Acoustic Stimulation, Alertness, Performance, Sleep Deprivation, Sleep Restriction
Conditions
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.
Interventions
DEVICEPhilips 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.
DEVICESham (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.
Sponsors
Philips Healthcare
Walter Reed Army Institute of Research (WRAIR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the effects of sleep deprivation/sleep restriction on performance using the Psychomotor Vigilance Task (PVT) | 8 days | Performed at approximately 75 minutes intervals throughout the sleep deprivation and recovery days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure current mood states using the Mood Analogue Scale (MAS) | 5 days | Computer based self adjective checklist of measure mood states |
| Measure latency to sleep using the Maintenance of Wakefulness Test (MWT) | 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. |
| Measure alertness using the Karolinska Sleepiness Scale (KSS) | 5 days | Computer based self rated level of sleepiness |
| Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4) | 5 days | Computer based series of mathematical calculations |
| Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video | 5 days | Sleep will be measured during the night using polysomnography |
| Measure various aspects of Sleep and Wakefulness using Actigraphy | 22 days | A watch-like device called an actigraph will measure movement to determine wake and sleep |
| Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery | 5 days | Computer based battery testing various aspects of mood |
Countries
United States
Contacts
Primary ContactJohn D Hughes, MD
Outcome results
None listed