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

The Bionics Institute of Australia

Status: Enrolling

Conditions: Hearing Impairment

Treatments: Other: Provision of standard audiological test results only; Other: Provision of standard audiological + fNIRS test results

Study type: Interventional

Funder types: Other

Identifiers

NCT05847426

90457

Details and patient eligibility

About

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?

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 24+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Provision of standard audiological + fNIRS test results

Experimental group

Description:

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.

Treatment:

Other: Provision of standard audiological + fNIRS test results

Provision of standard audiological test results only

Active Comparator group

Description:

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.

Treatment:

Other: Provision of standard audiological test results only