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Feasibility, Effectiveness and Efficacy of the PowerSleep Device

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ClinicalTrials.gov Identifier: NCT02797678
Recruitment Status : Completed
First Posted : June 13, 2016
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

Brief Summary:

The purpose of this study is test the effectiveness of the PowerSleep auditory stimulation device on sleep quality and daytime functioning in individuals who have insufficient sleep.

The PowerSleep device is a non-invasive portable device designed to increase deep sleep, potentially reducing daytime sleepiness related to insufficient sleep. The device is meant to be worn while a person is sleeping. The device delivers soft audio tones (below 65dB (decibels)/ normal speaking voice) via headphones periodically throughout the night and records the electrical activity of the brain (electroencephalogram (EEG)). The device consists of a headband with 4 sensors on the forehead, one sensor behind the right ear, headphones covered by speaker foam over each ear, and a cable which connects the headband to an upper arm band. The armband contains the device electronics. The headband and the armband are connected via adjustable Velcro closure. This device has not been released for sale and is considered investigational.

The study includes approximately 30 people from four study sites. It is anticipated that a total of up to 10 people will complete the study at this site. This study is designed to last up to 6 weeks.


Condition or disease Intervention/treatment Phase
Sleep Sleep Disorders Not Due to A Substance or Known Physiological Condition Device: Powersleep Device: Sham Powersleep Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Feasibility, Effectiveness and Efficacy of the PowerSleep Device
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Powersleep Stim, PowerSleep Sham
Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night for one week. Participants will then be crossed over and will wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers for one week
Device: Powersleep
Participants will receive 5 nights of stimulation

Device: Sham Powersleep
Participants will receive 5 nights of no stimulation

Sham Comparator: 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 for one week. Participants will then wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night for one week.
Device: Powersleep
Participants will receive 5 nights of stimulation

Device: Sham Powersleep
Participants will receive 5 nights of no stimulation




Primary Outcome Measures :
  1. Amount of Slow Wave Activity Detected by the Powersleep Device With and Without Stimulation [ Time Frame: 10 nights ]

    Slow wave activity levels will be compared analyzed by using the PowerSleep Device with stimulation and without stimulation (sham).

    For the analysis of SWA, six-second-long NREM epochs were considered. Every 30 s-long window was subdivided into five epochs and the sleep stage of the window was assigned to every epoch.

    The SWA of each epoch was estimated from the epoch's power spectrum density (PSD) by integrating over the frequency range spanning from 0.5 to 4 Hz.

    The PSD per epoch was estimated according to the Welch method with a four- second long Hanning window (ensuring 0.25 Hz frequency resolution), a two-second-long overlap, and 1024 points to calculate the Fourier transform.

    Since μ-arousal events have spike-like temporal characteristics that manifest as high values in the spectral domain, epochs containing annotated-arousals were discarded from SWA analysis. The average SWA was calculated by taking the average slow-wave activity over all considered NREM epochs


  2. Amount of Cumulative Slow Wave Activity Detected by the Powersleep Device With and Without Stimulation [ Time Frame: 10 nights ]

    For the analysis of SWA, six-second-long NREM epochs were considered. Every 30 s-long window was subdivided into five epochs and the sleep stage of the window was assigned to every epoch.

    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.



Secondary Outcome Measures :
  1. Changes in Vigilance Scores as Measured by the Psychomotor Vigilance Task (PVT) [ Time Frame: 10 nights ]

    To measure trends of vigilance of one work week (4 nights of home use and one night in the sleep lab) with active PowerSleep (delivering audio tones) as compared to a one work week (4 nights of home use and one night in the sleep lab) of sham (delivering no audio tones).

    The measure of vigilance scored was average reaction time in milliseconds.


  2. Changes in Memory Scores as Measured by the Paired-Associate-Learning (PAL) [ Time Frame: 2 nights ]
    Participants performed a learning activity of an 80 word pair list the night of the in-lab visit and then completed a recall in the morning following the overnight in the sleep lab. The results listed below are the mean and standard deviation of the PowerSleep treatment week compared to the Sham treatment week.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide written informed consent prior to admission
  • Able to read, write and speak English
  • Adult volunteers aged 21-50 working full time; 5 consecutive days (M-F)
  • Self-reported regular sleep schedule
  • Self-reported sleep duration of > 5hrs. and ≤ 6.5hrs. (verified by 3 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 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.
  • 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 shift 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.
  • Pregnancy
  • 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 OSA (Obstructive Sleep Apnea) based on STOP-BANG Questionnaire ("yes" on at least 3 of 7 questions)
  • High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire
  • Excessive alcohol intake (self-report > 14 drinks / wk.)
  • Self-report of binge alcohol consumption ( >5 drinks) on any one day during the week prior to the randomization, during the device use period, and during the wash-out period
  • Excessive caffeine consumption (> 500mg/day combining all caffeinated drinks regularly absorbed during workdays.) Caffeine intake must be regular and maintained throughout study and on testing days (available at test sites)
  • 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.
  • Individuals who self-report moderate hearing loss.
  • Inability to achieve appropriate headband fit.
  • Planned air travel or travel across more than one time zone one month prior to and or during the anticipated period of the study with PowerSleep device use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797678


Locations
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United States, Georgia
NeuroTrials Research Inc
Atlanta, Georgia, United States, 30342
United States, Missouri
St. Lukes Hospital
Chesterfield, Missouri, United States, 63017
Clayton Sleep Institute
Saint Louis, Missouri, United States, 63143
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Philips Respironics
Investigators
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Principal Investigator: Russell Rosenberg, PhD NeuroTrials Research, Inc.

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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT02797678     History of Changes
Other Study ID Numbers: CAI-16025-PSPIL-LO
First Posted: June 13, 2016    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders