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

Primary Purpose

Hearing Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Provision of standard audiological + fNIRS test results
Provision of standard audiological test results only
Sponsored by
The Bionics Institute of Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Impairment focused on measuring Infants, