment session can last from approximately 30 minutes to approximately 60 minutes, and the subject can initiate treatment approximately 3 hours prior to the expected onset of sleep.

[0046] In another embodiment, the treatment method may include delivering vestibular stimulation with different parameters, which may be effective for different types of subjects or have different outcomes related to the expected start of the treatment and sleep cycle. For example, a frequency range from about 0.0001 Hz to about 10,000 Hz, and a range from about 0.01 mA to about 5 mA, can be used for any type of waveform and duty cycle, from square waves to sine waves to pulses. Treatment can be delivered simply by an electrode placed on one side of the user's head at a general location where vestibular nerve stimulation can be performed. The user can initiate treatment at any time before going to bed and initiate treatment sessions of any duration from about 1 minute to about 120 minutes.

[0047] It should also be noted that this method of delivering stimulation aims to promote sleep within the circadian rhythm segment without producing a shaking sensation, by delivering stimulation at frequencies of approximately 0.25 Hz and at least below approximately 0.5 Hz. These frequencies, sometimes referred to as “subsensory VeNS,” are slow and provide sufficiently low power to avoid producing a shaking sensation, allowing the subject to receive the VeNS before going to bed and then terminating the treatment before bedtime. In contrast, frequencies of approximately 25 Hz have also proven effective and were detected as too high for the subject. The device can be removed after going to bed, eliminating any potential discomfort often caused by other devices that need to be worn in bed while attempting to fall asleep.

[0048] verify

[0049] With the trademark VESTIBULATOR TM The comparable commercially available VeNS device, sold by GoodVibrations Engineering Ltd in Ontario, Canada, has been used in numerous studies at other institutions (Barnett-Cowan and Harris, 2009; Trainor et al., 2009). This device operates using eight AA batteries, ensuring the voltage never exceeds 12V. According to the manufacturer's specifications, the device can deliver a maximum current of 2.5mA. (Compared to VESTIBULATOR) TM In contrast, the present invention uses a more user-friendly device (e.g., a controller (knob, slider, or similar device) on the side of the housing to adjust the delivered current) in the VESTIBULATOR TM In this context, similar adjustments can only be made by first writing... Script, and then via Upload it remotely so that the VESTIBULATOR can be reprogrammed. TM (Settings to be used).

[0050] Because very small currents are used during VeNS, this technology is considered safe (Fitzpatrick and Day, 2004; Hanson, 2009). Specifically, although the current may cause arrhythmias, including ventricular fibrillation, the threshold for this is in the range of 75 mA to 400 mA, far exceeding the current levels that battery-powered VeNS devices can deliver. Furthermore, the electrodes will only be applied to the scalp, such as... Figure 14 As shown, but not close to the skin above the chest.

[0051] Resistance heating can occur due to high-voltage electrical stimulation of the skin. However, the voltage and current delivered during VeNS (typically below 1 mA) are far below the levels that would cause this risk. However, skin pain may occur due to pH changes. This can be alleviated by using platinum electrodes with a large surface area (approximately 2 inches in diameter) and aloe vera conductive gel.

[0052] It might be desirable to monitor the subject's heart rate (HR) to determine the cardiac frequency during VeNS treatment. The heart rate can then be used to adjust the frequency of the sinusoidal VeNS to maintain a certain ratio between the heart rate and the sinusoidal VeNS frequency, thereby avoiding interference with baroreceptor activity. For example, a ratio of 0.5 between the sinusoidal VeNS frequency and the heart rate would be appropriate.

[0053] During the VeNS administration, such as Figure 14 As shown, one platinum electrode is attached to the skin above one mastoid process, and another electrode is attached to the skin above the other mastoid process. The electrodes may be coated with a conductive gel containing aloe vera. The device is activated to deliver a sinusoidal current of approximately 0.1 mA (given an intermammary resistance of approximately 500 kOhm) with a frequency of approximately 0.25 Hz. The typical current range of the device will be from approximately 0.001 mA to approximately 5 mA. Subjects should remain seated or lying down throughout the treatment to avoid unforeseen events due to balance changes during vestibular stimulation. The device is set to automatically stop after one hour; however, subjects may discontinue treatment earlier if desired. Subjects should remain seated until their balance returns to normal, which should occur shortly after the VeNS device has been turned off.

