Oxidative stress and obstructive sleep apnoea; effect of withdrawing continuous positive airway pressure therapy: a randomised controlled trial

Oxford University Hospitals NHS Trust (UK)0 个研究点目标入组 42 人开始时间: 2012年8月1日最近更新: 2019年2月11日

适应症

试验速览

•1. Objectively confirmed obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (ODI, =4% dips) of >20 (this threshold will exclude subjects with borderline OSA, in whom there may be little experimental effect)
•2. Currently >20/h oxygen desaturations (=4% dips) returning during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP, prior to entry into the study
•3. Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI <10 with treatment (derived from CPAP download data)
•4. Written informed consent

•1. Previous ventilatory failure (awake resting arterial oxygen saturation <93% or arterial PCO2 > 6kPa) or severe respiratory disorders other than OSA
•2. Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (>180/110mmHg), severe arterial hypotension (<90/60mmHg)
•3. Previously diagnosed with Cheyne-Stokes breathing
•4. Current professional driver
•5. History of any sleep-related driving or other accident
•6. Age <20 or >75 years at trial entry
•7. Acute upper respiratory infection
•8. Mental or physical disability precluding informed consent or compliance with the protocol
•9. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability)

发起方

Oxford University Hospitals NHS Trust (UK)