Systems and methods for sleep induction

Abstract

This application relates to a system and method for sleep induction. A sleep induction device includes a headband, a plurality of transcranial stimulation electrodes, and control electronics for driving the electrodes. The sleep induction device can be worn by an awake user before attempting to sleep. The control electronics are configured to cause the stimulation electrodes to emit a sequence of stimulation waveforms separated by stimulation intervals. The stimulation waveforms may have low-delta waveform characteristics, which can characterize non-REM stage 3 sleep. The stimulation intervals may last approximately 4-8 seconds, and the stimulation intervals may last approximately 10 to 30 seconds. The sleep induction period may include multiple alternating stimulation and non-stimulation intervals. The sleep induction period may last approximately 5 to approximately 30 minutes.

Description

Technical Field

[0001] This application relates to a system and method for inducing sleep. Background Technology

[0002] Sleep is an essential activity for humans and other animals. Sleep can be characterized by: a period of inhibition of sensory activity; reduced muscle activity, especially voluntary muscle activity; and a general reduction in interaction with the surrounding environment. Several important physiological functions occur during sleep, including but not limited to processes involving metabolism, muscle and bone growth and repair, wound healing, and memory consolidation in the brain. Lack of sleep or quiet sleep may reduce or interfere with these processes and is also associated with cardiovascular disease and diabetes. Conditions that may inhibit sleep or quiet sleep include, but are not limited to, sleep apnea, bruxism, nocturia, restless legs syndrome, and insomnia.

[0003] Insomnia can be associated with difficulty falling asleep or waking up during normal sleep. Approximately 10% to 30% of the general population already exhibit some form of insomnia. However, the incidence of insomnia is likely much higher in older adults (65 years and older), possibly ranging from about 50% to 60% of that group. Higher levels of insomnia may be found in this age group. According to some surveys, approximately 60 million people in the United States alone suffer from some form of insomnia.

[0004] Some approaches to managing insomnia may involve using medication to help induce or promote sleep. Examples of such medications include melatonin, benzodiazepines, sedatives, and sedative / hypnotic drugs such as zolpidem. Melatonin can help users fall asleep, but the onset of sleep may only be about 15 minutes faster than without medication. Among other risks, users of benzodiazepines and zolpidem may face the risk of psychological or physical dependence. Therefore, alternative medications for inducing sleep that do not carry the risks associated with medication are desirable. Summary of the Invention

[0005] Systems and methods for inducing sleep using time-varying currents (transcranial electrical stimulation or tES) applied to the head of an awake individual are disclosed. In one aspect, the systems and methods may include the use of a device worn immediately before sleep to deliver the intervention. The device may require two sets of electrodes, with anodes positioned near the top of the forehead on both sides and approximately above each eye, and cathodes positioned behind the ears on the mastoid bone approximately on the same side as each pair of anodes. In one instance, the electrodes may deliver a slow time-varying current between approximately 0.5 Hz and approximately 4 Hz for less than 120 minutes. This slow time-varying current is believed to slow neural activity and synchronize it to more closely resemble the brain state during sleep. In another aspect, sensory stimulation may also be applied, which may be modulated at the same frequency or harmonic frequency as the tES. The sensory stimulation signal may be delivered with a consistent time delay relative to the slow time-varying current of the transcranial stimulation current (i.e., the sensory stimulation signal and the transcranial stimulation current may be phase-locked). In some aspects, there may be no time delay between the sensory stimulation signal and the transcranial electrical stimulation signal, and therefore the two signals may be delivered in phase. In some other respects, the time delay between the sensory stimulation signal and the transcranial electrical stimulation signal may cause the two signals to be delivered out of phase. The sensory stimulation can include any form of sensory stimulation, which can include visual or auditory stimulation.

[0006] In one aspect, a device for inducing sleep in a conscious user may include a headband having: a headband; a plurality of transcranial stimulation electrodes disposed within the headband; and a control system disposed within the headband and electrically connected to the plurality of transcranial stimulation electrodes. The control system may further include a processor and a memory device configured to store instructions. When executed by the processor, the instructions may cause the processor to alternately transmit transcranial stimulation current to the plurality of transcranial stimulation electrodes for a first time period; and then cease transmitting the transcranial stimulation current for a second time period. The transcranial stimulation current may be characterized by a transcranial stimulation waveform, and the transcranial stimulation waveform may have low-delta waveform amplitude and frequency characteristics.

[0007] In one aspect, a system for inducing sleep in a conscious user may include a mobile communication device and a headgear. The headgear may include a headband, a plurality of transcranial stimulation electrodes, and a control system disposed within the headband and electrically connected to the plurality of transcranial stimulation electrodes. The control system may further include: an antenna configured to receive wireless communication signals from the mobile communication device; a processor communicating data with the antenna; and a memory device. The memory device may be configured to store instructions that, when executed by the processor, cause the processor to: receive one or more signals transmitted by the mobile communication device via the antenna; transmit a transcranial stimulation current to the plurality of transcranial stimulation electrodes based on the one or more signals received from the mobile communication device, for a first time period; and stop transmitting the transcranial stimulation current based on the one or more signals received from the mobile communication device, for a second time period. The transcranial stimulation current may be characterized by a transcranial stimulation waveform, and the transcranial stimulation waveform may have low-delta waveform amplitude and frequency characteristics. Attached Figure Description

[0008] Figure 1 An example of a user of a sleep-inducing device having a head cap placed on the head, according to one aspect of this disclosure, is depicted.

[0009] Figure 2A Depicting one aspect of this disclosure Figure 1 The example of the headgear demonstrates several of its components.

[0010] Figure 2B Depicting one aspect of this disclosure Figure 2A A detailed schematic diagram of the control electronics is shown.

[0011] Figure 3A and 3B An example of the location of stimulation electrodes when a head cap is worn on the head, according to one aspect of this disclosure, is shown.

[0012] Figure 4 The application of electrical stimulation and sensory stimulation to a user of a sleep induction device according to one aspect of the present disclosure is illustrated graphically.

[0013] Figure 5 A side view of the human brain according to one aspect of this disclosure is shown, depicting its various functional areas.

[0014] Figure 6 An example of a human EEG record during non-REM sleep stage 3 is depicted according to one aspect of this disclosure.