[0054] In one embodiment, the VeNS device, provided by Neurovalens Ltd., is used to deliver stimulation. This device delivers, for example... Figure 4The VeNS current waveform shown consists of a 0.25Hz AC square wave with a 50% duty cycle. The next procedure involved each subject individually undergoing indirect calorimetry for the first 30 minutes to establish a baseline. Then, each subject underwent a one-hour bipolar VeNS treatment in both ears, where electrodes were placed on the skin above each mastoid process, as shown. Figure 14 As shown. As mentioned above, a 0.25Hz AC square wave with a duty cycle of 50% was delivered at a current of 0.6mA to all subjects, although the equipment used was capable of delivering larger currents.

[0055] Figure 5A It is a graphical representation of the sleep data of subjects before using the VeNS device, showing the frequency and duration of sleep stages during sleep. Figure 10 B is a graphical representation of sleep data from subjects after using the VeNS device, showing the frequency and duration of sleep stages during sleep. These graphical representations indicate an increase in the number and duration of REM, light, and deep sleep stages, and a decrease in the number and duration of wakefulness stages after using the VeNS device.

[0056] Similarly, Figure 6A This is a graphical representation of the sleep stages of the subjects before using the VeNS device, and Figure 6B This is a graphical representation of the sleep stages of the subjects after using the VeNS device. Furthermore, the number and duration of REM, light, and deep sleep stages increased after using the device, while the number and duration of awake sleep stages decreased significantly.

[0057] In another study, a group of participants underwent 28 days of measurements—14 days of pre-treatment measurements to establish baseline Insomnia Severity Index (ISI) scores, and 14 days of in-treatment measurements to determine the potential impact of treatment on the participants' mean ISI. The primary objective of this study was to assess the impact of VeNS delivery at the onset of sleep on ISI scores. A secondary objective was to provide initial data indicating the “duration of effectiveness” that would allow for a more appropriate RCT design. In this study, approximately 30 minutes of VeNS was delivered approximately one hour before the onset of sleep using the aforementioned VeNS device from Neurovalens GmbH.

[0058] Figure 7This is a graph showing the mean Insomnia Severity Index (ISI) score of a group of subjects before and after a period of VeNS therapy. The mean baseline ISI was calculated to be 15.7 (SD 4.7) (moderate insomnia). After a 14-day course of VeNS therapy, the repeated ISI score was calculated to be 8.15 (SD 3.6) (subclinical insomnia). This result was statistically significant (p < 0.00001).

[0059] Figure 8 This is a graph showing the distribution of ISI categories in this group of subjects before and after a period of VeNS therapy, demonstrating the potential amount of clinically significant change in insomnia levels over the measurement period.

[0060] Figure 9 This is a graph showing the average subjective calmness ratings of the group of subjects over time before and after treatment. The self-rated score of 'calmness' (range 0-4) on the second day was calculated as 1.6 (SD 0.63) and used as the baseline, increasing to 2.01 (SD 0.79) during week 1 and to 2.67 (SD 0.56) during week 2.

[0061] This preliminary study supports the hypothesis that VeNS, when delivered regularly before the onset of sleep, has a positive impact on ISI scores. Although a subjective measure, the feeling of 'next-day calm' appeared to be significantly improved over a two-week period of VeNS delivery. The results suggest that VeNS may have a positive effect on sleep even when delivered before the onset of sleep. Therefore, the mechanism of action of VeNS is more complex than that of nonspecific rocking movements and may be secondary to the direct effects of the vestibular system on circadian rhythm pacemakers and other sleep regulation nuclei in the brainstem.

[0062] Given its low-risk and non-invasive nature, VeNS has the potential to be used as a non-pharmacological therapy to manage mild to moderate insomnia.

[0063] Vestibular stimulation device

[0064] Figure 10 and Figure 11 A possible embodiment of a VeNS circuit system that can be used to perform the methods of the present invention is shown. Device 20 includes a time-varying galvanic current source that can be software-programmed using a microcontroller. In one embodiment, vestibular stimulation can be provided via a head-mounted portable electronic device that is comfortably positioned in an area of ​​the user's head, in which stimulation can be delivered to one or both sides of the user's vestibular nerves.

