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Trial registered on ANZCTR


Registration number
ACTRN12617001155381
Ethics application status
Approved
Date submitted
3/07/2017
Date registered
8/08/2017
Date last updated
5/04/2022
Date data sharing statement initially provided
5/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of programmed hearing aids on the brain: the CogniAid trial
Scientific title
Randomized controlled trial on the effect of programmed hearing aids on cognition in older New Zealanders
Secondary ID [1] 292337 0
Health Research Council (NZ) Reference 17/164
Universal Trial Number (UTN)
U1111-1198-6847
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 303883 0
Reduced cognitive reserve 303884 0
Condition category
Condition code
Ear 303246 303246 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double blind two arm 12-month randomised controlled trial comparing ‘usual care’ to a modified hearing aid fitting. The modified hearing aid fitting "CogniAid" settings:. The intervention group will receive processing with minimised signal distortion consisting of linear-slow processing (e.g. linear input-output processing, output limiting compression, non-adaptive manually selected directional microphone, moderate slow-acting noise reduction with manual program switching. The participant and clinician will decide the brand, model and technology level best suited on the basis of a hearing needs assessment. The aids will be programmed and matched to NAL-R linear hearing aid targets. If acoustic feedback occurs the ear-coupling system used (domes, ear moulds) will be modified for tighter acoustic seal before digital feedback methods are employed.
Intervention code [1] 298515 0
Treatment: Devices
Comparator / control treatment
The control group will receive current best practice hearing aid selection and fitting. The participant and clinician will decide the brand, model and technology level best suited on the basis of a hearing needs assessment. The selected aids Digital Signal processing (DSP) will emphasise audibility of sound using WDRC and signal “cleaning” to remove noise using fast-adaptive processing. The hearing aids will be programmed to the NAL-NL2 prescription procedure.
Control group
Active

Outcomes
Primary outcome [1] 302625 0
The primary outcome measure will be the NIH toolbox age-adjusted composite cognitive score . These measures will be obtained using the iPad based NIH APP. The age adjusted Cognitive Function Composite score is comprised of several components, derived standard scores are based on the composite distribution and corrected relative age-related norms.
Timepoint [1] 302625 0
12 months
Secondary outcome [1] 336547 0
Secondary outcome measures will include changes in the NIH tool-box age adjusted composite cognitive score at 6 and 12 months.
Timepoint [1] 336547 0
6 and 12 months
Secondary outcome [2] 337071 0
HHIE-S, a hearing questionnaire.
Timepoint [2] 337071 0
6 and 12 months
Secondary outcome [3] 337072 0
WIN (Word in noise test).
Timepoint [3] 337072 0
6 and 12 months
Secondary outcome [4] 337073 0
MAPHAB a hearing questionnaire.
Timepoint [4] 337073 0
6 and 12 Months
Secondary outcome [5] 337074 0
Hours of hearing aid use determined using the on-board datalogging recordings of the hearing aids.
Timepoint [5] 337074 0
Continuous measurement for 12 months, the hearing aids record useage as hours or minutes, depending on model. The measure is continuous, hours of use will be recorded at 6 and 12 months.

Eligibility
Key inclusion criteria
Participants will be new hearing aid users aged 65 or older, and have below median NIH toolbox age-adjusted composite cognition scores
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons with median and greater NIH toolbox composite cognition scores will be excluded from the trial. Current hearing aid users will not be recruited. Persons with fluctuating hearing loss or fast-progressing ongoing otologic disease or requiring referrals to psychiatric or mental health services will be excluded. Persons with severe-profound hearing loss sufficient to make auditory cognition test materials inaudible will not be included. Persons unable to manually adjust aids using controls on the aid or remote control will be excluded. Persons with previous history of stroke or traumatic brain injury are excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involvs contacting the holder of the allocation
schedule who is at central administration site. Participants will be randomly assigned 1:1 to intervention or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization will be blocked and stratified to ensure ethnicity and age-adjusted cognition score are balanced in the two groups. The randomization lists will be created using SAS 9.4. Protocols will ensure adherence to allocation concealment. Participants, research assistants and statistician will be blinded to allocation until study completion.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Details of the individual’s hearing loss, hearing aids and datalogging with participant details will be entered into “NOAH” databases (https://www.himsa.com/) at the participating clinics. The NIH toolbox generates a spreadsheet of data for each test undertaken. This data will be duplicated and along with other test results and observations will be securely imported into an MS Excel database at the department of Epidemiology and Biostatistics at the University of Auckland. All analyses will be performed using SAS version 9.4 (SAS Institute Inc. Cary NC). Data analyses will be specified a priori in a statistical analysis plan prepared by the study statistician. The primary hypothesis of a difference in NIH toolbox age adjusted composite cognitive score at 12 months post randomization between the intervention and control group will be analysed using a general linear mixed model with age adjusted composite cognitive score as the continuous outcome and ethnicity, centre, baseline cognition score, hearing and group as explanatory variables. The “intention-to-treat” principle will be applied for all those completing 12 month follow up. Other outcomes will be tested by using nonparametric techniques, logistic regression, linear regression, or generalized linear mixed model, depending on the distribution of the variable. A "Redcap" database is being used to manage data for future analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2017
Actual
30/07/2018
Date of last participant enrolment
Anticipated
2/08/2019
Actual
18/10/2021
Date of last data collection
Anticipated
Actual
6/12/2021
Sample size
Target
66
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 9035 0
New Zealand
State/province [1] 9035 0

Funding & Sponsors
Funding source category [1] 296885 0
Government body
Name [1] 296885 0
Health Research Council
Country [1] 296885 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand.
Country
New Zealand
Secondary sponsor category [1] 295892 0
University
Name [1] 295892 0
University of Canterbury
Address [1] 295892 0
20 Kirkwood Ave, Upper Riccarton, Christchurch 8041
Country [1] 295892 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298105 0
The University of Auckland Human Participants Ethics Committtee
Ethics committee address [1] 298105 0
Ethics committee country [1] 298105 0
New Zealand
Date submitted for ethics approval [1] 298105 0
30/06/2017
Approval date [1] 298105 0
19/07/2017
Ethics approval number [1] 298105 0
019538

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76006 0
A/Prof Grant Donald Searchfield
Address 76006 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand.
Country 76006 0
New Zealand
Phone 76006 0
+64 9 923 6316
Fax 76006 0
Email 76006 0
g.searchfield@auckland.ac.nz
Contact person for public queries
Name 76007 0
Grant Donald Searchfield
Address 76007 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand.
Country 76007 0
New Zealand
Phone 76007 0
+64 9 923 6316
Fax 76007 0
Email 76007 0
g.searchfield@auckland.ac.nz
Contact person for scientific queries
Name 76008 0
Grant Donald Searchfield
Address 76008 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand.
Country 76008 0
New Zealand
Phone 76008 0
+64 9 923 6316
Fax 76008 0
Email 76008 0
g.searchfield@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.