Randomized, Double-Blind, Cross-Over Study Comparing the Efficacy of Immediate and Extended-Release Melatonin as a Supplement Affecting the Sleep Cycle in Patients With Parkinson Disease and Rapid Eye Movement Sleep Behavior Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in sleep cycle
研究概览
简要总结
The purpose of this research is to compare the efficacy of immediate versus extended-release melatonin as a supplement affecting the sleep cycle in patients with Parkinson disease and Rapid Eye Movement Sleep Behavior Disorder.
详细描述
Enrolled patients with Parkinson disease and previously diagnosed rapid eye movement sleep behavior disorder, who are being treated at Mayo Clinic in Florida, will be randomized to receive either immediate-release melatonin or extended-release melatonin and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks separated by a washout period of 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.
- •Patient registered to Parkinson's disease database of Mayo Clinic Florida.
排除标准
- •Patients who are using other sleep aids or medications (Clonazepam).
- •Patients who are not willing to undertake 1 week of washout period.
- •Patients who do not sign a consent for research.
结局指标
主要结局
Change in sleep cycle
时间窗: Baseline and 4 weeks
Assessed by the self-reported modified Mayo Sleep questionnaire (MSQ) which consists of 8 questions related to sleep behavior in the past month.
次要结局
未报告次要终点