Effect of obstructive sleep apnoea on retinal vasculature reactivity following CPAP withdrawal

niversity of Oxford (UK)0 个研究点目标入组 37 人开始时间: 2014年10月23日最近更新: 2022年3月7日

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35201404/ (added 25/02/2022)

•1. Objectively confirmed obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (ODI, >4% dips) or AHI of >20 (this threshold will exclude participants with borderline OSA, in whom there may be little experimental effect)
•2. Currently >20/h oxygen desaturations (>4% dips) returning on any night during home nocturnal pulse oximetry performed for 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
•4. ODI <10 during treatment (obtained during the preliminary week of oximetry monitoring, from the first 3 nights of oximetry monitoring on CPAP, before the 4 nights CPAP withdrawal)
•5. Age between 20 and 75 years at trial entry
•6. 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 accident or other accident
•6. Acute inflammatory disease
•7. Acute or chronic hepatic or renal disease
•8. Known type 1 or 2 diabetes (likely to have low retinal reactivity even on CPAP)
•9. Known severe vascular disease (likely to have low retinal reactivity even on CPAP)
•10. Mental or physical disability precluding informed consent or compliance with the protocol
•11. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability)
•12. Epilepsy: flickering light used for retinal provocation could lead to a seizure
•13. Lens opacities: this could lead to insufficient contrast and make it impossible to image the retinal vasculature

发起方

niversity of Oxford (UK)