About this trial
The goal of this clinical trial is to find out whether hearing test results using functional near-infrared spectroscopy (fNIRS) will help to fast-track early intervention for infants born with a hearing loss. fNIRS is a method of imaging brain activity using light. The main questions are:
1. Can audiologists make more confident decisions about the optimal interventions at different critical points in the hearing care pathway when they are given additional fNIRS information compared to when they have standard audiology test results alone? 2. Is the experience of their infant having an fNIRS test acceptable and comfortable for the parents or care givers?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Is the managing audiologist for the infant who's results are being provided.
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.
Trial design
Crossover
Treatments tested in this trial
Provision of standard audiological + fNIRS test results
Other interventionInfants 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.
Provision of standard audiological test results only
Other interventionThe provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.
Treatment groups
Trial outcomes
Primary outcomes
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
The questionnaire responses that the participating audiologists provide will measure their confidence in making the appropriate next decision for the infant using a sliding scale (0 (no confidence) to 100 (high confidence)). The data from the sliding scale responses for the same audiologist/infant will be subtracted (confidence with fNIRS minus confidence without fNIRS) to obtain the raw data for analysis.
Secondary outcomes
Parental/Guardian perception of acceptability of fNIRS test process and usefulness of fNIRS test results
The results of a parent questionnaire developed by the Advisory Committee (which includes parent members) will be qualitatively evaluated to determine if the fNIRS test process was acceptable, and the test results were perceived as useful. The results will also indicate whether there are aspects of the test process that could be improved in future to make it more acceptable to parents.
Sponsors and contacts
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