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 range18 Years – 39 Years
SexALL
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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…
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