Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
U.S. Army Medical Research and Development Command
Study ID
NCT02945501
Status
Recruiting
Apply to this trial

Conditions

  • Mental Competency
  • Sleep Deprivation

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • NeuroConn DC Stimulator PLUS — DEVICE
    Prior 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 — DEVICE
    Prior 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.

Study Details

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.

Key Dates

Start date
Oct 27, 2016
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects Who Received TES SO
    Participants will sleep for approximately a two hour period and receive TES SO via the NeuroConn DC Stimulator PLUS during the second hour of that two hour sleep period. They will then experience a 46 hour period of sleep deprivation, during which cognitive performance, mood and subjective and objective aspects of sleepiness will be assessed approximately every 75 minutes beginning on the night of restricted sleep/treatment.
  • Sham Comparator: Received SHAM (no TES SO)
    Participants will sleep for approximately a two hour period and receive a SHAM (no TES SO) during the second hour of that two hour sleep period. They will then experience a 46 hour period of sleep deprivation, during which cognitive performance, mood and subjective and objective aspects of sleepiness will be assessed approximately every 75 minutes beginning on the night of restricted sleep/treatment.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Naval Medcical Research Center (NMRC) Clincal Trials CenterBethesdaMaryland20889-5607
John D. Hughes, CDR, MC, USN
[email protected]
301-319-9350

Find similar trials in Bethesda, MD

By research site
Naval Medcical Research Center (NMRC) Clincal Trials Center· Bethesda, MD

Related Studies