Trial Outcomes & Findings for Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation (NCT NCT03600194)

Last Updated: 2021-06-14

Results Overview

It is hypothesized that one night of in-lab use of a PowerSleep system (Prototype 1) or NorthWestern (Prototype 2) under an active condition (tones played to increase slow-wave activity), as compared to one night of in-lab use of the same PowerSleep system (prototype 1) or Prototype 2 under a sham condition (no tones played) will result in a significant increase (≥ 5%) in cumulative or average slow-wave activity (SWA) in nonREM sleep across the whole night of sleep compared to sham. Note: The relative ability of Prototype 1 versus Prototype 2 to increase the magnitude of SWA in sleep will also be compared.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

5 weeks

Results posted on

2021-06-14

Participant Flow

Because of all of the different randomization variations, participants could have received the powersleep or the northwestern device first and then could have been randomized to stim or sham first for both set of devices, data has been presented by device rather than overnight device configurations.

Participant milestones

Participant milestones
Measure	All Participants Consented All participants consented to the study but not enter into the In-lab phase.	PowerSleep First, Northwestern Second Participants in this arm received the PowerSleep device first and the Northwestern device second. Participants were randomized to receive PowerSleep Stim or Sham first. Participants and study staff were blinded to assignment. In this arm soft audio tones (below 65dB) will be administered by the PowerSleep Stim Device during deep sleep as determined by the functionality of the device. T PowerSleep Stim: The PowerSleep Stim device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. Soft audio tones (below 65dB) will be administered via the speakers system during deep sleep as determined by the functionality of the device. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time. PowerSleep Sham: the same device as stim with audio turned off.	Northwestern First, PowerSleep Second In this arm participants were randomized to received Stim or Sham of the Northwestern device first and the PowerSleep device second. The NorthWestern Stim device is set up will function similarly to the PowerSleep prototype. Acoustic stimulation provided by headphones with an audible soft volume that do not result in arousals will be used. Northwestern Stim: The Northwestern Stim Device will function similarly to the PowerSleep device, but stimulation will be provided using a standard PC (computer) setup at the bedside using standard polysomnogram (PSG) electrodes. EEG will be monitored and slow wave sleep (SWS) identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves and to control acoustic stimulation in a phase-locked manner (targeting the up phase of the slow wave). Acoustic stimulation will be provided by headphones with an audible soft volume that do not result in arousals. Northwestern Sham: Exact same set-up as the stim version but with audio tones turned off.
Screening STARTED	38	0	0
Screening COMPLETED	11	0	0
Screening NOT COMPLETED	27	0	0
In Lab Phase STARTED	0	5	6
In Lab Phase COMPLETED	0	5	6
In Lab Phase NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screening Population n=38 Participants All participants that were consented.
Age, Continuous	29.4 years STANDARD_DEVIATION 6.8 • n=99 Participants
Sex: Female, Male Female	24 Participants n=99 Participants
Sex: Female, Male Male	14 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	7 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	10 Participants n=99 Participants
Race (NIH/OMB) White	17 Participants n=99 Participants
Race (NIH/OMB) More than one race	3 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	38 participants n=99 Participants
Body Mass Index (BMI)	26.2 kg/m^2 STANDARD_DEVIATION 5.6 • n=99 Participants

