Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Sleep Onset Latency
研究概览
简要总结
The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.
详细描述
Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstructive sleep apnea
排除标准
- •Cognitive impairment
- •Active alcohol or substance abuse
- •Active use of other sedative-hypnotic agents
- •Active use of fluvoxamine (drug interaction with Ramelteon
- •Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel
- •Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome
- •Severe Chronic Obstructive Pulmonary Disease
研究组 & 干预措施
Ramelteon
Ramelteon 8 mg oral before bedtime
干预措施: rozerem (Drug)
sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep Onset Latency
时间窗: 4 weeks
Time to sleep onset as determined by polysomnography
次要结局
未报告次要终点