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

RECRUITING

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?.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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

Is the managing audiologist for the infant who's results are being provided.

There are no exclusion criteria other than not meeting the inclusion criteria.

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Eligibility

Age eligible for study : 24 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-05-02

Primary completion: 2028-04-28

Study completion finish: 2028-04-28

Study type

HEALTH_SERVICES_RESEARCH

Phase

Trial ID

NCT05847426

Intervention or treatment

OTHER: Provision of standard audiological + fNIRS test results

OTHER: Provision of standard audiological test results only

Conditions

• Hearing Impairment

Condition: Hearing Impairment
OTHER: Provision of standard audiological + fNIRS test results and other drugs
East Melbourne, Victoria, Australia
Sponsor: The Bionics Institute of Australia

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Find a site

Closest Location:

Bionics Institute

Research sites nearby

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Bionics Institute
East Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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.	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.
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.	OTHER: 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.

Participant Group/Arm

Intervention/Treatment

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.

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.

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.

OTHER: 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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

Frequently Asked Questions

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References

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