Health TrialsbyHealthPanel

Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

ConditionsSleep DeprivationSleep RestrictionAcoustic StimulationPerformanceAlertness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorWalter Reed Army Institute of Research (WRAIR)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Subjects Who Received Acoustic StimulationExperimental treatment 1 intervention
Group B: Subjects Who Received Sham (no Acoustic Stimulation)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
8 days

Secondary outcomes

1

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

Computer based series of mathematical calculations

Time frame
5 days
2

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

Computer based self adjective checklist of measure mood states

Time frame
5 days
3

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.

Time frame
5 days
4

Measure alertness using the Karolinska Sleepiness Scale (KSS)

Computer based self rated level of sleepiness

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Walter Reed Army Institute of Research (WRAIR)

Lead sponsor

Philips Healthcare

Collaborator

Source ClinicalTrials.gov
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