Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Study Overview
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Brief Summary
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The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.

Official Title
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Melatonin Replacement for Treatment of Sleep Disruption

Conditions
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Insomnia, Spinal Cord Injury, Tetraplegia, Sleep Disorders

Intervention / Treatment
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* Drug: Ramelteon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older, male or female veterans of any racial or ethnic group Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal cord Absence of melatonin production Time since SCI is greater than 6 months [no cases of acute spinal cord injury] Subjective complaint of sleep disruption Exclusion Criteria: Current use of fluvoxamine (Luvox , antidepressant), rifampin (antimycobacterial), ketoconazole (Nizoral , antifungal), or fluconazole (Diflucan , antifungal) [these interact with the same liver enzyme that is the primary metabolizer of ramelteon]; use of sleep medications is okay Hepatic dysfunction Concomitant use of over-the-counter melatonin Pregnancy or breast feeding Currently or have within the past six months met DSM-IV (Diagnosis and Statistical Manual IV) criteria for drug or alcohol abuse or dependence or AUDIT score >19 Acute illness or unstable chronic illness. Use of continuous positive airway pressure (CPAP) for treatment of sleep apnea is acceptable. No travel across three or more time zones within three weeks or during the protocol Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramelteon then placebo<br>8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over) | Drug: Ramelteon<br>* 8 mg nightly<br>* Other names: Rozerem;|
| Experimental: Placebo then ramelteon<br>placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over) | Drug: Placebo<br>* Nightly 8mg of placebo (same appearance as ramelteon)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Wakefulness After Sleep Onset (WASO) | Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subjective Morning Alertness | Measured as the median of the average morning alertness (measured from 1-7 on the Stanford Sleepiness Scale, a Likert-like scale in which higher values are lower alertness) of the three weeks of either placebo or ramelteon treatment | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, melatonin, spinal cord injury, insomnia, tetraplegia