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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05847426




Registration number
NCT05847426
Ethics application status
Date submitted
27/04/2023
Date registered
6/05/2023

Titles & IDs
Public title
Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
Scientific title
Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
Secondary ID [1] 0 0
90457
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Impairment 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Provision of standard audiological + fNIRS test results
Other interventions - Provision of standard audiological test results only

Experimental: Provision of standard audiological + fNIRS test results - The treatment arm involves the provision of additional fNIRS sound detection and speech discrimination test results to the audiologists, in addition to standard audiology information. Standard information includes:

1. At diagnosis: unaided Auditory Brainstem Response results;
2. After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials;
3. After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2);
4. After initial cochlear implant programming: behavioural observations.

Active comparator: Provision of standard audiological test results only - The standard audiology information available to the audiologists includes:

1. At diagnosis: unaided Auditory Brainstem Response results;
2. After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials;
3. After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2);
4. After initial cochlear implant programming: behavioural observations.


Other interventions: Provision of standard audiological + fNIRS test results
Infants with hearing loss will be tested using functional near-infrared spectroscopy (fNIRS) and a patented analysis algorithm to measure sound detection and discrimination. Their standard audiological test results will also be collected from their audiology service provider/s. Both sets of test results will be given to the participating audiologists in the experimental arm.

Other interventions: Provision of standard audiological test results only
The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in confidence of audiological clinical management decisions when fNIRS hearing test results are included with standard audiological information compared to when using standard information alone
Timepoint [1] 0 0
Between each infant's completed fNIRS testing session and 2 months after
Secondary outcome [1] 0 0
Parental/Guardian perception of acceptability of fNIRS test process and usefulness of fNIRS test results
Timepoint [1] 0 0
Within 2 weeks after their child's fNIRS testing session

Eligibility
Key inclusion criteria
The above eligibility applies to the participating audiologists who are in the experimental and control arms of the study

Audiologist

* Is a qualified audiologist who meets the criteria for membership of Audiology Australia.
* Has at least 1 year of experience in paediatric diagnostic, hearing aid or cochlear implant audiology service provision in Australia.
* Provides a signed and dated informed consent form.

Audiologist
Minimum age
24 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria (only for a specific infant test result):

* Is the managing audiologist for the infant who's results are being provided.

Infants are also recruited into the study to have an fNIRS assessment performed. They do not participate further after the fNIRS test.

Infant Inclusion criteria:

* Between the ages of 1 and 24 months at the time of fNIRS testing.
* Has permanent hearing loss in one or both ears as determined by audiological diagnostic testing.
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Infant

* There are no exclusion criteria other than not meeting the inclusion criteria.

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



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/04/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Bionics Institute - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Bionics Institute of Australia
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Professor Colette McKay
Address 0 0
Bionics Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Professor Colette McKay
Address 0 0
Country 0 0
Phone 0 0
+61 3 9667 7541
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Beginning 1 month following analysis and article publication, the following data will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept Bionics Institute's conditions for access:

* Raw anonymized confidence rating scores linked to the questionnaire question, infant subgroup (type and degree of hearing loss categories), and point in clinical care pathway.
* study protocol and statistical analysis plan if not already clear in the publication

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data, study protocol, and statistical analysis plan will be available from one month following trial analysis and article publication, for a period of 10 years.
Available to whom?
Data can only be accessed if the researchers are from a recognized research institution, the proposed use of the data has been ethically reviewed and approved by an independent committee, and the researchers accept Bionics Institute's conditions for access.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05847426