Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT01207050
Eligibility Criteria:
Inclusion Criteria:
1. History of traumatic brain injury (TBI) as determined by any of the following at least 1 month prior to study entry:
* Glasgow Coma Scale Score \< 15
* Loss of consciousness greater than 5 minutes
* Post traumatic amnesia greater than 30 minutes
* Abnormal neuro-imaging findings after TBI
* Evidence of neurologic deficit as a result of TBI
2. Endorsement of any of the following by self-report or proxy-report:
* Problems falling or staying asleep
* Daytime sleepiness or fatigue (either cognitive or physical)
* These symptoms must be identified as having an onset after TBI
* Score of \> 5 on the Pittsburgh Sleep Quality Index (PSQI)
3. Typical bedtime between 8pm and midnight with wake-up time between 6am and 10am on weekdays.
4. Must be living in the community
5. In the opinion of the Study Team, the participant must be deemed reliable and likely to make all study visits
Exclusion Criteria:
1. Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the actigraph
2. Individuals using other known hypnotic agents (i.e., benzodiazepines, diphenhydramine, zolpidem) will be considered for participation but must have refrained from using sleep medication for two weeks prior to the study and throughout the course of the study
3. Movement disorder or spasticity affecting both upper extremities
4. Severe pain or history of chronic pain
5. Individuals with multiple musculoskeletal injuries
6. Taking luvox or fluvoxamine (medication that potentially interact with ramelteon
7. Liver disease
8. Patients who are ventilator-dependent
9. Penetrating head TBI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01207050
Study Brief:
Protocol Section:
NCT01207050