Actively Recruiting

Phase Not Applicable
Age: 24Years +
All Genders
Healthy Volunteers
NCT05847426

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

Led by The Bionics Institute of Australia · Updated on 2025-08-19

40

Participants Needed

5

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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?

CONDITIONS

Official Title

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

Who Can Participate

Age: 24Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Qualified audiologist with membership in Audiology Australia
  • At least 1 year of experience in pediatric diagnostic, hearing aid, or cochlear implant audiology in Australia
  • Signed and dated informed consent form
  • Infants aged between 1 and 24 months at the time of fNIRS testing
  • Infants with permanent hearing loss in one or both ears confirmed by diagnostic testing
  • Infants with a legally acceptable representative able to provide informed consent
Not Eligible

You will not qualify if you...

  • Audiologists who are the managing audiologist for the infant whose results are provided
  • Infants not meeting the inclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

The Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, Australia, 3002

Not Yet Recruiting

2

Bionics Institute

Fitzroy, Victoria, Australia, 3065

Actively Recruiting

3

Barwon Health

Geelong, Victoria, Australia, 3220

Not Yet Recruiting

4

Hearing Australia

Moonee Ponds, Victoria, Australia, 3039

Not Yet Recruiting

5

The Royal Children's Hospital

Parkville, Victoria, Australia, 3052

Actively Recruiting

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Research Team

P

Professor Colette McKay

CONTACT

D

Dr Julia Wunderlich

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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