Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
NCT ID:
NCT03600194
Group ID:
EG003
Title:
Northwestern Stim
Description:
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.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
11
Other Number Affected:
0
Other Number At Risk:
11
Study:
NCT03600194
Results Section:
NCT03600194
Adverse Events Module:
NCT03600194