CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
PowerSleep Stim +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03162328
NCT03162328N/ACompleted
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A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Effectiveness and Efficacy of the PowerSleep Device

Philips Respironics·interventional·Posted May 22, 2017·Updated Mar 24, 2021

In Brief

A clinical study evaluating PowerSleep Stim and PowerSleep Sham for Sleep Deprivation and 2 related conditions. Completed, enrolled 84 participants across 7 sites.

Detailed Summary

This study is a randomized, double-blind, placebo-controlled cross-over study designed to evaluate the effectiveness and efficacy of 2 consecutive work days of nightly use of active versus sham PowerSleep devices in adults with self-imposed restricted sleep schedules. The primary analysis will be intent-to-treat with the secondary analysis as an as-treated analysis. The expected duration of the study for each participant is up to 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Deprivation, Insufficient Sleep Syndrome, Healthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 22, 2017
Enrollment StartApr 25, 2017
Primary CompletionNov 10, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.1 years ago

Interventions

PowerSleep Stimdevice

Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.

PowerSleep Shamdevice

Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.