Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep (NCT02945501) | Clinical Trial Compass
RecruitingNot Applicable
Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep
United States40 participantsStarted 2016-10-27
Plain-language summary
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.
Who can participate
Age range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
* Must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified.
Exclusion Criteria:
* Self-reported habitual nightly sleep amounts outside the target range of 6 - 9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist)
* Self-reported nighttime lights-out times earlier than 2100 hours on average during weeknights (Sunday through Thursday) or later than 2300. (Post-consent Checklist)
* Self-reported morning wake-up times later than 0800 on average during weekdays (Monday through Friday) (Post-consent Checklist)
* Self-reported habitual napping (\> 1 time a week in conjunction with normal sleep habits) (Post-consent Checklist)
* A rating of 6 or below on question 2 or 3 of the Nonrestorative Sleep Scale, indicating the subject experiences relatively non-refreshing sleep
* An average time to sleep onset of greater than 20 minutes as indicated on the Post-consent Checklist
* Self-reported caffeine use in excess of 400 mg (e.g., approximately 8 caffeinated sodas or 4 12-oz cups of coffee) per day on average (Pos…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Point of care safety
Timeframe: Change from baseline at Days 8 - 15. Assessments will be conducted twice a day throughout all wakeful portions of in-laboratory period of study
Trial details
NCT IDNCT02945501
SponsorU.S. Army Medical Research and Development Command