Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index Score
研究概览
简要总结
Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.
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
- Single (Participant)
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
- •Sleep Apnea
排除标准
- •Sedative/psychoactive drug use recently
- •Other clinically significant sleep disorders
- •Previous treatment for obstructive sleep apnea (OSA)
- •Requires oxygen or bilevel PAP therapy
- •Clinically unstable medical condition
- •Recent shift work
- •Significant alcohol use
- •Other clinically significant causes of insomnia
- •Illicit drug use
- •Prescription stimulants
- •Safety restrictions
- •Unable to treat sleep apnea with positive airway pressure therapy
- •Communication barriers
- •Cognitive impairment
结局指标
主要结局
Insomnia Severity Index Score
时间窗: Between Baseline and Day 42.
Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.
次要结局
未报告次要终点