Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 39 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Walter Reed Army Institute of Research
Silver Spring, Maryland 20910
Contact:
Ruthie Ratcliffe
301-319-3131
ruthie.h.ratcliffe.civ@mail.mil

More Details

Status
Recruiting
Sponsor
Walter Reed Army Institute of Research (WRAIR)

Study Contact

John D Hughes, MD
301-319-3214
john.d.hughes4.ctr@mail.mil

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.