Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
The Bionics Institute of Australia
40 participants
May 2, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- The above eligibility applies to the participating audiologists who are in the experimental and control arms of the study
- 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.
- 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.
Exclusion Criteria2
- 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.
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Interventions
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.
The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT05847426