[0015] Figure 7One aspect of the AC current stimulation waveform according to one aspect of this disclosure is depicted.

[0016] Figure 8A and 8B Various aspects of the DC current stimulation waveform according to the present disclosure are depicted.

[0017] Figure 9 This is a block diagram of a method for using a sleep induction system including a headgear, according to one aspect of this disclosure. Detailed Implementation

[0018] As disclosed above, there is a desire to provide a drug-free treatment for insomnia. Such treatments may not have the same adverse effects as such medications, which may include dependence and the risk of adverse interactions with other medications taken by the insomnia patient. In one potential treatment, the patient may undergo non-invasive transcranial electrical stimulation. Such stimulation may, for example, consist of electrical waveforms similar to those naturally present in the brain when the patient is asleep. It is believed that external stimulation of the waking brain with waveforms similar to those generated during sleep may make the brain more likely to generate similar waveforms. In this way, the brain can be stimulated to initiate the process of entering a sleep state. This article discloses a system and method for inducing sleep by non-invasive transcranial electrical stimulation.

[0019] On one hand, a non-invasive transcranial sleep induction system may include a head cap that is configured to be worn by a person when awake and before going to bed. Figure 1 An example of such a headgear 100, worn by a conscious person before going to sleep, is shown. The headgear 100 may comprise a cloth or elastic headband 110, which may be positioned on the forehead and wrapped around the perimeter of the head. The headband 110 may be made of an elastic material to allow it to conform to the shape of the head. The headband 110 may be continuous or may comprise two end portions that can be fastened together (see [link to documentation]). Figure 2A (240 in the original text). The two end portions 240 can be fastened together by one or more means. Such fasteners can include, but are not limited to, clips, hook and loop fasteners, buttons, snaps, or any other type of fastener configured to secure the two ends of a cloth or elastic material together. On one hand, the headband 110 may consist only of material wrapped around the sides of the head. On the other hand, the headband may also include additional material 120 that spans across the top of the head and connects to the portion of the headband 110 that contacts the forehead and the portion of the headband 110 that contacts the back of the head.

[0020] Figure 2A Depicting Figure 1The headgear 100 is shown, and some of its components are illustrated. In addition to the headband, the headgear may include one or more EEG electrodes 210 and one or more stimulating electrodes 220a, 220b, 220a', 220b'. In some aspects, the EEG electrodes 210 may comprise silver / silver chloride electrodes. In some aspects, the stimulating electrodes 220a, 220b, 220a', 220b' may comprise hydrogel electrodes. It is understood that the EEG electrodes 210 and the stimulating electrodes 220a, 220b, 220a', 220b' are not limited to the types explicitly disclosed herein. Both the EEG electrodes 210 and the stimulating electrodes 220a, 220b, 220a', 220b' may be positioned to allow the respective electrode surfaces to contact the skin of the head. In some non-limiting examples, the headgear 100 may include multiple EEG electrodes 210. In some non-limiting examples, the head cap 100 may contain one, two, three, four, or any integer number of EEG electrodes 210. Similarly, the head cap 100 may contain one or more pairs of stimulating electrodes 220a, 220b. In some non-limiting examples, the head cap 100 may contain one, two, three, four, or any integer number of pairs of stimulating electrodes 220a, 220b, 220a', 220b'.

[0021] The headgear 100 may also include control electronics 230. Figure 2B The control electronics 230 is illustrated in more detail below. The control electronics 230 is configured to receive EEG signals 212 from EEG electrodes 210 and to provide transcranial stimulation currents 222 to stimulation electrodes 220a, 220b, 220a', and 220b'. In some aspects, the control electronics 230 may include a processor 250 and a memory component 260 configured to contain instructions, which, when executed by the processor 250, cause the processor 250 to receive the EEG signals 212 from the EEG electrodes 210 and to transmit transcranial stimulation currents 222 to the stimulation electrodes 220a, 220b, 220a', and 220b'. The control electronics 230 may also include one or more input amplifiers and / or filters 272 to receive, amplify, and filter the EEG signals 212 received from the EEG electrodes 210. In some instances, the control electronics 230 may also include components such as an analog-to-digital converter 274, which can convert an amplified and filtered EEG signal into an equivalent digital signal, which can be received by the processor 250 and stored in the memory component 260.

[0022] The control electronics 230 may also include components including a digital-to-analog converter 282 for receiving digital data relating to the stimulation waveform from the processor 250. The digital-to-analog converter 282 can convert the digital stimulation signal from the processor 250 into an analog signal that can be further amplified and filtered by an output amplifier and / or filter 284. The amplified analog stimulation signal can be supplied to a current driver 286 to provide the desired analog stimulation current 222 to the stimulation electrodes 220a, 220b, 220a', 220b'. In some aspects, the control electronics 230 may also include circuitry configured to limit the output current 222 to the stimulation electrodes 220a, 220b, 220a', 220b' to a predetermined value. In some aspects, the current driver 286 may include functionality for limiting the output current 222 to the stimulation electrodes 220a, 220b, 220a', 220b'. In one example, the output current 222 to the stimulating electrodes 220a, 220b, 220a', and 220b' can be limited to approximately 4 mA. In another example, the output current to the stimulating electrodes can be limited to approximately 250 μA. Other ranges of current output values ​​can be found between these two values. In some non-limiting instances, the output current to the stimulating electrodes 220a, 220b, 220a', 220b' may be limited to about 10 μA, about 50 μA, about 100 μA, about 150 μA, about 200 μA, about 250 μA, about 300 μA, about 350 μA, about 400 μA, about 450 μA, about 500 μA, about 550 μA, about 600 μA, about 650 μA, about 700 μA, about 750 μA, about 800 μA, about 850 μA, about 900 μA, about 950 μA, about 1 mA, about 2 mA, about 3 mA, about 4 mA, or any value or range thereof.

[0023] Additionally, control electronics 230 may include one or more antennas 290 configured to receive wireless communications from and transmit wireless communications to the mobile device. Memory component 260 may contain additional instructions that, when executed by processor 250, cause processor 250 to interpret the received wireless communications and perform functions based on the received communications. In a non-limiting example, processor 250 may interpret the received wireless communications as defining one or more values ​​of the waveform of transcranial stimulation current 222. Memory component 260 may also contain instructions that, when executed by processor 250, cause processor 250 to transmit wireless communications to the mobile device. The transmitted communications may include, but are not limited to, data regarding the state of headgear 100, data defining one or more EEG signals 212 received from the user of headgear 100, or other relevant data.

