NCT03162328

A Study of the Effectiveness and Efficacy of the PowerSleep Device

A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Effectiveness and Efficacy of the PowerSleep Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Deprivation
• Insufficient Sleep Syndrome
• Healthy

Interventions

Type	Name	Description
DEVICE	PowerSleep Stim	Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
DEVICE	PowerSleep Sham	Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.

Timeline

• Start date: 2017-04-25
• Primary completion: 2017-11-10
• Completion: 2017-11-10
• First posted: 2017-05-22
• Last updated: 2021-03-24
• Results posted: 2019-01-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study