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Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

Primary Purpose

Sleep Deprivation, Sleep Restriction, Acoustic Stimulation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Philips SmartSleep Acoustic Stimulation Device

Sham (no Acoustic Stimulation)

About this trial

This is an interventional treatment trial for Sleep Deprivation

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Walter Reed Army Institute of ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Subjects Who Received Acoustic Stimulation

Subjects Who Received Sham (no Acoustic Stimulation)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Computer based series of mathematical calculations

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

Computer based self adjective checklist of measure mood states

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.

Measure alertness using the Karolinska Sleepiness Scale (KSS)

Computer based self rated level of sleepiness

Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery

Computer based battery testing various aspects of mood

Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video

Sleep will be measured during the night using polysomnography

Measure various aspects of Sleep and Wakefulness using Actigraphy

A watch-like device called an actigraph will measure movement to determine wake and sleep

Full Information

NCT ID

NCT05309473

First Posted

February 17, 2022

Last Updated

June 28, 2022

Sponsor

Walter Reed Army Institute of Research (WRAIR)

Collaborators

Philips Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT05309473

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 14, 2022 (Actual)

Primary Completion Date

October 2025 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Walter Reed Army Institute of Research (WRAIR)

Collaborators

Philips Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation, Sleep Restriction, Acoustic Stimulation, Performance, Alertness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subjects Who Received Acoustic Stimulation

Arm Type

Experimental

Arm Description

Arm Title

Subjects Who Received Sham (no Acoustic Stimulation)

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Philips SmartSleep Acoustic Stimulation Device

Intervention Description

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

Intervention Name(s)

Sham (no Acoustic Stimulation)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT)

Description

Performed at approximately 75 minutes intervals throughout the sleep deprivation and recovery days

Time Frame

8 days

Secondary Outcome Measure Information:

Title

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

Description

Computer based series of mathematical calculations

Time Frame

5 days

Title

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

Description

Computer based self adjective checklist of measure mood states

Time Frame

5 days

Title

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

Description

Time Frame

5 days

Title

Measure alertness using the Karolinska Sleepiness Scale (KSS)

Description

Computer based self rated level of sleepiness

Time Frame

5 days

Title

Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery

Description

Computer based battery testing various aspects of mood

Time Frame

5 days

Title

Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video

Description

Sleep will be measured during the night using polysomnography

Time Frame

5 days

Title

Measure various aspects of Sleep and Wakefulness using Actigraphy

Description

A watch-like device called an actigraph will measure movement to determine wake and sleep

Time Frame

22 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

John D Hughes, MD

Phone

301-319-3214

john.d.hughes4.ctr@mail.mil

Facility Information:

Facility Name

Walter Reed Army Institute of Research

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20910

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruthie Ratcliffe

Phone

301-319-3131

ruthie.h.ratcliffe.civ@mail.mil

First Name & Middle Initial & Last Name & Degree

Kajsa Carlsson

Phone

301-319-9287

kajsa.e.carlsson.ctr@mail.mil

12. IPD Sharing Statement

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Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

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