[0024] In some aspects, the control electronics 230 may be stored in a bag or pouch housed within the headband 110. The control electronics 230 may include one or more control switches (e.g., on / off switches) for controlling the operation of the control electronics 230. The control electronics 230 may also include one or more indicators related to the operation of the control electronics 230. For example, optical indicators (such as indicator light 234) may indicate the power status of the control electronics 230 or the wireless connection status of the control electronics 230 with a mobile communication device.

[0025] Figure 3A and 3B The diagram schematically depicts some exemplary locations of the stimulating electrodes 220a, 220b, 220a', and 220b' when positioned on the user's head. In some respects, the stimulating electrodes 220a, 220b, 220a', and 220b' can consist of one or more pairs of electrodes. Figure 3 depicts two pairs of electrodes (320a, 320b and 320a', 320b'). Each pair of electrodes can include an anterior electrode (320a, 320a') and a posterior electrode (320b, 320b'). In some instances, the anterior electrode (320a, 320a') of the electrode pair can be positioned on the forehead near the frontal cortex or prefrontal cortex. Using an internationally recognized 10-20 cranial electrode positioning system, one or more anterior stimulating electrodes (320a, 320a') can be placed in frontal pole (FP) 1 or 2 positioning. Figure 3B As shown, the prestimulatory electrode 320a can be positioned at or near (FP)1, and the prestimulatory electrode 320a' can be positioned at or near (FP)2. In alternative examples, one or more prestimulatory electrodes (320a, 320a') can be placed in frontal (F)3 or 4 positions. For example, prestimulatory electrode 320a can be placed near frontal (F)3 position (not shown), and prestimulatory electrode 320a' can be placed near frontal (F)4 position (not shown). One or more electrodes placed in F3 or F4 positions can be placed near the dorsal / lateral prefrontal cortex.

[0026] The posterior stimulating electrodes 320b and 320b' can be placed on the skin covering the mastoid process, at location A1 or 2. The posterior stimulating electrodes 320b and 320b' can be located near the inferior lateral temporal lobe cortex. It will be appreciated that for each pair of stimulating electrodes 320a, 320b or 320a', 320b', the posterior electrode (e.g., 320b) is located on the same side of the head as the anterior stimulating electrode (e.g., 320a). One or more posterior electrodes 320b and 320b' can be located at alternative sites at the back of the head. However, since hair may interfere with the ability of the posterior electrodes 320b and 320b' to properly conduct current, location A1 or 2 is likely preferred for most users of the headgear 100.

[0027] One or more EEG electrodes 210 can be located at any convenient position on the user's head. As an example and as... Figure 2A As depicted, one or more EEG electrodes 210 may be substantially collinear with the prestimulation electrodes. Therefore, one or more EEG electrodes 210 may be located near the user's frontal or prefrontal cortex. Similarly, hair may interfere with the function of the EEG electrodes 210 and may reduce the sensitivity of the EEG electrodes 210 to EEG waveforms generated by the brain. Therefore, one or more EEG electrodes 210 may preferably be located within the headgear 100 to directly contact the forehead skin near the user's frontal or prefrontal cortex.

[0028] The headgear 100 can be integrated into a sleep induction system. The sleep induction system may also include a mobile computing device, which may contain user software (such as a software application) configured to cooperate with the control electronics 230 of the headgear 100. Non-limiting examples of the mobile computing device may include a mobile phone, smartphone, tablet computer, or similar device. The mobile computing device may communicate with the control electronics 230 via a wireless connection (such as, but not limited to, Bluetooth™, Bluetooth Low Energy™, WiFi, or other wireless connections). In some aspects, the mobile computing device may communicate with the control electronics 230 via a wired connection such as a serial link. It is understood that the mobile computing device may include a processor, a memory device, and one or more interface devices. The memory device may contain instructions as user software or an application program, which can be executed by the processor to implement one or more functions. One or more interface devices may be used to receive input from the user to guide one or more functions of the mobile device. Alternatively, one or more interface devices may be used to provide output information to the user, such as information relating to the status or function of the mobile device or the sleep induction system. Such interface devices may include one or more buttons, a keyboard, a touchpad, or a microphone for receiving user voice commands. User interface devices may include one or more visual screens, light sources, or audio sources for user output.

[0029] User software (or "app") installed on a mobile computing device allows the user to control the operation of the control electronics 230 of the headgear 100. In one aspect, the user can use the app to start and stop transcranial stimulation periods. In another aspect, the user can use the app to adjust timing parameters associated with transcranial stimulation periods. In yet another aspect, the user can use the app to adjust the type of stimulation waveform applied to the stimulation electrodes 220a, 220b. In yet another aspect, the user can use the app to activate or deactivate one or more sensory stimuli that can operate simultaneously with the stimulation waveforms. In yet another aspect, the user can use the app to record EEG waveforms from the user while awake or asleep. In some aspects, the app residing in the mobile computing device may include a user interface that the user can use to control the functions of the app. The user interface may include, but is not limited to, icons that, when activated, can activate one or more functions of the app. The user interface may also include space for receiving text commands input by the user (e.g., via a touchscreen keyboard). The user interface may also display information to the user about a sleep induction program that the user has programmed into the mobile device. The user interface may provide the user with any other type of useful information about the sleep induction system or program.