[0065] Figure 10The basic components of an embodiment of the stimulation device 20 are shown, including a constant current source based on an operational amplifier (“op-amp”). A voltage is applied to the scalp 10 via electrodes 4 and 6 and is measured by operational amplifier 12. In an exemplary embodiment, operational amplifier 12 may be a general-purpose operational amplifier, an example being the LM741 series operational amplifier, which is widely available commercially. Choosing a suitable operational amplifier will be within the skill level of the art. If the voltage returning from the scalp 10 to pin 2 (inverting input) of operational amplifier 12 differs from the reference voltage +9V at pin 3 (non-inverting input), the operational amplifier draws from the +18V input at pin 7 to increase the voltage output at pin 6, thereby increasing the current on the scalp 10 to maintain a constant current level. Load resistor 16 is 250 ohms. Adjustment of potentiometer 14 provides gain control by reducing the voltage input from pin 2 to operational amplifier 12, thereby controlling the amount of current flowing through the scalp. In a preferred embodiment, the +9V and +18V inputs are provided by one or more batteries (not shown), or a conventional DC converter with appropriate safety settings can be used.

[0066] Figure 11 The diagram in the image shows the addition of control components. Figure 1 In the basic stimulator circuit 20, a transistor 22 powered by a pulse-width modulation (PWM) output (MOSI (master output / slave input, pin 5) of an ATtiny13 microcontroller 24 (Atmel Corporation, San Jose, California) or a similar device can be used to control the stimulator's gain. The PWM causes the transistor to pull more or less of the voltage entering operational amplifier 12 (pin 2) to ground, thereby modulating the amount of current flowing through the scalp.

[0067] In a preferred embodiment, the device components and any external interfaces will be enclosed in the housing 30 (e.g., Figure 14Inside (as shown), the housing has appropriate user controls 32 for appropriately selecting stimulation parameters. Note that the knob is shown for illustrative purposes only, and other types of controls, including switches, buttons, pressure bumps, sliders, touchscreens, or other interface devices, can be used. Optional design components that can be added to expand the device's functionality include memory storage devices, such as memory cards or electrically erasable programmable read-only memory (EEPROM), which would allow recording of the stimulation time, duration, and intensity. This can be achieved by programming the microcontroller 24 to output logic-level 3.4V pulses (TTL (transistor-to-transistor logic)) from the remaining digital output (MISO (master input / slave output, pin 6)) to a secure digital (SD) memory card, EEPROM, USB flash drive, or other data storage device via an appropriate port on the device housing. Alternatively, the +18V input can be obtained through an integrated charge pump or DC-DC boost converter (such as, for example, the MAX629 or MAX1683 (not shown)). This design feature has the benefit of reducing the device size by generating the necessary +18V input from a smaller battery (which may be disposable or lithium-ion rechargeable). Additional features may include wireless communication circuitry, as known in the art, for programming and / or data collection from a remote computing device, which may include a personal computer, smartphone, or tablet.

[0068] Other functions for implementing VeNS in this invention may include the ability to pulse current at precise intervals and durations, as a sine wave with adjustable amplitude and period, and even at precise intervals with switching polarities.

[0069] Additional options for promoting and / or enhancing the administration of VeNS may include built-in biofeedback capabilities to adjust stimulation parameters for optimal effect based on signals generated by sensors monitoring subject activity and / or biological characteristics such as motion, position, heart rate, etc. For example, real-time cardiac data measured by a heart rate sensor or monitor can be used as input to the VeNS device to trigger automatic adjustment of the sinusoidal VeNS frequency to an appropriate, possibly pre-programmed, heart rate fraction. Real-time data on user motion or position measured by an accelerometer can also be used as input to control stimulation to improve utility and safety. For example, if excessive motion or change in user position is detected, treatment can be terminated, or the user can be warned about a change in position that may have adverse effects. The heart rate sensor / monitor and / or accelerometer may be separate devices communicating with the VeNS device of the present invention via wired or wireless connections. Alternatively, the sensors may be directly integrated into the VeNS device to form a wearable “sensing and treating” system. With the development of new sensors and their adaptation to mobile computing technologies for “smart” wearable mobile health devices, the “sensing and healing” VeNS device can deliver closely customized stimulation based on a large amount of sensor data input into the device.

