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Behavioural Intervention

Wearable tES for Insomnia

N/A
Recruiting
Led By John K Werner, MD PhD
Research Sponsored by Uniformed Services University of the Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with sleep onset insomnia
Self report insomnia diagnosis (ISI score ≥15)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial examines using a device to reduce sleep onset latency & make insomnia-sufferers more rested & content with sleep.

Who is the study for?
This trial is for adults aged 18-70 with sleep onset insomnia who are Tricare eligible. They can have had non-drug therapy like CBT if it ended over two weeks ago and haven't used sleep meds recently. Excluded are those with hearing aids, metal implants (except dental), tattoos on the head, substance abuse issues, unstable psychiatric disorders, recent major surgery or hospitalization, neurological conditions, or excessive alcohol intake.Check my eligibility
What is being tested?
The study tests a device called PeakSleep against a sham (fake) treatment to see if it helps people with insomnia fall asleep faster and feel more rested. It uses tDCS applied to the frontal lobe of the brain to potentially improve sleep quality.See study design
What are the potential side effects?
While not explicitly listed in your information provided, typical side effects of tDCS may include mild tingling at the electrode sites during application, itching under the electrodes, headache after use or fatigue. Serious side effects are rare but could involve skin irritation or burns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with difficulty falling asleep.
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I have been diagnosed with insomnia.
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I am between 18 and 70 years old and eligible for Tricare.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep Onset Latency Change from Baseline
Secondary outcome measures
EEG spectral changes from baseline (Delta power increase)
Heart rate variability change from baseline
ISI Change from Baseline
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: StimulationActive Control1 Intervention
Short duration repetitive (SDR-) tES with a frequency of 0.75Hz
Group II: Sham ConditionPlacebo Group1 Intervention
Sham condition using a low current amplitude at 25 Hz.

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Who is running the clinical trial?

Uniformed Services University of the Health SciencesLead Sponsor
121 Previous Clinical Trials
90,884 Total Patients Enrolled
2 Trials studying Insomnia
86 Patients Enrolled for Insomnia
John K Werner, MD PhDPrincipal InvestigatorUniformed Services University of the Health Sciences
~38 spots leftby Sep 2025
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