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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Who Received Acoustic Stimulation | Experimental | 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. |
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| Subjects Who Received Sham (no Acoustic Stimulation) | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure simple arithmetic processing using the Mathematical Processing Subtest of the Automated Neuropsychological Assessment Metrics 4 (ANAM4) | Computer based series of mathematical calculations | 5 days |
| Measure current mood states using the Mood Analogue Scale (MAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John D Hughes, MD | Contact | 301-319-3214 | john.d.hughes4.ctr@mail.mil |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Institute of Research | Recruiting | Silver Spring | Maryland | 20910 | United States |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| 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. |
|
Computer based self adjective checklist of measure mood states |
| 5 days |
| 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. | 5 days |
| Measure alertness using the Karolinska Sleepiness Scale (KSS) | Computer based self rated level of sleepiness | 5 days |
| Measure various aspects of mood using the Walter Reed Army Institute of Research (WRAIR) Mood Battery | Computer based battery testing various aspects of mood | 5 days |
| Measure various aspects of Sleep and Wakefulness using Polysomnographic measurements with video | Sleep will be measured during the night using polysomnography | 5 days |
| Measure various aspects of Sleep and Wakefulness using Actigraphy | A watch-like device called an actigraph will measure movement to determine wake and sleep | 22 days |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |