Status:
UNKNOWN
Effect of Rozerem on Sleep Among People With Traumatic Brain Injury
Lead Sponsor:
Kessler Foundation
Conditions:
Insomnia
Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjectiv...
Detailed Description
Although research has begun to examine sleep quality within the traumatic brain injury (TBI) population, most of the studies found in the research literature utilize subjective, self-report measures t...
Eligibility Criteria
Inclusion
- 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
- 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)
- Typical bedtime between 8pm and midnight with wake-up time between 6am and 10am on weekdays.
- Must be living in the community
- In the opinion of the Study Team, the participant must be deemed reliable and likely to make all study visits
Exclusion
- Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the actigraph
- 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
- Movement disorder or spasticity affecting both upper extremities
- Severe pain or history of chronic pain
- Individuals with multiple musculoskeletal injuries
- Taking luvox or fluvoxamine (medication that potentially interact with ramelteon
- Liver disease
- Patients who are ventilator-dependent
- Penetrating head TBI
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01207050
Start Date
September 1 2010
End Date
December 1 2014
Last Update
September 9 2014
Active Locations (1)
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1
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052