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Trial registered on ANZCTR


Registration number
ACTRN12617001616369
Ethics application status
Approved
Date submitted
22/11/2017
Date registered
11/12/2017
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Date results information initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
This research study will use Magnetic Resonance Imaging (MRI) techniques to learn whether hearing aids do have an effect on cognitive function and the brain of older adults with hearing loss.
Scientific title
Using Magnetic Resonance Imaging to Investigate the Effects of Hearing Aid Use on Brain Activity and Cognitive Function in Older Adults with Sensorineural Hearing Loss.

Secondary ID [1] 293394 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 305539 0
Cognitive decline 305540 0
Depression 305541 0
Condition category
Condition code
Ear 304771 304771 0 0
Deafness
Mental Health 304772 304772 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 304773 304773 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First-time hearing aid users will wear a pair of hearing aids for six (6) months to address their hearing loss. These are MoxiFit Flex trial hearing aids supplied by Unitron which will be worn by participants at all convenient times (except when asleep or in water). Practice of lipreading is not part of the intervention but it is expected to occur in response to hearing loss. Therefore, a simple lipreading test will be conducted before each MRI scan.
Only a random sample of first time hearing aid users will have extensive MRI scanning at baseline (i.e. before hearing aid fitting) and at six months (i.e. after using hearing aids for a period of six months).
Intervention code [1] 299642 0
Treatment: Devices
Comparator / control treatment
Long-term hearing aid users, with at least one year hearing aid use experience, will continue to wear their hearing aids for the study period (six (6) months).
Control group
Active

Outcomes
Primary outcome [1] 303994 0
The Incongruent Stroop cognitive performance task using Swinburne University Computerised Cognitive Assessment Battery (SUCCAB) measures is primary outcome [1]. This outcome will be measured at baseline and at six months, after hearing aid intervention.
Timepoint [1] 303994 0
Six months after baseline assessments
Secondary outcome [1] 340674 0
Depression, Anxiety and Stress (DASS) composite score.
Timepoint [1] 340674 0
From baseline to six months.
Secondary outcome [2] 340675 0
The Berkman-Syme Social Network Index aggregated into a single score
Timepoint [2] 340675 0
From baseline to six months
Secondary outcome [3] 340733 0
Pure Tone Audiometric (PTA) hearing measure
Timepoint [3] 340733 0
Baseline to 6 months
Secondary outcome [4] 341000 0
Lipreading Ability Test
Timepoint [4] 341000 0
Baseline to 6 months
Secondary outcome [5] 365929 0
Brain activity which will be measured using MRI technology (SPM12 - Wellcome Department of Neurology) for a random sample of first-time hearing aid users.
Timepoint [5] 365929 0
Baseline to 6 months
Secondary outcome [6] 365930 0
The Simple Reaction Time cognitive performance task, assessed using Swinburne University Computerised Cognitive Assessment Battery (SUCCAB), is secondary outcome measure [6]. This outcome will be measured at baseline and at six months, after hearing aid intervention.
Timepoint [6] 365930 0
Baseline to 6 months
Secondary outcome [7] 365931 0
The Complex Reaction Time cognitive performance task, assessed using Swinburne University Computerised Cognitive Assessment Battery (SUCCAB), is secondary outcome measure [7]. This outcome will be measured at baseline and at six months, after hearing aid intervention.
Timepoint [7] 365931 0
Baseline to 6 months
Secondary outcome [8] 365932 0
The Immediate Recognition Memory cognitive performance task, assessed using Swinburne University Computerised Cognitive Assessment Battery (SUCCAB), is secondary outcome measure [8]. This outcome will be measured at baseline and at six months, after hearing aid intervention.
Timepoint [8] 365932 0
Baseline to 6 months
Secondary outcome [9] 365933 0
The Delayed Recognition Memory cognitive performance task, assessed using Swinburne University Computerised Cognitive Assessment Battery (SUCCAB), is secondary outcome measure [9]. This outcome will be measured at baseline and at six months, after hearing aid intervention.
Timepoint [9] 365933 0
Baseline to 6 months
Secondary outcome [10] 365934 0
The Spatial Working Memory cognitive performance task, assessed using Swinburne University Computerised Cognitive Assessment Battery (SUCCAB), is secondary outcome measure [10]. This outcome will be measured at baseline and at six months, after hearing aid intervention.
Timepoint [10] 365934 0
Baseline to 6 months
Secondary outcome [11] 365935 0
The Contextual Recognition Memory cognitive performance task, assessed using Swinburne University Computerised Cognitive Assessment Battery (SUCCAB), is secondary outcome measure [11]. This outcome will be measured at baseline and at six months, after hearing aid intervention.
Timepoint [11] 365935 0
Baseline to 6 months
Secondary outcome [12] 365936 0
The Congruent Stroop cognitive performance task, assessed using Swinburne University Computerised Cognitive Assessment Battery (SUCCAB), is secondary outcome measure [12]. This outcome will be measured at baseline and at six months, after hearing aid intervention.
Timepoint [12] 365936 0
Baseline to 6 months

