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Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

NCT01207050 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-09-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ramelteon

8mg capsule taken within one half hour of bedtime each night over the three night study period.

DIETARY_SUPPLEMENT

Placebo

Control treatment

Sponsors & Collaborators

  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Anthony Lequerica, PhD · Kessler Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01207050 on ClinicalTrials.gov