Bilevel Versus Servoventilation in Complex Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- apnea-hypopnea index
研究概览
简要总结
Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.
详细描述
Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.
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
- 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
- •Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment
排除标准
- •primary central sleep apnea non-compliance to CPAP therapy
研究组 & 干预措施
Bilevel
Bilevel therapy
干预措施: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany) (Device)
Servoventilation
servoventilation therapy
干预措施: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany) (Device)
结局指标
主要结局
apnea-hypopnea index
时间窗: at 6 weeks
apneas and hypopneas under therapy
次要结局
- Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy(at 6 weeks)
研究者
Dominic Dellweg, M.D.
Attending physician sleep laboratoy and home mechanical ventilation unit
Krankenhaus Kloster Grafschaft