Actively Recruiting
Slow-wave Sleep Enhancement Using Acoustic Stimulation to Facilitate Performance Recovery During Restricted Sleep After Sleep Deprivation
Led by Walter Reed Army Institute of Research (WRAIR) · Updated on 2024-04-23
44
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Walter Reed Army Institute of Research (WRAIR)
Lead Sponsor
P
Philips Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether brief sounds or tones played during a limited recovery sleep period after 40 hours of sleep deprivation can enhance the restorative effects of sleep and improve performance during the following awake period. This study involves healthy adults aged 18 to 39 and aims to understand how acoustic stimulation during slow-wave sleep affects alertness and cognitive functions. Participants will experience two nights of approximately four-hour recovery sleep after sleep deprivation. During these recovery sleeps, one group will receive acoustic stimulation via the Philips SmartSleep device during slow-wave sleep, while the other group will receive sham treatment without acoustic stimulation. The device is applied prior to bedtime on both recovery nights to deliver or withhold the acoustic signals. Throughout the study, participants' performance and alertness will be assessed using various tests including the Psychomotor Vigilance Task, mathematical processing tests, mood scales, and sleepiness scales over several days. Sleep and wakefulness will also be monitored via polysomnographic recordings and actigraphy. The study includes safety monitoring and adherence checks, with total participation spanning multiple days to capture effects during and after sleep deprivation and recovery.
CONDITIONS
Brief Title
Acoustic Stimulation During Restricted Sleep After Sleep Deprivation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men and non-pregnant, non-lactating women aged 18 to 39 years (inclusive)
- Must score at least 80% on a comprehension quiz about the study protocol
- Individuals who fail the quiz may retake it once after reviewing protocol information
You will not qualify if you...
- Must have learned English as a first language
- Must have a body mass index (BMI) below 30
- Must not have current or past sleep problems or symptoms indicating a sleep disorder
- Must get 6 to 9 hours of sleep per night and maintain a regular sleep/wake schedule
- Must not regularly consume excessive caffeine, alcohol, or smoke cigarettes
- Must not be taking certain medications, determined case by case
- Must test negative for illicit drugs
- Women must not be pregnant or nursing
- Must not be participating in another clinical trial
- Must have a social security or tax identification number for study payment
- Must not have a history of cardiovascular, neurological, pulmonary, kidney, liver, or recent psychiatric disorders requiring hospitalization or extended medication use in the past 10 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility criteria
Duration - 3 days
Participants undergo 40 hours of sleep deprivation followed by two nights of approximately four hours of recovery sleep each night. During the recovery sleep, participants receive either acoustic stimulation or sham stimulation via the Philips SmartSleep device applied to the head.
Daily visits during sleep deprivation and recovery nights
Duration - Up to 22 days
Participants are assessed over several days for performance, mood, alertness, and sleep measurements using various tests and monitoring devices.
Multiple assessments including Psychomotor Vigilance Task, mood scales, sleep tests, and actigraphy monitoring
Trial Site Locations
Total: 1 location
1
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Actively Recruiting
Research Team
J
John D Hughes, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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