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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

25/06/2021

Date data sharing statement 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hearing loss

Cognitive decline

Depression

Condition category

Condition code

Ear

Deafness

Mental Health

Studies of normal psychology, cognitive function and behaviour

Mental Health

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]

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]

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]

Six months after baseline assessments

Secondary outcome [1]

Depression, Anxiety and Stress (DASS) composite score.

Timepoint [1]

From baseline to six months.

Secondary outcome [2]

The Berkman-Syme Social Network Index aggregated into a single score

Timepoint [2]

From baseline to six months

Secondary outcome [3]

Pure Tone Audiometric (PTA) hearing measure

Timepoint [3]

Baseline to 6 months

Secondary outcome [4]

Lipreading Ability Test

Timepoint [4]

Baseline to 6 months

Secondary outcome [5]

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]

Baseline to 6 months

Secondary outcome [6]

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]

Baseline to 6 months

Secondary outcome [7]

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]

Baseline to 6 months

Secondary outcome [8]

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]

Baseline to 6 months

Secondary outcome [9]

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]

Baseline to 6 months

Secondary outcome [10]

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]

Baseline to 6 months

Secondary outcome [11]

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]

Baseline to 6 months

Secondary outcome [12]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Stopped early

Data analysis

No data analysis planned

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Other reasons/comments

Other reasons

Study has stopped early due to changes in MRI requirements

Date of first participant enrolment

Anticipated

11/12/2017

Actual

8/01/2018

Date of last participant enrolment

Anticipated

Actual

31/10/2018

Date of last data collection

Anticipated

31/07/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3132 - Mitcham

Recruitment postcode(s) [2]

3122 - Hawthorn

Funding & Sponsors

Funding source category [1]

University

Name [1]

Swinburne University of Technology

Address [1]

Swinburne University of Technology
John Street, Hawthorn Vic 3122

Country [1]

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]

Individual

Name [1]

Ms. Joanna Nkyekyer

Address [1]

Swinburne University of Technology
John Street, Hawthorn Vic 3122

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr. Matthew Hughes

Address [2]

Swinburne University of Technology
John Street, Hawthorn Vic 3122

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Associate Professor Andrew Pipingas

Address [3]

Swinburne University of Technology
John Street, Hawthorn Vic 3122

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Associate Professor Sunil Bhar

Address [4]

Swinburne University of Technology
John Street, Hawthorn Vic 3122

Country [4]

Australia

Other collaborator category [1]

Individual

Name [1]

Ms. Alison Hennessy

Address [1]

Alison Hennessy Audiology,
444 Mitcham Road,
Mitcham Vic 3132

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swinburne's Human Research Ethics Committee (SUHREC)

Ethics committee address [1]

Swinburne Research (H68),
Swinburne University of Technology
John Street, Hawthorn
P O Box 218, HAWTHORN VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/09/2017

Approval date [1]

18/11/2017

Ethics approval number [1]

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

Prof Denny Meyer

Address

Swinburne University of Technology
John Street, Hawthorn Vic 3122
Melbourne - Australia

Country

Australia

Phone

+61 3 92144824

Fax

dmeyer@swin.edu.au

Contact person for public queries

Name

Joanna Nkyekyer

Address

Swinburne University of Technology
John Street, Hawthorn Vic 3122
Melbourne - Australia

Country

Australia

Phone

+61 4 22733157

Fax

jnkyekyer@swin.edu.au

Contact person for scientific queries

Name

Denny Meyer

Address

Swinburne University of Technology
John Street, Hawthorn Vic 3122
Melbourne - Australia

Country

Australia

Phone

+61 4 22733157

Fax

dmeyer@swin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Summarized data will be made available in publications.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1068	Study protocol				Hughes ME, Nkyekyer J, Innes-Brown H, Rossell SL, ... [More Details]

Results publications and other study-related documents

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