Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

NCT ID: NCT05309473

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2026-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Subjects Who Received Acoustic Stimulation

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.

Group Type: EXPERIMENTAL

Philips SmartSleep Acoustic Stimulation Device

Intervention Type: 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 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.

Group Type: SHAM_COMPARATOR

Sham (no Acoustic Stimulation)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: lead

Responsible Party

JOHN D. HUGHES

Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Walter Reed Army Institute of Research

Silver Spring, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John D Hughes, MD

Role: CONTACT

john.d.hughes4.ctr@mail.mil

301-319-3214

Facility Contacts

Ruthie Ratcliffe

Role: primary

ruthie.h.ratcliffe.civ@mail.mil

301-319-3131

Kajsa Carlsson

Role: backup

kajsa.e.carlsson.ctr@mail.mil

301-319-9287

Other Identifiers

2901

Identifier Type: -

Identifier Source: org_study_id