The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The differences of supine bicycle exercise echocardiographic parameters and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.
研究概览
简要总结
The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been reported, and improvement of diastolic function after continuous positive airway pressure (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function by supine bicycle exercise echocardiography is lacking. The investigators hypothesized that 3 months of CPAP therapy in OSA patients will significantly improve diastolic functional parameters measured by exercise stress echocardiography. Patients with severe OSA (Apnea-hypopnea index > 30) will be included in this study, and randomized to CPAP versus sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity, 24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP therapy and parameters will be compared.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patietns≥20 and ≤75 years-old
- •Patients who diagnosed as obstructive sleep apnea and AHI>30 on polysomnography
排除标准
- •Age < 20 years-old
- •Left ventricular dysfunction (LVEF<50%) or structural heart disease on transthoracic echocardiography
- •Diabetes mellitus
- •Significant cardiac valvular disease (≥moderate)
- •Severe hypertension (>180/110mmHg)
- •Moderate or severe kidney disease (eGFR < 60 mL/min )
- •Clinically significant liver disease
- •History of coronary artery disease
- •malignancy or autoimmune disease
- •Acute/chronic infection status
- •Pregnant status
- •Patients taking anxiolytics or sedatives
结局指标
主要结局
The differences of supine bicycle exercise echocardiographic parameters and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.
时间窗: after 3 months intervention (CPAP)
The differences of supine bicycle exercise echocardiogrphic parameters (diastolic function grade, mitral inflow parameters, mitral tissue doppler parameters, E/E') and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.
次要结局
未报告次要终点