[0030] In one respect, the sleep induction system can be used as follows. While awake, the user can place the headgear 100 on their head and adjust the headband 110 as needed to ensure physical contact between the electrodes and the appropriate portion of the head. The user can then power on the control electronics 230. The user can activate an application on a mobile device to control the transcranial stimulation current generated by the headgear 100 during the duration of the stimulation period. The stimulation period can consist of electrical stimulation time intervals separated by non-stimulation intervals. The stimulation time intervals can range from approximately 4 seconds to approximately 8 seconds. Some non-limiting examples of stimulation time intervals can include approximately 4 seconds, approximately 5 seconds, approximately 6 seconds, approximately 7 seconds, approximately 8 seconds, or any value or range of values ​​(including endpoints) thereof. The non-stimulation intervals can range from approximately 1 second to approximately 60 seconds. Non-limiting examples of such stimulus intervals may include any value or range of values ​​(including endpoints) of approximately 1 second, approximately 5 seconds, approximately 10 seconds, approximately 15 seconds, approximately 20 seconds, approximately 25 seconds, approximately 30 seconds, approximately 35 seconds, approximately 40 seconds, approximately 45 seconds, approximately 50 seconds, approximately 55 seconds, approximately 60 seconds, or more. Stimulation periods may range from approximately 5 minutes to approximately 120 minutes, wherein consecutive stimulus periods are separated by stimulus intervals. Non-limiting examples of the duration of a stimulus period may include any value or range of values ​​(including endpoints) of approximately 5 minutes, approximately 10 minutes, approximately 20 minutes, approximately 30 minutes, approximately 40 minutes, approximately 50 minutes, approximately 60 minutes, approximately 70 minutes, approximately 80 minutes, approximately 90 minutes, approximately 100 minutes, approximately 110 minutes, approximately 120 minutes, or more.

[0031] It can be recognized that the duration of stimulation intervals, stimulation intervals, and stimulation periods can be adjusted individually or collectively to optimize sleep induction for a specific user. In some aspects, a stimulation cycle can consist of a single stimulation interval followed by a single stimulation interval. A stimulation period can consist of multiple sequential stimulation cycles. Each stimulation cycle can be characterized by a stimulation duty cycle, which can be calculated as the ratio of the stimulation interval to the total duration of the stimulation cycles. The exemplary values ​​of transcranial stimulation disclosed above can be considered in the following manner: The stimulation waveform can approximate a delta waveform having a time interval between approximately 0.5 seconds and approximately 2.0 seconds. The duration of a single stimulation interval can range from approximately 4 seconds to approximately 8 seconds. Thus, a single stimulation interval can contain from approximately 2 delta waveforms to approximately 16 delta waveforms. As disclosed above, the stimulation interval can last from approximately 10 seconds to approximately 60 seconds. By defining a stimulation cycle as consisting of a stimulation interval and a stimulation interval value, the range of the stimulation cycle can be between approximately 14 seconds and approximately 68 seconds. In the examples disclosed above, the duty cycle of such stimulation cycles can therefore range between approximately 6% and approximately 57%. However, in an unrestricted context, alternative duty cycles can range between approximately 5% and approximately 95%. Non-limiting examples of the duty cycle include approximately 5%, approximately 15%, approximately 25%, approximately 35%, approximately 45%, approximately 55%, approximately 65%, approximately 75%, approximately 85%, approximately 95%, or any value or range of values ​​(inclusive) between these values. Therefore, all these parameters of the sleep induction period—including the type of sensory stimulation, the length of the stimulation period, the length of the non-stimulatory interval, the duty cycle of the stimulation cycle, and the length of the sleep induction period—can be programmed by the user in the mobile device via the application's user interface.

[0032] In some aspects, the sleep induction system may also provide additional sensory stimulation that is phase-locked with the transcranial electrical stimulation (TCS). It is understood that if the phase difference between two signals does not change (or does not change significantly) over time, the two signals can be considered phase-locked with each other. Non-limiting examples of such sensory stimulation may include visual and auditory stimulation. In some aspects, an application programmed in a mobile device may include graphic stimulation for viewing on a visual display of the mobile device, thereby providing visual stimulation. The visual stimulation displayed on the visual display of the mobile device may include one or more visual characteristics modulated in accordance with the TCS waveform. Non-limiting examples of such modulated visual characteristics may include display brightness, display color, patterns on the display, or any combination or combination thereof. It is understood that modulation of one or more visual characteristics means modulating one or more visual characteristics at the frequency of the TCS waveform or harmonics of said frequency. Thus, if the TCS waveform is a human delta wave waveform (frequency range between about 0.5 Hz and about 2 Hz), the visual characteristics may be modulated at the delta wave frequency or any positive integer multiple (harmonic) of the delta wave frequency.

[0033] The mobile device can also provide auditory sensory stimulation. In some instances, the auditory stimulation can be played through the mobile device's speaker. In another instance, the auditory stimulation can be provided as an output to headphones or earphones that can be plugged into the auditory output jack of the mobile device. The auditory stimulation can include one or more auditory characteristics modulated in accordance with the transcranial electrical stimulation waveform. Non-limiting examples of modulating auditory characteristics can include auditory amplitude, auditory frequency, or a combination of both. It is understood that modulation of one or more auditory characteristics means modulating one or more auditory characteristics at the frequency of the transcranial electrical stimulation waveform or harmonics of said frequency. Thus, if the transcranial electrical stimulation waveform is a human delta wave waveform (frequency range between about 0.5 Hz and about 2 Hz), the auditory characteristics can be modulated at the delta wave frequency or any positive integer multiple (harmonic) of the delta wave frequency.

[0034] Figure 4 It demonstrates the application of transcranial electrical stimulation along with one or more sensory stimuli for sleep induction. Figure 4 The graphs depicting the electrical amplitude of the transcranial electrical stimulation waveform 420 versus time, and the sensory amplitude of the sensory stimulation waveform 425 versus time, are shown. For example, the sensory stimulation waveform 425 can be associated with auditory stimulation. (The last sentence appears to be incomplete and possibly refers to a different topic.) Figure 4 It can be seen that the modulation frequency of the sensory stimulation waveform 425 has approximately the same frequency as that of the electrical stimulation waveform 420. Furthermore... Figure 4As depicted in the diagram, as indicated by line 427, the two waveforms (420 and 425) are phase-locked. It can be recognized that the maximum amplitude values ​​of the transcranial electrical stimulation waveform 420 and the sensory stimulation waveform 425 are consistent. However, it can be recognized that the two phase-locked signals do not need to be consistent. As disclosed above, if the phase difference between the first and second signals is practically time-invariant, then the first signal can be phase-locked relative to the second signal. Therefore, Figure 4 The transcranial electrical stimulation waveform 420 and sensory stimulation waveform 425 depicted herein may have a phase difference of approximately 0, thus being synchronized. Alternatively, the transcranial electrical stimulation waveform 420 and sensory stimulation waveform 425 may have a non-zero phase difference. As a non-limiting example, the phase difference between the transcranial electrical stimulation waveform 420 and sensory stimulation waveform 425 may be approximately 180°, thus being out of phase.

