Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

NCT05309473 | Recruiting FDA Device

• 1 other identifier: 2901
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4)

  5 days

• Measure current mood states using the Mood Analogue Scale (MAS)

  5 days

• Measure latency to sleep using the Maintenance of Wakefulness Test (MWT)

  5 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

Study Arms (2)

Subjects Who Received Acoustic Stimulation

EXPERIMENTAL

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.

Device: Philips SmartSleep Acoustic Stimulation Device

Subjects Who Received Sham (no Acoustic Stimulation)

SHAM COMPARATOR

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.

Device: Sham (no Acoustic Stimulation)

Interventions

Philips SmartSleep Acoustic Stimulation Device 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.

Subjects Who Received Acoustic Stimulation

Sham (no 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 Sham (no acoustic stimulation) during the four hours of sleep.

Subjects Who Received Sham (no Acoustic Stimulation)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR): lead
• Philips Healthcare: collaborator

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

John D Hughes, MD

CONTACT

301-319-3214; john.d.hughes4.ctr@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: April 4, 2022
• Study Start: March 14, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

US (1)