Clinical trial NCT05309473: Acoustic Stimulation During Restricted Sleep After Sleep Deprivation
Official title: Slow-wave Sleep Enhancement Using Acoustic Stimulation to Facilitate Performance Recovery During Restricted Sleep After Sleep Deprivation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Deprivation
Sleep Restriction
Acoustic Stimulation
Performance
Alertness
Lead sponsor: Walter Reed Army Institute of Research (WRAIR)
Sponsor class: FED
Collaborators: name: Philips Healthcare
First posted: 2022-04-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)
timeFrame: 8 days
Secondary outcomes:
measure: Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)
timeFrame: 5 days
measure: Measure current mood states using the Mood Analogue Scale (MAS)
timeFrame: 5 days
measure: Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)
timeFrame: 5 days
measure: Measure alertness using the Karolinska Sleepiness Scale (KSS)
timeFrame: 5 days
measure: Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery
timeFrame: 5 days
measure: Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video
timeFrame: 5 days
measure: Measure various aspects of Sleep and Wakefulness using Actigraphy
timeFrame: 22 days
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
References: