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A Study of the Effectiveness and Efficacy of the PowerSleep Device

NCT03162328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-03-24

Study results available
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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

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.

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2017-11-10
Completion
2017-11-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03162328 on ClinicalTrials.gov