A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year
研究概览
简要总结
This randomized, controlled trial is designed to test whether treatment of sleep disordered breathing (SDB) with positive airway pressure (PAP) therapy alters the natural history of atrial fibrillation (AF). Patients with recent AF who are now in sinus rhythm, and found to have SDB (obstructive and/or central sleep apnea) by formal sleep study but without complaints of daytime sleepiness, are randomized to PAP therapy to eradicate SDB or to usual care (medical management as prescribed by the patient's cardiologist).
详细描述
Sleep apnea is a common disorder which is increasingly implicated in the pathogenesis of cardiovascular disease. Observational data suggest that sleep apnea may play a role in the development of atrial fibrillation (AF), and may even predispose to recurrence of AF following electrical cardioversion (DCCV). Because of biases and confounders inherent to observational studies, we propose a randomized clinical trial to assess the effects of treatment of sleep apnea in subjects with AF treated with DCCV. Following polysomnography, subjects with sleep apnea will be randomized to positive airway pressure (PAP) or usual medical care and followed for up to one year to compare a primary outcome of AF recurrence rate.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 yrs
- •Successful electrical or chemical cardioversion within previous 2 weeks
- •Greater than 2 episodes symptomatic AF in previous 6 months
排除标准
- •Currently on PAP therapy
- •Moderate to severe pulmonary disease
- •Neurologic impairment (h/o cerebrovascular accident (CVA), transient ischemic attack (TIA), neuromuscular disease, diaphragmatic paralysis)
- •Severe cardiac disease (LVEF<40%, greater than mild to moderate valvular disease)
- •Post cardiac surgery AF
- •Congenital heart disease
- •Renal disease (Scr > 2.5)
- •Excessive ethanol (EtOH) use (>2 drinks/day)
- •Anatomically fixed nasal obstruction (severe septal deviation, uncontrolled rhinitis)
- •History of motor vehicle or occupational accident related to sleepiness.
- •Epworth Sleepiness Scale score >18 (out of maximum score of 24).
研究组 & 干预措施
Therapeutic Positive Airway Pressure
Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
干预措施: Adaptive Servo-Ventilation (Device)
Usual Care
Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
干预措施: Usual Care (Other)
结局指标
主要结局
Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year
时间窗: 1 year
次要结局
- Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)(baseline, 12 months)
- Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit(baseline, 12 months)