ASPREE-HEARING: HEAring, Retinal Imaging, Neurocognition in older Generations (low-dose aspirin and age-related hearing loss)

Phase 4

Active, not recruiting

• Conditions: Age-related hearing loss; Cognitive decline; Ear - Deafness; Neurological - Other neurological disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12614000496617
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1262

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing threshold shift: This will be assessed by otoscopy, air and bone conduction audiometry and the Listening in Spatialised Noise-Sentences test.[3 years]

Secondary Outcome Measures

Name	Time	Method
Cognitive decline measured by Modified Mini-Mental State Examination (3MS)[3 years];Retinal vasculature changes as measured by Retinal Vessel Imaging (RVI)[3 years];Inflammatory biomarker changes: The inflammatory biomarkers which will be assessed using serum assay of IL-6, TNF-alpha, and CRP.[3 years]