Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

Not Applicable

Recruiting

• Conditions: Alertness; Sleep Restriction; Acoustic Stimulation; Performance; Sleep Deprivation
• Interventions: Device: Philips SmartSleep Acoustic Stimulation Device; Device: Sham (no Acoustic Stimulation)

• Registration Number: NCT05309473
• Lead Sponsor: Walter Reed Army Institute of Research (WRAIR)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-17
• Study Start: 2022-03-14
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects Who Received Acoustic Stimulation	Philips SmartSleep Acoustic Stimulation Device	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.
Subjects Who Received Sham (no Acoustic Stimulation)	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.

Primary Outcome Measures

Name	Time	Method
Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)	8 days	Performed at approximately 75 minutes intervals throughout the sleep deprivation and recovery days

Secondary Outcome Measures

Name	Time	Method
Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)	5 days	Computer based series of mathematical calculations
Measure various aspects of Sleep and Wakefulness using Actigraphy	22 days	A watch-like device called an actigraph will measure movement to determine wake and sleep
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)	5 days	Subjects will be escorted to their individual darkened, sound-attenuated bedrooms and allowed to lie down on their beds. They will be instructed to close their eyes and try to remain awake. Polysomnography will be monitored online.
Measure alertness using the Karolinska Sleepiness Scale (KSS)	5 days	Computer based self rated level of sleepiness
Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery	5 days	Computer based battery testing various aspects of mood
Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video	5 days	Sleep will be measured during the night using polysomnography
Measure current mood states using the Mood Analogue Scale (MAS)	5 days	Computer based self adjective checklist of measure mood states

Trial Locations

Locations (1)

Walter Reed Army Institute of Research; 🇺🇸 Silver Spring, Maryland, United States