Comparison of Three Modalities of Continuous Positive Pressure Airway Treatment for 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
- 93
- 试验地点
- 2
- 主要终点
- objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)
研究概览
简要总结
The purpose of this study is to compare the treatment adherence and effects in three modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea.
详细描述
Obstructive sleep apnea (OSA) is a common disorder that is associated with substantial morbidity, including excessive daytime sleepiness, hypertension, and cardiovascular disease. Although Continuous Pressure Airway Pressure (CPAP) is effective treatment of objective and subjective complaints, adherence to CPAP therapy is suboptimal. Recently, pressure-relief CPAP (C-flex,A-flex; Respironics; Murrysville, PA) is available. The present study is single-blind,prospective, randomised, crossover study to compare the adherence and effects of therapy with C-flex, A-flex, and autoadjusting CPAP after 3 months of CPAP treatment.
Additionally, after 3 months of CPAP treatment, the patients who treated with C-flex and A-flex will crossovered, we will acess to change of adherence and effects of CPAP treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
- •Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography.
排除标准
- •Subjects diagnosed with CSA by overnight polysomnography.
- •Subjects ever used CPAP for OSA.
结局指标
主要结局
objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)
时间窗: 3 months
次要结局
- subjective, objective satisfaction and complaints for CPAP therapy(3 months)
- respiratory events (ie. apnea-hypopnea index)(3 months)
- change of positive airway pressure(3 months)
- quality of life etc.(3 months)
研究者
Toru Oga
Medical doctor
Kyoto University, Graduate School of Medicine