[0035] Figure 5 This diagram illustrates parts of the brain that may respond to transcranial electrical stimulation and sensory stimulation. The general layout of the human brain may include: the prefrontal cortex 510, the somatic motor association area (premotor cortex) 515, the primary motor cortex in the precentral gyrus 520, the primary sensory cortex in the postcentral gyrus 525, the somatic sensory association area 530, the visual association area 535, the visual cortex 540, the language cortex (Wernicke's area) 545, the auditory cortex 550, the auditory association area 555, and Broca's area (language production) 560. Reference Figure 3A , 3B The transcranial electrical stimulation electrodes 320a and 320a' can be located near the prefrontal cortex 510, for example, at 580. It can be recognized that pairing visual stimulation with transcranial electrical stimulation may induce coordinated stimulation of region 582, which is adjacent to or contains the visual association area 535 and the visual cortex 540. Similarly, it can be recognized that pairing auditory stimulation with transcranial electrical stimulation may induce coordinated stimulation of region 584, which is adjacent to or contains the language cortex (Wernicke's area) 545, the auditory cortex 550, and the auditory association area 555.

[0036] Transcranial electrical stimulation can produce waveforms similar to those produced by the user's brain during sleep (e.g., during non-REM stage 3 sleep). Figure 6An example of this EEG waveform 600 is depicted, which has an amplitude measured in μV and a duration measured in seconds. The waveform may have a relatively large amplitude (peak-to-trough) and may be characterized by time periods corresponding to frequencies in the range of approximately 0.5 Hz to approximately 2 Hz. Non-limiting examples of the waveform's frequency may include any value or range of values ​​(inclusive) of approximately 0.5 Hz, approximately 0.55 Hz, approximately 0.6 Hz, approximately 0.65 Hz, approximately 0.7 Hz, approximately 0.75 Hz, approximately 0.8 Hz, approximately 0.85 Hz, approximately 0.9 Hz, approximately 0.95 Hz, approximately 1.0 Hz, approximately 1.5 Hz, approximately 2.0 Hz, or between these values. This frequency may correspond to the frequency of the low delta waves 610 of a sleeping user.

[0037] In one instance, the transcranial electrical stimulation waveform can be characterized by a frequency of approximately 0.75 Hz. In some instances, such as... Figure 7 The described transcranial electrical stimulation waveform 710 can be a waveform recorded from a sleeping patient (see [link to original text]). Figure 6 The recorded EEG signal 600 (segment 610). The low-δ waveform of this recording can have a bipolar voltage range in terms of amplitude values ​​(positive and negative). In some alternative instances, such as Figure 8A The described transcranial electrical stimulation waveform 810 can be a recorded low-δ waveform with an amplitude shifted to the unipolar (positive only) range. In yet another example, such as Figure 8B The described transcranial electrical stimulation waveform 815 can be a monopolar envelope of the recorded low-δ waveform with amplitude shift.

[0038] In some aspects, the transcranial electrical stimulation waveform may have been previously recorded from the user. In this regard, the user may wear a headgear 100 during sleep, and EEG electrodes 210 may record the user's EEG activity 600 during sleep. An application on the mobile device may have the capability to receive, analyze, and record the user's EEG activity 600 during sleep. The application may include algorithms specifically designed to detect non-REM sleep activity and record appropriate low-delta phase EEG signals (e.g., 610). The application can then use this waveform (e.g., 710) as the transcranial electrical stimulation waveform during sleep induction. In one aspect, the low-delta waveform may be constructed from the overall average of multiple low-delta waveforms recorded from the user during sleep. In another aspect, the low-delta waveform may be constructed from the overall average of low-delta waveforms recorded from multiple sleepers. In this case, it may not be necessary for a specific user to wear a headgear during sleep to record a user-specific waveform. According to one aspect, the mobile device application may be configured to transmit information characterizing the transcranial stimulation waveform to the control electronics 230 of the headgear 100. In some respects, users can determine which type of waveform to use during sleep induction—user-specific waveform, amplitude-shifted waveform, waveform envelope, or overall waveform. Users can configure a mobile device application to transmit the desired waveform to the headgear.

[0039] Figure 9 One aspect of a method for using a system for inducing sleep is outlined. In one example, a user can use an application on a mobile device to select the type of transcranial stimulation waveform and the type 910 of sensory stimulation waveform. As disclosed above, the user can select parameters for controlling the two waveforms (such as the stimulation duration and the length of the stimulation interval). The user can also select the duration of the stimulation period (defined by multiple stimulation durations separated by stimulation intervals). In some cases, the user can also control the amplitude of the transcranial stimulation waveform and the sensory stimulation waveform. In some cases, a healthcare professional can determine the characteristics of the waveforms. Then, based on the control software in the application, the system can apply both the transcranial stimulation waveform 915 and the sensory stimulation waveform 920, coordinating their respective modulations. These stimuli can then be applied to the user before they fall asleep.

[0040] Various aspects of this disclosure have been shown and described. Further adaptations of the methods and systems described herein can be made by those skilled in the art through appropriate modifications without departing from the scope of this disclosure. Several potential modifications of this kind have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, aspects, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not required. Therefore, the scope of this disclosure should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

[0041] While various details have been set forth in the foregoing description, it should be understood that various aspects of systems and methods for using sleep enhancement during sleep can be practiced without these specific details. Those skilled in the art will recognize that the components (e.g., operations), devices, objects, and the accompanying discussions described herein are used as examples to clarify concepts, and various configuration modifications are contemplated. Therefore, as used herein, the specific examples and accompanying discussions are intended to represent a more general category of the examples. In general, the use of any specific example is intended to represent the category of the examples, and the omission of specific components (e.g., operations), devices, and objects should not be considered limiting.

