A Study of the Effectiveness and Efficacy of the PowerSleep Device

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Effectiveness and Efficacy of the PowerSleep Device

Conditions
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Sleep Deprivation, Insufficient Sleep Syndrome, Healthy

Intervention / Treatment
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* Device: PowerSleep Stim
* Device: PowerSleep Sham


Participation Criteria
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Eligibility Criteria
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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 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 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized, double-blind, placebo-controlled cross-over study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Powersleep Sham, PowerSleep Stim<br>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<br>* Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.<br>Device: PowerSleep Sham<br>* Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.<br>|
| Experimental: Powersleep Stim, PowerSleep Sham<br>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<br>* Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.<br>Device: PowerSleep Sham<br>* Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 4 nights | 
| Changes in Cognitive Testing - Verbal Fluency | To evaluate the relationship between cognitive testing changes and changes in SWA. Verbal fluency is a type of cognitive testing in which participants are required to generate as many words directly related to the instructions as they can. This task has three conditions each arm:letter fluency (F,A,S and B,H,R),category fluency (Animals, Boys names and clothing girls names) and category switching (Fruits and furniture and vegetables and musical instruments). Each trial with each condition lasts for 60 seconds. Total correct responses are calculated by counting the number of correct words generated for each condition: letter fluency, category fluency and switching Total repetition errors are calculated by counting any response that is repeated within the 60sec trial for each condition. Total set-loss errors are any response that violates any of the criterion rules of the condition (for example saying Bill instead of Beth for girls names) for each condition. | 4 nights | 
| Average Subjective Sleepiness Scales. | Average subjective sleepiness scales, as measured by scores on a scale of 0 to 10, PowerSleep Sham over 2 works nights of use as compared to PowerSleep Stim over 2 works nights of use. For these outcomes the 0 was the worst, 10 being the best. Sleepiness scales were completed each morning following after the 2 nights of the one condition and the 2 nights in the other condition. The values of 2 nights (mornings after) are averaged and compared to the average of the 2 nights the following week. Therefore the timeframe is 4 nights. | 2 days following each intervention, over 9 days | 
| Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale | Average subjective sleepiness between PowerSleep Sham nights as compared to PowerSleep Stim nights on the Karolinska Sleepiness Scale 1 - very alert, 9 - very sleepy, great effort to keep awake Sleepiness scales were completed each morning following after the 2 nights of the one condition and the 2 nights in the other condition. The averages of the 2 nights (mornings after) are compared to the averages of the 2 nights (mornings after) the following week. Therefore the timeframe is 4 nights. | 2 days following each intervention, over 9 days | 
| Average of Subjective Sleepiness Scale- Samn Perelli | Average subjective sleepiness between PowerSleep Sham as compared to PowerSleep Stim on the Samn Perelli questionnaire 1 - fully alert, wide awake, extremely peppy and 7 - completely exhausted, unable to function effectively, ready to drop Sleepiness scales were completed each morning following after the 2 nights of the one condition and the 2 nights in the other condition. The averages of the 2 nights (mornings after) are compared to the average of the 2 nights(mornings after) the following week. Therefore the timeframe is 4 nights. | 2 days following each intervention, over 9 days | 
| Psychomotor Vigilance Test - Reaction Times | To measure trends of vigilance of (2 nights) of home use randomized with active PowerSleep (delivering audio tones) as compared to (2 nights) of sham (delivering no audio tones). This measured how quickly participants reacted to visual stimulus. Reaction time is the latency at which the participant reacts to a visual stimulus > 100 ms. | 4 nights | 
| Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses. | To measure trends of vigilance of (2 nights) of home use randomized with active PowerSleep (delivering audio tones) as compared to (2 nights) of sham (delivering no audio tones). Anticipations are the increase in errors of commission (responses without a stimulus) response time <100ms. Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms. | 4 nights | 
| Psychomotor Vigilance Test - Average Speed | To measure trends of vigilance of (2 nights) of home use randomized with active PowerSleep (delivering audio tones) as compared to (2 nights) of sham (delivering no audio tones). This measured the average speed with which participants respond to a visual stimulus. The average speed is 1/RT (also called reciprocal response time or response speed). | 4 nights |