Status:
ENROLLING_BY_INVITATION
Optimizing Volunteer Comfort for Transcranial Electrical Stimulation (TES): An Assessment
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Performance Enhancing Product Use
Sleep
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
Transcranial electrical stimulation (TES) utilizing weak electrical fields (\<5 milliamps of current - as proposed in the present pilot study) is an extremely safe therapeutic technique in use for ove...
Detailed Description
In this study, volunteers will be divided into groups based on the nature of the stimulation waveform utilized (DC 0.75 Hz, modified AC 0.75 Hz, AC sinusoidal 3.0 Hz or pulsed stimulation of up to 500...
Eligibility Criteria
Inclusion
- Inclusion criteria - healthy adult men and non-pregnant, non-lactating women aged 18-39 years, inclusive.
- Exclusion criteria - The following exclusion criteria apply to all volunteers, are consistent with those used in our other sleep studies, and are applied in this protocol in order to obtain a sample of volunteers who are likely to be representative of future study populations:
- 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):
- Nighttime lights-out times earlier than 2100 hours on average during weeknights (Sunday through Thursday) for the past month
- Morning wake-up times later than 0900 on average during weekdays (Monday through Friday) for the past month.
- 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)
- Reported habitual napping (\> 3 times a week in conjunction with normal sleep habits)
- Resting blood pressure above 140/90
- Resting pulse \> 110
- Neurologic disorder (to include but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders)
- Kidney disease
- History of psychiatric disorder requiring hospitalization or psychiatric medication for any length of time
- Beck Depression Inventory score of 14 or above
- Underlying pulmonary disease requiring daily inhaler use
- Regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week) within the last 1 year
- Positive nicotine/cotinine screen as determined by NicCheck™ I test strips
- Heavy alcohol use to be determined by the PI or his/her representative (minimum limit to define heavy alcohol use is 14 drinks per week)
- Use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana)
- Known liver disease or liver abnormalities as determined by a laboratory test
- Self-reported history of caffeine use in excess of 400 mg (approximately 8 caffeinated sodas or 3-4 cups of coffee) per day on average
- Pregnancy (females)
- Inability to read and sign consent
- Use of certain medications (including use of vitamins or supplements), to be determined on a case-by-case basis by the examining study licensed physician.
- BMI ≥ 30 (Obese Class I or greater)
- The PI also maintains the prerogative to disqualify a volunteer if it is deemed that the volunteer's participation would be unsafe for the volunteer or staff or would be disruptive to study conduct.
Exclusion
Key Trial Info
Start Date :
May 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 12 2029
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04474015
Start Date
May 24 2014
End Date
February 12 2029
Last Update
March 28 2025
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