Comparison of Auto-Continuous Positive Airway Pressure Device(Auto-CPAP) With Conventional Fixed CPAP in Chinese Patients With Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
研究概览
简要总结
AutoCPAP would lead to better compliance than FixCPAP
详细描述
A prospective, randomized crossover cohort. Study subjects consisted of patients newly diagnosed with obstructive sleep apnea (OSA) confirmed with sleep study. All are CPAP naïve.
Randomization:
Arm 1: auto CPAP sleep study then auto CPAP for 2 months Arm 2: fixed CPAP titration then fixed CPAP for 2 months
Then switch over to the other arm
Trial end after 4 months, compliance and other parameters would be compared between two arms as described in the endpoint session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects should be CPAP naïve.
- •OSA confirmed with sleep study
- •Presence of daytime symptoms with excessive daytime sleepiness
- •Age between 18 to 65
- •RDI greater than 30
- •Agreed to participate in trial with informed consent signed
排除标准
- •Patients not suitable to nasal CPAP because of facial abnormality leading to poor mask fitting.
- •Patients with known COPD with type II failure
- •Patients with known heart failure.
- •Patients with predominant central sleep apnea.
- •Patients need bilevel positive airway pressure ventilation.
- •Patients refusing to participate the trial.
- •Patients have difficulty to follow up regularly.
- •patients with untreated or under treatment of hypothyroidism
结局指标
主要结局
To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.
To compare patient acceptance of the different type of treatment.
次要结局
未报告次要终点