Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
Launched by THE BIONICS INSTITUTE OF AUSTRALIA · Apr 27, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to help identify hearing loss in infants using a technique called functional near-infrared spectroscopy, or fNIRS. This method uses light to see how the brain is working, which could help audiologists make better decisions about the best treatments for babies with hearing impairment. The researchers want to find out if having this extra information from fNIRS helps audiologists provide quicker and more accurate interventions, and whether parents feel that the fNIRS test is comfortable and acceptable for their child.
To join the study, infants need to be between 1 and 24 months old and diagnosed with permanent hearing loss in one or both ears. Parents will need to give their consent for their child's participation. The audiologists involved must be qualified and have experience working with children. During the study, the infants will undergo the fNIRS test, but they won’t need to participate further after that. This trial is currently recruiting participants, and it aims to improve early support for children with hearing challenges.
Gender
ALL
Eligibility criteria
- • 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.
About The Bionics Institute Of Australia
The Bionics Institute of Australia is a leading research organization dedicated to advancing biomedical engineering and developing innovative bionic technologies. With a focus on transforming healthcare through groundbreaking research, the Institute collaborates with academic institutions, industry partners, and healthcare providers to design and implement clinical trials that explore novel therapies and devices. Committed to improving patient outcomes, the Bionics Institute leverages its expertise in neurotechnology, prosthetics, and sensory devices to push the boundaries of medical science and enhance the quality of life for individuals with disabilities and chronic conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
East Melbourne, Victoria, Australia
Patients applied
Trial Officials
Professor Colette McKay
Principal Investigator
The Bionics Institute of Australia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported