IP Library Granted Patent US 10,537,703
Granted Patent B2
US 10,537,703 · App. 15/460,138 · Granted Jan 21, 2020

Systems and methods for transdermal electrical stimulation to improve sleep

Inventors: William J. Tyler (Cave Creek, AZ); Alyssa M. Boasso (Brookline, MA); Hailey M. Mortimore (Boston, MA); Sumon K. Pal (Boston, MA); Jonathan Charlesworth (Menlo Park, CA)
Assignee: Thync Global, Inc.
A61M21/02A61N1/0456A61N1/36025A61M2021/0072A61M2230/06A61M2230/42A61M2230/63
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Quick Facts
Patent No.
US 10,537,703
App. No.
15/460,138
Granted
Jan 21, 2020
Kind
B2
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 (41)

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.

Assignments (2)
SECURITY INTEREST Recorded Mar 30, 2020
From: THYNC GLOBAL, INC.
To: NOOSPHERE VENTURE PARTNERS LP
Reel/Frame 052260/0669 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 4, 2019
From: TYLER, WILLIAM J.; BOASSO, ALYSSA M.; MORTIMORE, HAILEY M.; PAL, SUMON K.; CHARLESWORTH, JONATHAN
To: THYNC GLOBAL, INC.
Reel/Frame 051182/0496 →
Continuity (39)
Continuation In Part PCTUS2016012128 · Jan 5, 2016
Continuation In Part 15264224 · Sep 13, 2016
Continuation In Part 14558604 · Dec 2, 2014
Continuation In Part 14091121 · Nov 26, 2013
Continuation In Part 15170878 · Jun 1, 2016
Continuation In Part 14715470 · May 18, 2015
Continuation In Part 14715476 · May 18, 2015
Continuation In Part 15169445 · May 31, 2016
Provisional Application 62308845 · Mar 15, 2016
Provisional Application 62268084 · Dec 16, 2015
Provisional Application 62213949 · Sep 3, 2015
Provisional Application 62200256 · Aug 3, 2015
Provisional Application 62190211 · Jul 8, 2015
Provisional Application 62170111 · Jun 2, 2015
Provisional Application 62169522 · Jun 1, 2015
Provisional Application 62169523 · Jun 1, 2015
Provisional Application 62168615 · May 29, 2015
Provisional Application 62100004 · Jan 5, 2015
Provisional Application 62100022 · Jan 5, 2015
Provisional Application 62099950 · Jan 5, 2015
Provisional Application 62100029 · Jan 5, 2015
Provisional Application 62099960 · Jan 5, 2015
Provisional Application 62076459 · Nov 6, 2014
Provisional Application 62075896 · Nov 6, 2014
Provisional Application 62076459 · Nov 6, 2014
Provisional Application 62002910 · May 25, 2014
Provisional Application 61994860 · May 17, 2014
Provisional Application 61907394 · Nov 22, 2013
Provisional Application 61900880 · Nov 6, 2013
Provisional Application 61888910 · Oct 9, 2013
Provisional Application 61875891 · Sep 10, 2013
Provisional Application 61875424 · Sep 9, 2013
Provisional Application 61845845 · Jul 12, 2013
Provisional Application 61841308 · Jun 29, 2013
Provisional Application 61770479 · Feb 28, 2013
Provisional Application 61767945 · Feb 22, 2013
Provisional Application 61765795 · Feb 17, 2013
Provisional Application 61729851 · Nov 26, 2012
Related Publication 20170182285A1 · Jun 29, 2017
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