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NCT02797678 · ClinicalTrials.gov registry record · NA
Feasibility, Effectiveness and Efficacy of the PowerSleep Device
A NA study, sponsored by Philips Respironics.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT02797678: Completed NA study, sponsored by Philips Respironics.
NCT02797678 is a NA study that has completed, run by Philips Respironics. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02797678, a NA study, has completed, sponsored by Philips Respironics.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is test the effectiveness of the PowerSleep auditory stimulation device on sleep quality and daytime functioning in individuals who have insufficient sleep. The PowerSleep device is a non-invasive portable device designed to increase deep sleep, potentially reducing daytime sleepiness related to insufficient sleep. The device is meant to be worn while a person is sleeping. The device delivers soft audio tones (below 65dB (decibels)/ normal speaking voice) via headphones periodically throughout the night and records the electrical activity of the brain (electroencephalogram (EEG)). The device consists of a headband with 4 sensors on the forehead, one sensor behind the right ear, headphones covered by speaker foam over each ear, and a cable which connects the headband to an upper arm band. The armband contains the device electronics. The headband and the armband are connected via adjustable Velcro closure. This device has not been released for sale and is considered investigational. The study includes approximately 30 people from four study sites. It is anticipated that a total of up to 10 people will complete the study at this site. This study is designed to last up to 6 weeks.
Primary Outcome
Slow wave activity levels will be compared analyzed by using the PowerSleep Device with stimulation and without stimulation (sham). For the analysis of SWA, six-second-long NREM epochs were considered. Every 30 s-long window was subdivided into five epochs and the sleep stage of the window was assigned to every epoch. The SWA of each epoch was estimated from the epoch's power spectrum density (PSD) by integrating over the frequency range spanning from 0.5 to 4 Hz. The PSD per epoch was estima
Interventions
- DEVICE Powersleep
- DEVICE Sham Powersleep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-01 |
| Phase | NA |
What the finished NCT02797678 record still lists
NCT02797678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Powersleep is the first listed.
NCT02797678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02797678 about?
NCT02797678 is a clinical study titled "Feasibility, Effectiveness and Efficacy of the PowerSleep Device". The purpose of this study is test the effectiveness of the PowerSleep auditory stimulation device on sleep quality and daytime functioning in individuals who have insufficient sleep. The PowerSleep device is a non-invasive portable device designed to increase deep sleep, potentially reducing daytim...
What is the current status of trial NCT02797678?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2016-06. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02797678?
The interventions under investigation include: Powersleep (DEVICE), Sham Powersleep (DEVICE).
Who is sponsoring clinical trial NCT02797678?
This trial is sponsored by Philips Respironics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02797678's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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