Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Apnea/hypopnea index
研究概览
简要总结
The purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. In the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. In the second group, patients will use an oronasal mask first and a nasal mask during the second night. The results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with central sleep apnea, not responding to treatment with CPAP
- •Indication for treatment with ASV
排除标准
- •Patients < 18 years old
研究组 & 干预措施
Oronasal - Nasal
Patients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night.
干预措施: Switch from oronasal to nasal mask during ASV treatment (Device)
Nasal - Oronasal
Patients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night.
干预措施: Switch from nasal to oronasal mask during ASV treatment (Device)
结局指标
主要结局
Apnea/hypopnea index
时间窗: Two nights
Effect on respiratory events
次要结局
- Sleep architecture(Two nights)
- Mask comfort VAS(Two nights)
- Device leaks data(Two nights)
- Sleep efficiency(Two nights)