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NCT03665844 · ClinicalTrials.gov registry record · NA
Smart Sleep In-home Validation Extension Study
A NA study, sponsored by Philips Respironics.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
NCT03665844: Completed NA study, sponsored by Philips Respironics.
NCT03665844 is a NA study that has completed, run by Philips Respironics. The registered enrollment target is 61 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
NCT03665844, a NA study, has completed, sponsored by Philips Respironics.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
Study Summary
This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting. It is intended to provide data related to product use and cognitive testing incorporating a longer baseline period for comparison purposes. It will include adults (21-50 yr. old) who are working full time and report shortened sleep due to lifestyle. For the purposes of this study, shortened sleep is defined as sleeping at least 5 hrs. of sleep per night, and sleeping less than or equal to 7 hrs. at least 3 nights per week. Participants also increase their sleep duration by ≥ 1 hour on the weekends. In addition, participants report a sleep latency ≤ 30 minutes less than or equal to 3 nights per week. Participants are generally healthy individuals who have not been diagnosed with any sleep-related medical conditions. In addition, participants diagnosed with major organ system diseases or requiring oxygen therapy are excluded from participation. Up to 75 individuals will be consented in order to complete a total of 50 participants using a nonrandomized design. The study involves an initial screening visit followed by home use of the SmartSleep device with SleepMapper app. The home use will include an initial week of baseline use followed by 3 weeks of use with boost on. Study staff will contact participants after the first week of use as a reminder. Participants will be asked to complete a battery of cognitive tests upon wake up each morning. Participants will be asked to complete a question twice daily during the home use period. Additional phone calls may occur on an as needed basis if issues arise. The final visit will be an in facility visit in which all study equipment will be returned. The anticipated study duration will be up to 6 weeks (including the 4 weeks of use period).
Primary Outcome
Efficacy will be evaluated based on the average of seven nights of use collecting baseline data compared to the average of twenty one nights of active SmartSleep, while in the home setting. SWA accumulation over Non-Rapid Eye Movement (NREM) sleep (CSWA) will be analyzed for each night in the active condition using as reference the average CSWA across baseline nights.
Interventions
- DEVICE SmartSleep Boost On
- DEVICE SmartSleep Boost Off
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-08-14 |
| Est. Completion | 2018-11-07 |
| Phase | NA |
What the finished NCT03665844 record still lists
NCT03665844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 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 SmartSleep Boost On is the first listed.
NCT03665844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03665844 about?
NCT03665844 is a clinical study titled "Smart Sleep In-home Validation Extension Study". This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting. It is intended to provide data related to product use and cognitive testing incorporating a longer baseline period for comparison purpos...
What is the current status of trial NCT03665844?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2018-08-14. Estimated completion is 2018-11-07.
What interventions are being tested in trial NCT03665844?
The interventions under investigation include: SmartSleep Boost On (DEVICE), SmartSleep Boost Off (DEVICE).
Who is sponsoring clinical trial NCT03665844?
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 NCT03665844's enrollment target sits among peer trials
61 1164th 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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