Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Clinical Global Impression scale
研究概览
简要总结
To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
详细描述
Investigators planned to administer low (2mg) and high (6mg) dose slow-release melatonin and the placebo for 4 weeks and evaluate Clinical Global Impression scale, RBD questionnaire, PSQI, Epworth sleepiness scale, and quality of life questionnaire (SF-36v2) before and after the treatment along with possible side effects and drug compliance.
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
- Triple (Participant, Care Provider, 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
- •REM sleep behavior disorder according to ICSD-3 criteria
- •No cognitive deficit or symptom of Parkinsonism
- •Those with written consent.
排除标准
- •who took medication (ex. clonazepam) for REM sleep behavior disorder
- •with degenerative neurologic disorder (ex. Parkinson's disease, Multiple System Atrophy, Lewy-body dementia, etc.)
- •who took medication that can affect REM sleep behavior disorder (anti-depressant: SSRI, TCA, MAO-inhibitor)
- •who is unable to answer questionnaires
- •who have hypersensitive reaction to medications
- •Pregnant women or breastfeeding
- •who are diagnosed with other parasomnia disorder
- •with severe medical disorder (severe liver failure, respiratory failure, heart failure, malignant tumor, etc.)
研究组 & 干预措施
Circadin 2mg
low-dose (2mg) slow-release melatonin for 1 month.
干预措施: Circadin (Drug)
Circadin 6mg
high-dose (6mg) slow-release melatonin for 1 month.
干预措施: Circadin (Drug)
Placebo
Administer placebo pills with identical morphology
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Clinical Global Impression scale
时间窗: baseline and 4 weeks
Changes in RBDQ-HK score (RBD questionnaire-HK)
时间窗: Baseline and 4 weeks
次要结局
- Sleepiness questionnaire(after taking the treatment for 4 weeks)
- Quality of life questionnaire(after taking the treatment for 4 weeks)
- Sleep quality questionnaire(after taking the treatment for 4 weeks)
- Changes in Dream enactment behavior frequency described in sleep diary(Baseline and 4 weeks)
- Drug adverse effect(4 weeks)
研究者
Ki-Young Jung
Professor
Seoul National University Hospital