[0070] Figure 12 An exemplary prototype of the device 40 of the present invention is illustrated schematically, which uses commercially available... The Uno single-board microcontroller 42 (Arduino, LLC, Cambridge, Massachusetts) is implemented, and this single-board microcontroller is based on the ATmega328 microcontroller (Artermel Corporation, San Jose, California). The microcontroller 42 includes fourteen digital input / output pins (six of which can be used as pulse width modulation (PWM) outputs), six analog inputs, a 16MHz ceramic resonator, a USB connection, a power socket, an ICSP plug, and a reset button. The circuit's +14.8VDC power supply is provided by battery 49. For example, four lithium-ion batteries are used (each providing 3.7V (1300mAh)), and these lithium-ion batteries are preferably rechargeable via charging port 51.

[0071] PWM allows for precise control of the output waveform. In this case, the waveform employs a repetitive half-sine wave pattern with positive deflection, such as... Figure 13A As shown. The frequency has been predefined as 0.25Hz, but can be manually controlled or adjusted in response to signals from a sensor such as a heart rate sensor (see example). Figure 14The input from the sensor is set to different values. The user can manually control the amplitude by adjusting potentiometer 48, allowing a range of 0 to 14.8V to be supplied to the electrode. This adjustment can be achieved by rotating a knob, moving a slider (physically or via a touchscreen), or any other known user control mechanism. Alternatively, the potentiometer setting can be automatically adjusted in response to the input signal from the sensor. Relay 44 transmits the voltage adjustment to graphic display 45 to provide a readout of the selected voltage and / or current.

[0072] Relay 46 can be used to effectively reverse the polarity of the current with a pulse every second. This effect is... Figure 13B As shown, the sinusoidal pattern changes polarity to generate a complete sinusoidal waveform, producing alternating stimulation periods of approximately 1 second for the left mastoid electrode 50L and the right mastoid electrode 50R.

[0073] The device may optionally include a tri-color LED 52 that provides a visual display of the device's status (i.e., diagnostic guidance), such as an indication that the device is working properly or that the battery needs charging.

[0074] Optional design components may include a touchscreen configuration that combines potentiometer control, digital displays of voltage and current, and other operating parameters and / or usage history. For example, it may display remaining battery power, previous stimulation statistics, and changes in resistance. Additional features may include control over waveform variations, such as frequency variations and changes in wave type (e.g., square wave, pulse, or random noise). Microprocessor platforms (or any similar platforms) are ideally suited for feedback control or manual control based on external signal sources and in conjunction with frequency, intensity, or other stimulus parameters. For example, Microprocessor platform (if configured) (Regarding ability) can be determined by Wireless control via smartphones, laptops, PCs, tablets, or other mobile devices allows the mobile device's touchscreen to be used to control and / or display VeNS stimulation parameters without requiring a dedicated screen on the device. The mobile device can also be configured to store and analyze data from previous stimuli, providing trends and statistics regarding long-term stimulation (e.g., over 6 months). This application allows programs to monitor and guide users on their progress and goals, highlighting body measurements and weight changes relative to the stimulation period.

[0075] Used to promote sleep Figure 12 An exemplary operation sequence of an embodiment may include the following steps:

[0076] When the push-button power switch 41 is activated, the (multiple) batteries 49 supply 5 volts DC to the microprocessor 42 through a 5-volt regulator and a 1-amp fuse (shown in the figure but not separately labeled).

[0077] LED 52 will flash green three times to indicate that power is "on". If it flashes blue, the battery needs to be charged. While voltage is being supplied to electrodes 50L and 50R, LED 52 will flash red at regular intervals (e.g., 30 seconds to 1 minute).

[0078] Microprocessor 42 generates a 0.75VDC half-wave symbol. The amplifier amplifies the voltage to 14.8 volts. The sine wave completes half a cycle in 1 second (i.e., the frequency of the sine wave is 0.25Hz). Potentiometer 48 can change the voltage from 0 volts to 14.8 volts.

[0079] After one half-cycle is completed, relay 46 switches the polarity of electrodes 50L and 50R, and microprocessor 42 sends the other half-cycle. Relay 46 switches the polarity again and continues as long as the unit is "on". This sends a full sine wave up to +14.8VDC to the electrodes, with the full voltage swing modulated by potentiometer 48.

[0080] The digital display 45 provides a visual indication of the voltage and current delivered to the electrodes 50L and 50R. Depending on the size and complexity of the display, the voltage and current values ​​can be displayed simultaneously or alternately for a short duration, such as 3 seconds.

