Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- subjective sleepiness and other OSAS symptoms
研究概览
简要总结
Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances, objective vigilance, and it is cost-effective compared to conventional fixed continuous positive airway pressure.
详细描述
- To investigate whether computer controlled continuous positive airway pressure (autoCPAP) improves subjective sleepiness, quality of life, objective vigilance, and nocturnal respiration to a similar degree as conventional fixed continuous positive airway pressure in the initial phase of treatment and over the subsequent 2 years during home therapy
- To investigate the cost of autoCPAP compared to fixed CPAP therapy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Excessive sleepiness, and Epworth Sleepiness Score > or = 8
- •Apnea- Hypopnea-Index (AHI) > or = 10/hour
- •Age 18-75
排除标准
- •Psychophysiological incapacity to perform questionnaires
- •Other sleep disorders
- •Psychiatric disease requiring treatment
- •Previous CPAP therapy
- •Previous uvulopalatopharyngoplasty
- •Chronic nasal obstruction that required treatment for more than 1 month
- •COPD, with FEV1 < 50% predicted
- •Symptomatic cardiovascular disease requiring treatment defined as congestive heart failure > NYHA II
- •Previous stroke with neurological residuum
- •Cheyne-Stokes respiration
- •Chronic pain syndromes, fibromyalgia
- •Drug or alcohol addiction
研究组 & 干预措施
1
constant CPAP
干预措施: constant CPAP devices (Device)
2
automatic CPAP
干预措施: automatic CPAP devices (Device)
结局指标
主要结局
subjective sleepiness and other OSAS symptoms
时间窗: 3 months, 1 year, 2 years
percentage of withdrawal and cross-over to other CPAP mode
时间窗: 3 months, 1 year, 2 years
blood pressure
时间窗: 3 months, 1 year, 2 years
cost/utility ratios
时间窗: 3 months, 1 year, 2 years
quality of life
时间窗: 3 months, 1 year, 2 years
objective vigilance
时间窗: 3 months, 1 year, 2 years
次要结局
- major outcomes in subgroups of patients with severe and mild OSAS(3 months, 1 year, 2 years)
- treatment adherence(3 months, 1 year, 2 years)
- circulating markers of inflammation and cardiovascular risk(3 months, 1 year, 2 years)
- nocturnal respiratory disturbances(3 months, 1 year, 2 years)
- side effects(3 months, 1 year, 2 years)
研究者
Konrad E. Bloch
Professor
University of Zurich