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.
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.
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)
Parallel
NeuroConn DC Stimulator PLUS
DevicePrior to bedtime on the sleep restriction night, 4 transcranial stimulation electrodes (two on each hemisphere) will be applied to the scalps of each subject. Subjects will receive a one hour period of SO stimulation, for a total of approximately two hours of sleep.
SHAM TES
DevicePrior to bedtime on the sleep restriction night, 4 placebo transcranial stimulation electrodes (two on each hemisphere) will be applied to the scalps of each subject. Subjects will sleep for approximately 2 hours without stimulation.
Point of care safety
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. Vital signs (blood pressure, pulse, and temperature) will be recorded and abnormal values will be reported to PI who will determine if events meet criteria and definition of an unanticipated device effect (UADE).
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
Performed at approximately 75 minutes intervals throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on night of sleep restriction.
Measure the efficiency and accuracy of simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)
Computer based series of mathematical calculations consisting of 3 single digit numbers (e.g. 3+4-5) and indicate if the value of the answer is less than or greater than 5.
Measure current mood states using the Mood Analogue Scale (MAS)
Computer based self adjective checklist to measure mood states along six subscales: tension-anxiety, anger-hostility, depression-dejection, vigor-activity, fatigue-inertia, and confusion-bewilderment. Adjectives are rated on a scale 1 (not at all) to 6 (extremely).
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)
Subjects will be escorted to their individual darkened, sound-attenuated bedrooms and allowed to lie down on their beds. They will be instructed to close their eyes and try to remain awake. Polysomnography will be monitored online.
Click on the lead sponsor to view all of their trials.
U.S. Army Medical Research and Development Command
Lead sponsor
Walter Reed Army Institute of Research (WRAIR)
Collaborator
