Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
All Genders
Healthy Volunteers
ID05309473

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

Age: 18Years - 39Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to assess eligibility criteria

Treatment

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

Follow-up

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

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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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