Recruiting

Acoustic Stimulation

Sponsor:

Walter Reed Army Institute of Research (WRAIR)

Code:

NCT05309473

Conditions

Sleep Deprivation

Sleep Restriction

Acoustic Stimulation

Performance

Alertness

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Interventions

Philips SmartSleep Acoustic Stimulation Device

Sham (no Acoustic Stimulation)

Study Details

Brief summary:

The purpose of this study is to determine if brief sounds or tones presented within a restricted period of recovery sleep after a period of sleep deprivation will enhance restorative properties and improve performance during a subsequent period of wakefulness.

Conditions

Sleep Deprivation

Sleep Restriction

Acoustic Stimulation

Performance

Alertness

Study ID

NCT05309473

Start date

Mar 14, 2022

Status verified date

Apr, 2024

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

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 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.

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 of your height and weight)
  • You must not have current or a history of sleeping problems (for example, insomnia or sleep 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 normal sleep/wake schedule
  • You must not drink excessive amounts of caffeine, alcohol, or smoke cigarettes regularly
  • 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 be paid for screening and participation in the study
  • You cannot have a history of the following conditions: Cardiovascular disease, a neurologic disorder, pulmonary disease requiring inhaler use, kidney disease or kidney abnormalities, liver disease of liver abnormalities, a history of psychiatric disorder requiring hospitalization or medication within the last two years or for a continuous period of more than 6 months in the last ten years

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Subjects Who Received Acoustic Stimulation

Following 40 hours of deprivation participants will sleep for approximately a four hour recovery sleep period and receive acoustic stimulation via the Philips SmartSleep during slow-wave sleep. They will then sleep for second night of four hour recovery sleep and receive acoustic stimulation via the Philips Smart Sleep device during slow-wave sleep again.

sham comparator: Subjects Who Received Sham (no Acoustic Stimulation)

Following 40 hours of deprivation participants will sleep for approximately a four hour recovery sleep period and receive Sham (no acoustic stimulation) via the Philips SmartSleep during slow-wave sleep. They will then sleep for second night of four hour recovery sleep and receive Sham (no acoustic stimulation) via the Philips Smart Sleep device during slow-wave sleep again.

Interventions

Philips SmartSleep Acoustic Stimulation Device

Prior to bedtime on the first two recovery nights, a Philips SmartSleep device will be applied to the head of each subject. Subjects will receive acoustic stimulation during the four hours of sleep.

Sham (no Acoustic Stimulation)

Prior to bedtime on the first two recovery nights, a Philips SmartSleep device will be applied to the head of each subject. Subjects will receive Sham (no acoustic stimulation) during the four hours of sleep.

Primary outcome measure

  • Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT) [ Time Frame: 8 days ]

Central Contacts and Locations

Central contacts

John D Hughes, MD

301-319-3214john.d.hughes4.ctr@mail.mil

Locations

Walter Reed Army Institute of Research

Recruiting

Silver Spring, Maryland, United States, 20910

Contacts

Ruthie Ratcliffe

301-319-3131ruthie.h.ratcliffe.civ@mail.mil

Kajsa Carlsson

301-319-9287kajsa.e.carlsson.ctr@mail.mil

More Information

Sponsor

Walter Reed Army Institute of Research (WRAIR)

Last update posted

Apr 23, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed Army Institute of Research (WRAIR) on 2024-04-23.