Actively Recruiting
Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep
Led by U.S. Army Medical Research and Development Command · Updated on 2025-06-13
40
Participants Needed
1
Research Sites
578 weeks
Total Duration
On this page
Sponsors
U
U.S. Army Medical Research and Development Command
Lead Sponsor
W
Walter Reed Army Institute of Research (WRAIR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine if the enhancement of electroencephalographic (EEG) slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation (SO) frequency, during a restricted period of nocturnal sleep, enhances the restorative properties of that period of sleep and improves performance during a subsequent period of sleep deprivation.
CONDITIONS
Official Title
Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
- Must demonstrate adequate understanding of the study by scoring at least 80% on a short quiz, with one chance to retest if needed
You will not qualify if you...
- Habitual nightly sleep outside 6 to 9 hours on average
- Nighttime lights-out time earlier than 9:00 PM or later than 11:00 PM on weeknights
- Morning wake-up time after 8:00 AM on weekdays
- Habitual napping more than once a week
- Non-refreshing sleep indicated by low scores on the Nonrestorative Sleep Scale
- Average time to fall asleep longer than 20 minutes
- Daily caffeine use over 400 mg
- Extreme scores on Morningness-Eveningness Questionnaire
- Depression score of 14 or higher on Beck Inventory
- High score on Self-Evaluation Questionnaire
- History of cardiovascular, neurological, pulmonary, kidney, or liver disease
- Recent psychiatric hospitalization or treatment within last 2 years or longer than 3 months
- Nicotine use exceeding one cigarette or equivalent per week in last year
- Heavy alcohol use defined as 14 or more drinks per week
- Use of drugs or products unsafe to stop during study
- Current use of illicit drugs including benzodiazepines, amphetamines, cocaine, or marijuana
- Positive pregnancy test
- Resting blood pressure above 140/90 or pulse over 110, unless repeat normal
- Body mass index (BMI) of 30 or higher
- Clinically significant abnormal lab results
- Positive urine test for nicotine or drugs at screening
- Use of sleep aids within past year
- Inability to read or sign consent
- Lack of access to a quiet, dark sleep environment from 9:00 PM to 7:00 AM for seven nights
- Participation in other clinical trials
- Any other medical or safety concerns as determined by study investigator
- Volunteers with depression scores above cutoff will be referred for mental health support
- Screening results reviewed by licensed investigator who may require re-screening if study start is over 90 days from screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Naval Medcical Research Center (NMRC) Clincal Trials Center
Bethesda, Maryland, United States, 20889-5607
Actively Recruiting
Research Team
J
John D. Hughes, CDR, MC, USN
CONTACT
T
Thomas J Balkin, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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