Eligibility
Key inclusion criteria
1) 55 to 90 years
2) A good working knowledge of English
3) Mild or moderate sensorineural hearing loss with a pure-tone average (PTA) of thresholds at 0.5 – 6 kHz in both ears
4) Willing to undergo two (2) one hour MRI scans over a period of 6 months
5) Willing to wear hearing aids for six (6) months
6) Must have been wearing hearing aids for at least one (1) year (only for people with hearing aid experience)
7) Written consent to participate in the study

Minimum age
55 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Any significant visual impairment that would prevent reading
2) Suspected cognitive impairment (defined as a score less than or equal to 23 on the MMSE)
3) Severe or profound hearing loss
4) Any person suffering from claustrophobia
5) Any person with a pacemaker, metal clips or arteries or certain implanted devices
6) Any left-handed person

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Methods:
No previous studies exist to determine what effect sizes can be expected for this study. This is only a pilot study which will provide initial estimates for the relevant means, standard deviations and effect sizes.

Chi-squared and MANOVA analyses will be used to compare the groups in terms of demographics and baseline outcome measures. Mixed Model Repeated Measures analyses will be conducted to test for significant differences between the groups in terms of changes that occur in the outcome measures from baseline to 6 months.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 18133 0
3132 - Mitcham
Recruitment postcode(s) [2] 18134 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 298020 0
University
Name [1] 298020 0
Swinburne University of Technology
Address [1] 298020 0
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Country [1] 298020 0
Australia
Primary sponsor type
Individual
Name
Professor Denny Meyer
Address
Centre for Mental Health
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Country
Australia
Secondary sponsor category [1] 297093 0
Individual
Name [1] 297093 0
Ms. Joanna Nkyekyer
Address [1] 297093 0
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Country [1] 297093 0
Australia
Secondary sponsor category [2] 297098 0
Individual
Name [2] 297098 0
Dr. Matthew Hughes
Address [2] 297098 0
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Country [2] 297098 0
Australia
Secondary sponsor category [3] 297099 0
Individual
Name [3] 297099 0
Associate Professor Andrew Pipingas
Address [3] 297099 0
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Country [3] 297099 0
Australia
Secondary sponsor category [4] 297100 0
Individual
Name [4] 297100 0
Associate Professor Sunil Bhar
Address [4] 297100 0
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Country [4] 297100 0
Australia
Other collaborator category [1] 279820 0
Individual
Name [1] 279820 0
Ms. Alison Hennessy
Address [1] 279820 0
Alison Hennessy Audiology,
444 Mitcham Road,
Mitcham Vic 3132
Country [1] 279820 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299055 0
Swinburne's Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 299055 0
Swinburne Research (H68),
Swinburne University of Technology
John Street, Hawthorn
P O Box 218, HAWTHORN VIC 3122

