Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Automated REM without atonia index
研究概览
简要总结
This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.
详细描述
This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril).
Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.
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
- Single (Outcomes Assessor)
盲法说明
Mask treatment arm when analyzing polysomnography.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •REM sleep behavior disorder (ICSD-3 criteria)
排除标准
- •Neurological disorder including epilepsy or stroke
- •History of psychiatric illness
- •Neurodegenerative disease including dementia or parkinsonism.
- •Medication affecting sleep within 1 month
- •Intake of melatonin or clonazepam within 1 week.
- •Unable to complete questionnaires
研究组 & 干预措施
Melatonin 2mg
4 weeks of 2mg of prolonged release Melatonin
干预措施: Melatonin 2mg (Drug)
ClonazePAM 0.5 MG
4 weeks of 0.5mg of rivotril
干预措施: ClonazePAM 0.5 MG (Drug)
结局指标
主要结局
Automated REM without atonia index
时间窗: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Percentage seconds with chin EMG amplitude\<1uV/ Total REM seconds.
次要结局
- Clinical Global Impression of RBD symptom severity(4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg)
- REM sleep behavior disorder symptom severity(4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg)
- Sleep quality(4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg)
- Depression(4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg)
研究者
Won Chul Shin
Professor
Kyung Hee University Hospital at Gangdong