[0042] Furthermore, while several forms have been shown and described, the applicant's intention is not to limit or restrict the scope of the appended claims to such details. Many modifications, variations, alterations, substitutions, combinations, and equivalents of those forms can be implemented without departing from the scope of this disclosure, and such modifications, variations, alterations, substitutions, combinations, and equivalents will be apparent to those skilled in the art. Moreover, the structure of each element associated with a described form can alternatively be described as a component for providing the function performed by said element. Furthermore, where the materials of certain components are disclosed, other materials may be used. Therefore, it should be understood that the foregoing description and the appended claims are intended to cover all such modifications, combinations, and variations falling within the scope of the disclosed forms.

[0043] For the sake of brevity and clarity, selected aspects of the foregoing disclosure have been shown in block diagram form rather than in detail. Some portions of the detailed description provided herein can be presented according to instructions for manipulating data stored in computer memory. Such descriptions and representations are used by those skilled in the art to describe and communicate the substance of their work to others skilled in the art. Generally, an algorithm refers to a self-consistent sequence of steps that produces a desired result, where a "step" refers to the manipulation of a physical quantity, which may (but does not necessarily) take the form of electrical or magnetic signals capable of being stored, transmitted, combined, compared, and otherwise manipulated. These signals are typically referred to as bits, values, elements, symbols, characters, terms, numbers, etc. These terms and similar terms may be associated with appropriate physical quantities and are merely convenient labels applied to these quantities.

[0044] Unless otherwise specifically stated, as is apparent from the foregoing disclosure, it should be understood that throughout the foregoing disclosure, discussions using terms such as “processing,” “operation,” “calculation,” “determining,” or “displaying” refer to the actions and processes of a computer system or similar electronic computing device that manipulates and converts data represented as physical (electronic) quantities in the registers and memories of the computer system into other data represented in a similar manner as physical quantities in the computer system’s memory or registers or other such information storage, transmission, or display devices.

[0045] In a general sense, those skilled in the art will recognize that the aspects described herein, which can be implemented individually and / or jointly by a wide variety of hardware, software, firmware, or any combination thereof, can be considered as constituting various types of "circuit systems." Therefore, "circuit system" as used herein includes, but is not limited to: circuit systems having at least one discrete circuit; circuit systems having at least one integrated circuit; circuit systems having at least one application-specific integrated circuit; circuit systems forming general-purpose computing devices configured by computer programs (e.g., general-purpose computers configured by computer programs that at least partially execute the processes and / or devices described herein, or microprocessors configured by computer programs that at least partially execute the processes and / or devices described herein); circuit systems forming memory devices (e.g., various forms of random access memory); and / or circuit systems forming communication devices (e.g., modems, communication switches, or optoelectronic devices). Those skilled in the art will recognize that the subject matter described herein can be implemented in an analog or digital manner, or some combination thereof.

[0046] The foregoing detailed description has illustrated various forms of apparatus and / or processes using block diagrams, flowcharts, and / or examples. Where such block diagrams, flowcharts, and / or examples contain one or more functions and / or operations, those skilled in the art will understand that each function and / or operation within such block diagrams, flowcharts, or examples can be implemented individually and / or collectively by a wide variety of hardware, software, firmware, or virtually any combination thereof. In one form, several portions of the subject matter described herein can be implemented by application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), digital signal processors (DSPs), or other forms of integration. However, those skilled in the art will recognize that some aspects of the forms disclosed herein can be implemented, in whole or in part, equivalently in integrated circuits as one or more computer programs running on one or more computers (e.g., one or more programs running on one or more computer systems), one or more programs running on one or more processors (e.g., one or more programs running on one or more microprocessors), firmware, or virtually any combination thereof, and that, in light of this disclosure, designing circuit systems and / or writing software and / or firmware code will be entirely within the capabilities of those skilled in the art. Furthermore, those skilled in the art will understand that the mechanisms of the subject matter described herein can be distributed as program products in various forms, and the illustrative form of the subject matter described herein applies regardless of the specific type of signal-bearing medium used to actually perform the distribution. Examples of signal-bearing media include, but are not limited to, the following: recordable media, such as floppy disks, hard disks, optical discs (CDs), digital video discs (DVDs), digital magnetic tapes, computer memory, etc.; and transmission media, such as digital and / or analog communication media (e.g., fiber optic cables, waveguides, wired communication links, wireless communication links (e.g., transmitters, receivers, transmission logic, receiving logic, etc.)).

[0047] In some instances, the terms “coupled” and “connected” and their derivatives may be used to describe one or more elements. It should be understood that these terms are not intended to be synonyms. For example, the term “connected” may be used to describe aspects indicating that two or more elements are in direct physical or electrical contact with each other. In another instance, the term “coupled” may be used to describe aspects indicating that two or more elements are in direct physical or electrical contact with each other. However, the term “coupled” may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other. It should be understood that the depicted architectures of different components housed within or connected to different other components are merely examples, and many other architectures can actually be implemented to achieve the same functionality. Conceptually, any arrangement of components used to achieve the same functionality is effectively “associated” so that the desired functionality is realized. Therefore, any two components combined herein to achieve a particular function can be considered “associated” with each other so that the desired functionality is realized, regardless of the architecture or intermediate components. Similarly, any two components thus associated can be considered as "operably connected" or "operably coupled" to each other to achieve the desired function, and any two components that can be thus associated can also be considered as "operably coupled" to each other to achieve the desired function. Specific examples of being operably coupled include, but are not limited to, components that can physically cooperate and / or physically interact, and / or components that can wirelessly interact and / or components that can logically interact and / or components that can logically interact.

[0048] In other instances, one or more components may be referred to herein as “configured to,” “configurable to,” “operable to,” “adaptable,” “capable of,” “adaptable,” etc. Those skilled in the art will recognize that “configured to” can generally encompass active state components and / or inactive state components and / or standby state components, unless the context requires otherwise.

[0049] While specific aspects of this disclosure have been shown and described, it will be apparent to those skilled in the art that changes and modifications can be made based on the teachings herein without departing from the subject matter and its broader aspects described herein, and therefore, the scope of the appended claims will cover all such changes and modifications falling within the true scope of the subject matter described herein. Those skilled in the art will understand that, in general, the terminology used herein, particularly in the appended claims (e.g., the body of the appended claims), is generally intended to be “open-ended” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “including but not limited to,” etc.). Those skilled in the art will further understand that if a particular number is intended in the introduced claim, then this intention will be expressly stated in the claim, and if such a statement is not present, then this intention is not present. For example, to aid understanding, the appended claims may contain the use of the introductory phrases “at least one” and “one or more” to introduce the claim statement. However, the use of such phrases should not be construed as implying that a claim statement introduced by the indefinite article "a" or "an" limits any particular claim containing such an introduced claim statement to a claim containing only one such statement, even when the same claim contains the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim statements.

