阿司匹林对睡眠呼吸暂停患者神经认知结局、影像学及视网膜影响的研究——SNORE-ASA研究的原理与方法
The Study of Neurocognitive Outcomes, Radiological and Retinal Effects of Aspirin in Sleep Apnoea- rationale and methodology of the SNORE-ASA study.
作者信息
Ward Stephanie Alison, Storey Elsdon, Woods Robyn L, Hamilton Garun S, Kawasaki Ryo, Janke Andrew L, Naughton Matthew T, O'Donoghue Fergal, Wolfe Rory, Wong Tien Y, Reid Christopher M, Abhayaratna Walter P, Stocks Nigel, Trevaks Ruth, Fitzgerald Sharyn, Hodgson Lauren A B, Robman Liubov, Workman Barbara, McNeil John J
机构信息
Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia; Monash Ageing Research Centre (MONARC), Monash University, The Kingston Centre, Warrigal Rd, Cheltenham 3192, Australia.
Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia; Department of Neuroscience (Medicine), Monash University, The Alfred Hospital, Commercial Rd, Melbourne 3004, Australia.
出版信息
Contemp Clin Trials. 2018 Jan;64:101-111. doi: 10.1016/j.cct.2017.10.016. Epub 2017 Oct 31.
PURPOSE
Sleep disordered breathing (SDB) is highly prevalent in older adults. Increasing evidence links SDB to the risk of dementia, mediated via a number of pathways, some of which may be attenuated by low-dose aspirin. This study will evaluate, in a healthy older cohort, the prospective relationship between SDB and cognitive function, changes in retinal and cerebral microvasculature, and determine whether low-dose aspirin ameliorates the effects of SDB on these outcomes over 3years.
DESIGN
SNORE-ASA is a sub-study of the ASPirin in Reducing Events in the Elderly (ASPREE) randomised, multi-centre, placebo-controlled trial evaluating the effect of daily 100mg aspirin on disability-free and dementia-free survival in the healthy older adult aged 70 and over. At baseline, 1400 ASPREE participants successfully underwent a home sleep study with a home sleep study screening device for SDB; and 296 underwent both 1.5 Tesla brain magnetic resonance imaging (MRI) and retinal vascular imaging (RVI). Cognitive testing, brain MRI and RVI is being repeated after 3years.
PRIMARY OUTCOME MEASURES
Change in the modified mini-mental state examination score. Secondary outcome measures are changes in other cognitive tests, and changes in abnormal parameters on RVI and volume of white matter hyper-intensities on brain MRI.
CONCLUSION
Identifying preventive therapies for delaying the onset of dementia is of paramount importance. The results of this study will help clarify the impact of the SDB on risk of cognitive decline and cerebral small vessel disease, and whether low-dose aspirin can ameliorate cognitive decline in the setting of SDB.
SNORE-ASA TRIAL REGISTRATION: ACTRN12612000891820: The Principal ASPREE study is registered with the International Standardized Randomized Controlled Trials Register, ASPirin in Reducing Events in the Elderly, Number: ISRCTN83772183 and clinicaltrials.gov Number NCT01038583.
目的
睡眠呼吸障碍（SDB）在老年人中极为普遍。越来越多的证据表明，SDB通过多种途径与痴呆风险相关，其中一些途径可能会被低剂量阿司匹林减弱。本研究将在一个健康的老年队列中评估SDB与认知功能、视网膜和脑微血管变化之间的前瞻性关系，并确定低剂量阿司匹林在3年内是否能改善SDB对这些结果的影响。
设计
SNORE-ASA是“老年人阿司匹林减少事件”（ASPREE）随机、多中心、安慰剂对照试验的一项子研究，该试验评估每日100mg阿司匹林对70岁及以上健康老年人无残疾和无痴呆生存期的影响。在基线时，1400名ASPREE参与者使用家庭睡眠研究筛查设备成功进行了家庭睡眠研究以检测SDB；296人同时接受了1.5特斯拉脑磁共振成像（MRI）和视网膜血管成像（RVI）。3年后将重复进行认知测试、脑MRI和RVI。
主要结局指标
改良简易精神状态检查评分的变化。次要结局指标是其他认知测试的变化，以及RVI异常参数的变化和脑MRI上白质高信号体积的变化。
结论
确定延缓痴呆发病的预防性治疗至关重要。本研究结果将有助于阐明SDB对认知衰退风险和脑小血管疾病的影响，以及低剂量阿司匹林在SDB情况下是否能改善认知衰退。
SNORE-ASA试验注册：ACTRN12612000891820：主要的ASPREE研究已在国际标准化随机对照试验注册库注册，即“老年人阿司匹林减少事件”，编号：ISRCTN83772183，以及在clinicaltrials.gov上注册，编号NCT01038583。
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