A Study of the Effectiveness and Efficacy of the PowerSleep Device

• Sponsor: Philips Respironics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03162328
• Collaborator: (none)
• Enrollment: 84
• Locations: 7
• Arms: 2
• Actual Duration (Months): 6.5
• Patients Per Site: 12
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation; Insufficient Sleep Syndrome; Healthy	Device: PowerSleep Stim; Device: PowerSleep Sham	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: randomized, double-blind, placebo-controlled cross-over studyrandomized, double-blind, placebo-controlled cross-over study
• Masking: Double (Participant, Investigator)
• Masking Description: Participants are randomized to two different therapies: Sham or Stimulation. Sites are masked as they are randomized to: Therapy A or Therapy B
• Primary Purpose: Treatment
• Official Title: A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Effectiveness and Efficacy of the PowerSleep Device
• Actual Study Start Date: Apr 25, 2017
• Actual Primary Completion Date: Nov 10, 2017
• Actual Study Completion Date: Nov 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo 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. 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; Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.; Device: PowerSleep Sham; Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.
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. 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; Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.; Device: PowerSleep Sham; Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.

Outcome Measures

Primary Outcome Measures

1. Average Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation [4 nights]

   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.

2. Cumulative Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation [4 nights]

   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.

Secondary Outcome Measures

1. Changes in Multiple Sleep Latency Test (MSLT) [4 nights]

   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.

2. Paired Associates Learning (PAL) [4 nights]

   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.

3. Changes in Cognitive Testing - Verbal Fluency [4 nights]

   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. Average Subjective Sleepiness Scales. [2 days following each intervention, over 9 days]

   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.

5. Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale [2 days following each intervention, over 9 days]

   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.

6. Average of Subjective Sleepiness Scale- Samn Perelli [2 days following each intervention, over 9 days]

   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.

7. Psychomotor Vigilance Test - Reaction Times [4 nights]

   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.

8. Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses. [4 nights]

   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.

9. Psychomotor Vigilance Test - Average Speed [4 nights]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sleep Disorders Center of Alabama	Birmingham	Alabama	United States	35213
2	Arkansas Center for Sleep Medicine	Little Rock	Arkansas	United States	72211
3	Florida Lung & Sleep Associates	Lehigh Acres	Florida	United States	33971
4	NeuroTrials Research Inc.	Atlanta	Georgia	United States	30342
5	Center for Sleep and Wake Disorders	Chevy Chase	Maryland	United States	20815
6	Clayton Sleep Institute	Saint Louis	Missouri	United States	63143
7	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Philips Respironics

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 18, 2017

More Information

Publications

None provided.

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT03162328
• Other Study ID Numbers: AI-16128-PSPIV-LO
• First Posted: May 22, 2017
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Sleep Deprivation

Study Results

Participant Flow

Recruitment Details	84 participants across 7 sites were screened for eligibility for this study. Recruitment was open April 2017 through November 2017.
Pre-assignment Detail	Of the 84 participants screened, 63 were found to be eligible,however 1 eligible participant withdrew at the randomization visit, but prior to randomization. 1 participant withdrew after being randomized. 1 participant did not complete all study visits, but had enough device data to be included in the analysis.

Arm/Group Title	Screening Population	Powersleep Sham, PowerSleep Stim	Powersleep Stim, PowerSleep Sham
Arm/Group Description	All patients that signed consent are considered for the screening population.	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. PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	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. PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.
Period Title: Screening Period
STARTED	84	0	0
COMPLETED	62	0	0
NOT COMPLETED	22	0	0
Period Title: Screening Period
STARTED	0	30	32
COMPLETED	0	30	31
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Screening Population
Arm/Group Description	All patients that signed consent are considered for the screening population.
Overall Participants	84
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	84 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.70 (8.04)
Sex: Female, Male (Count of Participants)
Female	49 58.3%
Male	35 41.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 14.3%
Not Hispanic or Latino	72 85.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	25 29.8%
White	55 65.5%
More than one race	4 4.8%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	84 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.79 (5.14)
Heart Rate (beats per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats per minute]	71.38 (10.77)
Blood Pressure- Systolic (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	118.80 (15.71)
Blood Pressure- Diastolic (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	76.42 (10.58)
Epworth Sleepiness Scale Total (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.48 (3.74)
insomnia severity index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.31 (5.33)
Temperature (degrees Farenheit) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [degrees Farenheit]	97.76 (0.89)
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	172.48 (41.80)
Neck Circumference (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	35.09 (3.93)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

