Study to determine whether low-dose aspirin in healthy older adults prevents cognitive decline in those identified as having moderate to severe sleep apnoea: the SNORE-ASA substudy of the Aspirin in Reducing Events in the Elderly (ASPREE) study.
Study of Neurocognitive Outcomes, Radiological and retinal effects of Aspirin in Sleep Apnoea to determine the effects of daily low-dose aspirin 100mg versus placebo on cognitive outcomes in the setting of sleep apnoea, in healthy older adults aged 70 and over.
Monash University
1,500 participants
Mar 27, 2012
Interventional
Conditions
Summary
Sleep Disordered Breathing (SDB) is very common in older adults. Previous studies have identified that approximately 50% of adults aged 70 and over have some degree of SDB. Obstructive Sleep Apnoea (OSA) is the most common form and refers to intermittent obstructions to airflow during sleep, most often associated with snoring. While OSA has been shown to be associated with cognitive dysfunction in middle aged adults, the effect of OSA on cognitive outcomes in older adults is less well established, as there have been few prospective studies. SNORE-ASA will investigate whether sleep apnoea in healthy older adults is associated with cognitive decline over three years of follow-up, and whether daily low dose aspirin is protective against this cognitive decline associated with sleep apnoea. The study will also examine how sleep apnoea may cause cognitive decline in older adults, by using brain MRI and retinal photography to determine whether sleep apnoea causes hypoxaemia-induced small blood vessel flow problems (ischaemia), and whether aspirin alters this process.
Eligibility
Inclusion Criteria3
- Enrolling into the parent ASPREE study.
- Aged 70 and over
- Able and willing to provide informed consent
Exclusion Criteria2
- History of a diagnosed cardiovascular event, including AMI and stroke, atrial fibrillation, serious intercurrent illness likely to cause death within 5 years, cognitive impairment or dementia, disability, anaemia, a current or recurrent condition with a high risk of major bleeding, absolute contraindication or allergy to aspirin.
- Also known history of sleep apnoea and/ or current use of continuous positive airways pressure (CPAP) at night
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Interventions
This study is a sub study of the Aspirin in Reducing Events in the Elderly study (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org). ASPREE is a double blinded, randomised controlled trial of low dose daily aspirin, 100mg oral tablets versus placebo, taken daily for five years in healthy participants aged 70 and over, followed over 5 years for the primary outcomes of dementia-free survival and disability-free survival. It is a primary prevention study. The SNORE-ASA study will involve a subset of newly enrolling participants in the parent ASPREE study. Prior to randomisation into the parent ASPREE study, SNORE-ASA participants take home a small, light and portable home sleep apnoea screening device named ApneaLink Plus. This device has a nasal cannula to measure airflow, a finger clip pulse oximeter, and can calculate the Apnoea Hypnoea Index (AHI) and Oxygen Desaturation Index (ODI), both of which are measures of the presence and severity of sleep apnoea. Participants are required to wear this for one night only, at study entry only. While participants in the ASPREE study are randomised to oral aspirin 100mg or placebo taken once a day for five years, the SNORE-study outcome measures will be performed after 3 years. However, unblinding of whether the SNORE-ASA participants were randomised to either placebo or aspirin will not take place until after the 5 years of the parent ASPREE study. A further subset of participants in the SNORE-ASA study will undergo a brain MRI and have retinal vascular imaging (also called retinal photography) at baseline and after 3 years to investigate the mechanism by which sleep apnoea may potentiate cognitive decline, and how aspirin may be protective against this.
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ACTRN12612000891820