IRCT20220105053635N1招募中3 期
Evaluation of effect of melatonin tablet administration or placebo on insomnia and daytime sleepiness in patients with obstructive sleep apnea and insomnia (COMISA) treated with continuous positive airway pressure: A randomized double-blind placebo-controlled trial
Prescribing and rational use of medicine research center0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •Age: 18-65 years old
- •Moderate- severe OSA ( apnea -hypopnea index = 15 times per hours)
- •Using CPAP for a minimum duration of one month
- •PSQI questionnaire point should be =5
- •The patient declares his / her commitment to strictly follow the study instructions, participate in visits and take interventions.
排除标准
- •Severe pulmonary disease ( life expectancy less than 6 months)
- •Severe heart disease ( life expectance less than 6 months)
- •Severe neurologic disease ( example: dementia, Parkinson disease)
- •Major psychiatric disorder ( drug users, bipolar disorder, psychiatric disease in 3 months ago
- •Using drugs which interfere with sleeping and breathing
- •Known allergic reactions to melatonin according to past allergic history
- •Pregnancy or lactation
- •Hypothyroidism
- •Restless leg syndrome
- •Shift workers
研究者
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