[0081] Other device options may include user controls to allow the application of current in pulses with precise intervals and durations, thereby generating sine waves with adjustable amplitude and period and / or switching polarity at precise intervals. External control and monitoring via smartphones or other mobile devices as described above may also be included. Further input and processing capabilities may be included for interface connectivity and feedback control via external or internal sensors.

[0082] Figure 14An exemplary VeNS electrode 34 is shown, positioned on the skin behind the auricle of the left ear 36 of the subject to be treated, and above its left mastoid process. The mastoid process is indicated by dashed line 38. The right electrode (not shown) will be placed in the same manner on the skin above the right mastoid process and behind the right auricle. It should be noted that the electrode placement shown is provided as an example only. In fact, the laterality of the electrode application (e.g., the electrodes are precisely positioned above both mastoid processes) is not considered critical, as long as each electrode is close enough to the vestibular system to apply the desired stimulation. Electrode 34 is connected to the stimulation device 40 (inside housing 30) via lead 33. A manual control (shown herein as a simple knob 32) can be operated to control the current or other parameters. As mentioned above, alternative control devices include sliders, touchscreens, buttons, or other conventional control devices. External control signals (e.g., signals from the heart rate monitor 35) can be input to the device wirelessly as shown or via a lead extending between the sensor and the device. Electrodes (such as commercially available 2×2-inch platinum electrodes for transcutaneous electrical nerve stimulation (TENS)) can be used to minimize any potential skin pain. Conductive gel 37 can be coated between the subject's scalp and the contact surface of the electrode to enhance conductivity and reduce the risk of skin pain.

[0083] The actual amount of current received by the subject depends on the scalp resistance (I). 头皮 =V 电极 / R 头皮 This resistance can vary with user sweating, changes in electrode position, or loss of contact with the skin. It appears that the current levels cited in the literature can only be delivered when scalp resistance is much lower than its actual value. Measurements conducted in conjunction with the development of the method and device of this invention indicate that interplasty resistance is typically between 200 and 500 kiloohms. Therefore, if a VeNS device were actually used to transmit 1 mA, the voltage would be between 200 and 500 V according to Ohm's law. Battery-powered devices typically used to apply current to VeNSs simply cannot generate such an output. Therefore, existing reports appear inaccurate regarding the actual current delivered in VeNSs.

[0084] Existing technology designs lack consideration for the unique scalp resistance of each subject, and therefore may be unable to deliver an effective current to each patient. In this invention, this limitation is overcome by taking into account the variability of scalp resistance between subjects and compensating for fluctuations in scalp resistance that may occur throughout the process. To compensate for small and fluctuating changes in scalp resistance during current application, the VeNS device of this invention may include an internal feedback loop that continuously compares the desired current with the actual current measured on the scalp and automatically compensates for any discrepancies. If R 头皮 If V increases, then电极 Increase to compensate. Conversely, when R 头皮 As the voltage drops, the current decreases. This dynamic feedback compensation loop provides a constant current to the scalp throughout the duration of the process, regardless of fluctuations in electrode-scalp impedance.

[0085] Computer-implemented examples

[0086] Figure 15 This is a block diagram illustrating an example wired or wireless system 550 that can be used in conjunction with the various embodiments described herein. For example, system 550 can be used as or in conjunction with a vestibular nerve stimulation device, as previously discussed. Figure 1 As described in Figure 6. System 550 can be a conventional personal computer, computer server, personal digital assistant, smartphone, tablet, or any other processor-equipped device capable of wired or wireless data communication. As will be apparent to those skilled in the art, other computer systems and / or architectures may also be used.

[0087] System 550 preferably includes one or more processors, such as processor 560. Additional processors may also be provided, such as auxiliary processors for managing input / output, auxiliary processors for performing floating-point mathematical operations, dedicated microprocessors (e.g., digital signal processors) with architectures suitable for fast execution of signal processing algorithms, slave processors (e.g., back-end processors) subordinate to the main processing system, and additional microprocessors, controllers, or coprocessors in dual- or multi-processor systems. Such auxiliary processors may be discrete processors or may be integrated with processor 560.

