The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA: a Clinical Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Number of participants with documented AFib recurrence
研究概览
简要总结
This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive sleep apnea.
详细描述
This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive sleep apnea. The study is designed as a multi-center randomized control trial, which plans to recruit 129 atrial fibrillation patients with obstructive sleep apnea (86 in the intervention group with atrial fibrillation standard care and positive airway pressure therapy, 43 in the control group with atrial fibrillation standard care but no positive airway pressure therapy). The subjects will in total visit the hospital 4 times during their 6 months follow-up period, at baseline, 1st, 3rd, and 6th month. Subjects will undergo questionnaire surveys and medical examinations at each visit. The primary objective is to compare after 6months, the clinical failure rate between the group with positive airway pressure therapy and the group with no positive airway pressure 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
- None
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
- •Symptomatic paroxysmal or persistent atrial fibrillation:
- •Paroxysmal: at least having one episode every month for the last recent 6 months. Each episode with symptoms lasting for over 30 minutes and at least one episode is documented (≥30 seconds episode length, documented by ECG).
- •Persistent: lasting over 7 days to 1 year persistent AF with ECG documented.
- •Implement a rhythm control strategy, including:
- •Ablation and restored on sinus rhythm after the procedure.
- •Underwent medical or electrical cardioversion during hospitalization and restored on sinus rhythm before enrollment.
- •OSA diagnosed with PSG test showing AHI≥10;
- •18 ≤ Age ≤ 75;
- •Willing to participate in the study;
- •Able to provide informed consent;
- •Having access to smartphones and the internet, and be capable of using them.
排除标准
- •BMI > 30 kg/m2;
- •LVEF ≤ 40% or HF with NYHA III/ IV;
- •Other atrial arrhythmias, atrial flatter;
- •Myocardial infarction;
- •Hypertrophic Cardiomyopathy (HCM);
- •Congenital heart disease;
- •A clear diagnosis with heart valve diseases (including moderate-severe mitral stenosis/ insufficiency, moderate-severe aortic stenosis/ insufficiency);
- •Hyperthyroidism heart disease;
- •Other acute diseases leading to temporary AF;
- •In surgery perioperative period;
- •Accepted other cardiothoracic surgery except for ablation;
- •PSG test showing mainly central apneas (Cheyne-Stokes breathing);
- •Pulmonary diseases causing dyspnea at rest or on minimal exertion;
- •With other active major organ system disease that is not suitable for study participation, such as cancer, severe liver diseases, severe kidney diseases, etc.;
- •With significantly impaired cognitive function, having severe problems in learning, memory, perception, and problem solving, and are unable to understand or not be competent to the informed consent;
- •Having already accepted treatment to the sleep apnea syndrome;
- •Having received intervention in any other trial within 30 days prior to the planned recruitment.
结局指标
主要结局
Number of participants with documented AFib recurrence
时间窗: From baseline to the event occurs, up to 6 months.
The primary outcome is number of participants with documented clinical failure. The documented clinical failure is defined as fulfilling any one of the following situations: documented recurrence of atrial fibrillation, atrial flutter or atrial tachycardia (lasting more than 30 seconds), new prescription of antiarrhythmic drugs (class I or III), repeat ablation (for patients underwent ablation at baseline) or new ablation (for patients used antiarrhythmic drugs for rhythm control at baseline).
次要结局
- Changes from baseline in self-rated AF symptoms at 1 month, 3 months and 6 months.(Baseline, the 1st month, 3rd month and 6th month.)
- Changes from baseline in daytime sleepiness at 1 month, 3 months and 6 months.(The 1st month, 3rd month and 6th month.)
- Change from baseline in atrial fibrillation burden at 6 months(Baseline, the 6th month.)
- Changes from baseline in quality of life at 3 months and 6 months.(Baseline, the 3rd month and 6th month.)
- Other cardiovascular events(From baseline to the event occurs, up to 6 months.)