Multi-centre randomised controlled trial to investigate the efficacy of nasal continuous positive airway pressure treatment to reduce cardiovascular risk and symptoms in mild to moderate sleep apnoea

Oxford Radcliffe Hospitals NHS Trust (UK)0 个研究点目标入组 400 人开始时间: 2005年10月5日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Objectively confirmed obstructive sleep apnoea on respiratory polysomnography, with a >4% arterial oxygen desaturation index of >7.5/hour
•2. Written informed consent

•1. Sleep apnoea symptoms of sufficient severity that CPAP is mandated by current trial evidence, such that randomisation to a control would be unethical (this decision is in the hands of the randomising physician as the equipoise point varies between units, but guidance on this is presented later)
•2. Ventilatory failure (awake resting arterial oxygen saturation <93% or arterial pCO2 >6kPa)
•3. Clinic BP more than 180/110
•4. Cheyne-Stokes breathing on respiratory polysomnography
•5. Current Heavy Goods Vehicle or Public Service Vehicle driving licence holder
•6. Any sleep related accident
•7. Age <45 or >75 years at trial entry (age range selected as it is typical for patients with OSA and will have a significant cardiovascular event rate)
•8. Previous exposure to CPAP or non-invasive ventilation
•9. Mental or physical disability precluding informed consent or compliance with the protocol for the duration of the study
•10. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability)
•11. Any co-incidental illness making survival for two years unlikely

发起方

Oxford Radcliffe Hospitals NHS Trust (UK)