[0088] Preferably, the processor 560 is connected to a communication bus 555. The communication bus 555 may include a data channel for facilitating information transfer between the system 550's storage devices and other peripheral components. The communication bus 555 may further provide a set of signals for communicating with the processor 560, including a data bus, an address bus, and a control bus (not shown). The communication bus 555 may include any standard or non-standard bus architecture, such as, for example, an Industry Standard Architecture (“ISA”), an Extended Industry Standard Architecture (“EISA”), a Micro Channel Architecture (“MCA”), a Peripheral Component Interconnect (“PCI”) local bus, or a bus architecture based on standards published by the Institute of Electrical and Electronics Engineers (“IEEE”), including the IEEE 488 Universal Interface Bus (“GPIB”), IEEE 696 / S-100, etc.

[0089] System 550 preferably includes main memory 565 and may also include auxiliary memory 570. Main memory 565 provides storage for instructions and data for programs executed on processor 560. Typically, main memory 565 is a semiconductor-based memory such as dynamic random access memory (“DRAM”) and / or static random access memory (“SRAM”). Other semiconductor-based memory types include, for example, synchronous dynamic random access memory (“SDRAM”), Rambus dynamic random access memory (“RDRAM”), ferroelectric random access memory (“FRAM”), etc., including read-only memory (“ROM”).

[0090] Auxiliary storage 570 may optionally include internal storage 575 and / or removable media 580, such as floppy disk drives, magnetic tape drives, optical disc (“CD”) drives, digital versatile optical disc (“DVD”) drives, etc., which are read from and / or written to in a known manner. Removable storage media 580 may be, for example, floppy disks, magnetic tapes, CDs, DVDs, SD cards, etc.

[0091] Removable storage medium 580 is a non-transitory computer-readable medium on which computer-executable code (i.e., software) and / or data is stored. The computer software or data stored on removable storage medium 580 is read into system 550 for execution by processor 560.

[0092] In alternative embodiments, auxiliary storage 570 may include other similar means for allowing computer programs or other data or instructions to be loaded into system 550. Such means may include, for example, external storage medium 595 and interface 570. Examples of external storage medium 595 may include external hard disk drives, external optical drives, or external magneto-optical drives.

[0093] Other examples of auxiliary memory 570 may include semiconductor-based memories such as programmable read-only memory (“PROM”), erasable programmable read-only memory (“EPROM”), electrically erasable read-only memory (“EEPROM”), or flash memory (block-oriented memory similar to EEPROM). Also included are any other removable storage media 580 and a communication interface 590, which allow software and data to be transferred from external media 595 to system 550.

[0094] System 550 may also include an input / output (“I / O”) interface 585. I / O interface 585 facilitates input and output from external devices. For example, I / O interface 585 can receive input from a keyboard or mouse and can provide output to a display. I / O interface 585 is capable of facilitating input and output from a variety of alternative types of human-machine interface and machine interface devices.

[0095] System 550 may also include a communication interface 590. Communication interface 590 allows software and data to be transferred between system 550 and external devices (e.g., printers), networks, or information sources. For example, computer software or executable code can be transferred from a network server to system 550 via communication interface 590. Examples of communication interfaces 590 include modems, network interface cards (“NICs”), wireless data cards, communication ports, PCMCIA slots and cards, infrared interfaces, and IEEE 1394 FireWire, etc.

[0096] Preferably, the communication interface 590 implements industry-standard protocols such as Ethernet IEEE 802, Fibre Channel, Digital Subscriber Line (“DSL”), Asynchronous Digital Subscriber Line (“ADSL”), Frame Relay, Asynchronous Transfer Mode (“ATM”), Integrated Digital Services Network (“ISDN”), Personal Communication Services (“PCS”), Transmission Control Protocol / Internet Protocol (“TCP / IP”), Serial Line Internet Protocol / Point-to-Point Protocol (“SLIP / PPP”), but custom or non-standard interface protocols may also be implemented.

[0097] Software and data transmitted via communication interface 590 typically take the form of electrical communication signals 605. These signals 605 are preferably provided to communication interface 590 via communication channel 600. In one embodiment, communication channel 600 may be a wired or wireless network or any other type of communication link. Communication channel 600 carries signals 605 and can be implemented using various wired or wireless communication methods, including wires or cables, optical fibers, traditional telephone lines, cellular telephone links, wireless data communication links, radio frequency (“RF”) links, or infrared links, etc.

