The Study of Neurocognitive Outcomes, Radiological and Retinal Effects of Aspirin in Sleep Apnoea- rationale and methodology of the SNORE-ASA study

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 betwe...

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Vydáno v:Contemporary Clinical Trials Ročník 64; s. 101 - 111
Hlavní autoři: 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.
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States Elsevier Inc 01.01.2018
Elsevier BV
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ISSN:1551-7144, 1559-2030, 1559-2030
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Shrnutí: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. 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. 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. 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. 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.
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Author’s contributions
SW was responsible for project inception, design, funding, supervision of project manager, and first draft of manuscript. ES, RLW, BW, JM were involved in project inception, funding and leadership, and ES in training field staff in the cognitive testing. GH, MN and FO’D were involved in project inception, funding and design especially related to measures of sleep apnoea and reporting of sleep studies. TW, RK, LH and LR were involved in design of the retinal imaging sub-study. AJ was involved in design of MRI analyses and sub-study, and attracting funding. WA and NS were involved in leadership of the project at other sites. RW provided sample size and statistical analysis plans. CR has had input into study design and operation. RT and SF provide important input into study operations and recruitment. All authors have read and contributed to the manuscript.
ISSN:1551-7144
1559-2030
1559-2030
DOI:10.1016/j.cct.2017.10.016