5 data sets were lost in the Sham/Stim condition: 1 - noisy data, 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
Measure Participants	52	52
Mean (Standard Deviation) [microvolts^2]	1649.41 (896.05)	1643.84 (847.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Powersleep Sham, PowerSleep Stim
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.363
	Comments
	Method	Wilcoxon Signed Ranks Test
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

5 data sets were lost in the Sham/Stim condition: 1 - noisy data, 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
Measure Participants	52	52
Mean (Standard Deviation) [microvolts^2×minute]	1437304 (1290198)	1444740 (1220632)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Powersleep Sham, PowerSleep Stim
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.291
	Comments
	Method	Wilcoxon Signed Ranks Test
	Comments

3. Secondary Outcome

Title	Changes in Multiple Sleep Latency Test (MSLT)
Description	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

Outcome Measure Data

Analysis Population Description

1 participant was excluded from the analysis because of a nap in between treatment nights 1 participant was excluded from the analysis because they did not complete the final night of the study 4 data sets were lost in the Sham/Stim condition: 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
Measure Participants	51	51
Mean (Standard Deviation) [minutes]	10.3 (5.4)	10.3 (5.3)

4. Secondary Outcome

Title	Paired Associates Learning (PAL)
Description	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.
Time Frame	4 nights

Outcome Measure Data

Analysis Population Description

1 participant was excluded from the analysis because they did not complete the final night of the study 4 data sets were lost in the Sham/Stim condition: 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over 1 participant did not complete the learning in the evening therefore data was unscorable.

Arm/Group Title	Powersleep Sham	Powersleep Stim
Arm/Group Description	PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
Measure Participants	51	51
PAL Differences (morning - evening responses)	7.45 (8.38)	8.51 (7.5)
Correct Responses (evening recall)	21.76 (10.74)	23.82 (14.37)
Correct Responses (morning recall)	29.22 (12.11)	32.33 (17.19)

5. Secondary Outcome

Title	Changes in Cognitive Testing - Verbal Fluency
Description	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.
Time Frame	4 nights

Outcome Measure Data

Analysis Population Description

5 participants did not have verbal fluency recorded therefore were unable to be scored 1 participant was excluded from the analysis because they did not complete the final night of the study 1 participant was excluded because they had to repeat second work week 8 data sets were lost because they were not crossed over

Arm/Group Title	Powersleep Sham	Powersleep Stim
Arm/Group Description	PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	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.
Measure Participants	46	46
Category Fluency - Total Correct	42.5 (8.15)	42.52 (7.77)
Category Fluency - Total Repetition Errors	1.04 (1.11)	0.74 (1.06)
Category Fluency - Total Set Loss Errors	0.7 (1.59)	0.61 (1.16)
Category Switching - Number Correct	14.67 (2.25)	13.8 (2.55)
Category Switching - Number of Repetition Errors	0.17 (0.49)	0.39 (0.71)
Category Switching - Number of Set Loss Errors	0.35 (0.74)	0.37 (0.80)
Letter Fluency - Total Correct	38.28 (9.36)	38.72 (11.35)
Letter Fluency - Total Repetition Errors	0.98 (1.29)	1.26 (1.5)
Letter Fluency - Total Set Loss Errors	0.63 (0.9)	0.41 (1.15)

6. Secondary Outcome

Title	Average Subjective Sleepiness Scales.
Description	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.
Time Frame	2 days following each intervention, over 9 days

Outcome Measure Data

Analysis Population Description

8 data sets were lost in the analysis as participants were randomized but not crossed over to the other arm of the study. 1 data set was lost because the wrong form was administered. 1 participant did not complete the final overnight

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
Measure Participants	51	51
How alert you feel?	6.36 (2.18)	6.61 (2.19)
How deep was your sleep?	6.25 (2.13)	6.52 (1.99)
How mentally refreshed you feel?	6.35 (2.07)	6.68 (2.11)
Rate your sleep quality?	6.18 (2.11)	6.38 (2.08)

