Trial Outcomes & Findings for Feasibility, Effectiveness and Efficacy of the PowerSleep Device (NCT NCT02797678)

Last Updated: 2019-01-11

Results Overview

Slow wave activity levels will be compared analyzed by using the PowerSleep Device with stimulation and without stimulation (sham). For the analysis of SWA, six-second-long NREM epochs were considered. Every 30 s-long window was subdivided into five epochs and the sleep stage of the window was assigned to every epoch. The SWA of each epoch was estimated from the epoch's power spectrum density (PSD) by integrating over the frequency range spanning from 0.5 to 4 Hz. The PSD per epoch was estimated according to the Welch method with a four- second long Hanning window (ensuring 0.25 Hz frequency resolution), a two-second-long overlap, and 1024 points to calculate the Fourier transform. Since μ-arousal events have spike-like temporal characteristics that manifest as high values in the spectral domain, epochs containing annotated-arousals were discarded from SWA analysis. The average SWA was calculated by taking the average slow-wave activity over all considered NREM epochs

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

10 nights

Results posted on

2019-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	Screening Phase This is all participants that signed consent for this study.	PowerSleep Stim, PowerSleep Sham This arm are participants that were randomized to PowerSleep Stim mode first and then PowerSleep Sham.	PowerSleep Sham, PowerSleep Stim This arm are participants that were randomized to PowerSleep Sham first, and then PowerSleep Stim.	PowerSleep Stim - Extension Study Those participants that completed the primary trial, participated in an extension study.
Screening Phase STARTED	62	0	0	0
Screening Phase COMPLETED	37	0	0	0
Screening Phase NOT COMPLETED	25	0	0	0
First Intervention (5 Nights) STARTED	0	20	17	0
First Intervention (5 Nights) COMPLETED	0	19	17	0
First Intervention (5 Nights) NOT COMPLETED	0	1	0	0
Washout STARTED	0	19	17	0
Washout COMPLETED	0	19	17	0
Washout NOT COMPLETED	0	0	0	0
Second Intervention (5 Nights) STARTED	0	19	17	0
Second Intervention (5 Nights) COMPLETED	0	19	16	0
Second Intervention (5 Nights) NOT COMPLETED	0	0	1	0
Sub-Study STARTED	0	0	0	9
Sub-Study COMPLETED	0	0	0	9
Sub-Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Screening Phase This is all participants that signed consent for this study.	PowerSleep Stim, PowerSleep Sham This arm are participants that were randomized to PowerSleep Stim mode first and then PowerSleep Sham.	PowerSleep Sham, PowerSleep Stim This arm are participants that were randomized to PowerSleep Sham first, and then PowerSleep Stim.
Screening Phase Meeting Inclusion/Exclusion criteria	25	0	0
First Intervention (5 Nights) study/device use non-compliance	0	1	0
Second Intervention (5 Nights) study/device use non-compliance	0	0	1

Baseline Characteristics

Feasibility, Effectiveness and Efficacy of the PowerSleep Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=62 Participants All participants that were consented for this study are including in the baseline measures.
Age, Continuous	35.8 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants
Body Mass Index	27.6 kg/m^2 STANDARD_DEVIATION 8.1 • n=5 Participants

PRIMARY outcome

Timeframe: 10 nights

Population: 7 completed participants were excluded from the final analysis for the following reasons: 3 - non-scorable data - signal interference 3 - did not cross over 1 - did not meet inclusion/exclusion criteria

Outcome measures

Outcome measures
Measure	Powersleep n=28 Participants Participants will wear the PowerSleep device with soft audio tones (below 65dB to prevent arousals from sleep) administered via the speakers during deep sleep throughout the night. Powersleep: Participants will receive 5 nights of stimulation	Sham Powersleep n=28 Participants Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers. Sham Powersleep: Participants will receive 5 nights of no stimulation
Amount of Slow Wave Activity Detected by the Powersleep Device With and Without Stimulation	1367.9 microvolts^2 Standard Deviation 491.6	1291.3 microvolts^2 Standard Deviation 431.9

PRIMARY outcome

Timeframe: 10 nights

For the analysis of SWA, six-second-long NREM epochs were considered. Every 30 s-long window was subdivided into five epochs and the sleep stage of the window was assigned to every epoch. 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.

Outcome measures

Outcome measures
Measure	Powersleep n=28 Participants Participants will wear the PowerSleep device with soft audio tones (below 65dB to prevent arousals from sleep) administered via the speakers during deep sleep throughout the night. Powersleep: Participants will receive 5 nights of stimulation	Sham Powersleep n=28 Participants Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers. Sham Powersleep: Participants will receive 5 nights of no stimulation
Amount of Cumulative Slow Wave Activity Detected by the Powersleep Device With and Without Stimulation	1333663.5 microvolts^2x minute Standard Deviation 583242.2	1462267.3 microvolts^2x minute Standard Deviation 852742.1

SECONDARY outcome

Timeframe: 10 nights

To measure trends of vigilance of one work week (4 nights of home use and one night in the sleep lab) with active PowerSleep (delivering audio tones) as compared to a one work week (4 nights of home use and one night in the sleep lab) of sham (delivering no audio tones). The measure of vigilance scored was average reaction time in milliseconds.

Outcome measures

Outcome measures
Measure	Powersleep n=28 Participants Participants will wear the PowerSleep device with soft audio tones (below 65dB to prevent arousals from sleep) administered via the speakers during deep sleep throughout the night. Powersleep: Participants will receive 5 nights of stimulation	Sham Powersleep n=28 Participants Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers. Sham Powersleep: Participants will receive 5 nights of no stimulation
Changes in Vigilance Scores as Measured by the Psychomotor Vigilance Task (PVT)	251.4 milliseconds Standard Deviation 31.47	252.1 milliseconds Standard Deviation 32.79

SECONDARY outcome

Timeframe: 2 nights

Population: Only 22 participants completed the PAL the morning after the overnight in the sleep lab. 6 participants did not complete the PAL on both nights.

Participants performed a learning activity of an 80 word pair list the night of the in-lab visit and then completed a 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.