Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- exercise capacity
研究概览
简要总结
The purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders
- Trial with medicinal product
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
acetazolamide
1 week therapy, cross-over design
干预措施: acetazolamide (Drug)
Placebo tablet
One week, cross-over design
干预措施: Placebo tablet (Drug)
supplemental oxygen during nights
One week, cross-over design
干预措施: Supplemental oxygen (Other)
Non-invasive ventilation
One week, cross-over design
干预措施: Non-invasive ventilation (Procedure)
room air
room air applied via sham-oxygen-concentrator
干预措施: Room air (Other)
结局指标
主要结局
exercise capacity
时间窗: 1 week
Assessment by the 6 minute walk distance
Quality of Life
时间窗: 1 week
Assessment by the short form of the SF 36 questionnaire
次要结局
- sleep related breathing disorders(1 week)
- hemodynamics measured by echocardiography(1 week)
- venous blood analysis(1 week)
- Nocturnal oxygen desaturation(1 week)
- arterial blood analysis(1 week)
- Vigilance(1 week)