title: Slowing the progression of age-related hearing loss: Rationale and study design of the ASPIRIN in HEARING, retinal vessels imaging and neurocognition in older generations (ASPREE-HEARING) trial.
abstract: BACKGROUND
  Age-related hearing loss (ARHL) is a leading cause of disability in the elderly. Low-grade inflammation and microvessel pathology may be responsible for initiating or exacerbating some of the hearing loss associated with aging. A growing body of evidence demonstrates an association of hearing loss with cognitive decline. A shared etiological pathway may include a role of inflammation, alongside vascular determinants. The ASPREE-HEARING study aims to determine whether low-dose aspirin decreases the progression of ARHL, and if so, whether this decrease in progression is also associated with retinal microvascular changes and/or greater preservation of cognitive function.
  
  
  METHODS
  A three year double-blind, randomized controlled trial of oral 100mg enteric-coated aspirin or matching placebo, enrolling 1262 Australians aged ≥70years with normal cognitive function and no overt cardiovascular disease. The primary outcome is the change in mean pure tone average hearing threshold (decibels) in the better ear, over a 3-year period. Secondary outcomes consist of changes in retinal microvascular indicators, and changes in cognitive function. Participants are recruited from a larger trial, ASPirin in Reducing Events in the Elderly (ASPREE), which is designed to assess whether daily low dose aspirin will extend disability-free life.
  
  
  CONCLUSIONS
  ASPREE-HEARING will determine whether aspirin slows development or progression of ARHL, and will interrogate the relationship between inflammatory and microvascular mechanisms that may underlie the effects of aspirin on ARHL. This study will improve understanding of the patterns of comorbidity with, and the relationships between, aging and ARHL, alongside modeling the impacts of ARHL.
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: Judy.Lowthian@monash.edu.
authors.forename: J A
authors.initials: JA
authors.lastname: Lowthian
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: Carlene.Britt@monash.edu.
authors.forename: C J
authors.initials: CJ
authors.lastname: Britt
authors.affiliation: Department of Audiology and Speech Pathology, University of Melbourne, Parkville, Melbourne, Australia. Electronic address: grance@unimelb.edu.au.
authors.forename: G
authors.initials: G
authors.lastname: Rance
authors.affiliation: School of Medicine, Johns Hopkins Hospital, Baltimore, USA. Electronic address: flin1@jhmi.edu.
authors.forename: F R
authors.initials: FR
authors.lastname: Lin
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: Robyn.Woods@monash.edu.
authors.forename: R L
authors.initials: RL
authors.lastname: Woods
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: Rory.Wolfe@monash.edu.
authors.forename: R
authors.initials: R
authors.lastname: Wolfe
authors.affiliation: Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia. Electronic address: Mark.Nelson@utas.edu.au.
authors.forename: M R
authors.initials: MR
authors.lastname: Nelson
authors.affiliation: National Acoustic Laboratory, Macquarie University, New South Wales, Australia. Electronic address: harvey.dillon@nal.gov.au.
authors.forename: H A
authors.initials: HA
authors.lastname: Dillon
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: Stephanie.Ward@monash.edu.
authors.forename: S
authors.initials: S
authors.lastname: Ward
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: Chris.Reid@monash.edu.
authors.forename: C M
authors.initials: CM
authors.lastname: Reid
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: Jessica.Lockery@monash.edu.
authors.forename: J E
authors.initials: JE
authors.lastname: Lockery
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Parkville, Melbourne, Australia. Electronic address: thanh.nguyen@unimelb.edu.au.
authors.forename: T T
authors.initials: TT
authors.lastname: Nguyen
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: John.McNeil@monash.edu.
authors.forename: J J
authors.initials: JJ
authors.lastname: McNeil
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne 3004, Australia. Electronic address: Elsdon.Storey@monash.edu.
authors.forename: E
authors.initials: E
authors.lastname: Storey
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use*; D001301:Audiometry, Pure-Tone; D001315:Australia; D003071:Cognition; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008609:Mental Status Schedule; D011304:Presbycusis / Q000517:prevention & control*; D012171:Retinal Vessels / Q000473:pathology*; D013067:Speech Perception
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001241:Aspirin
keywords: Age-related hearing loss; Aspirin; Cognitive function; Presbyacusis; Randomized controlled trial; Retinal vessels