Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- AHI- score (apnea- hypopnea- index)
研究概览
简要总结
Part 1.Comparison of manual pressure titration in laboratory of sleep disorders with Autoset T APAP device from Resmed. Hypothesis: There is no difference in efficiency between manual and automatical titration.
Part 2. Comparison of CPAP and APAP therapy in the home while 3 month by Questionaire and device data.
Hypothesis: There is a difference in compliance and efficiency between CPAP and APAP mode.
详细描述
A cross over, simple blind study design has been created for a controlled trial to compare pressure titration and therapy with the Autoset T device.
Part 1: After a baseline polysomnography (PSG) a selected group of patients with obstructive sleep apnea will be titrated in two more nights in a sleep lab under APAP mode and CPAP mode. We compare the sleep quality and the AHI, oxygen saturation, leakage.
Part 2: Over a time range of 12 weeks the patients got two kinds of therapy modes at home: CPAP and APAP (each six weeks. We compare the objective and subjective therapy by compliance, device data, Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI, german version).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 18 to 80 years
排除标准
- •pregnancy
- •consumption of soporifics
- •pulmonal or cardial diseases
- •operation advised by ear, nose and throat specialist
- •missing linguistic skills in german
结局指标
主要结局
AHI- score (apnea- hypopnea- index)
时间窗: 3 months
AHI (apnea- hypopnea- index): Number of Apneas and Hypopneas/hour as a function of the type of positive airway pressure supply used- automated (APAP) vs. the standard, manually titrated and fixes continuous (CPAP).
次要结局
- Number of device-using hours(3 months)