Slow-wave Sleep Enhancement Using Acoustic Stimulation to Facilitate Performance Recovery During Restricted Sleep After Sleep Deprivation

Walter Reed Army Institute of Research (WRAIR)1 site in 1 country44 target enrollmentMarch 14, 2022

ConditionsSleep Deprivation Sleep Restriction Acoustic Stimulation Performance Alertness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Deprivation
Sponsor: Walter Reed Army Institute of Research (WRAIR)
Enrollment: 44
Locations: 1
Primary Endpoint: Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 14, 2022

End Date

October 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Walter Reed Army Institute of Research (WRAIR)

Responsible Party

Principal Investigator

JOHN D. HUGHES

Neurologist

Walter Reed Army Institute of Research (WRAIR)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)

Time Frame: 8 days

Performed at approximately 75 minutes intervals throughout the sleep deprivation and recovery days

Secondary Outcomes

Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)(5 days)
Measure various aspects of Sleep and Wakefulness using Actigraphy(22 days)
Measure alertness using the Karolinska Sleepiness Scale (KSS)(5 days)
Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery(5 days)
Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)(5 days)
Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video(5 days)
Measure current mood states using the Mood Analogue Scale (MAS)(5 days)