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Recruiting NCT06100185

Wearable Transcranial Electrical Stimulation (tES) for Insomnia

Trial Parameters

Condition Insomnia
Sponsor Uniformed Services University of the Health Sciences
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-10-25
Completion 2025-12
Interventions
PeakSleepSham

Brief 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.

Eligibility Criteria

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 imp

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