A Study of the Effectiveness and Efficacy of the PowerSleep Device

NCT ID: NCT03162328

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2017-11-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Powersleep Sham, PowerSleep Stim

Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers. After 2 nights in the lab in the sham condition participants will cross-over to the other arm of the trial the following week. Week 2 - Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.

Group Type: PLACEBO_COMPARATOR

PowerSleep Stim

Intervention Type: DEVICE

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

PowerSleep Sham

Intervention Type: DEVICE

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

Powersleep Stim, PowerSleep Sham

Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. After 2 nights in the lab in the stim condition participants will cross-over to the other arm of the trial the following week. Week 2 - Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.

Group Type: EXPERIMENTAL

PowerSleep Stim

Intervention Type: DEVICE

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

PowerSleep Sham

Intervention Type: DEVICE

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

Interventions

PowerSleep Stim

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

Intervention Type: DEVICE

PowerSleep Sham

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Able to provide written informed consent prior to admission
• Able to read, write and speak English
• Adult volunteers aged 21-50 years
• Working full time with a regular work schedule; Full time is considered 4- 10 hour days or 5- 8 hour days with a start time of 7am or later
• Self-reported regular sleep schedule who are able to maintain their sleep schedule during the course of the study
• Self-reported sleep duration of > 5hrs. and ≤ 7 hrs. +/- 15 minutes (verified by 6 work days of ambulatory sleep monitoring with wrist actigraphy and daily logs)
• Self-reported sleep latency > 30 minutes no more than once / wk. (time to fall asleep)
• Self-reported wake time after sleep onset ≤ 30 minutes
• Participants who regularly use an alarm clock during the work week and who self-report:

i. Regular time in bed (TIB) on work days of ≤7 hours ii. Regular increase in sleep duration by ≥ 1 hour during non-work days as compared to work days, either by nocturnal bedtime extension of via a daytime nap

Exclusion Criteria

• Participation in another interventional study in the past 30 days.
• Previously enrolled in a PowerSleep study.
• Major controlled* or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, Chronic Obstructive Pulmonary Disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)
• Currently working night, swing, split or rotating shift.
• Current use or use of within the past month of a prescription or over-the-counter sleep medication or stimulant; use of psychoactive medication (based on self-report and review with a study clinician). Refer to table below for examples.
• Pregnant or currently breast feeding
• Current Smokers or using nicotine replacement therapy. Those that have been nicotine free for 30 days will be included.
• Body Mass Index > 40 kg/m2
• Prior diagnosis of any sleep disorder including

1. Obstructive Sleep Apnea (AHI ≥15 events/hour) - from ambulatory or in lab polysomnography

2. Restless legs syndrome, or periodic limb movement disorder

3. Insomnia

4. Parasomnia

• High Risk of Obstructive Sleep Apnea (OSA) based on STOP-BANG Questionnaire ("yes" on at least 4 of 8 questions)
• High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire
• High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher)
• Self-reported history of excessive alcohol intake- self-report > 21 drinks / wk or binge alcohol consumption ( >5 drinks per day)
• Excessive caffeine consumption (> 650mg/day combining all caffeinated drinks regularly absorbed during workdays.) Caffeine intake must be regular and maintained throughout study and on testing days
• Individuals who self-report a history of recurrent seizures or epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
• Individuals who self-report severe contact dermatitis or allergy to silicone, nickel or silver.
• Individuals who self-report moderate hearing loss.
• Inability to achieve appropriate headband fit.
• Planned travel across more than one time zone one month prior to and or during the anticipated period of the study with PowerSleep device use
• Intentional naps during the work week.
• Alpha-Delta waveforms as determined by Baseline night PowerSleep Device data collection

• Participants who are on a stable and well-tolerated pharmacological treatment for hypertension, dyslipidemia, or thyroid replacement will not be excluded as long as they continue to take their medication at the same dose and at the same time(s) of day.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, United States

Florida Lung & Sleep Associates

Lehigh Acres, Florida, United States

NeuroTrials Research Inc.

Atlanta, Georgia, United States

Center for Sleep and Wake Disorders

Chevy Chase, Maryland, United States

Clayton Sleep Institute

St Louis, Missouri, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AI-16128-PSPIV-LO

Identifier Type: -

Identifier Source: org_study_id