Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

September 8, 2014 updated by: Anthony Lequerica, Kessler Foundation

Pilot Study: The Effect of Rozerem on Sleep Disturbance After Traumatic Brain Injury

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 that can be problematic in terms of response accuracy when used with populations that have known cognitive deficits (Baños, LaGory, Sawrie, Faught, Knowlton, Prasad, Kuzniecky and Martin, 2004). Because TBI often results in a diminished capacity for self-reflective awareness, obtaining reliable sleep-related information is difficult to do through surveys alone (Fleming, Strong, Ashton, 1996; Vanderploeg, Belanger, Duchnick, and Curtiss, 2007).

A number of studies have attempted to objectify the measurement of sleep quality in TBI rehabilitation by having nursing staff keep an overnight log to document whether the patient was asleep or awake at hourly intervals (Burke, Shah, Schneider, Ahangar, & Al Aladai, 2004; Worthington & Melia, 2006). Because this results in only one single observation point per hour, it misses the nuances of the sleep/wake cycle obtained through more continuous measurement throughout the night and is still somewhat subjective and dependent on the observer's judgment.

Polysomnography, the electrophysiological measurement of sleep, is widely used in the clinical setting to diagnose sleep disorders. Using this more objective measure, Masel and colleagues (2001) found a high prevalence of posttraumatic hypersomnia, sleep apnea-hypopnea syndrome and periodic limb movement disorder that was not identified through self-report measures (Masel, Scheibel, Kimbark, & Kuna, 2001). This illustrates the limitations of self-report questionnaires and highlights the need for more objective measures. However, the high cost and inconvenience of polysomnography, requiring multiple electrodes attached to the face, head, and other parts of the body, make it less practical for research studies.

These limitations of subjective self-report measures and the cost and inconvenience of polysomnography suggest the need for alternative methods of measurement. With the use of an actigraph, a small, highly sensitive, accelerometer (motion detector) worn on the wrist over a period of days, a number of sleep-related variables can be derived through the analysis of motion and rest patterns using a computer algorithm (Coffield & Tryon, 2004). Variables such as sleep latency, total time asleep, and number of nocturnal awakenings derived through actigraphy are comparable to those obtained via polysomnography, and recent research studies demonstrate the validity of actigraph-based sleep/wake estimates among individuals with acquired brain injury (Muller, Czymmek, Thone-Otto, & Von Cramon, 2006; Tweedy & Trost, 2005; Schuiling, Rinkel, Walchenbach, & de Weerd, 2005). Thus, actigraphy represents a means of measurement that will enable the collection of objective data in the comfort of the sleeper's usual environment in a manner that is less invasive and more cost-effective than polysomnography, and more reliable than self-report measures alone.

The most widely researched treatments for sleep disturbance are problematic for individuals with TBI due to their effects on cognition and risk for dependence. With a high prevalence of sleep/wake disorders found among individuals with TBI, Rozerem is a promising treatment option to improve sleep quality that is less likely to exacerbate cognitive sequelae of TBI and less likely to result in dependence.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rozerem (Ramelteon)
The primary drug of interest is a melatonin agonist for the treatment of insomnia.
Drug: Ramelteon
8mg capsule taken within one half hour of bedtime each night over the three night study period.
Other Names:
  • Rozerem
Placebo Comparator: Sugar pill
Control condition.
Dietary supplement: Placebo
Control treatment
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: At third week of treatment
Sleep Latency (the number of minutes it takes for the participant to fall asleep after getting into bed), and Total Sleep Time (number of minutes asleep between getting into bed for the night and getting out of bed in the morning).
At third week of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale
Time Frame: After completing two weeks of treatment
Measure of subjective daytime sleepiness.
After completing two weeks of treatment
Cognitive Performance
Time Frame: After completing two weeks of treatment
Performance on a computer-administered continuous performance test.
After completing two weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Investigators

  • Principal Investigator: Anthony Lequerica, PhD, Kessler Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-604-08
  • 10-3222-BIR-E-0 (Other Grant/Funding Number: New Jersey Commission on Brain Injury Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Injury

Clinical Trials on Ramelteon

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe