Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- CPAP adherence
研究概览
简要总结
The aim of this trial is to compare two different ways of CPAP titration:
CAP titration with fixed pressure vs. auto-titrating CPAP.
详细描述
Continuous positive airway pressure (CPAP) for the treatment of moderate obstructive sleep apnea (OSA) is only reimbursed in Belgium after in-laboratory overnight titration. Nevertheless, in a recent clinical practice guideline of the AASM, it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP (APAP) at home in OSA patients without significant comorbidities. Indeed, several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration. Up to now, evidence for home titration with fixed CPAP (and follow-up via telemonitoring) is very limited. The use of sleep laboratory space is costly and limits access for diagnostic studies. This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate OSA (obstructive AHI 15-30/u on initial PSG)
排除标准
- •Presence of hypoventilation
- •Presence of central sleep apnea (central AHI ≥ 15)
结局指标
主要结局
CPAP adherence
时间窗: 3 months
Usage of the device (mean number of hours/day)
次要结局
- Proportion of good titration(2 weeks)
- Epworth Sleepiness Scale(3 months)
- Blood pressure(3 months)
- Hospital contacts(3 months)
- Mask leaks(2 weeks)
- Effective pressure level(2 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(3 months)
- Residual apnea/hypopnea index(2 weeks)
- Residual device AHI(3 months)
- 36-Item Short Form Health Survey(3 months)