Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
NCT ID:
NCT03600194
Description:
None
Frequency Threshold:
0
Time Frame:
5 weeks
Study:
NCT03600194
Study Brief:
Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Northwestern Sham | 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. | 0 | None | 0 | 11 | 1 | 11 | View |
| PowerSleep Stim | 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. | 0 | None | 0 | 11 | 0 | 11 | View |
| PowerSleep Sham | 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. | 0 | None | 0 | 11 | 1 | 11 | View |
| Northwestern Stim | 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. | 0 | None | 0 | 11 | 0 | 11 | View |
| Screening Population | All participants that were consented. | 0 | None | 0 | 38 | 1 | 38 | View |
Serious Events(If Any):