Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Completed · Phase 4 · Has a placebo group

Conditions studied: Insomnia, Spinal Cord Injury, Tetraplegia, Sleep Disorders

In brief

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.

Key facts

Study ID

NCT00507546

Run by

US Department of Veterans Affairs

People needed

12

Starts

2007-07-01

Expected to finish

2011-07-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Palo Alto Health Care System — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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