Ethics committee country [1] 299055 0
Australia
Date submitted for ethics approval [1] 299055 0
22/09/2017
Approval date [1] 299055 0
18/11/2017
Ethics approval number [1] 299055 0
SHR Project 2017/266

Summary
Brief summary
Background: Sensorineural hearing loss is one of the most prevalent chronic conditions affecting older adults, and its occurrence is expected to increase with advancing age. Hearing aids have been proven to be a successful intervention for alleviating sensorineural hearing loss.
Previous Research: A recent neuroimaging study has found that this type of hearing loss may cause parts of the brain to atrophy. Older adults suffering from brain atrophy associated with hearing loss will likely struggle to understand speech. Some of the psychosocial consequences of sensorineural hearing loss include depression and social isolation. There is also evidence that brain atrophy is correlated with the recruitment of compensatory mechanisms for auditory and language processing. Research is needed to focus on determining how this compensatory recruitment relates to cognitive decline.
Study Objective: This study will use MRI techniques to determine whether hearing aids do have an effect on brain structure and cognitive function in older adults with sensorineural hearing loss. This will be established using a combination of auditory and visual stimuli to characterise participants hearing abilities.
Method: Study participants will consist of older adults between 55 and 90 years with either mild or moderate symmetric sensorineural hearing loss. Consented participants will undergo hearing assessments, complete paper-based questionnaires, perform cognitive tests and undergo MRI scans at the time of recruitment (and again at 6 months). Participants will belong to one of 2 groups: first-time hearing aid users and long term hearing aid users.
Study Hypotheses
1. Comparing the results of the cognition tests and the two MRI scans of the long-term and first-time hearing aid users over a 6 month period, it is expected that initially cognitive abilities will be less preserved in first-time hearing aid users than in long-term hearing aid users, but the wearing of hearing aids by first-time hearing aid users is expected to reduce this disadvantage within 6 months.
2. Also, both first-time hearing aid users and long-term hearing aid users are expected to practice lip reading in order to supplement their language processing, resulting in the use of both the auditory and visual components of the brain during the initial MRI sensory integration task. However differences are expected in terms of the plasticity within the visual and auditory cortex of long-term and first-time hearing aid users.
3. After wearing hearing aids for 6 months, it is expected that first-time hearing aid users will experience a decreased reliance on the visual networks of the brain for language processing with no change for long-term hearing aid users.
Results from the study will inform strategies for aural rehabilitation, hearing aid delivery and future hearing loss intervention trials and neuroimaging studies. Results of this study will be published in a peer-reviewed journal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79130 0
Prof Denny Meyer
Address 79130 0
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Melbourne - Australia
Country 79130 0
Australia
Phone 79130 0
+61 3 92144824
Fax 79130 0
Email 79130 0
dmeyer@swin.edu.au
Contact person for public queries
Name 79131 0
Ms Joanna Nkyekyer
Address 79131 0
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Melbourne - Australia
Country 79131 0
Australia
Phone 79131 0
+61 4 22733157
Fax 79131 0
Email 79131 0
jnkyekyer@swin.edu.au
Contact person for scientific queries
Name 79132 0
Prof Denny Meyer
Address 79132 0
Swinburne University of Technology
John Street, Hawthorn Vic 3122
Melbourne - Australia
Country 79132 0
Australia
Phone 79132 0
+61 4 22733157
Fax 79132 0
Email 79132 0
dmeyer@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summarized data will be made available in publications.
What supporting documents are/will be available?
Study protocol
Attachments/websites
Type [1] 1068 0
Study protocol
URL/details/comments [1] 1068 0
Hughes ME, Nkyekyer J, Innes-Brown H, Rossell SL, Sly D, Bhar S, Pipingas A, Hennessy A, Meyer D. The neural, cognitive and psychosocial effects of hearing aid use in older adults with post-lingual sensorineural hearing loss: A protocol for a prospective cohort study JMIR Research Protocols. (forthcoming/in press) DOI: 10.2196/resprot.9916 URL: http://preprints.jmir.org/preprint/9916
Attachment [1] 1068 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary