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

NCT05847426 | Recruiting

• 1 other identifier: 90457
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief 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. 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. 2.Is the experience of their infant having an fNIRS test acceptable and comfortable for the parents or care givers?

Conditions

Hearing Impairment

Keywords

Infants; Early intervention; functional near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• Change in confidence of audiological clinical management decisions when fNIRS hearing test results are included with standard audiological information compared to when using standard information alone

  The questionnaire responses that the participating audiologists provide will measure their confidence in making the appropriate next decision for the infant using a sliding scale (0 (no confidence) to 100 (high confidence)). The data from the sliding scale responses for the same audiologist/infant will be subtracted (confidence with fNIRS minus confidence without fNIRS) to obtain the raw data for analysis.

  Between each infant's completed fNIRS testing session and 2 months after

Secondary Outcomes (1)

• Parental/Guardian perception of acceptability of fNIRS test process and usefulness of fNIRS test results

  Within 2 weeks after their child's fNIRS testing session

Study Arms (2)

Provision of standard audiological + fNIRS test results

EXPERIMENTAL

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.

Other: Provision of standard audiological + fNIRS test results

Provision of standard audiological test results only

ACTIVE COMPARATOR

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.

Other: Provision of standard audiological test results only

Interventions

Provision of standard audiological + fNIRS test results OTHER

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 + fNIRS test results

Provision of standard audiological test results only OTHER

The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.

Provision of standard audiological test results only

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Bionics Institute of Australia: lead

Study Sites (5)

The Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

NOT YET RECRUITING

Bionics Institute

Fitzroy, Victoria, 3065, Australia

RECRUITING

Barwon Health

Geelong, Victoria, 3220, Australia

NOT YET RECRUITING

Hearing Australia

Moonee Ponds, Victoria, 3039, Australia

NOT YET RECRUITING

The Royal Children's Hospital

Parkville, Victoria, 3052, Australia

RECRUITING

Related Publications (6)

• 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.

  PMID: 34907273 BACKGROUND

• 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.

  PMID: 35071689 BACKGROUND

• 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.

  PMID: 34051607 BACKGROUND

• 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.

  PMID: 33362260 BACKGROUND

• 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.

  PMID: 31985534 BACKGROUND

• 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.

  PMID: 29633049 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor Colette McKay

  The Bionics Institute of Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Colette McKay

CONTACT

+61 3 9667 7541; cmckay@bionicsinstitute.org

Dr Julia Wunderlich

CONTACT

+61 3 9667 7500; hearingstudy@bionicsinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leader, Translational Hearing Research and Principal Scientist

Model Details: The intervention (provision of additional fNIRS information) will be applied to audiologists in a cross-over design, wherein each audiologist will receive the anonymized current audiological information about a particular infant twice: once with, and once without the additional fNIRS information. Each time, the audiologist will answer questions about key management decisions via a questionnaire and rate their confidence in their decision using a sliding scale. The change in confidence (difference between the two sliding scale answers for the audiologist) when having access to additional fNIRS information will be the raw data analysed. 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.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): April 28, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data, study protocol, and statistical analysis plan will be available from one month following trial analysis and article publication, for a period of 10 years.
• Access Criteria: Data can only be accessed if the researchers are from a recognized research institution, the proposed use of the data has been ethically reviewed and approved by an independent committee, and the researchers accept Bionics Institute's conditions for access.

Locations

AU (5)