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

Hearing Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847426
• Other study ID #: 90457
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: April 28, 2028

Study information

• Verified date: July 2023
• Source: The Bionics Institute of Australia
• Contact: Professor Colette McKay
• Phone: +61 3 9667 7541
• Email: cmckay[@]bionicsinstitute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

Universal newborn hearing screening (UNHS) has reduced the age of diagnosis of permanent childhood hearing loss from several years down to several weeks. While this is highly desirable, the early diagnosis raises challenges for the audiologists who manage these infants. The challenges are due to a lack of relevant audiological information, particularly about an infant's ability to discriminate between different speech sounds, and, for infants with Auditory Neuropathy, their degree of hearing impairment, which is required to make key management decisions. The missing information causes intervention delays at several time-critical points along the standard hearing care pathway that could seriously affect speech and language development for the infant, with life-long social, educational and employment consequences. The goal of this trial is to assess whether the addition of audiological information provided by fNIRS assessments can address these challenges for audiologists who care for infants with different types of hearing loss and at the different critical decision points in the care pathway.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 28, 2028
• Est. primary completion date: April 28, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Australia	Bionics Institute	East Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
The Bionics Institute of Australia

Country where clinical trial is conducted

Australia, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Parental/Guardian perception of acceptability of fNIRS test process and usefulness of fNIRS test results	The results of a parent questionnaire developed by the Advisory Committee (which includes parent members) will be qualitatively evaluated to determine if the fNIRS test process was acceptable, and the test results were perceived as useful. The results will also indicate whether there are aspects of the test process that could be improved in future to make it more acceptable to parents.	Within 2 weeks after their child's fNIRS testing session