A Study of the Effectiveness and Efficacy of the PowerSleep Device

Philips Respironics84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sleep Deprivation Insufficient Sleep Syndrome Healthy

Interventions

PowerSleep StimDEVICE

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

PowerSleep ShamDEVICE

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (7)

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 4 nights

Secondary Outcomes

Changes in Multiple Sleep Latency Test (MSLT)

To evaluate the relationship between MSLT (sleep latency) and changes in SWA. This evaluated the average length of time it took a participant to fall asleep (in minutes) for each of the 4 naps in each condition, after two nights of sham and two nights of stim.

Time frame: 4 nights

Paired Associates Learning (PAL)

To measure trends of memory of 2 weeks of home use randomized with active PowerSleep (delivering audio tones) as compared to a two weeks of sham (delivering no audio tones). Participants answered completed an 80 word pair memory 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. Learning was completed on the last night in the lab in each arm, with recall in the morning. PAL Differences (morning - evening responses): Difference between number correct the morning recall and the evening recall Correct Responses (evening recall): number of correct responses during the evening recall Correct Responses (morning call): number of correct responses during the morning recall, after the night in the sleep lab.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.