PRIMARY outcome

Timeframe: 5 weeks

Outcome measures

Outcome measures
Measure	PowerSleep Stim n=11 Participants In this arm soft audio tones (below 65dB) will be administered by the PowerSleep Stim Device during deep sleep as determined by the functionality of the device. PowerSleep Stim: The PowerSleep Stim device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. Soft audio tones (below 65dB) will be administered via the speakers system during deep sleep as determined by the functionality of the device. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.	PowerSleep Sham n=11 Participants This PowerSleep Sham device is the same as the PowerSleep Stim device, however, it can be configured in a mode that does not play audio tones PowerSleep Sham: The PowerSleep Sham device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. There are no audio tones played in the Sham condition. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.	Northwestern Stim n=11 Participants The NorthWestern Stim device is set up will function similarly to the PowerSleep prototype. Acoustic stimulation provided by headphones with an audible soft volume that do not result in arousals will be used. Northwestern Stim: The Northwestern Stim Device will function similarly to the PowerSleep device, but stimulation will be provided using a standard PC (computer) setup at the bedside using standard PSG electrodes. EEG will be monitored and slow wave sleep (SWS) identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves and to control acoustic stimulation in a phase-locked manner (targeting the up phase of the slow wave). Acoustic stimulation will be provided by headphones with an audible soft volume that do not result in arousals.	Northwestern Sham n=11 Participants The Northwestern Sham device will be the same as the Northwestern Stim set up, however no audio tones will be played. NorthWestern Sham: The Northwestern Sham device is set up will function similarly to the PowerSleep prototype. EEG will be monitored and SWS identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves. Participant will wear headphones but no audio tones played in the Sham condition.
The Effects of the Auditory Stimulation on the Cumulative or Average Slow-wave Activity (SWA) Delivered by the PowerSleep & Northwestern Systems in Adults With Mildly Sleep Restricted Schedules as Determined by Device and PSG Scoring Outputs.	2083.9 microvolts^2 Standard Deviation 1229.7	1830.9 microvolts^2 Standard Deviation 975.5	2317.0 microvolts^2 Standard Deviation 1272.2	1723.1 microvolts^2 Standard Deviation 806.3

SECONDARY outcome

Timeframe: 5 weeks

The secondary aim of the study is to assess the impact of active versus sham PowerSleep and NorthWestern systems on measures of daytime function (Psychomotor Vigilance Task - Brief ).The Psychomotor Vigilance Task is a sustained-attention, reaction-time task that measures the speed with which participants respond to a visual stimulus. The score is fastest reaction time during a 3 minute assessment.

Outcome measures

Outcome measures
Measure	PowerSleep Stim n=11 Participants In this arm soft audio tones (below 65dB) will be administered by the PowerSleep Stim Device during deep sleep as determined by the functionality of the device. PowerSleep Stim: The PowerSleep Stim device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. Soft audio tones (below 65dB) will be administered via the speakers system during deep sleep as determined by the functionality of the device. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.	PowerSleep Sham n=11 Participants This PowerSleep Sham device is the same as the PowerSleep Stim device, however, it can be configured in a mode that does not play audio tones PowerSleep Sham: The PowerSleep Sham device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. There are no audio tones played in the Sham condition. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.	Northwestern Stim n=11 Participants The NorthWestern Stim device is set up will function similarly to the PowerSleep prototype. Acoustic stimulation provided by headphones with an audible soft volume that do not result in arousals will be used. Northwestern Stim: The Northwestern Stim Device will function similarly to the PowerSleep device, but stimulation will be provided using a standard PC (computer) setup at the bedside using standard PSG electrodes. EEG will be monitored and slow wave sleep (SWS) identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves and to control acoustic stimulation in a phase-locked manner (targeting the up phase of the slow wave). Acoustic stimulation will be provided by headphones with an audible soft volume that do not result in arousals.	Northwestern Sham n=11 Participants The Northwestern Sham device will be the same as the Northwestern Stim set up, however no audio tones will be played. NorthWestern Sham: The Northwestern Sham device is set up will function similarly to the PowerSleep prototype. EEG will be monitored and SWS identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves. Participant will wear headphones but no audio tones played in the Sham condition.
The Effects of Active and Sham Conditions of PowerSleep and Northwestern University Systems on Psychomotor Vigilance Task - Brief	310.7 milliseconds Standard Deviation 202.6	245.6 milliseconds Standard Deviation 37.0	247.4 milliseconds Standard Deviation 43.6	248.6 milliseconds Standard Deviation 41.3

SECONDARY outcome

Timeframe: 5 weeks

The secondary aim of the study is to assess the impact of active versus sham PowerSleep and NorthWestern systems on measures of daytime function (Paired Associated Learning). The Paired Associates Learning Task is a well-established cognitive task used to assess declarative memory. Participants are presented with word pairs to learn. Immediately following and again in the morning after they wake up they are tested on the recall of the words. The recall testing involves showing participants one word and they are asked to state the paired word that they learned previously. Overnight memory retention is determined by the difference in the number of recalled words between morning retrieval testing after sleep and immediate recall performance at learning before sleep. The testing is scored by a technician and may also be recorded for scoring confirmation. The score is the difference between the post wake up test and evening recall test.