[0050] Furthermore, even when a specific number of the introduced claim statements are explicitly stated, those skilled in the art will recognize that such statements should generally be interpreted as referring to at least the stated number (e.g., in the absence of other modifiers, simply stating "two statements" generally means at least two statements or two or more statements). Moreover, in cases where idiomatic expressions such as "at least one of A, B, and C, etc." are used, generally, such constructions are intended to be understood by those skilled in the art as such idiomatic expressions (e.g., "a system having at least one of A, B, and C" would include, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.). In cases where idiomatic expressions such as "at least one of A, B, or C, etc." are used, the intention of such constructions is generally that those skilled in the art will understand that the idiomatic expressions (e.g., "a system having at least one of A, B, or C" would include, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.). Those skilled in the art will further understand that, generally, whether in the specification, claims, or drawings, separating words or phrases presenting two or more alternative terms should be understood to account for the possibility of including one of the terms, any one of the terms, or both of the terms, unless the context otherwise indicates. For example, the phrase "A or B" would typically be understood to include the possibility of "A" or "B" or "A and B".

[0051] Regarding the appended claims, those skilled in the art will understand that the operations described herein can generally be performed in any order. Furthermore, although various flows of operations are presented in one or more sequences, it should be understood that the operations can be performed in other orders than those shown, or that the operations can be performed simultaneously. Examples of such alternative orderings may include overlapping, interleaving, interrupted, reordered, ascending, preparatory, supplementary, simultaneous, inverted, or other varied orderings, unless the context otherwise requires. Moreover, terms such as “in response to,” “related to,” or other past tense adjectives are generally not intended to exclude such variations, unless the context otherwise requires.

[0052] It is important to note that any reference to "one aspect" or "an aspect" or "one form" implies that a particular feature, structure, or characteristic described in connection with said aspect is included in at least one aspect. Therefore, the phrases "in one aspect" or "in an aspect" appearing throughout this specification do not necessarily all refer to the same aspect. Furthermore, a particular feature, structure, or characteristic may be combined in any suitable manner within one or more aspects.

[0053] Regarding the use of virtually any plural and / or singular terms herein, those skilled in the art can translate plural to singular and / or singular to plural as needed by the context and / or application. For clarity, various singular / plural arrangements are not explicitly described herein.

[0054] In some cases, the use of a system or method can occur within a territory, even if components are located outside the territory. For example, in the context of distributed computing, the use of a distributed computing system can occur within a territory, even if parts of the system (e.g., repeaters, servers, processors, signal-bearing media, transmitting computers, receiving computers, etc., located outside the territory) may be located outside the territory.

[0055] All of the above-mentioned U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, non-patent publications, or any other disclosures mentioned in this specification and / or listed in any application data sheet are incorporated herein by reference to the extent that they do not conflict with this document. Thus, and to the extent necessary, the disclosures expressly set forth herein supersede any conflicting material incorporated by reference. Any material or portion thereof that is said to be incorporated herein by reference but conflicts with existing definitions, statements, or other disclosures set forth herein will be incorporated only to the extent that such incorporated material does not conflict with existing disclosures.

[0056] In summary, the numerous benefits arising from adopting the concepts described herein have been described. One or more of the above descriptions have been presented for illustrative and descriptive purposes. They are not intended to be exhaustive or limited to the exact forms disclosed. Modifications and variations are possible in light of the above teachings. The one or more forms described have been chosen and described to illustrate principles and practical applications, thereby enabling those skilled in the art to utilize the various forms and make various modifications suitable for the intended particular use. The overall scope is intended to be defined by the claims filed herein.

[0057] Various embodiments are described in the following numbered examples:

[0058] Example 1. A device for inducing sleep in a conscious user, the device comprising:

[0059] Headgear, the headgear comprising:

[0060] Headband;

[0061] Multiple transcranial stimulation electrodes, said multiple transcranial stimulation electrodes being disposed within the headband; and

[0062] A control system, wherein the control system is disposed within the headband and electrically communicated with the plurality of transcranial stimulation electrodes, wherein the control system comprises:

[0063] Processor; and

[0064] A memory device configured to store instructions that, when executed by the processor, cause the processor to alternately:

[0065] Transcranial stimulation current is transmitted to the plurality of transcranial stimulation electrodes for a first time period; and

[0066] The transcranial stimulation current transmission was stopped, and continued for the second time period.

[0067] The transcranial stimulation current is characterized by a transcranial stimulation waveform, and

[0068] The transcranial stimulation waveform described therein has low delta waveform amplitude and frequency characteristics.

[0069] Example 2. According to the device described in Example 1, the frequency of the transcranial stimulation waveform is between about 0.5 Hz and about 4 Hz.

[0070] Example 3. The apparatus according to any one or more of Examples 1 to 2, wherein the frequency of the transcranial stimulation waveform is about 0.75 Hz.

[0071] Example 4. The apparatus according to any one or more of Examples 1 to 3, wherein the first time period is about 4 seconds to about 8 seconds.

[0072] Example 5. The apparatus according to any one or more of Examples 1 to 4, wherein the second time period is from about 10 seconds to about 30 seconds.

[0073] Example 6. The apparatus according to any one or more of Examples 1 to 5, wherein the plurality of transcranial stimulation electrodes comprises a plurality of pairs of transcranial stimulation electrodes.

[0074] Example 7. The apparatus according to Example 6, wherein each of the plurality of transcranial stimulation electrodes comprises a pre-stimulation electrode and a post-stimulation electrode.

[0075] Example 8. An apparatus according to any one or more of Examples 1 to 7, wherein the control system further includes one or more antennas configured to transmit and receive wireless communication signals.

[0076] Example 9. An apparatus according to any one or more of Examples 1 to 8, further comprising one or more EEG electrodes, and the memory device further storing instructions that, when executed by the processor, cause the processor to receive and store one or more EEG waveforms received from the one or more EEG electrodes.

