Phase 4
Completed N=8
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Source: ClinicalTrials.gov NCT00507546 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Amount of Wakefulness After Sleep Onset (WASO) — 72.3; 76.5 Minutes — p=0.70
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Wakefulness After Sleep Onset (WASO) |
72.3; 76.5 | 0.70 |
| SECONDARY Change in Subjective Morning Alertness |
2.86; 3.14 | 0.35 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00507546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.