None listed
Conditions
Brief summary
Age related hearing loss (ARHL) is a very common disorder in older adults. Previous studies have demonstrated that up to 2/3 of those over the age of 70 years may be affected. There is no known cure for the disease nor preventive actions for the disease progression. While ARHL has recently been associated with cognitive decline, the synergistic effect of age related hearing loss and cognitive decline has never been observed with a treatment intervention. ASPREE-HEARING will investigate whether ARHL is affected by aspirin vs placebo. It will also examine in healthy older adults the association between age related heariang loss and cognitive decline in adults over a 3 year follow up period and whether daily low dose aspirin is protective against hearing threshold change and cognitive decline. The study will also appraise the potential vascular mechanism of hearing loss by using retinal vascular imaging.
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.
The ASPREE HEARING participants will undergo their
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. The ASPREE HEARING participants will undergo their baseline assessments prior to randomisation to one of the two treatment arms, aspirin or placebo, or within one month of randomisation. The ASPREE-HEARING study will involve a subset of newly enrolling participants in the parent ASPREE study. Prior to randomisation into the parent ASPREE study, ASPREE HEARING participants will complete two baseline questionnaires (the Hearing & Noise Exposure History and the HHIE-S Hearing Handicap Inventory), undergo otoscopy, air and bone audiometry, and listening in spatialised noise-sentences tests. These measures will be conducted again at the Year 1, 2 and 3 visits. The participants will also be invited to undergo retinal imaging and have inflammatory biomarkers measured at baseline and at year 3. While participants in the ASPREE study are randomised to oral aspirin 100mg or placebo taken once a day for five years, the ASPREE HEARING study outcome measures will be performed annually over a 3 year period. However, unblinding of whether the participants who were randomised to either placebo or aspirin will not take place until after the 5 years of the parent ASPREE study. Medication counts are recorded annually to assess adherence to aspirin/placebo treatment.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Enrolments into the ASPREE parent study, aged 70 years and over who are able and willing to provide informed consent
Exclusion criteria
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. Specific exclusion criteria for participation in ASPREE-HEARING include the presence of bilateral Lyric or internal hearing aids or bilateral cochlear imnplants.
Outcome results
None listed