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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 24
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Australia
The Royal Victorian Eye and Ear Hospital
NOT_YET_RECRUITING
East Melbourne
Bionics Institute
RECRUITING
Fitzroy
Barwon Health
NOT_YET_RECRUITING
Geelong
Hearing Australia
NOT_YET_RECRUITING
Moonee Ponds
The Royal Children's Hospital
RECRUITING
Parkville
Contact Information
Primary
Professor Colette McKay
cmckay@bionicsinstitute.org
+61 3 9667 7541
Backup
Dr Julia Wunderlich
hearingstudy@bionicsinstitute.org
+61 3 9667 7500
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2028-04-28
Participants
Target number of participants: 40
Treatments
Experimental: Provision of standard audiological + fNIRS test results
The treatment arm involves the provision of additional fNIRS sound detection and speech discrimination test results to the audiologists, in addition to standard audiology information. Standard information includes:~1. At diagnosis: unaided Auditory Brainstem Response results;~2. After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials;~3. After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2);~4. After initial cochlear implant programming: behavioural observations.
Active_comparator: Provision of standard audiological test results only
The standard audiology information available to the audiologists includes:~1. At diagnosis: unaided Auditory Brainstem Response results;~2. After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials;~3. After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2);~4. After initial cochlear implant programming: behavioural observations.
Related Therapeutic Areas
Sponsors
Leads: The Bionics Institute of Australia

This content was sourced from clinicaltrials.gov