US2020147340A1PendingUtilityA1

Systems and methods for transdermal electrical stimulation to improve sleep

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Assignee: THYNC GLOBAL INCPriority: Nov 26, 2012Filed: Jan 13, 2020Published: May 14, 2020
Est. expiryNov 26, 2032(~6.4 yrs left)· nominal 20-yr term from priority
A61M 2205/3569A61M 2021/0027A61M 2021/0083A61M 2230/10A61N 1/36025A61M 2205/3553A61M 2230/63A61M 2205/18A61M 2205/502A61M 2205/70A61M 2230/65A61M 2210/06A61M 2230/14A61M 2021/0016A61B 5/4806A61M 2021/0072A61M 2205/8206A61M 21/02A61N 1/0456A61M 2205/3584A61M 2205/3592A61M 2209/01A61M 2230/60A61M 2230/06A61M 2205/3561A61B 5/4836A61M 2230/42
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Claims

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

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A transdermal electrical stimulation (TES) device for non-invasively reducing sleep onset and increasing sleep duration, the device comprising:
 a first electrode configured to attach to a subject's head or neck at a first location;   a second electrode configured to attach to the subject's head or neck at a second location; and   a controller having a waveform generator coupled to the first and second electrodes, the waveform generator configured to deliver a sleep inducing ensemble waveform to subject via the first and second electrodes, the sleep inducing ensemble waveform characterized by an electrical stimulation having a peak amplitude of greater than 3 mA, a frequency of greater than 250 Hz, and a duty cycle of greater than 10%, wherein the controller is configured to continue 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 device of  claim 1 , wherein the device is configured to allow the subject to select one or more of: stimulation duration, frequency, peak amplitude, and duty cycle. 
     
     
         3 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply a biphasic electrical stimulation. 
     
     
         4 . The device of  claim 3 , wherein the controller is configured to cause the waveform generator to apply an asymmetric biphasic electrical stimulation with respect to positive and negative going phases. 
     
     
         5 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having a duty cycle ranging from 10% and 90%. 
     
     
         6 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having a duty cycle ranging from 30% and 60%. 
     
     
         7 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having a peak amplitude of 5 mA or greater. 
     
     
         8 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having a frequency of greater than 500 Hz. 
     
     
         9 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having a frequency of greater than 750 Hz. 
     
     
         10 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having a frequency of greater than 5 kHz. 
     
     
         11 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation for a stimulation duration of at least five minutes. 
     
     
         12 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having amplitude modulation. 
     
     
         13 . The device of  claim 12 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having the amplitude modulation with a frequency of less than 250 Hz. 
     
     
         14 . The device of  claim 1 , wherein the controller is configured to cause the waveform generator to apply the electrical stimulation having a burst mode. 
     
     
         15 . The device of  claim 1 , wherein at least one of the first and second electrodes is configured to attach to the subject's temple region. 
     
     
         16 . The device of  claim 1 , wherein at least one of the first and second electrodes is configured to attach to the subject's neck above the vertebra prominens. 
     
     
         17 . A transdermal electrical stimulation (TES) device for non-invasively reducing sleep onset and increasing sleep duration, the device comprising:
 a first electrode configured to attach on a subject's head or neck at a first location;   a second electrode configured to attach on the subject's head or neck at a second location; and   a controller having a waveform generator coupled to the first and second electrodes, the waveform generator configured to cause the first and second electrodes to apply an electrical stimulation to the subject that induces a change in cognitive state and improves sleep and mood in the subject, wherein the 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 electrical stimulation is asymmetric with respect to positive and negative going phases.   
     
     
         18 . The device of  claim 17 , wherein the device is configured to allow the subject to select one or more of: stimulation duration, frequency, peak amplitude, and duty cycle. 
     
     
         19 . The device of  claim 17 , wherein the first electrode is configured to attach on the subject's head and the second electrode is configured to attach on the subject's neck. 
     
     
         20 . The device of  claim 17 , further comprising at least one sensor configured to monitoring one or more of: galvanic skin resistance, heart rate, heart rate variability, or breathing rate of the subject.

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