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NCT03162328 · ClinicalTrials.gov registry record · NA
A Study of the Effectiveness and Efficacy of the PowerSleep Device
A NA study of Healthy and Sleep Deprivation, sponsored by Philips Respironics.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
- 7
- Study locations
NCT03162328: Completed NA study of Healthy and Sleep Deprivation, sponsored by Philips Respironics.
NCT03162328 is a NA study of Healthy and Sleep Deprivation that has completed, run by Philips Respironics. The registered enrollment target is 84 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (87% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03162328, a NA study of Healthy and Sleep Deprivation, has completed, sponsored by Philips Respironics.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study is a randomized, double-blind, placebo-controlled cross-over study designed to evaluate the effectiveness and efficacy of 2 consecutive work days of nightly use of active versus sham PowerSleep devices in adults with self-imposed restricted sleep schedules. The primary analysis will be intent-to-treat with the secondary analysis as an as-treated analysis. The expected duration of the study for each participant is up to 4 weeks.
Primary Outcome
It is hypothesized that the use of active PowerSleep over two work nights of use, as compared to the sham device over two work nights of use, will result in a significant increase (≥5%), in mean total slow-wave activity (SWA). Slow wave activity (SWA) corresponds to the EEG power in the 0.5 to 4 Hz band during non-rapid eye movement (NREM) sleep. SWA reflects the number and amplitude of slow-waves and determines the speed with which sleep-need dissipates.
Conditions Studied
Interventions
- DEVICE PowerSleep Stim
- DEVICE PowerSleep Sham
Study Locations (7)
Alabama
- Sleep Disorders Center of Alabama - Birmingham
Arkansas
- Arkansas Center for Sleep Medicine - Little Rock
Florida
- Florida Lung & Sleep Associates - Lehigh Acres
Georgia
- NeuroTrials Research Inc. - Atlanta
Maryland
- Center for Sleep and Wake Disorders - Chevy Chase
Missouri
- Clayton Sleep Institute - St Louis
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-04-25 |
| Est. Completion | 2017-11-10 |
| Phase | NA |
What the finished NCT03162328 record still lists
NCT03162328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which PowerSleep Stim is the first listed.
NCT03162328 lists 7 locations in 7 states (Alabama, Arkansas, Florida).
Frequently Asked Questions
What is clinical trial NCT03162328 about?
NCT03162328 is a clinical study titled "A Study of the Effectiveness and Efficacy of the PowerSleep Device". This study is a randomized, double-blind, placebo-controlled cross-over study designed to evaluate the effectiveness and efficacy of 2 consecutive work days of nightly use of active versus sham PowerSleep devices in adults with self-imposed restricted sleep schedules. The primary analysis will be in...
What is the current status of trial NCT03162328?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2017-04-25. Estimated completion is 2017-11-10.
What conditions does trial NCT03162328 study?
This clinical trial studies the following conditions: Healthy, Sleep Deprivation, Insufficient Sleep Syndrome.
What interventions are being tested in trial NCT03162328?
The interventions under investigation include: PowerSleep Stim (DEVICE), PowerSleep Sham (DEVICE).
Who is sponsoring clinical trial NCT03162328?
This trial is sponsored by Philips Respironics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03162328 being conducted?
This trial has 7 study locations across Alabama, Arkansas, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03162328's enrollment target sits among peer trials
84 267th of 1090 higher than 821 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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