Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
NCT ID: NCT05847426
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-05-02
2028-04-28
Brief Summary
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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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Detailed Description
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A pool of at least 40 experienced audiologists will be recruited to participate in the study. In addition, infants with different types and degree of hearing loss, and at the different critical points in their care pathway will be recruited to provide fNIRS test results. For each infant, a group of ten paediatric audiologists will be randomly selected from the large pool and will be provided with anonymised audiological test results. Each audiologist will receive the current test results of the infant twice, once with, and once without the additional fNIRS test results, with 2 months between. Half (5 randomly selected) will receive the standard plus additional fNIRS test results before the standard-alone results and the other half in reverse order. The audiologists will be asked, via a questionnaire, to make clinical decisions relevant to the infant's point in the hearing care pathway and to rate their confidence in their decisions on a sliding scale.
Infants will be recruited for fNIRS tests at each of four points in the care pathway (after diagnosis, after first hearing aid provision, when optimal hearing aid program is established, and after cochlear implantation. The critical management decisions at these four points are, respectively: Is a hearing aid needed?; Is the hearing aid optimally programmed for the infant?; Would the infant be better off with a cochlear implant instead of their hearing aid?; and Is the cochlear implant programmed optimally for the infant?
Parents/guardians will also be surveyed about their experience with the fNIRS test.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
To test the main hypothesis (that including fNIRS information increases confidence in making management decisions) separately for different hearing loss category groups and different points in the care pathway, 232 infants will be recruited to undergo fNIRS testing, divided into subgroups each with target numbers based on power calculation.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Provision of standard audiological + fNIRS test results
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.
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.
Provision of standard audiological test results only
The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.
Interventions
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Provision of standard audiological + fNIRS test results
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.
Provision of standard audiological test results only
The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
Infants are also recruited into the study to have an fNIRS assessment performed. They do not participate further after the fNIRS test.
24 Years
ALL
Yes
Sponsors
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The Bionics Institute of Australia
OTHER
Responsible Party
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Colette McKay
Leader, Translational Hearing Research and Principal Scientist
Principal Investigators
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Professor Colette McKay
Role: PRINCIPAL_INVESTIGATOR
The Bionics Institute of Australia
Locations
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The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia
Bionics Institute
Fitzroy, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Hearing Australia
Moonee Ponds, Victoria, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Mao D, Wunderlich J, Savkovic B, Jeffreys E, Nicholls N, Lee OW, Eager M, McKay CM. Speech token detection and discrimination in individual infants using functional near-infrared spectroscopy. Sci Rep. 2021 Dec 14;11(1):24006. doi: 10.1038/s41598-021-03595-z.
Paranawithana I, Mao D, Wong YT, McKay CM. Reducing false discoveries in resting-state functional connectivity using short channel correction: an fNIRS study. Neurophotonics. 2022 Jan;9(1):015001. doi: 10.1117/1.NPh.9.1.015001. Epub 2022 Jan 18.
Shader MJ, Luke R, Gouailhardou N, McKay CM. The use of broad vs restricted regions of interest in functional near-infrared spectroscopy for measuring cortical activation to auditory-only and visual-only speech. Hear Res. 2021 Jul;406:108256. doi: 10.1016/j.heares.2021.108256. Epub 2021 Apr 28.
Zhou X, Sobczak G, McKay CM, Litovsky RY. Comparing fNIRS signal qualities between approaches with and without short channels. PLoS One. 2020 Dec 23;15(12):e0244186. doi: 10.1371/journal.pone.0244186. eCollection 2020.
Weder S, Shoushtarian M, Olivares V, Zhou X, Innes-Brown H, McKay C. Cortical fNIRS Responses Can Be Better Explained by Loudness Percept than Sound Intensity. Ear Hear. 2020 Sep/Oct;41(5):1187-1195. doi: 10.1097/AUD.0000000000000836.
Weder S, Zhou X, Shoushtarian M, Innes-Brown H, McKay C. Cortical Processing Related to Intensity of a Modulated Noise Stimulus-a Functional Near-Infrared Study. J Assoc Res Otolaryngol. 2018 Jun;19(3):273-286. doi: 10.1007/s10162-018-0661-0. Epub 2018 Apr 9.
Other Identifiers
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90457
Identifier Type: -
Identifier Source: org_study_id
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