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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Allocation to Sleep Improvement App | Participants will be instructed to engage with the Dein Schlaf. Dein Tag. smartphone app, log their behaviors in-app, and track their sleep daily for the duration of the study (12 weeks). Participants will be instructed to start the sleep tracking device via their iOS device before lying down in bed and turning off the lights to go to sleep. In the morning, participants will turn off the sleep tracking device as soon as they wake up and decide to leave the bed. At the three time points (baseline, 6 weeks, and 12 weeks), participants will be instructed to complete online assessments on self-reported sleep quality, health perception, psychosocial factors and sleep-permissive behaviors (i.e., preventative health) Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore: The Dein Schlaf. Dein Tag. application powered by SleepScore is a validated sleep measurement application using sonar technology that also provides evidenced-based sleep advice and sleep education content based on a user's objectively measured nightly sleep data. As participants engage with the app, the Dein Schlaf. Dein Tag. application provides personalized and dynamic sleep content and sleep and circadian rhythm improvement advice based in the principles of sleep hygiene, sleep-circadian science, and cognitive behavioral psychology. Participants will also receive personalized sleep challenges tailored to improve their sleep and circadian rhythms. | 0 | None | 0 | 318 | 0 | 318 | View |
| Allocation to Waitlist Control Group | At the three time points (baseline, 6 weeks, and 12 weeks) participants assigned to the wait-list control group will be instructed to complete online assessments on self-reported sleep quality, health perception, psychosocial factors and sleep-permissive behaviors (i.e., preventative health) | 0 | None | 0 | 319 | 0 | 319 | View |