Web Based Cognitive-behavioral Therapy in Patients With Obstructive Sleep Apnoea Syndrome and Insomnia: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Insomnia Severity
研究概览
简要总结
Obstructive sleep apnea (OSA) and insomnia often occur in the same patient. Recent studies have demonstrated the efficacy of cognitive behavioral therapy (CBT-I) in patients with insomnia and OSA. Our aim is to verify the efficacy of web based CBT-I in patients with OSA and insomnia and the effect of web based CBT-I on the acceptance and adherence to CPAP (Continuous Positive Airway Pressure) therapy.
详细描述
Obstructive sleep apnea is one of the most common sleep disorders with high prevalence in males sex, is often associated with insomnia. The presence of both sleep disorders generates a vicious circle that exacerbates the clinical picture, makes difficult to accept and adhere to CPAP therapy and increase cardiovascular risk. CBT-I is considered the best treatment for insomnia and recent research has demonstrated the efficacy of CBT-I also when insomnia is associated with OSA. After six month of treatment we will test the efficacy of web-based CBT-I in patients with OSA and insomnia in comparison to one session of psycho education on sleep, OSA, insomnia, the interaction among them and the influence on CPAP adherence.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apnea-Hypopnea Index (AHI) ≥5
排除标准
- •Complex sleep apnea
- •Psychiatric comorbidies
研究组 & 干预措施
Arm of CBT-I treatment
Web cognitive behavioral therapy was administered before starting CPAP use by a psychologist expert in behavioral sleep medicine and expert in CBT-I. CBT-I was administered according to the same model and standard visual approach in patients with insomnia. Five sessions are scheduled: sleep psycho-education, sleep restriction, stimulus control, sleep hygiene and challenging beliefs and perception of sleep.
干预措施: web based cognitive-behavioral therapy (Behavioral)
Arm of psycho-education session
Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use
干预措施: web based cognitive-behavioral therapy (Behavioral)
Arm of control TAU (Treatment As Usual)
The control group will receive TAU. Each patient will start to use CPAP after the diagnosis according to AASM (American Academy of Sleep Medicine) guideline.
结局指标
主要结局
Insomnia Severity
时间窗: six months of CPAP use
Assessed by Insomnia Severity Index
Insomnia Severity
时间窗: Baseline
Assessed by Insomnia Severity Index
次要结局
- Adherence to CPAP therapy(six months of use)