Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Phase 4

Completed

• Conditions: Insomnia; Spinal Cord Injury; Tetraplegia; Sleep Disorders
• Interventions: Drug: Placebo; Drug: Ramelteon

• Registration Number: NCT00507546
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-25
• Study First Posted: 2007-07-26
• Primary Completion: 2010-12
• Study Completion: 2011-07
• Results First Submitted: 2013-09-13
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-25
• Last Update Submitted: 2014-04-25
• Results First Posted: 2014-05-22
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo then ramelteon	Placebo	placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)
Ramelteon then placebo	Ramelteon	8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over)

Primary Outcome Measures

Name	Time	Method
Amount of Wakefulness After Sleep Onset (WASO)	10 weeks	Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment

Secondary Outcome Measures

Name	Time	Method
Change in Subjective Morning Alertness	10 weeks	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

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States