ACTRN12613001178730已完成不适用
Treating Comorbid Insomnia with Obstructive Sleep Apnoea (COMISA): A randomised controlled trial evaluating the effectiveness of a new treatment strategy incorporating Cognitive Behaviour Therapy for Insomnia (CBTi) plus treatment as usual for patients with combined insomnia and sleep apnoea
Prof Doug McEvoy0 个研究点目标入组 140 人开始时间: 2013年10月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •1. Age greater than or equal to18 years of age up to and including 75 years of age. 2. An apnoea/hypopnoea index (AHI) greater than 15 events per hour of sleep by polysomnography (PSG) with clinical diagnosis of OSA confirmed by treating consultant respiratory physician. 3. Recommended by treating sleep physician for CPAP treatment. 4. A diagnosis of Insomnia to ICSD-2 criteria, Insomnia Severity Index Score greater than 13.
排除标准
- •1. Severe daytime sleepiness, or other reason, which in the opinion of the treating physician would cause undue risk to the patient’s safety during the CBTi treatment period while awaiting CPAP treatment.
- •2. Any other sleep disorder (eg REM behaviour disorder, severe restless legs syndrome) which in the opinion of the treating physician is the dominant sleep diagnosis and which requires immediate treatment. Patients with other medical or psychiatric conditions (e.g. depression & anxiety) will not be excluded, but diagnoses recorded from the patient’s file for reporting and analysis purposes.
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