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:
EG002
Title:
PowerSleep Sham
Description:
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.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
11
Other Number Affected:
1
Other Number At Risk:
11
Study:
NCT03600194
Results Section:
NCT03600194
Adverse Events Module:
NCT03600194