Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Performance; Sleep Deprivation; Sleep Restriction; Alertness; Acoustic Stimulation
• Intervention / Treatment: Device: Philips SmartSleep Acoustic Stimulation Device; Device: Sham (no Acoustic Stimulation)

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John D Hughes, MD; Phone Number: 301-319-3214; Email: john.d.hughes4.ctr@mail.mil

Study Locations

• United States
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Recruiting
      • Walter Reed Army Institute of Research
      • Contact: Ruthie Ratcliffe; Phone Number: 301-319-3131; Email: ruthie.h.ratcliffe.civ@mail.mil
      • Contact: Kajsa Carlsson; Phone Number: 301-319-9287; Email: kajsa.e.carlsson.ctr@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Measure current mood states using the Mood Analogue Scale (MAS)	Computer based self adjective checklist of measure mood states	5 days
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
Measure alertness using the Karolinska Sleepiness Scale (KSS)	Computer based self rated level of sleepiness	5 days
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
Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video	Sleep will be measured during the night using polysomnography	5 days
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

Collaborators and Investigators

• Sponsor: Walter Reed Army Institute of Research (WRAIR)
• Collaborators: Philips Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Estimated): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: 2901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes