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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Veröffentlicht in:Contemporary Clinical Trials Jg. 64; S. 101 - 111
Hauptverfasser: 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.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States Elsevier Inc 01.01.2018
Elsevier BV
Schlagworte:
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
Cognitive decline
Retinal vascular imaging
Low-dose aspirin
Brain magnetic resonance imaging
Sleep disordered breathing
Dementia
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.
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
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– name: j Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Vic, Australia
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– name: e School of Clinical Sciences, Monash University, 246 Clayton Rd, Clayton, Vic 3168, Australia
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ContentType Journal Article
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CorporateAuthor The ASPREE Study Group
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Research Support, Non-U.S. Gov't
Journal Article
Research Support, N.I.H., Extramural
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ISSN 1551-7144
1559-2030
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Keywords Cognitive decline
Retinal vascular imaging
Low-dose aspirin
Brain magnetic resonance imaging
Sleep disordered breathing
Dementia
Language English
License Copyright © 2017 Elsevier Inc. All rights reserved.
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content type line 23
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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.
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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
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PublicationTitle Contemporary Clinical Trials
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  doi: 10.1016/S0161-6420(99)90525-0
– volume: 2
  start-page: 804
  issue: 10
  year: 2014
  ident: 10.1016/j.cct.2017.10.016_bb0285
  article-title: Continuous positive airway pressure in older people with obstructive sleep apnoea syndrome (PREDICT): a 12-month, multicentre, randomised trial
  publication-title: Lancet Respir. Med.
  doi: 10.1016/S2213-2600(14)70172-9
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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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StartPage 101
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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https://dx.doi.org/10.1016/j.cct.2017.10.016
https://cir.nii.ac.jp/crid/1873679867427460864
https://www.ncbi.nlm.nih.gov/pubmed/29097299
https://www.proquest.com/docview/1963279785
https://pubmed.ncbi.nlm.nih.gov/PMC6753831
Volume 64
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