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Recruiting NCT05309473

Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

No phase Interventional Sleep Deprivation Sleep Restriction Acoustic Stimulation Performance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Philips SmartSleep Acoustic Stimulation Device, Sham (no Acoustic Stimulation).
Who it may be relevant to
Registry conditions: Sleep Deprivation, Sleep Restriction, Acoustic Stimulation, Performance. Basic parameters: 18 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT) [Time frame: 8 days]
Secondary outcome measures (7)
  • Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4) [Time frame: 5 days]
  • Measure current mood states using the Mood Analogue Scale (MAS) [Time frame: 5 days]
  • Measure latency to sleep using the Maintenance of Wakefulness Test (MWT) [Time frame: 5 days]
  • Measure alertness using the Karolinska Sleepiness Scale (KSS) [Time frame: 5 days]
  • Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery [Time frame: 5 days]
  • Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video [Time frame: 5 days]
  • Measure various aspects of Sleep and Wakefulness using Actigraphy [Time frame: 22 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Walter Reed Army Institute of Research — Silver Spring

Identifiers

NCT: NCT05309473 · 2901

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