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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 is a NA study that has completed, run by Philips Respironics. The registered enrollment target is 61 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03665844
The ClinicalTrials.gov registry entry for NCT03665844 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 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 SmartSleep Boost On is the first listed.
NCT03665844 reports 0 study locations.
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.
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