7. Secondary Outcome

Title	Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale
Description	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.
Time Frame	2 days following each intervention, over 9 days

Outcome Measure Data

Analysis Population Description

4 data sets were lost in the Sham/Stim condition: 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over 1 participant napped between overnights and was excluded from the daytime measures 1 participant did not complete the final overnight

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
Measure Participants	51	51
Mean (Standard Deviation) [score on a scale]	3.97 (1.62)	3.76 (1.97)

8. Secondary Outcome

Title	Average of Subjective Sleepiness Scale- Samn Perelli
Description	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.
Time Frame	2 days following each intervention, over 9 days

Outcome Measure Data

Analysis Population Description

8 data sets were lost as participants were not crossed over to the other arm of the trial. 1 participant napped between overnights and was excluded from the daytime measures 1 participant did not complete the final overnight

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.	PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
Measure Participants	51	51
Mean (Standard Deviation) [score on a scale]	3.07 (1.06)	2.88 (1.26)

9. Secondary Outcome

Title	Psychomotor Vigilance Test - Reaction Times
Description	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.
Time Frame	4 nights

Outcome Measure Data

Analysis Population Description

2 participants completed the wrong PVT 1 participant did not complete the final overnight 1 participant did not complete the PVT after wake-up 8 data sets were lost as participants did not cross over 1 participant napped in between overnights and the data was no usable

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	All participants who wore the PowerSleep deice in the sham condition for at least one night.	All Participants who wore the PowerSleep device in the Stim condition.
Measure Participants	48	48
Average 10% fastest reaction time	192.59 (14.68)	187.97 (16.72)
Average reaction time	258.77 (32.78)	254.24 (38.00)
Average 10% slowest reaction time	433.16 (128.13)	428.07 (180.61)

10. Secondary Outcome

Title	Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses.
Description	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.
Time Frame	4 nights

Outcome Measure Data

Analysis Population Description

2 participants completed the wrong PVT 1 participant did not complete the final overnight 1 participant did not complete the PVT after wake-up 8 data sets were lost as participants did not cross over 1 participant napped in between overnights and the data was no usable

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	All participants who wore the PowerSleep deice in the sham condition for at least one night.	All Participants who wore the PowerSleep device in the Stim condition.
Measure Participants	48	48
Number of anticipations	4.35 (5.29)	5.77 (10.92)
Number of Lapses	4.9 (5.2)	3.9 (4.83)

11. Secondary Outcome

Title	Psychomotor Vigilance Test - Average Speed
Description	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).
Time Frame	4 nights

Outcome Measure Data

Analysis Population Description

2 participants completed the wrong PVT 1 participant did not complete the final overnight 1 participant did not complete the PVT after wake-up 8 data sets were lost as participants did not cross over 1 participant napped in between overnights and the data was no usable

Arm/Group Title	Powersleep Sham	PowerSleep Stim
Arm/Group Description	All participants who wore the PowerSleep deice in the sham condition for at least one night.	All Participants who wore the PowerSleep device in the Stim condition.
Measure Participants	48	48
Mean (Standard Deviation) [1/s]	4.14 (0.43)	4.22 (0.39)

Adverse Events

Time Frame	All Adverse Events were collected over a 6 week period
Adverse Event Reporting Description	An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study device, whether or not considered related to study device. AEs will include: Changes in the general condition of the participant Subjective symptoms offered by or elicited from the participant; Signs observed by the investigator or study personnel;
Arm/Group Title	Screening Period		PowerSleep Sham, PowerSleep Stim		Powersleep Stim, PowerSleep Sham
Arm/Group Description	All Study participants that were consented to the study.		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. PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.		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. PowerSleep Stim: Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. PowerSleep Sham: Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.
All Cause Mortality
	Screening Period		PowerSleep Sham, PowerSleep Stim		Powersleep Stim, PowerSleep Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/30 (0%)		0/32 (0%)
Serious Adverse Events
	Screening Period		PowerSleep Sham, PowerSleep Stim		Powersleep Stim, PowerSleep Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/30 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Screening Period		PowerSleep Sham, PowerSleep Stim		Powersleep Stim, PowerSleep Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/30 (0%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.