Clinical trial NCT03162328: A Study of the Effectiveness and Efficacy of the PowerSleep Device
Official title: A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Effectiveness and Efficacy of the PowerSleep Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Insufficient Sleep Syndrome
Healthy
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, double-blind, placebo-controlled cross-over study
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Average Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation
timeFrame: 4 nights
measure: Cumulative Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation
timeFrame: 4 nights
Secondary outcomes:
measure: Changes in Multiple Sleep Latency Test (MSLT)
timeFrame: 4 nights
measure: Paired Associates Learning (PAL)
timeFrame: 4 nights
measure: Changes in Cognitive Testing - Verbal Fluency
timeFrame: 4 nights
measure: Average Subjective Sleepiness Scales.
timeFrame: 2 days following each intervention, over 9 days
measure: Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale
timeFrame: 2 days following each intervention, over 9 days
measure: Average of Subjective Sleepiness Scale- Samn Perelli
timeFrame: 2 days following each intervention, over 9 days
measure: Psychomotor Vigilance Test - Reaction Times
timeFrame: 4 nights
measure: Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses.
timeFrame: 4 nights
measure: Psychomotor Vigilance Test - Average Speed
timeFrame: 4 nights
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Center for Sleep Medicine
state: Arkansas
city: Lehigh Acres
country: United States
facility: Florida Lung & Sleep Associates
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc.
state: Georgia
city: Chevy Chase
country: United States
facility: Center for Sleep and Wake Disorders
state: Maryland
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: