NCT00507546已完成4 期
Melatonin Replacement for Treatment of Sleep Disruption
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Amount of Wakefulness After Sleep Onset (WASO)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ramelteon then placebo
Experimental
8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over)
干预措施: Ramelteon (Drug)
Placebo then ramelteon
Experimental
placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)
干预措施: Placebo (Drug)
结局指标
主要结局
Amount of Wakefulness After Sleep Onset (WASO)
时间窗: 10 weeks
Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment
次要结局
- Change in Subjective Morning Alertness(10 weeks)
研究者
研究点 (1)
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