Clinical trial NCT05847426: Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
Official title: Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Impairment
Keywords: Infants
Early intervention
functional near-infrared spectroscopy
Lead sponsor: The Bionics Institute of Australia
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Between each infant's completed fNIRS testing session and 2 months after
Secondary outcomes:
measure: Parental/Guardian perception of acceptability of fNIRS test process and usefulness of fNIRS test results
timeFrame: Within 2 weeks after their child's fNIRS testing session
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Bionics Institute
state: Victoria
Study officials:
affiliation: The Bionics Institute of Australia
name: Professor Colette McKay
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.