Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

NCT01207050 | Unknown Phase 4

• 2 other identifiers: D-604-0810-3222-BIR-E-0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Insomnia; Brain Injury

Keywords

sleep disorders; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  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 Outcomes (2)

• Epworth Sleepiness Scale

  After completing two weeks of treatment

• Cognitive Performance

  After completing two weeks of treatment

Study Arms (2)

Rozerem (Ramelteon)

EXPERIMENTAL

The primary drug of interest is a melatonin agonist for the treatment of insomnia.

Drug: Ramelteon

Sugar pill

PLACEBO COMPARATOR

Control condition.

Dietary Supplement: Placebo

Interventions

Ramelteon DRUG

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

Also known as: Rozerem

Rozerem (Ramelteon)

Placebo DIETARY_SUPPLEMENT

Control treatment

Also known as: sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

Location

Related Publications (10)

• Banos JH, LaGory J, Sawrie S, Faught E, Knowlton R, Prasad A, Kuzniecky R, Martin RC. Self-report of cognitive abilities in temporal lobe epilepsy: cognitive, psychosocial, and emotional factors. Epilepsy Behav. 2004 Aug;5(4):575-9. doi: 10.1016/j.yebeh.2004.04.010.

  PMID: 15256196 BACKGROUND

• Fleming JM, Strong J, Ashton R. Self-awareness of deficits in adults with traumatic brain injury: how best to measure? Brain Inj. 1996 Jan;10(1):1-15. doi: 10.1080/026990596124674.

  PMID: 8680388 BACKGROUND

• Vanderploeg RD, Belanger HG, Duchnick JD, Curtiss G. Awareness problems following moderate to severe traumatic brain injury: Prevalence, assessment methods, and injury correlates. J Rehabil Res Dev. 2007;44(7):937-50. doi: 10.1682/jrrd.2006.12.0163.

  PMID: 18075951 BACKGROUND

• Burke DT, Shah MK, Schneider JC, Ahangar B, Al Aladai S. Sleep-wake patterns in brain injury patients in an acute inpatient rehabilitation hospital setting. The Journal of Applied Research 4(2):239-244, 2004.

  BACKGROUND

• Worthington AD, Melia Y. Rehabilitation is compromised by arousal and sleep disorders: results of a survey of rehabilitation centres. Brain Inj. 2006 Mar;20(3):327-32. doi: 10.1080/02699050500488249.

  PMID: 16537274 BACKGROUND

• Masel BE, Scheibel RS, Kimbark T, Kuna ST. Excessive daytime sleepiness in adults with brain injuries. Arch Phys Med Rehabil. 2001 Nov;82(11):1526-32. doi: 10.1053/apmr.2001.26093.

  PMID: 11689971 BACKGROUND

• Coffield TG, Tryon WW. Construct validation of actigraphic sleep measures in hospitalized depressed patients. Behav Sleep Med. 2004;2(1):24-40. doi: 10.1207/s15402010bsm0201_3.

  PMID: 15600222 BACKGROUND

• Muller U, Czymmek J, Thone-Otto A, Von Cramon DY. Reduced daytime activity in patients with acquired brain damage and apathy: a study with ambulatory actigraphy. Brain Inj. 2006 Feb;20(2):157-60. doi: 10.1080/02699050500443467.

  PMID: 16421064 BACKGROUND

• Schuiling WJ, Rinkel GJ, Walchenbach R, de Weerd AW. Disorders of sleep and wake in patients after subarachnoid hemorrhage. Stroke. 2005 Mar;36(3):578-82. doi: 10.1161/01.STR.0000154862.33213.73. Epub 2005 Jan 27.

  PMID: 15677579 BACKGROUND

• Tweedy SM, Trost SG. Validity of accelerometry for measurement of activity in people with brain injury. Med Sci Sports Exerc. 2005 Sep;37(9):1474-80. doi: 10.1249/01.mss.0000177584.43330.ae.

  PMID: 16177597 BACKGROUND

Related Links

• Click here for further information about this study

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Injuries; Sleep Wake Disorders; Brain Injuries, Traumatic

Interventions

ramelteon; Sugars

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Anthony Lequerica, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychologist and Clinical Research Scientist

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

US (1)