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 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
NCT ID:
NCT03047720
Group ID:
EG000
Title:
S1: Lully Device Plus Behavioral Modifications
Description:
The S1 therapeutic phase of this study was: 6 weeks of behavioral modifications plus the Lully device
The family received counseling on behavioral modifications during initial baseline phase to follow throughout S1.
During this phase, a scheduled awakening was performed each night with the Lully pod following the scheduled awakening protocol using Lully Sleep Guardian. This was used to reliably produce a brief awakening by titrating the device to a minimal awakening stimulus during the first night of use. If the brief awakening could not be produced using the Lully pod, the parent was to gently awaken the child
Participants were asked to enter responses daily into a Lully Study app. The questions the participant was prompted to answer were to serve to document occurrence of bedwetting and the degree of wetness.
In addition, the family were asked to complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
12
Other Number Affected:
0
Other Number At Risk:
12
Study:
NCT03047720
Results Section:
NCT03047720
Adverse Events Module:
NCT03047720