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

Not Applicable

Recruiting

• Conditions: Hearing Impairment

• Registration Number: NCT05847426
• Lead Sponsor: The Bionics Institute of Australia

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. 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?

Detailed 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.

Study Timeline

• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Study Start: 2023-05-02
• Study First Posted: 2023-05-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Primary Completion: 2028-04-28
• Study Completion: 2028-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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	Between each infant's completed fNIRS testing session and 2 months after	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Bionics Institute; 🇦🇺 East Melbourne, Victoria, Australia