Transcranial Electrical Stimulation for Sleep Deprivation
This study is looking at whether a special type of brain stimulation, called transcranial electrical stimulation (TES) at Slow Oscillation (SO) frequency, can improve how well you recover from a short night's sleep. Researchers want to see if this stimulation, given during a brief sleep period, helps you perform better when you're sleep-deprived. You would receive either the active NeuroConn DC Stimulator PLUS device or a placebo (SHAM TES) during a two-hour sleep period. The study is open to healthy men and non-pregnant, non-lactating women aged 18 to 39 years. The main goal is to check the safety of the stimulation over 8 to 15 days, with assessments twice daily during your wakeful periods in the lab. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 40 participants. Participants will be randomly assigned to receive either the active stimulation or a sham (placebo) stimulation.
- What's involved
- Your participation would involve a 2-hour screening visit, 7 days at home, and a 138-hour (about 6 days) in-laboratory study period, for a total of 15 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored for 8 to 15 days, with assessments conducted twice a day throughout all wakeful portions of the in-laboratory period.
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NCT02945501
Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep
Recruiting
NAAges 18–39InterventionalTreatmentU.S. Army Medical Research and Development CommandGovernment-funded
~40 participants
Updated 2025-06-13 on ClinicalTrials.gov
What's tested:NeuroConn DC Stimulator PLUSSHAM TES
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Point of care safety
Measured over Change from baseline at Days 8 - 15. Assessments will be conducted twice a day throughout all wakeful portions of in-laboratory period of study
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- John D. Hughes, CDR, MC, USN · PRINCIPAL_INVESTIGATOR · Naval Medical Research Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Volunteers meeting the Beck cut-off (a score of at least 14) and who carry health insurance will be instructed to call their health insurance Mental Health / Substance Abuse referral number.
Volunteers meeting the first cut-off (score of at least 14 who are not insured will be provided with a community mental health referral contact specific to their county of residence.
The review of the medical history with the volunteer and the physical examination itself will be performed by an appropriately licensed study investigator. Results of screening urine and blood tests will be reviewed by an appropriately licensed study investigator. The Post-consent Checklist will be administered by a trained research technician and reviewed by the study principal investigator or an appropriately licensed study investigator. If an appropriately licensed study investigator deems it medically advisable, the investigator will share abnormal results with the volunteer, who will be referred to his/her personal physician for follow-up.
A volunteer who has been cleared for participation may participate in a session if the first day of the session is within 90 days of the screening date. If the first day of the study session is 91 or more days since the volunteer has been screened, the volunteer must re-screen to ensure there has not been a change in eligibility status.
Exclusion
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 (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)
Score of 41 or above on the Self-Evaluation Questionnaire
History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction) (Medical History and Examination Form)
History of neurologic disorder (to include, but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders) (Medical History and Examination form; sleep items on Post-Consent Checklist)
Underlying pulmonary disease requiring daily inhaler use (Medical History and Examination form)
Kidney disease or kidney abnormalities (Medical History and Examination form, laboratory results)
Liver disease or liver abnormalities (Medical History and Examination form, laboratory results)
Self-reported history of psychiatric disorder requiring hospitalization or psychiatric product within the last 2 years or for more than 3 months at one time. (Medical History and Examination form)
Self-reported or suspected regular nicotine use or addiction, defined as more than 1 cigarette or equivalent per week, within the last 1 year (Medical History and Examination form)
Self-reported or suspected heavy alcohol use; minimum limit to define heavy alcohol use is 14 drinks per week or as determined by the examining appropriately licensed study investigator (Medical History and Examination form)
Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases, to be determined on a case-by-case basis by the examining appropriately licensed study investigator (Medical History and Examination form)
Self-reported or suspected current use of other illicit drugs, to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana (Medical History and Examination form)
Positive urine pregnancy result
Resting blood pressure above 140/90 or resting pulse \> 110 (Medical History and Examination form). Note that if a repeat measurement is within range then the volunteer will not be excluded.
BMI ≥ 30 (Obese Class I or greater) (Medical History and Examination form)
Clinically significant values (as determined by the appropriately licensed study investigator reviewing the study) for any hematology or chemistry parameter. The appropriately licensed study investigator reviewing the laboratory values may opt to repeat any clinically significant tests and include volunteers whose repeat test values are not clinically significant.
Positive urine nicotine/cotinine result during screening visit (NicCheck™ I test strip results)
Positive urine drug result during screening visit
Any use of sleep aids during the 1 year prior to screening
Inability to read and sign consent
Lack of access to a quiet, dark environment conducive to sleep from 2100 until 0700 during a seven night period at the beginning of the study
Participation in any ongoing clinical trials.
What this trial measures
- Point of care safetyChange 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).