Systems and methods for transdermal electrical stimulation to improve sleep

• US 10,537,703 B2
• Filed: 03/15/2017
• Issued: 01/21/2020
• Est. Priority Date: 11/26/2012
• Status: Active Grant

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thync Global, Inc.
• Inventors: Tyler, William J., Boasso, Alyssa M., Mortimore, Hailey M., Pal, Sumon K., Charlesworth, Jonathan
• Primary Examiner(s): Dorna, Carrie R
• Application Number:
  US15/460,138
• Publication Number:
  US 20170182285A1
• Time in Patent Office: 1,042 Days
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61M 2021/0016 by the smell sense
• CPC Class Codes: A61M 2021/0027 by the hearing sense
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 2021/0083 especially for waking up
• CPC Class Codes: A61M 21/02 for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2210/06 Head
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/10 : Electroencephalographic signals
• CPC Class Codes: A61M 2230/14 : Electro-oculogram [EOG]
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61N 1/0456 : Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36025 : for treating a mental or cerebral condition

Abstract

Methods and apparatuses for improving sleep by transdermal electrical stimulation (TES). In general, described herein are methods for applying TES to a subject, and particularly the subject'"'"'s head (e.g., temple/forehead region) and/or neck with an TES waveform adapted to improve sleep, including reducing sleep onset (falling to sleep) more quickly and/or lengthening the duration of sleep. TES waveform(s) particularly well suited to enhancing sleep are also described herein.

Claims

1. A method of non-invasively reducing sleep onset and increasing sleep duration, the method comprising:

attaching a first electrode to a subject'"'"'s head or neck at a first location and a second electrode to the subject'"'"'s head or neck at a second location, wherein the first and the second electrode are coupled to a transdermal electrical stimulation (TES) applicator worn by the subject;

applying a sleep inducing ensemble waveform characterized by an electrical stimulation between the first and second electrodes, wherein the electrical stimulation has a peak amplitude of greater than 3 mA, a frequency of greater than 250 Hz, and a duty cycle of greater than 10%; and

continuing application of the electrical stimulation for a stimulation duration of at least one minute to enhance sleepiness, sustain sleep or to enhance sleepiness and sustain sleep.

2. The method of claim 1, wherein attaching comprises adhesively attaching.

3. The method of claim 1, wherein attaching comprises attaching the first electrode to the subject'"'"'s temple region.

4. The method of claim 1, wherein attaching comprises attaching the second electrode to the subject'"'"'s neck above the subject'"'"'s vertebra prominens.

5. The method of claim 1, further comprising allowing the subject to select a set of parameters for the electrical stimulation to be applied, wherein the set of parameters includes one or more of:

stimulation duration, frequency, peak amplitude, and duty cycle.

6. The method of claim 1, further comprising wearing the electrodes while the subject sleeps.

7. The method of claim 1, further comprising removing the first and second electrodes and TES applicator prior to the subject sleeping.

8. The method of claim 1, wherein applying comprises applying a biphasic electrical stimulation.

9. The method of claim 1, wherein applying comprises applying a biphasic electrical stimulation and further wherein the biphasic electrical stimulation is asymmetric with respect to positive and negative going phases.

10. The method of claim 1, wherein applying comprises applying the electrical stimulation having a duty cycle of between 10% and 90%.

11. The method of claim 1, wherein applying comprises applying the electrical stimulation having a duty cycle of between 30% and 60%.

12. The method of claim 1, wherein applying comprises applying the electrical stimulation having a peak amplitude of 5 mA or greater.

13. The method of claim 1, wherein applying comprises applying the electrical stimulation having a frequency of greater than 500 Hz.

14. The method of claim 1, wherein applying comprises applying the electrical stimulation having a frequency of greater than 750 Hz.

15. The method of claim 1, wherein applying comprises applying the electrical stimulation having a frequency of greater than 5 kHz.

16. The method of claim 1, wherein continuing application of the electrical stimulation for a stimulation duration comprises continuing for a stimulation duration of at least five minutes.

17. The method of claim 1, wherein applying comprises applying the electrical stimulation having amplitude modulation.

18. The method of claim 1, wherein applying comprises applying the electrical stimulation having amplitude modulation, and further wherein the amplitude modulation has a frequency of less than 250 Hz.

19. The method of claim 1, wherein applying comprises applying the electrical stimulation having a burst mode.

20. The method of claim 1, wherein the first location is on the subject'"'"'s head and the second location is on the subject'"'"'s neck.

21. A wearable transdermal electrical stimulation (TES) applicator for facilitating, inducing, and/or maintaining sleep in a subject, the device comprising:

a body;

a first electrode;

a second electrode; and

a TES control module at least partially within the body and comprising a processor, a timer and a waveform generator, wherein the TES control module is adapted to deliver a sleep inducing ensemble waveform characterized by a transdermal biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a duty cycle of greater than 10 percent, a frequency of 250 Hz or greater, and an intensity of 3 mA or greater, wherein the biphasic transdermal electrical stimulation is asymmetric with respect to positive and negative going phases;

wherein the wearable TES applicator weighs less than 50 grams; and

at least one sensor configured to be coupled to the body for sleep monitoring of the subject.

22. The device of claim 21, wherein the duty cycle is between 30% and 60%.

23. The device of claim 21, wherein the transdermal electrical stimulation has a frequency greater than 750 Hz.

24. The device of claim 21, wherein the transdermal electrical stimulation has a frequency greater than 5 kHz.

25. The device of claim 21, wherein the transdermal electrical stimulation comprises amplitude modulation.

26. The device of claim 21, wherein the transdermal electrical stimulation comprises amplitude modulation and wherein the amplitude modulation has a frequency of less than 250 Hz.

27. The device of claim 21, wherein the transdermal electrical stimulation comprises a burst mode.

28. The device of claim 21, wherein the transdermal electrical stimulation comprises a burst mode and wherein the frequency of bursting is less than 250 Hz.

29. The device of claim 21 wherein the at least one sensor is configured to measure the subject'"'"'s autonomic function.

30. The device of claim 21 wherein the at least one sensor is configured to measure the subject'"'"'s autonomic function, further wherein the measurement of autonomic function measures one or more of:

galvanic skin resistance, heart rate, heart rate variability, or breathing rate.

31. The device of claim 21 wherein the at least one sensor comprises a sensor to detect the subject'"'"'s movements.

32. A method for improving sleep comprising delivering a sleep inducing ensemble waveform characterized by transdermal electrical stimulation of a subject'"'"'s peripheral nerves of the head and neck and inducing a change in cognitive state that improves sleep and mood in the subject, wherein the transdermal electrical stimulation is 10 seconds or longer, has a duty cycle of greater than 10 percent, a frequency of 250 Hz or greater, and an intensity of 3 mA or greater, wherein the transdermal electrical stimulation is asymmetric with respect to positive and negative going phases.