[0098] Computer-executable code (i.e., computer programs or software) is stored in main memory 565 and / or auxiliary memory 570. The computer program can also be received via communication interface 590 and stored in main memory 565 and / or auxiliary memory 570. When executed, this computer program enables system 550 to perform the various functions of the present invention as described above.

[0099] In this specification, the term "computer-readable medium" is used to refer to any non-transitory computer-readable storage medium used to provide computer-executable code (e.g., software and computer programs) to system 550. Examples of such media include main memory 565, secondary storage 570 (including internal memory 575, removable media 580, and external storage media 595), and any peripheral device communicatively coupled to communication interface 590 (including a network information server or other network device). These non-transitory computer-readable media are means for providing executable code, programming instructions, and software to system 550.

[0100] In embodiments implemented using software, the software may be stored on a computer-readable medium and loaded into system 550 via removable medium 580, I / O interface 585, or communication interface 590. In such embodiments, the software is loaded into system 550 in the form of an electrical communication signal 605. When executed by processor 560, the software preferably causes processor 560 to perform the inventive features and functions described above.

[0101] System 550 also includes optional wireless communication components that facilitate wireless communication via voice and data networks. The wireless communication components include an antenna system 610, a radio system 615, and a baseband system 620. In system 550, radio frequency (“RF”) signals are transmitted and received through the air by the antenna system 610 under the control of the radio system 615.

[0102] In one embodiment, antenna system 610 may include one or more antennas and one or more multiplexers (not shown) that perform switching functions to provide transmit and receive signal paths for antenna system 610. In the receive path, received RF signals may be coupled from the multiplexer to a low-noise amplifier (not shown) that amplifies the received RF signals and transmits the amplified signals to radio system 615.

[0103] In alternative embodiments, radio system 615 may include one or more radio devices configured to communicate at various frequencies. In one embodiment, radio system 615 may combine a demodulator (not shown) and a modulator (not shown) in a single integrated circuit (“IC”). The demodulator and modulator may also be separate components. In the incoming path, the demodulator removes the RF carrier signal, leaving the baseband received audio signal transmitted from radio system 615 to baseband system 620.

[0104] If the received signal contains audio information, the baseband system 620 decodes the signal and converts it into an analog signal. The signal is then amplified and sent to a speaker. The baseband system 620 also receives analog audio signals from a microphone. These analog audio signals are converted into digital signals and encoded by the baseband system 620. The baseband system 620 also encodes the digital signals for transmission and generates a baseband transmission audio signal that is routed to the modulator section of the radio system 615. The modulator mixes the baseband transmission audio signal with an RF carrier signal to generate an RF transmission signal that is routed to the antenna system and can pass through a power amplifier (not shown). The power amplifier amplifies the RF transmission signal and routes it to the antenna system 610, where the signal is switched to the antenna port for transmission.

[0105] The baseband system 620 is also communicatively coupled to the processor 560. The central processing unit 560 accesses data storage areas 565 and 570. Preferably, the central processing unit 560 is configured to execute instructions (i.e., computer programs or software) that can be stored in memory 565 or auxiliary memory 570. The computer program can also be received from the baseband processor 610 and stored in data storage area 565 or auxiliary memory 570, or executed upon receipt. When executed, such a computer program enables system 550 to perform the various functions of the present invention as described above. For example, data storage area 565 may include various software modules (not shown) executable by processor 560.

[0106] Various embodiments can also be implemented primarily in hardware, for example using components such as application-specific integrated circuits (“ASICs”) or field-programmable gate arrays (“FPGAs”). The implementation of a hardware state machine capable of performing the functions described herein will also be apparent to those skilled in the art. Various embodiments can also be implemented using a combination of hardware and software.

[0107] Furthermore, those skilled in the art will recognize that the various illustrative logic blocks, modules, circuits, and method steps described with respect to the foregoing figures and embodiments disclosed herein can generally be implemented as electronic hardware, computer software, or a combination of both. To clearly demonstrate this interchangeability between hardware and software, the functionality of each illustrative component, block, module, circuit, and step has generally been described above. Whether such functionality is implemented as hardware or software depends on the specific application and design constraints imposed on the overall system. Those skilled in the art can implement the described functionality in different ways for each particular application, but such implementation decisions should not be construed as departing from the scope of the invention. Furthermore, the grouping of functions within modules, blocks, circuits, or steps is for ease of description. Specific functions or steps can be moved from one module, block, or circuit to another without departing from the invention.

