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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| Published in: | Contemporary Clinical Trials Vol. 64; pp. 101 - 111 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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United States
Elsevier Inc
01.01.2018
Elsevier BV |
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| ISSN: | 1551-7144, 1559-2030, 1559-2030 |
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| Abstract | 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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| AbstractList | 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. 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.PURPOSESleep 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.DESIGNSNORE-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.PRIMARY OUTCOME MEASURESChange 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.CONCLUSIONIdentifying 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.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.SNORE-ASA TRIAL REGISTRATIONACTRN12612000891820: 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. 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. 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. AbstractPurposeSleep 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 3 years. DesignSNORE-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 100 mg 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 3 years. Primary outcome measuresChange 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. ConclusionIdentifying 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: ACTRN12612000891820The 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. |
| Author | Ward, Stephanie Alison Kawasaki, Ryo O'Donoghue, Fergal Trevaks, Ruth Woods, Robyn L. Abhayaratna, Walter P. Reid, Christopher M. McNeil, John J. Wong, Tien Y. Workman, Barbara Wolfe, Rory Stocks, Nigel Fitzgerald, Sharyn Hodgson, Lauren A.B. Hamilton, Garun S. Storey, Elsdon Robman, Liubov Naughton, Matthew T. Janke, Andrew L. |
| AuthorAffiliation | The ASPREE Study Group, Australia, USA |
| AuthorAffiliation_xml | – name: The ASPREE Study Group, Australia, USA – name: b Monash Ageing Research Centre (MONARC), Monash University, The Kingston Centre, Warrigal Rd, Cheltenham 3192, Australia – name: d Department of Lung and Sleep Medicine, Monash Health, 246 Clayton Rd, Clayton, Vic 3168, Australia – name: j Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Vic, Australia – name: a Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – name: e School of Clinical Sciences, Monash University, 246 Clayton Rd, Clayton, Vic 3168, Australia – name: o Discipline of General Practice, Adelaide Medical School, University of Adelaide, Corner of North Terrace and George St, Adelaide, SA 5000, Australia – name: k Singapore Eye Research Institute, Singapore National Eye Center, 11 Third Hospital Avenue, 168751, Singapore – name: g Centre for Advanced Imaging, University of Queensland, Building 57, Research Rd, The University of Queensland, St Lucia, QLD 4072, Australia – name: n College of Medicine, Biology and Environment, Australian National University, Building 4, The Canberra Hospital, Hospital Rd, Garran ACT, Canberra 2605, Australia – name: i Institute for Breathing and Sleep, Austin Health, Heidelberg, VIC 3084, Australia – name: p Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Opthalmology), University of Melbourne, 32 Gisborne St, East Melbourne, VIC 3002, Australia – name: q The ASPREE Study Group, Australia, USA – name: f Department of Vision Informatics (Topcon),Osaka University Graduate School of Medicine, E7 2-2 Yamada-oka, Suita-city, Osaka 565-1871, Japan – name: l Duke-NUS Medical School, National University of Singapore, 8 College Rd, 169857, Singapore – name: m School of Public Health, Curtin University, Kent St, Bentley, Perth, WA 6102, Australia – name: c Department of Neuroscience (Medicine), Monash University, The Alfred Hospital, Commercial Rd, Melbourne 3004, Australia – name: h The Department of Allergy, Immunology & Respiratory Medicine, Alfred Hospital, The Central Clinical School, Monash University, Commercial Rd, Melbourne, VIC 3004, Australia |
| Author_xml | – sequence: 1 givenname: Stephanie Alison surname: Ward fullname: Ward, Stephanie Alison email: Stephanie.Ward@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – sequence: 2 givenname: Elsdon surname: Storey fullname: Storey, Elsdon email: elsdon.storey@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – sequence: 3 givenname: Robyn L. surname: Woods fullname: Woods, Robyn L. email: Robyn.Woods@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – sequence: 4 givenname: Garun S. surname: Hamilton fullname: Hamilton, Garun S. email: Garun.Hamilton@monash.edu organization: Department of Lung and Sleep Medicine, Monash Health, 246 Clayton Rd, Clayton, Vic 3168, Australia – sequence: 5 givenname: Ryo surname: Kawasaki fullname: Kawasaki, Ryo email: ryo.kawasaki@ophthal.med.osakau.ac.jp organization: Department of Vision Informatics (Topcon),Osaka University Graduate School of Medicine, E7 2-2 Yamada-oka, Suita-city, Osaka 565-1871, Japan – sequence: 6 givenname: Andrew L. surname: Janke fullname: Janke, Andrew L. email: Andrew.janke@cai.uq.edu.au organization: Centre for Advanced Imaging, University of