Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Sleep Efficiency
研究概览
简要总结
This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older, admitted to the ICU
- •Expected length of stay of at least 48 hours
- •Not mechanically ventilated
- •Able to take oral medications.
- •Hemodynamically stable as determined by the treating ICU physician
- •Able to provide informed consent or have consent provided by a legally -authorized representative.
排除标准
- •Mechanically ventilated
- •Currently using melatonin prior to ICU admission,
- •Have neurological conditions that may significantly alter sleep architecture, such as traumatic brain injury, stroke, or severe dementia.
- •Pregnant or lactating individuals
- •Those individuals with a comfort measures-only status
研究组 & 干预措施
Melatonin arm
3mg Melatonin will be administered orally to all subjects.
干预措施: Melatonin (Drug)
结局指标
主要结局
Sleep Efficiency
时间窗: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler
, Total sleep time
时间窗: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler
Sleep Efficiency as measured by total sleep time over time in bed
时间窗: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler. Higher sleep efficiency is better.
, Total sleep time in hours and minutes
时间窗: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler.
, Delta to Theta ratio
时间窗: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler Higher delta to Theta ratio is better
, Arousal Index
时间窗: From enrollment to the end of 48 hours of the last subject's participation in the study
These measures are obtained from the sleep profiler. Lower arousal index is better
次要结局
未报告次要终点
研究者
Jag Sunderram, MD
Professor of Medicine
Rutgers, The State University of New Jersey