Healthy, Insufficient Sleep Syndrome, Sleep Deprivation
Conditions
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.
Interventions
DEVICEPowerSleep Stim
Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
DEVICEPowerSleep Sham
Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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
Intervention model description
randomized, double-blind, placebo-controlled cross-over study
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Screening Population All patients that signed consent are considered for the screening population. | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Screening Period | Did not meet inclusion/exclusion | 21 | 0 | 0 |
| Screening Period | Withdrawal by Subject | 1 | 0 | 0 |
| Study Period | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Screening Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants |
| Age, Continuous | 32.70 years STANDARD_DEVIATION 8.04 |
| Blood Pressure- Diastolic | 76.42 mmHg STANDARD_DEVIATION 10.58 |
| Blood Pressure- Systolic | 118.80 mmHg STANDARD_DEVIATION 15.71 |
| Body Mass Index | 26.79 kg/m^2 STANDARD_DEVIATION 5.14 |
| Epworth Sleepiness Scale Total | 5.48 units on a scale STANDARD_DEVIATION 3.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Heart Rate | 71.38 beats per minute STANDARD_DEVIATION 10.77 |
| insomnia severity index | 7.31 units on a scale STANDARD_DEVIATION 5.33 |
| Neck Circumference | 35.09 centimeters STANDARD_DEVIATION 3.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Region of Enrollment United States | 84 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 35 Participants |
| Temperature | 97.76 degrees Farenheit STANDARD_DEVIATION 0.89 |
| Weight | 172.48 pounds STANDARD_DEVIATION 41.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 0 / 84 | 0 / 30 | 0 / 32 |
| serious Total, serious adverse events | 0 / 84 | 0 / 30 | 0 / 32 |
Outcome results
Primary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Powersleep Sham | Average Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation | 1649.41 microvolts^2 | Standard Deviation 896.05 |
| PowerSleep Stim | Average Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation | 1643.84 microvolts^2 | Standard Deviation 847.34 |
p-value: 0.363Wilcoxon Signed Ranks Test
Primary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Powersleep Sham | Cumulative Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation | 1437304 microvolts^2×minute | Standard Deviation 1290198 |
| PowerSleep Stim | Cumulative Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation | 1444740 microvolts^2×minute | Standard Deviation 1220632 |
p-value: 0.291Wilcoxon Signed Ranks Test
Secondary
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.
Time frame: 2 days following each intervention, over 9 days
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Powersleep Sham | Average of Subjective Sleepiness Scale- Samn Perelli | 3.07 score on a scale | Standard Deviation 1.06 |
| PowerSleep Stim | Average of Subjective Sleepiness Scale- Samn Perelli | 2.88 score on a scale | Standard Deviation 1.26 |
Secondary
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.
Time frame: 2 days following each intervention, over 9 days
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Powersleep Sham | Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale | 3.97 score on a scale | Standard Deviation 1.62 |
| PowerSleep Stim | Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale | 3.76 score on a scale | Standard Deviation 1.97 |
Secondary
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.
Time frame: 2 days following each intervention, over 9 days
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Powersleep Sham | Average Subjective Sleepiness Scales. | How alert you feel? | 6.36 score on a scale | Standard Deviation 2.18 |
| Powersleep Sham | Average Subjective Sleepiness Scales. | How deep was your sleep? | 6.25 score on a scale | Standard Deviation 2.13 |
| Powersleep Sham | Average Subjective Sleepiness Scales. | How mentally refreshed you feel? | 6.35 score on a scale | Standard Deviation 2.07 |
| Powersleep Sham | Average Subjective Sleepiness Scales. | Rate your sleep quality? | 6.18 score on a scale | Standard Deviation 2.11 |
| PowerSleep Stim | Average Subjective Sleepiness Scales. | Rate your sleep quality? | 6.38 score on a scale | Standard Deviation 2.08 |
| PowerSleep Stim | Average Subjective Sleepiness Scales. | How alert you feel? | 6.61 score on a scale | Standard Deviation 2.19 |
| PowerSleep Stim | Average Subjective Sleepiness Scales. | How mentally refreshed you feel? | 6.68 score on a scale | Standard Deviation 2.11 |
| PowerSleep Stim | Average Subjective Sleepiness Scales. | How deep was your sleep? | 6.52 score on a scale | Standard Deviation 1.99 |
Secondary
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.
