Melatonin for Circadian Sleep Disorders in the Blind
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.
研究概览
简要总结
This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1). The second study phase identifies the optimum dose and timing of melatonin for regulating each individual's 24-hour sleep/waking cycle (including sub-study 2). The third study phase introduces a new independent variable, light (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study.
Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm. Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how individuals' endogenous melatonin production responds to bright outdoor light and Sub-study 4 tests a previous finding that artificial bright light exposed daily behind the knee can regulate the body clock. Sub-study 5 is an optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years(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
Melatonin
Subjects will be administered melatonin.
干预措施: Melatonin (Drug)
Light
干预措施: Light (Behavioral)
Regular Sleep Schedule
干预措施: Regular Sleep Schedule (Behavioral)
结局指标
主要结局
Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.
时间窗: 1 year
次要结局
- Treatment Effects on Sleep and Alertness Will be Assessed by Daily Diaries and Daily Wrist Actigraphic Monitoring. Subjective Benefits Will be Assessed With Daily Ratings of Alertness and Vigor.(1 year)
