Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 subjective measures. It will also show that improvement in sleep/wake patterns resulting from Rozerem will impact daytime functioning using objective and subjective measures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kessler Foundation

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