Time frame: 4 nights
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Category Fluency - Total Repetition Errors | 1.04 words | Standard Deviation 1.11 |
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Category Switching - Number of Set Loss Errors | 0.35 words | Standard Deviation 0.74 |
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Category Switching - Number Correct | 14.67 words | Standard Deviation 2.25 |
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Letter Fluency - Total Correct | 38.28 words | Standard Deviation 9.36 |
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Category Fluency - Total Set Loss Errors | 0.7 words | Standard Deviation 1.59 |
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Letter Fluency - Total Repetition Errors | 0.98 words | Standard Deviation 1.29 |
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Category Switching - Number of Repetition Errors | 0.17 words | Standard Deviation 0.49 |
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Letter Fluency - Total Set Loss Errors | 0.63 words | Standard Deviation 0.9 |
| Powersleep Sham | Changes in Cognitive Testing - Verbal Fluency | Category Fluency - Total Correct | 42.5 words | Standard Deviation 8.15 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Letter Fluency - Total Set Loss Errors | 0.41 words | Standard Deviation 1.15 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Category Fluency - Total Correct | 42.52 words | Standard Deviation 7.77 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Category Fluency - Total Repetition Errors | 0.74 words | Standard Deviation 1.06 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Category Fluency - Total Set Loss Errors | 0.61 words | Standard Deviation 1.16 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Category Switching - Number Correct | 13.8 words | Standard Deviation 2.55 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Category Switching - Number of Repetition Errors | 0.39 words | Standard Deviation 0.71 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Category Switching - Number of Set Loss Errors | 0.37 words | Standard Deviation 0.8 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Letter Fluency - Total Correct | 38.72 words | Standard Deviation 11.35 |
| PowerSleep Stim | Changes in Cognitive Testing - Verbal Fluency | Letter Fluency - Total Repetition Errors | 1.26 words | Standard Deviation 1.5 |
Secondary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Powersleep Sham | Changes in Multiple Sleep Latency Test (MSLT) | 10.3 minutes | Standard Deviation 5.4 |
| PowerSleep Stim | Changes in Multiple Sleep Latency Test (MSLT) | 10.3 minutes | Standard Deviation 5.3 |
Secondary
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.
Time frame: 4 nights
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Powersleep Sham | Paired Associates Learning (PAL) | PAL Differences (morning - evening responses) | 7.45 number of words | Standard Deviation 8.38 |
| Powersleep Sham | Paired Associates Learning (PAL) | Correct Responses (evening recall) | 21.76 number of words | Standard Deviation 10.74 |
| Powersleep Sham | Paired Associates Learning (PAL) | Correct Responses (morning recall) | 29.22 number of words | Standard Deviation 12.11 |
| PowerSleep Stim | Paired Associates Learning (PAL) | PAL Differences (morning - evening responses) | 8.51 number of words | Standard Deviation 7.5 |
| PowerSleep Stim | Paired Associates Learning (PAL) | Correct Responses (evening recall) | 23.82 number of words | Standard Deviation 14.37 |
| PowerSleep Stim | Paired Associates Learning (PAL) | Correct Responses (morning recall) | 32.33 number of words | Standard Deviation 17.19 |
Secondary
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).
Time frame: 4 nights
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Powersleep Sham | Psychomotor Vigilance Test - Average Speed | 4.14 1/s | Standard Deviation 0.43 |
| PowerSleep Stim | Psychomotor Vigilance Test - Average Speed | 4.22 1/s | Standard Deviation 0.39 |
Secondary
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.
Time frame: 4 nights
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Powersleep Sham | Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses. | Number of anticipations | 4.35 count of events | Standard Deviation 5.29 |
| Powersleep Sham | Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses. | Number of Lapses | 4.9 count of events | Standard Deviation 5.2 |
| PowerSleep Stim | Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses. | Number of anticipations | 5.77 count of events | Standard Deviation 10.92 |
| PowerSleep Stim | Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses. | Number of Lapses | 3.9 count of events | Standard Deviation 4.83 |
Secondary
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.
Time frame: 4 nights
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Powersleep Sham | Psychomotor Vigilance Test - Reaction Times | Average 10% fastest reaction time | 192.59 milliseconds | Standard Deviation 14.68 |
| Powersleep Sham | Psychomotor Vigilance Test - Reaction Times | Average reaction time | 258.77 milliseconds | Standard Deviation 32.78 |
| Powersleep Sham | Psychomotor Vigilance Test - Reaction Times | Average 10% slowest reaction time | 433.16 milliseconds | Standard Deviation 128.13 |
| PowerSleep Stim | Psychomotor Vigilance Test - Reaction Times | Average 10% fastest reaction time | 187.97 milliseconds | Standard Deviation 16.72 |
| PowerSleep Stim | Psychomotor Vigilance Test - Reaction Times | Average reaction time | 254.24 milliseconds | Standard Deviation 38 |
| PowerSleep Stim | Psychomotor Vigilance Test - Reaction Times | Average 10% slowest reaction time | 428.07 milliseconds | Standard Deviation 180.61 |