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Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)

RecruitingNAAges 24 Years - anyAllThe Bionics Institute of Australia
NCT05847426 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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?

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📋 Eligibility rules (as published)
The above eligibility applies to the participating audiologists who are in the experimental and control arms of the study Audiologist Inclusion Criteria: * 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 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 Exclusion Criteria: * There are no exclusion criteria other than not meeting the inclusion criteria.
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What it tests

  • Provision of standard audiological + fNIRS test results
  • Provision of standard audiological test results only
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Where

5 sites
The Royal Victorian Eye and Ear Hospital
East Melbourne, Australia
Bionics Institute
Fitzroy, Australia
Barwon Health
Geelong, Australia
Hearing Australia
Moonee Ponds, Australia
The Royal Children's Hospital
Parkville, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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