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NCT03600194 · ClinicalTrials.gov registry record · NA
Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation
A NA study, sponsored by Philips Respironics.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT03600194 is a NA study that has completed, run by Philips Respironics. The registered enrollment target is 38 participants.
The verdict
NCT03600194, a NA study, has completed, sponsored by Philips Respironics.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
This study is a randomized, single-blind, sham-controlled pilot cross-over trial comparing the feasibility, and efficacy of 2 nights of in lab use with active versus sham conditions in adults with sleep restricted schedules. The study involves the testing of 2 different prototypes both in the sham and active conditions The expected duration of the study for each participant is up to 5 weeks. It will include adults (21-50 yr. old) who report shortened sleep due to lifestyle. For the purposes of this study, shortened sleep is defined as sleeping at least 5.5 of sleep per night, and sleeping less than or equal to 7 hours of sleep +/- 15 minutes on at least 3/5 work/school nights. Participants also increase their sleep duration by ≥ 1 hour on non-work/school days. In addition, participants report a sleep latency ≤ 30 minutes and wake after sleep onset ≤ 30 minutes. Participants are generally healthy individuals who have not been diagnosed with any sleep-related medical conditions such as obstructive sleep apnea, insomnia, difficulty falling asleep on a nightly basis and deny difficulty staying asleep if awoken during sleep. In addition, participants diagnosed with major organ system diseases or requiring oxygen therapy are excluded from participation. Up to 60 individuals will be consented in order to complete a total of 10 participants using a cross over design. The study involves an initial screening visit followed by 1 week of actigraphy measurement to determine eligibility. Post eligibility, participants will undergo an additional week of actigraphy measurement. Participants will complete 2 overnight visits in the sleep lab per week, with one washout night in between. They will be randomly assigned to sham or active condition during the first of the overnight visits, and the other condition during the second overnight condition. Participants will return to the lab on the same nights the next week and receive the second device in both conditions. Participants will be
Interventions
- DEVICE PowerSleep Stim
- DEVICE PowerSleep Sham
- DEVICE Northwestern Stim
- DEVICE NorthWestern Sham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2019-07-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03600194
The ClinicalTrials.gov registry entry for NCT03600194 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 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 4 interventions - of which PowerSleep Stim is the first listed.
NCT03600194 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03600194 about?
NCT03600194 is a clinical study titled "Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation". This study is a randomized, single-blind, sham-controlled pilot cross-over trial comparing the feasibility, and efficacy of 2 nights of in lab use with active versus sham conditions in adults with sleep restricted schedules. The study involves the testing of 2 different prototypes both in the sham a...
What is the current status of trial NCT03600194?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2018-06-01. Estimated completion is 2019-07-25.
What interventions are being tested in trial NCT03600194?
The interventions under investigation include: PowerSleep Stim (DEVICE), PowerSleep Sham (DEVICE), Northwestern Stim (DEVICE), NorthWestern Sham (DEVICE).
Who is sponsoring clinical trial NCT03600194?
This trial is sponsored by Philips Respironics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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