Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309473
• Other study ID #: 2901
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: October 2026

Study information

• Verified date: April 2024
• Source: Walter Reed Army Institute of Research (WRAIR)
• Contact: John D Hughes, MD
• Phone: 301-319-3214
• Email: john.d.hughes4.ctr[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Acoustic Stimulation
• Alertness
• Performance
• Sleep Deprivation
• Sleep Restriction

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Silver Spring	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed Army Institute of Research (WRAIR)	Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)	Performed at approximately 75 minutes intervals throughout the sleep deprivation and recovery days	8 days
Secondary	Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)	Computer based series of mathematical calculations	5 days
Secondary	Measure current mood states using the Mood Analogue Scale (MAS)	Computer based self adjective checklist of measure mood states	5 days
Secondary	Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)	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.	5 days
Secondary	Measure alertness using the Karolinska Sleepiness Scale (KSS)	Computer based self rated level of sleepiness	5 days
Secondary	Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery	Computer based battery testing various aspects of mood	5 days
Secondary	Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video	Sleep will be measured during the night using polysomnography	5 days
Secondary	Measure various aspects of Sleep and Wakefulness using Actigraphy	A watch-like device called an actigraph will measure movement to determine wake and sleep	22 days