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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 is a NA study that has completed, run by Philips Respironics. The registered enrollment target is 62 participants.
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.
Interventions
- DEVICE Powersleep
- DEVICE Sham Powersleep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02797678
The ClinicalTrials.gov registry entry for NCT02797678 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Philips Respironics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Powersleep is the first listed.
NCT02797678 reports 0 study locations.
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.
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