NCT01690923已完成不适用
Nasal Pillows at High CPAP Pressure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- AHI on Nasal Mask and Pillows Mask
研究概览
简要总结
The aim of this evaluation is to test:
- Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
- Patient mask type preferences at high pressures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to give written informed consent
- •Patients who can read and comprehend English
- •Patients being treated for OSA for >6 months
- •Patients ≥ 18 years of age
- •Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O
- •Patients who can trial the trial masks up to 14 nights
- •Patients naive to pillows mask systems
排除标准
- •Patients using an inappropriate mask system
- •Patients using Bilevel flow generators
- •Patients who are pregnant
- •Patients who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
结局指标
主要结局
AHI on Nasal Mask and Pillows Mask
时间窗: 7 days
AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour
次要结局
- Usability(After 7 days of use)
研究者
研究点 (2)
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