Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05309473

Acoustic Stimulation 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 8 days

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

Secondary outcomes

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

    Time frame: 5 days

    Computer based series of mathematical calculations

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

    Time frame: 5 days

    Computer based self adjective checklist of measure mood states

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

    Time frame: 5 days

    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.

  4. Measure alertness using the Karolinska Sleepiness Scale (KSS)

    Time frame: 5 days

    Computer based self rated level of sleepiness

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

    Time frame: 5 days

    Computer based battery testing various aspects of mood

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

    Time frame: 5 days

    Sleep will be measured during the night using polysomnography

  7. Measure various aspects of Sleep and Wakefulness using Actigraphy

    Time frame: 22 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

John D Hughes, MD

CONTACT

[email protected]

301-319-3214

Sponsors and collaborators

Lead sponsor

Walter Reed Army Institute of Research (WRAIR)

Fed

Collaborators

  • Philips Healthcare

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 4, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.