Sleep DeprivationNCT03162328
A Study of the Effectiveness and Efficacy of the PowerSleep Device
A study testing PowerSleep Stim in people with Sleep Deprivation and Insufficient Sleep Syndrome, run by Philips Respironics at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Sleep Deprivation, Insufficient Sleep Syndrome, Healthy
- What is being tested?
- PowerSleep Stim
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Apr 2017to 10 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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:
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
NeuroTrials Research Inc.
Atlanta, Georgia, 30342
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Florida Lung & Sleep Associates
Lehigh Acres, Florida, 33971
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, 72211
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Clayton Sleep Institute
St Louis, Missouri, 63143
About this study
Official title: A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Effectiveness and Efficacy of the PowerSleep Device
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.
- Conditions
- Sleep Deprivation, Insufficient Sleep Syndrome, Healthy
- Being tested
- PowerSleep Stim, PowerSleep Sham
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Powersleep Sham, PowerSleep Stim | Placebo comparator | 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. Receives: Device: PowerSleep Stim; Device: PowerSleep Sham |
| Powersleep Stim, PowerSleep Sham | Experimental | 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. Receives: Device: PowerSleep Stim; Device: PowerSleep Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 nights
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 4 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start25 Apr 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, double-blind, placebo-controlled cross-over study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162328
- Sponsor's protocol ID
- AI-16128-PSPIV-LO
- Status last verified
- Mar 2021
- First submitted
- 16 May 2017
- Last updated
- 24 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No, this data will remain within Philips Respironics.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Multi-Site Randomized Cross-Over Study of the Effectiveness and Efficacy of the PowerSleep Device
- ClinicalTrials.gov ID
- NCT03162328
- Acronym / sponsor ID
- AI-16128-PSPIV-LO
- Conditions
- Sleep Deprivation, Insufficient Sleep Syndrome, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Posted 29 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled cross-over study
| Arm | Type | Receives |
|---|---|---|
| Powersleep Sham, PowerSleep Stim | Placebo comparator | Device: PowerSleep Stim, Device: PowerSleep ShamParticipants 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, PowerSleep Sham | Experimental | Device: PowerSleep Stim, Device: PowerSleep ShamParticipants 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PowerSleep StimParticipants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night. | Device | Powersleep Sham, PowerSleep Stim, Powersleep Stim, PowerSleep Sham |
| PowerSleep ShamParticipants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers. | Device | Powersleep Sham, PowerSleep Stim, Powersleep Stim, PowerSleep Sham |
Primary outcome
Average Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation
Time frame: 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.
Cumulative Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation
Time frame: 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.
9 secondary outcomes
Changes in Multiple Sleep Latency Test (MSLT)
Time frame: 4 nights
Paired Associates Learning (PAL)
Time frame: 4 nights
Changes in Cognitive Testing - Verbal Fluency
Time frame: 4 nights
Average Subjective Sleepiness Scales.
Time frame: 2 days following each intervention, over 9 days
Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale
Time frame: 2 days following each intervention, over 9 days
Average of Subjective Sleepiness Scale- Samn Perelli
Time frame: 2 days following each intervention, over 9 days
Psychomotor Vigilance Test - Reaction Times
Time frame: 4 nights
Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses.
Time frame: 4 nights
Psychomotor Vigilance Test - Average Speed
Time frame: 4 nights
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No, this data will remain within Philips Respironics.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PowerSleep Stim in people with Sleep Deprivation and Insufficient Sleep Syndrome, run by Philips Respironics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation (time frame: 4 nights). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.