ACTRN12616000903482尚未招募3 期
The Obstructive Sleep apnoea Intervention in AF (OSI-AF) randomised trial: Obstructive sleep apnoea treatment to reduce atrial fibrillation burden and morbidity
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
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 75 Years（—）
- 性别
- All
入选标准
- •1) Males and females with a history of paroxysmal (at least 2 prior attacks) or persistent AF (<12 months duration [in sinus rhythm at study entry]);
- •2) Age 18-75;
- •3) Polysomnography diagnosed OSA of at least moderate severity (AHI >=15);
- •4) Ability to provide informed consent.
排除标准
- •1) Severe OSA related hypoxemia (>10% sleep time with oxygen saturation <80%) and/or awake oxygen saturation less than 92%%
- •2) Severe respiratory disease (eg Chronic Obstructive Pulmonary Disease or (COPD)
- •3) Current or prior mechanical treatment for OSA with CPAP or MAS
- •4) >50% of apnoeas and/or hyponeas associated with Cheyne-Stokes Respiration (CSR) or Central Sleep Apnoea (CSA)
- •5) Increased risk of sleep-related accident and / or excessive sleepiness defined by any of:
- •* Severe sleepiness as defined by Epworth Sleepiness Scale (>15)
- •*Driver occupation (eg taxi, courier or truck driver)
- •*Sleepiness-related motor vehicle accident, or near accident, within last 12 months prior to enrolment
- •6) Any relative or absolute contra-indication to CPAP or MAS therapy including chronic cranial injury; recurrent pneumothorax; indication for oral-pharyngeal surgery, edentulous, or loose teeth
- •7) Any severe other cardiac disease likely to impact ability to comply:
研究者
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