Queensland, Building 57, Research Rd, The University of Queensland, St Lucia, QLD 4072, Australia – sequence: 7 givenname: Matthew T. surname: Naughton fullname: Naughton, Matthew T. email: M.Naughton@alfred.org.au organization: The Department of Allergy, Immunology & Respiratory Medicine, Alfred Hospital, The Central Clinical School, Monash University, Commercial Rd, Melbourne, VIC 3004, Australia – sequence: 8 givenname: Fergal surname: O'Donoghue fullname: O'Donoghue, Fergal email: Fergal.ODonoghue@austin.org.au organization: Institute for Breathing and Sleep, Austin Health, Heidelberg, VIC 3084, Australia – sequence: 9 givenname: Rory surname: Wolfe fullname: Wolfe, Rory email: rory.wolfe@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – sequence: 10 givenname: Tien Y. surname: Wong fullname: Wong, Tien Y. email: Tien_yin_wong@nuhs.edu.sg organization: Singapore Eye Research Institute, Singapore National Eye Center, 11 Third Hospital Avenue, 168751, Singapore – sequence: 11 givenname: Christopher M. orcidid: 0000-0001-9173-3944 surname: Reid fullname: Reid, Christopher M. email: chris.reid@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – sequence: 12 givenname: Walter P. surname: Abhayaratna fullname: Abhayaratna, Walter P. email: Walter.P.Abhayaratna@act.gov.au organization: College of Medicine, Biology and Environment, Australian National University, Building 4, The Canberra Hospital, Hospital Rd, Garran ACT, Canberra 2605, Australia – sequence: 13 givenname: Nigel surname: Stocks fullname: Stocks, Nigel email: Nigel.stocks@adelaide.edu.au organization: Discipline of General Practice, Adelaide Medical School, University of Adelaide, Corner of North Terrace and George St, Adelaide, SA 5000, Australia – sequence: 14 givenname: Ruth surname: Trevaks fullname: Trevaks, Ruth email: ruth.trevaks@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – sequence: 15 givenname: Sharyn surname: Fitzgerald fullname: Fitzgerald, Sharyn email: sharyn.fitzgerald@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – sequence: 16 givenname: Lauren A.B. surname: Hodgson fullname: Hodgson, Lauren A.B. email: labh@unimelb.edu.au organization: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Opthalmology), University of Melbourne, 32 Gisborne St, East Melbourne, VIC 3002, Australia – sequence: 17 givenname: Liubov surname: Robman fullname: Robman, Liubov email: liubov.robman@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia – sequence: 18 givenname: Barbara orcidid: 0000-0001-6520-9276 surname: Workman fullname: Workman, Barbara email: Barbara.Workman@monashhealth.org organization: Monash Ageing Research Centre (MONARC), Monash University, The Kingston Centre, Warrigal Rd, Cheltenham 3192, Australia – sequence: 19 givenname: John J. surname: McNeil fullname: McNeil, John J. email: john.mcneil@monash.edu organization: Department of Epidemiology and Preventive Medicine, Monash University, Level 5, 99 Commercial Rd, Melbourne 3004, Australia |
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| Keywords | Cognitive decline Retinal vascular imaging Low-dose aspirin Brain magnetic resonance imaging Sleep disordered breathing Dementia |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 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. |
| ORCID | 0000-0001-6520-9276 0000-0001-9173-3944 0000-0003-1249-6149 0000-0002-1049-5129 0000-0002-8448-1264 0000-0003-1840-6079 0000-0003-0547-5171 0000-0002-7492-6303 0000-0002-9018-0361 0000-0002-4908-0641 0000-0002-2126-1045 0000-0002-1439-3373 0000-0002-1744-2839 |
| OpenAccessLink | https://cir.nii.ac.jp/crid/1873679867427460864 |
| PMID | 29097299 |
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| PageCount | 11 |
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| PublicationDate | 2018-01-01 |
| PublicationDateYYYYMMDD | 2018-01-01 |
| PublicationDate_xml | – month: 01 year: 2018 text: 2018-01-01 day: 01 |
| PublicationDecade | 2010 |
| PublicationPlace | United States |
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| PublicationTitle | Contemporary Clinical Trials |
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| Snippet | 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,... AbstractPurposeSleep disordered breathing (SDB) is highly prevalent in older adults. Increasing evidence links SDB to the risk of dementia, mediated via a... |
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| SubjectTerms | 2736 Pharmacology (medical) Aged Aged, 80 and over Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Aspirin Aspirin - therapeutic use Brain magnetic resonance imaging Cardiovascular Cerebrovascular Circulation Cerebrovascular Circulation - drug effects Cognition Cognition - drug effects Cognitive decline Dementia Dose-Response Relationship, Drug Double-Blind Method Female Hematology, Oncology, and Palliative Medicine Humans Low-dose aspirin Male Mental Status and Dementia Tests Microvessels Microvessels - drug effects Prospective Studies Research Design Retina Retina - drug effects Retinal vascular imaging Sleep Apnea Syndromes Sleep Apnea Syndromes - drug therapy Sleep Apnea Syndromes - physiopathology Sleep disordered breathing |
| Title | The Study of Neurocognitive Outcomes, Radiological and Retinal Effects of Aspirin in Sleep Apnoea- rationale and methodology of the SNORE-ASA study |
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