Transcranial Electrical Stimulation at Slow Oscillation Frequency During NREM Sleep: An Assessment of Effects on the Restorative Properties of Sleep
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Deprivation
- Sponsor
- U.S. Army Medical Research and Development Command
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Point of care safety
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Detailed Description
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
Investigators
Eligibility Criteria
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
- •(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 (Post-consent Checklist; document provides exclusionary limits for various caffeinated products).
- •Score of lower than 31 or higher than 69 on the Morningness-Eveningness Questionnaire (MEQ form)
- •Score of 14 or above on the Beck Inventory Form (BDI form)
Outcomes
Primary Outcomes
Point of care safety
Time Frame: Change from baseline at Days 8 - 15. Assessments will be conducted twice a day throughout all wakeful portions of in-laboratory period of study
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).
Secondary Outcomes
- Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)(Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15)
- Measure alertness using the Karolinska Sleepiness Scale (KSS)(Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15)
- Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)(Days 11, 12, 13, 14 and 15)
- Measure current mood states using the Mood Analogue Scale (MAS)(Performed at approximately 75 minute intervals (+/-10 minutes) throughout the waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day and on the night of sleep restriction. Days 11 - 15)
- Measure the efficiency and accuracy of simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)(Performed at approximately 75 minute intervals throughout waking period, beginning approximately one hour post-awakening on the day prior to sleep restriction and on the recovery day. Days 11 - 15)
- Measure of declarative or associative learning using the Paired Word Associates Task (PWAT)(Within 60 minutes of bedtime on the sleep restriction night with a recall phase conducted approximately 20 and 120 minutes after awakening on the same night. Days 11 and 12)