Last updated: April 22, 2024
Sponsor: Walter Reed Army Institute of Research (WRAIR)
Overall Status: Active - Recruiting
Phase
N/A
Condition
Insomnia
Auditory Stimulation
Sleep Disorders
Treatment
Sham (no Acoustic Stimulation)
Philips SmartSleep Acoustic Stimulation Device
Clinical Study ID
NCT05309473
2901
Ages 18-39 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 atleast 80% correct on a short multiple-choice quiz. Individuals who fail to achieve apassing score on the initial quiz will be given one opportunity to retest after areview of protocol information. Individuals who fail the comprehension assessment forthe second time will be disqualified.
Exclusion
Exclusion Criteria:
- You must have learned English as your first language
- You must have a body mass index (BMI) below 30 (this is a mathematical calculation ofyour height and weight)
- You must not have current or a history of sleeping problems (for example, insomnia orsleep apnea), or symptoms that indicate a potential sleep disorder
- You must get an average of 6-9 hours of sleep per night and maintain a normalsleep/wake schedule
- You must not drink excessive amounts of caffeine, alcohol, or smoke cigarettesregularly
- You must not be on certain medications (determined on a case by case basis)
- You must test negative for illicit drugs
- Women must not be pregnant or nursing
- You must not be participating in another ongoing clinical trial
- You must have a social security number or tax identification number in order to bepaid for screening and participation in the study
- You cannot have a history of the following conditions: Cardiovascular disease, aneurologic disorder, pulmonary disease requiring inhaler use, kidney disease or kidneyabnormalities, liver disease of liver abnormalities, a history of psychiatric disorderrequiring hospitalization or medication within the last two years or for a continuousperiod of more than 6 months in the last ten years
Study Design
Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Sham (no Acoustic Stimulation)
Phase:
Study Start date:
March 14, 2022
Estimated Completion Date:
October 31, 2026
Connect with a study center
Walter Reed Army Institute of Research
Silver Spring, Maryland 20910
United StatesActive - Recruiting
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