NCT00338078已完成不适用
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Exercise capacity
研究概览
简要总结
The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.
详细描述
Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable heart failure with left ventricular dysfunction
- •Cheyne-Stokes respiration with central AHI>15 and obstructive AHI<5
排除标准
- •Heart infarction within 3 months.
- •Chronic obstructive pulmonary disease and daytime hypoxemia.
结局指标
主要结局
Exercise capacity
Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
Brain natriuretic peptide (BNP)
次要结局
- Polysomnography
- Echocardiography
- Radionuclide determination of ejection fraction
- Mortality and hospitalization for cardiovascular causes (combined and individually)
- Hospitality anxiety and depression scale
- Epworth sleepiness scale
- Karolinska sleepiness scale
- Routine lab (haemoglobins, thyroid status, creatinin)
- Urinary catecholamines
- Urinary cortisol
- Arrhythmias from 24 hour Holter-ECG registration
- Heart rate variability
研究者
研究点 (2)
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