A Study of the Effectiveness and Efficacy of the PowerSleep Device

NCT03162328 | Completed Results FDA Device

• 1 other identifier: AI-16128-PSPIV-LO
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (2)

• Average Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation

  It is hypothesized that the use of active PowerSleep over two work nights of use, as compared to the sham device over two work nights of use, will result in a significant increase (≥5%), in mean total slow-wave activity (SWA). Slow wave activity (SWA) corresponds to the EEG power in the 0.5 to 4 Hz band during non-rapid eye movement (NREM) sleep. SWA reflects the number and amplitude of slow-waves and determines the speed with which sleep-need dissipates.

  4 nights

• Cumulative Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation

  It is hypothesized that the use of active PowerSleep over two work nights of use, as compared to the sham device over two works nights of use, will result in a significant increase (≥5%), in mean total slow-wave activity (SWA).The integral of SWA (CSWA) over a sleep session, is directly proportional to the sleep-need dissipation occurring during said sleep session. In our research, both SWA and CSWA are evaluated as relative values having as reference the average SWA and CSWA over sham sleep sessions. CSWA is the integral of SWA which is why the unit of CSWA is microvolt\^2×minute.

  4 nights

Secondary Outcomes (9)

• Changes in Multiple Sleep Latency Test (MSLT)

  4 nights

• Paired Associates Learning (PAL)

  4 nights

• Changes in Cognitive Testing - Verbal Fluency

  4 nights

• Average Subjective Sleepiness Scales.

  2 days following each intervention, over 9 days

• Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale

  2 days following each intervention, over 9 days

Study Arms (2)

Powersleep Sham, PowerSleep Stim

PLACEBO COMPARATOR

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.

Device: PowerSleep Stim; Device: PowerSleep Sham

Powersleep Stim, PowerSleep Sham

EXPERIMENTAL

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.

Device: PowerSleep Stim; Device: PowerSleep Sham

Interventions

PowerSleep Stim DEVICE

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

Powersleep Sham, PowerSleep Stim; Powersleep Stim, PowerSleep Sham

PowerSleep Sham DEVICE

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

Powersleep Sham, PowerSleep Stim; Powersleep Stim, PowerSleep Sham

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (7)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, 72211, United States

Location

Florida Lung & Sleep Associates

Lehigh Acres, Florida, 33971, United States

Location

NeuroTrials Research Inc.

Atlanta, Georgia, 30342, United States

Location

Center for Sleep and Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Gary Garcia
• Organization: Philips

gary.garcia@philips.com

6085129475

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants are randomized to two different therapies: Sham or Stimulation. Sites are masked as they are randomized to: Therapy A or Therapy B
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled cross-over study

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 22, 2017
• Study Start: April 25, 2017
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: March 24, 2021
• Results First Posted: January 29, 2019

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)