ACTRN12621001213831招募中未知
Does treatment for moderate to severe obstructive sleep apnoea (OSA) improve heart rhythm control in patients following a catheter ablation for Atrial Fibrillation (AF) (SNORE-AF study)
Melbourne Health (Royal Melbourne Hospital)0 个研究点目标入组 220 人开始时间: 2021年9月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 79 Years（—）
- 性别
- All
入选标准
- •1.Paroxysmal or persistent atrial fibrillation referred for AF ablation. By definition this will include highly symptomatic patients with paroxysmal or persistent AF (ablation is completed as standard of care treatment and not a research study related procedure).
- •2.Moderate to severe predominant OSA defined as AHI 15 or greater and a central apnoea index/total apnoea index less than 20 percent (diagnosed by either in lab Polysomnography (PSG) or at home WatchPAT device)
- •3.Age 18 years to less than 80 years old
- •4.Able and willing to provide informed consent and comply with all testing and requirements.
- •5.Willing to use CPAP if randomised to the treatment arm
- •6.Willing to defer CPAP treatment by up to 12 months if randomised to the non-treatment arm.
排除标准
- •1.History of prior AF ablation procedure
- •2.Presence of other significant structural heart disease
- •a.Valvular heart disease ( moderate valvular regurgitation or stenosis)
- •b.Heart failure (Ejection fraction less than 45%; NYHA class 3 or 4)
- •c.Surgically corrected congenital heart disease (eg ASD repair)
- •d.Hypertrophic cardiomyopathy
- •e.Unstable coronary artery disease
- •f.Severe left atrial enlargement (LA diameter greater than 5.5cm)
- •3.Presence of other major comorbidities
- •a.Renal failure (eGFR less than 50)
- •b.Poorly controlled hypertension
- •4.AF due to a transient or reversible cause ie: postoperative cardiac or non-cardiac surgery, lung disease, hyperthyroidism
- •5.Long standing Persistent AF (long standing AF greater than 12 months with nil documentation of SR)
- •6.Patients in whom central apnoea index/total apnoea index make equal and greater than 20% total apnoeas
- •7.Patients in whom withholding CPAP is considered unethical:
- •a.these include patients with clinically severe symptoms of OSA defined as a history
- •of fall-asleep or near to fall-asleep accident.
- •b.patients with clinically moderate to severe daytime sleepiness
- •c.patients who frequent self-reported episodes of sleepiness or drowsiness while
- •d.person has had motor vehicle crash/es caused by inattention or sleepiness
- •e.patients in the opinion of the treating doctor, represents a significant driving risk as
- •a result of a sleep disorder
- •8.Patient whom wish to commence CPAP treatment after diagnosis of OSA
- •9.Patients who have previously been diagnosed and treated for OSA
- •10.Vulnerable Patient
- •11.Use of opiates or other respiratory depressants
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