Wearable Transcranial Electrical Stimulation (tES) for Insomnia
United States78 participantsStarted 2023-10-25
Plain-language summary
The purpose of this study is to investigate the ability of a translational device, Teledyne PeakSleep, to reduce sleep onset latency, reduce time awake after sleep onset and improve restfulness and the subjective benefits of sleep in a patient population with insomnia via transcranial direct current stimulation (tDCS) applied to frontal lobe circuits.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* diagnosed with sleep onset insomnia
* Self report insomnia diagnosis (ISI score ≥15)
* 18-70 years old that are Tricare eligible
* No pharmacologic or non-pharmacologic treatment for insomnia in the last 14 days, including over-the-counter medications such as diphenhydramine or cyclobenzaprine not using sedating medications (including over-the-counter) at bedtime in the last 14 days. These can include sedating antihistamines such as diphenhydramine/Benadryl, combination pills such as Tylenol or Advil PM, ZzzQuil. Psychiatric medications such as benzodiazepines (clonazepam/Klonopin, lorazepam/Ativan, diazepam/Valium, alprazolam/Xanax), anti-histamines (hydroxyzine/Atarax/Vistaril), or anti-psychotics (quetiapine/Seroquel).
Exclusion Criteria:
* Neurologic conditions such as seizures or conditions that increase the risk of seizures, including concussions within the last 3 months; moderate or severe traumatic brain injury; stroke; multiple sclerosis; or cognitive impairment with or without the use of prescription medication or requirement for hospitalization.
* Any psychiatric disorder requiring weekly or more frequent clinical monitoring or medication changes in the last 4 weeks.
* History of neurodevelopmental disorder such as attention deficit hyperactivity disorder, learning disability, or developmental delay
* Any inpatient hospitalization, major surgery, or medical procedure within the past 6 months
* Hearing impairments requiring implanted or exte…
What they're measuring
1
Sleep Onset Latency Change from Baseline
Timeframe: 5 weeks
Trial details
NCT IDNCT06100185
SponsorUniformed Services University of the Health Sciences