A Study of the Effectiveness and Efficacy of the PowerSleep Device

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep Deprivation, Insufficient Sleep Syndrome, Healthy

In brief

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.

Key facts

Study ID

NCT03162328

Run by

Philips Respironics

People needed

84

Starts

2017-04-25

Expected to finish

2017-11-10

Last updated by the study team

2021-03-24

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Obstructive Sleep Apnea (AHI ≥15 events/hour) - from ambulatory or in lab polysomnography
• Restless legs syndrome, or periodic limb movement disorder
• Insomnia
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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