Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

Walter Reed Army Institute of Research (WRAIR)

Status: Enrolling

Conditions: Performance; Alertness; Acoustic Stimulation; Sleep Restriction; Sleep Deprivation

Treatments: Device: Sham (no Acoustic Stimulation); Device: Philips SmartSleep Acoustic Stimulation Device

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT05309473

2901

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Subjects Who Received Acoustic Stimulation

Experimental group

Description:

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.

Treatment:

Device: Philips SmartSleep Acoustic Stimulation Device

Subjects Who Received Sham (no Acoustic Stimulation)

Sham Comparator group

Description:

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.

Treatment:

Device: Sham (no Acoustic Stimulation)