Comparison of Auto-Adjusting Positive Airway Pressure Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Oxygen Desaturation Index (ODI)
研究概览
简要总结
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged ≥ 18 years
- •Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
- •Naive to CPAP therapy
- •Participants willing and able to give written informed consent
排除标准
- •Participants requiring Bi-level PAP
- •Participants requiring supplemental oxygen
- •Participants who are pregnant
- •Subjects 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)
研究组 & 干预措施
Group 1
Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.
干预措施: APAP A (ResMed AirSense AutoSet) (Device)
Group 1
Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.
干预措施: APAP B (Apex iCH Auto) (Device)
Group 2
Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.
干预措施: APAP A (ResMed AirSense AutoSet) (Device)
Group 2
Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.
干预措施: APAP B (Apex iCH Auto) (Device)
结局指标
主要结局
Mean Oxygen Desaturation Index (ODI)
时间窗: 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.
Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour
Mean Apnoea-Hypopnoea-Index (AHI)
时间窗: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)
AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).
次要结局
- Hypopnoea-Index HI(1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B)
- Flow Limitation (%)(1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B)
- Obstructive Apnoea Index (OAI)(1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B)
- Central Apnoea Index (CAI)(1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B)
- Respiratory Effort Related Arousals RERAs(1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B)
- Mixed Apnoea Index (MAI)(1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B)
- Mean O2 Saturation(1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B)