A Study of the Safety of Ramelteon in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Mean oxygen saturation during sleep for the entire night measured by pulse oximetry.
研究概览
简要总结
The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.
详细描述
About 30% of the adult population report sleep disturbance and 10% meet diagnostic criteria for chronic insomnia. While 20 -25% of these individuals have primary insomnia the vast majority have an additional condition such as chronic obstructive pulmonary disease. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia related conditions or diseases that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism and greater rates of accidents.
Ramelteon, is being developed as a sleep promoting agent based on agonism of melatonin receptor subtype 1 and 2. Ramelteon is marketed in the United States as Rozerem™ for the treatment of insomnia characterized by difficulty with sleep initiation.
Sleep problems are common in patients with chronic obstructive pulmonary disease. There is evidence that traditional hypnotics can cause adverse respiratory effects in insomniac populations with respiratory disorders, and so the safety and efficacy of new hypnotic agents must be ascertained in this group of patients.
This study will examine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease. Study participation is anticipated to be about 6 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ramelteon 8 mg and Placebo
干预措施: Ramelteon and Placebo (Drug)
结局指标
主要结局
Mean oxygen saturation during sleep for the entire night measured by pulse oximetry.
时间窗: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
次要结局
- Mean oxygen saturation calculated for each hour of the night, as measured by pulse oximetry.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Mean oxygen saturation for rapid eye movement sleep stages, as measured by pulse oximetry.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Mean oxygen saturation for non- rapid eye movement sleep stages, as measured by pulse oximetry.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Minutes for which oxygen saturation was less than 80% as measured by pulse oximetry.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Minutes for which oxygen saturation was less than 90% as measured by pulse oximetry.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Apnea-hypopnea index as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Latency to persistent sleep as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Total sleep time as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Sleep efficiency as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Wake time after persistent sleep onset as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Number of awakenings after persistent sleep as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Percentage of time in rapid eye movement sleep as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Percentage of time in stage 1 sleep as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Percentage of time in stage 2 sleep as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Percentage of time in stage 3/4 sleep as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Latency to rapid eye movement sleep as determined by polysomnography.(Crossover Period 1 Night 1 and Crossover Period 2 Night 1)
- Subjective sleep latency as determined by postsleep questionnaire.(Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1)
- Subjective total sleep time as determined by postsleep questionnaire.(Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1)
- Subjective Sleep Quality as determined by postsleep questionnaire.(Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1)
- Subjective number of awakenings as determined by postsleep questionnaire.(Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1)