A Randomized Controlled Trial (RCT) of a Self-help Book for Insomnia in Patients With Co-morbid Obstructive Sleep Apnea (OSA) and Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Insomnia severity
研究概览
简要总结
Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment may be complicated in patients with co-morbid insomnia. This project evaluates the effects of a self-help book for insomnia in patients being treated with CPAP for OSA.
详细描述
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia in patients with obstructive sleep apnea (OSA) and co-morbid insomnia. 180 patients are randomized to either receive the self-help book (90 patients) or sleep hygiene advice (90 patients). Patients fill out questionnaires about sleep and health both at baseline and after three months. Furthermore, CPAP compliance and OSA severity will be evaluated after three months of CPAP use. The aim is to evaluate whether the self-help book will improve sleep parameters and CPAP 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, Investigator, Outcomes Assessor)
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
- •Patients diagnosed with OSA and scheduled for CPAP treatment.
- •Having co-morbid insomnia.
排除标准
- •Less than 18 years of age
- •Not fluent in Norwegian
研究组 & 干预措施
Self-help book
A self-help book for insomnia (written in Norwegian). Earlier proven to be effective among insomnia patients (without OSA co-morbidity).
干预措施: Self-help book for insomnia (Behavioral)
Sleep hygiene advice
A sheet of paper with sleep hygiene advice.
干预措施: Sleep hygiene advice (Behavioral)
结局指标
主要结局
Insomnia severity
时间窗: 3 months
Self-reported using a validated insomnia scale
次要结局
- CPAP compliance(3 months)
- Sleep apnea severity(3 months)
- Insomnia prevalence(3 months)
研究者
Bjorn Bjorvatn
Professor
University of Bergen