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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.
40 subjects will be enrolled and randomized to participate in this study. A 60 minute TES stimulation sequence consisting of a SO frequency stimulation (TES SO) using the NeuroConn DC Stimulator PLUS or a sham stimulation will be administered during the second hour of a two hour nocturnal sleep period. During wake period subjects will be tested using various cognitive, subjective and objective sleepiness and mood measures. Vital signs measurements will be taken to monitor general health issues. Up to 4 subjects will be enrolled per study session. Due to logistical reasons, no more then 2 subjects per session can be assigned to the TES SO group.
Screening visit = approx. 2 hours At-home component = 7 days In-laboratory study period = 138 hours Total in-laboratory period = approx. 138 hours per subject Total participation time (at home + in-laboratory components) = 15 days
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
NeuroConn DC Stimulator PLUS, SHAM TES
Not yet recruiting
U.S. Army Medical Research and Materiel Command
Published on BioPortfolio: 2016-10-27T05:38:22-0400
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