[0108] Furthermore, the various illustrative logic blocks, modules, and methods described with respect to the embodiments disclosed herein can be implemented or performed using a general-purpose processor, a digital signal processor (“DSP”), an ASIC, an FPGA, or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. The general-purpose processor may be a microprocessor, but in alternative embodiments, the processor may be any processor, controller, microcontroller, or state machine. The processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration.

[0109] Alternatively, the steps of the methods or algorithms described with respect to the embodiments disclosed herein may be embodied directly in hardware, as software modules executed by a processor, or a combination of both. The software modules may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disks, removable disks, CD-ROMs, or any other form of storage medium, including network storage media. Exemplary storage media may be coupled to the processor, enabling the processor to read information from and write information to the storage medium. In alternative embodiments, the storage medium may be integral with the processor. The processor and storage medium may also reside in an ASIC.

[0110] The above description of the disclosed embodiments enables those skilled in the art to perform or use the invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles described herein can be applied to other embodiments without departing from the spirit or scope of the invention. Therefore, it should be understood that the specification and drawings presented herein represent currently preferred embodiments of the invention and thus represent the broad subject matter covered by the invention. It should be further understood that the scope of the invention fully encompasses other embodiments that will be obvious to those skilled in the art, and therefore the scope of the invention is not limited.

Claims

1. A device for promoting sleep in human subjects by delivering vestibular nerve stimulation, the device comprising: At least one electrode is configured to be placed in electrical contact with the human subject and close to the vestibular system of the human subject; as well as A current source, connected to the at least one electrode and configured to deliver vestibular nerve stimulation to the human subject, wherein the current source is configured to deliver the vestibular nerve stimulation using a square wave having a frequency of 0.25 Hz, a current range of 0.01 mA to 1 mA, and a duty cycle of 50%, and wherein the vestibular nerve stimulation includes a subsensory frequency that avoids causing the human subject to experience a swaying sensation.

2. The device of claim 1, further comprising a controller connected to the current source for controlling the duration of delivery of the vestibular nerve stimulation from 30 minutes to 1 hour.

3. The device as claimed in claim 1, wherein, The current source is also configured to deliver the vestibular nerve stimulation using an alternating square wave.

4. The device as claimed in claim 1, wherein, The vestibular nerve stimulation is delivered via bipolar, binaural application.

5. A device for treating insomnia in a human subject using vestibular nerve stimulation prior to the subject's desired sleep time, comprising: At least one electrode is configured to be placed in electrical contact with the human subject and close to the vestibular system of the human subject; as well as A current source, connected to the at least one electrode and configured to deliver vestibular nerve stimulation to the human subject, wherein the current source is configured to deliver the vestibular nerve stimulation using a square wave having a frequency of 0.25 Hz, a current range of 0.01 mA to 1 mA, and a duty cycle of 50%, and wherein the vestibular nerve stimulation includes a subsensory frequency that avoids causing the human subject to experience a swaying sensation.

6. The device of claim 5, further comprising a controller connected to the current source for controlling the duration of delivery of the vestibular nerve stimulation from 30 minutes to 1 hour.

7. The device as claimed in claim 5, wherein, The current source is further configured to deliver the vestibular nerve stimulation using an alternating square wave.

8. The device as claimed in claim 5, wherein, The vestibular nerve stimulation is delivered via bipolar, binaural application.

9. A device for promoting sleep in human subjects, the device comprising: Electrodes are arranged to make electrical contact with the scalp of the human subject at locations corresponding to the vestibular system of the human subject. as well as An electrical source electrically connected to these electrodes is used to deliver vestibular nerve stimulation to the human subject, wherein the electrical source delivers vestibular nerve stimulation at a subsensory frequency of 0.25 Hz for 30 to 60 minutes during 1 to several hours of the human subject's desired sleep time to avoid causing the human subject to feel a swaying sensation.

10. The device as claimed in claim 9, wherein, Delivery of this vestibular nerve stimulation involves using an alternating polarity square wave with a current range of 0.01 mA to 1 mA and a duty cycle of 50%.

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