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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)
Must not have
Neurological Diagnosis including epileptic seizures, recent, multiple, or severe concussion, traumatic brain injury, stroke, multiple sclerosis, or cognitive impairment with or without the use of prescription medication or requirement for hospitalization
Current use of narcotics (opioid based medications for the treatment of pain (OxyContin, Percocet, Vicodin, etc.) with or without a prescription within the last year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neurological condition like epilepsy, severe concussion, brain injury, stroke, MS, or cognitive issues.
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I have used opioid painkillers in the past year.
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I was hospitalized for surgery or illness in the last 6 months.
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I have difficulty with movement and coordination.
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My mental health is stable; I haven't needed frequent doctor visits or medication changes in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sleep Onset Latency Change from Baseline
Secondary study objectives
EEG spectral changes from baseline (Delta power increase)
Heart rate variability change from baseline
ISI Change from Baseline
+4 moreTrial 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.
Find a Location
Who is running the clinical trial?
Uniformed Services University of the Health SciencesLead Sponsor
124 Previous Clinical Trials
90,616 Total Patients Enrolled
2 Trials studying Insomnia
86 Patients Enrolled for Insomnia
John K Werner, MD PhDPrincipal InvestigatorUniformed Services University of the Health Sciences