Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000496617
Ethics application status
Approved
Date submitted
2/05/2014
Date registered
12/05/2014
Date last updated
22/08/2019
Date data sharing statement initially provided
22/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
ASPREE-HEARING: HEAring, Retinal Imaging, Neurocognition in older Generations (low-dose aspirin and age-related hearing loss)
Scientific title
Study of audiometry, speech reception threshold, retinal vasculature, inflammatory marker and neurocognitive effects of aspirin in age-related hearing loss to determine the effects of daily low-dose aspirin 100mg versus placebo on hearing outcomes in the setting of in healthy older adults aged 70 years and over
Secondary ID [1] 284519 0
Nil
Universal Trial Number (UTN)
U1111-1156-2235
Trial acronym
ASPREE-HEARING
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related hearing loss
 291778 0
Cognitive decline 291838 0
Condition category
Condition code
Ear 292143 292143 0 0
Deafness
Neurological 292144 292144 0 0
Other neurological disorders
Inflammatory and Immune System 292145 292145 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289280 0
Prevention
Comparator / control treatment
placebo: identical in appearance to aspirin with the same enteric coating
Control group
Placebo

Outcomes
Primary outcome [1] 292020 0
Hearing threshold shift: This will be assessed by otoscopy, air and bone conduction audiometry and the Listening in Spatialised Noise-Sentences test.
Timepoint [1] 292020 0
3 years
Secondary outcome [1] 308009 0
Cognitive decline measured by Modified Mini-Mental State Examination (3MS)
Timepoint [1] 308009 0
3 years
Secondary outcome [2] 308010 0
Retinal vasculature changes as measured by Retinal Vessel Imaging (RVI)
Timepoint [2] 308010 0
3 years
Secondary outcome [3] 308011 0
Inflammatory biomarker changes: The inflammatory biomarkers which will be assessed using serum assay of IL-6, TNF-alpha, and CRP.
Timepoint [3] 308011 0
3 years

Eligibility
Key inclusion criteria
Enrolments into the ASPREE parent study, aged 70 years and over who are able and willing to provide informed consent
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment into the parent study ASPREE is thorugh general practitioner coinverstigators. Informed consent for participation in ASPREE is obtained by ASPRRE research staff. Enrolment into the ASPREE-HEARING takes place at the second baseline ASPREE visit, prior to randomisation to either aspirin or placebo. Randomisation takes place through the parent ASPREE study and all staff remain blinded to treatment allocation through the randomisation procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list is generated by an independent statistician using the STATA "ralloc" procedure with randomisation stratified for site and age (less than 80 yrs and greater than or equal to 80 yrs)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/04/2014
Actual
8/04/2014
Date of last participant enrolment
Anticipated
Actual
31/12/2014
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
1262
Accrual to date
Final
1262
Recruitment in Australia
Recruitment state(s)
ACT,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 289163 0
University
Name [1] 289163 0
Monash University
Country [1] 289163 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd Clayton, Victoria 3800
Country
Australia
Secondary sponsor category [1] 287832 0
None
Name [1] 287832 0
Address [1] 287832 0
Country [1] 287832 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290935 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 290935 0
Monash University,

Building 3E, Room 111, Clayton Campus, Wellington Road, ClaytonVic 3800, Australia
Ethics committee country [1] 290935 0
Australia
Date submitted for ethics approval [1] 290935 0
Approval date [1] 290935 0
07/04/2014
Ethics approval number [1] 290935 0

Summary
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.
Trial website
http://www.aspree.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48034 0
Prof Elsdon Storey
Address 48034 0
ASPREE National Coordinating Centre Ground Floor, Burnet Building 89 Commercial Rd Melbourne 3004 Victoria
Country 48034 0
Australia
Phone 48034 0
1800 728 745
Fax 48034 0
Email 48034 0
[email protected]
Contact person for public queries
Name 48035 0
Carlene Britt
Address 48035 0
ASPREE National Coordinating Centre Ground Floor, Burnet Building 89 Commercial Rd Melbourne 3004 Victoria
Country 48035 0
Australia
Phone 48035 0
1800 728 745
Fax 48035 0
+61 3 9903 0979
Email 48035 0
[email protected]
Contact person for scientific queries
Name 48036 0
Carlene Britt
Address 48036 0
ASPREE National Coordinating Centre Ground Floor, Burnet Building 89 Commercial Rd Melbourne 3004 Victoria
Country 48036 0
Australia
Phone 48036 0
1800 728 745
Fax 48036 0
+61 3 9903 0979
Email 48036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data will be available on request to approved applicants but not freely available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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