The effects of supplemental oxygen on obstructive sleep apnoea (OSA) and its vascular consequences during continuous positive airway pressure therapy withdrawal

niversity of Oxford0 个研究点目标入组 25 人开始时间: 2015年2月19日最近更新: 2021年6月7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/h or/and an apnoea/ hypopnoea index of >20/h (this threshold will exclude subjects with borderline OSA, in whom there may be little treatment effect).
•2. Currently >20/h oxygen desaturations (=4% dips) returning on any night during an ambulatory nocturnal pulse oximetry performed during a 4-night period without CPAP.
•3. Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI <10 with treatment (according to machine download data) and ODI<10 confirmed on CPAP during screening oximetry.
•4. Written informed consent
•5. Upper Age Limit 75 years, lower Age Limit 20 years

•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 CheyneStokes breathing.
•4. Current professional driver.
•5. Any sleep related accident.
•6. Age <20 or >75 years at trial entry.
•7. Severe nasal congestion.
•8. Mental or physical disability precluding informed consent or compliance with the protocol
•9. Nonfeasible trial followup (for example, distance from follow-up centre, physical inability).
•10. Current smoker

发起方