[0077] Example 10. A system for inducing sleep in a conscious user, the system comprising:

[0078] Mobile communication devices; and

[0079] Headgear, the headgear comprising:

[0080] Headband;

[0081] Multiple transcranial stimulation electrodes; and

[0082] A control system, wherein the control system is disposed within the headband and electrically communicated with the plurality of transcranial stimulation electrodes, wherein the control system comprises:

[0083] An antenna configured to receive wireless communication signals from the mobile communication device;

[0084] A processor that communicates data with the antenna; and

[0085] A memory device configured to store instructions that, when executed by the processor, cause the processor to:

[0086] The antenna receives one or more signals transmitted by the mobile communication device.

[0087] Based on the one or more signals received from the mobile communication device, a transcranial stimulation current is transmitted to the plurality of transcranial stimulation electrodes for a first time period; and

[0088] Based on the one or more signals received from the mobile communication device, the transmission of the transcranial stimulation current is stopped, continuing for a second time period.

[0089] The transcranial stimulation current is characterized by a transcranial stimulation waveform, and

[0090] The transcranial stimulation waveform described therein has low delta waveform amplitude and frequency characteristics.

[0091] Example 11. A system for inducing sleep in a conscious user according to Example 10, wherein the one or more signals transmitted from the mobile communication device to the antenna include data characterizing the transcranial stimulation current.

[0092] Example 12. A system for inducing sleep in a conscious user according to Example 11, wherein the mobile communication device is configured to transmit a sensory stimulation signal delivered with a consistent delay relative to the waveform of the transcranial stimulation current.

[0093] Example 13. The system for inducing sleep in a conscious user according to Example 12, wherein the sensory stimulation signal includes an audible signal or a visible signal.

[0094] Example 14. A system for inducing sleep in a conscious user according to Example 13, wherein the amplitude of the audible signal or the amplitude of the visible signal is modulated by a positive integer multiple of the frequency characteristics of the transcranial stimulation waveform.

[0095] Example 15. A system for inducing sleep in a conscious user according to any one or more of Examples 11 to 14, wherein the mobile communication device includes a second processor and a second memory device and one or more user interfaces, wherein the second memory device is configured to store instructions that, when executed by the second processor, cause the second processor to receive data input from a user through the one or more user interfaces.

[0096] Example 16. A system for inducing sleep in a conscious user according to Example 15, wherein the data input from the user includes the data characterizing the transcranial stimulation current.

[0097] Example 17. A system for inducing sleep in a conscious user according to any one or more of Examples 15 to 16, wherein the data input from the user includes data for characterizing sensory stimulation signals emitted by the mobile communication device.

[0098] Example 18. A system for inducing sleep in a conscious user according to any one or more of Examples 10 to 17, wherein the transcranial stimulation waveform has amplitude and frequency characteristics of an EEG waveform recorded from the conscious user when the conscious user is asleep.

Claims

1. A system for inducing sleep in a conscious user, the system comprising: Mobile communication devices; as well as Headgear, the headgear comprising: Headband; Multiple transcranial stimulation electrodes; and A control system, wherein the control system is disposed within the headband and electrically communicated with the plurality of transcranial stimulation electrodes, wherein the control system comprises: An antenna configured to receive wireless communication signals from the mobile communication device; A processor that communicates data with the antenna; and A memory device, the memory device including instructions, which, when executed by the processor, cause the processor to: The antenna receives one or more signals transmitted by the mobile communication device. Based on the one or more signals received from the mobile communication device, a transcranial stimulation current is transmitted to the plurality of transcranial stimulation electrodes for a first time period; and Based on the one or more signals received from the mobile communication device, the transmission of the transcranial stimulation current is stopped, continuing for a second time period. The transcranial stimulation current is characterized by a transcranial stimulation waveform. The transcranial stimulation waveform described therein has low delta waveform amplitude and frequency characteristics, and The mobile communication device will emit a sensory stimulation signal whose waveform is phase-locked relative to the transcranial stimulation current.

2. The system according to claim 1, wherein the frequency of the transcranial stimulation waveform is between 0.5 Hz and 4 Hz.

3. The system according to claim 1, wherein the frequency of the transcranial stimulation waveform is 0.75 Hz.

4. The system according to claim 1, wherein the first time period is 4 to 8 seconds.

5. The system according to claim 1, wherein the second time period is 10 seconds to 30 seconds.

6. The system of claim 1, wherein the plurality of transcranial stimulation electrodes comprises a plurality of pairs of transcranial stimulation electrodes.

7. The system of claim 6, wherein each of the plurality of transcranial stimulation electrodes comprises a pre-stimulation electrode and a post-stimulation electrode.

8. The system of claim 1, further comprising one or more EEG electrodes, and the memory device further storing instructions that, when executed by the processor, cause the processor to receive and store one or more EEG waveforms received from the one or more EEG electrodes.

9. The system for inducing sleep in a conscious user according to claim 1, wherein the one or more signals transmitted from the mobile communication device to the antenna include data characterizing the transcranial stimulation current.

10. The system for inducing sleep in a conscious user according to claim 9, wherein the mobile communication device includes a second processor and a second memory device and one or more user interfaces, wherein the second memory device is configured to store instructions that, when executed by the second processor, cause the second processor to receive data input from the conscious user through the one or more user interfaces.

11. The system for inducing sleep in a conscious user according to claim 10, wherein the data input from the user includes the data characterizing the transcranial stimulation current.

12. The system for inducing sleep in a conscious user according to claim 10, wherein the data input from the user includes data characterizing sensory stimulation signals emitted by the mobile communication device.

13. The system for inducing sleep in a conscious user according to claim 1, wherein the sensory stimulation signal includes an audible signal or a visible signal.

14. The system for inducing sleep in a conscious user according to claim 13, wherein the amplitude of the audible signal or the amplitude of the visible signal is modulated by a positive integer multiple of the frequency characteristics of the transcranial stimulation waveform.

15. The system for inducing sleep in a conscious user according to claim 1, wherein the transcranial stimulation waveform has amplitude and frequency characteristics of an EEG waveform recorded from the conscious user when the conscious user is asleep.

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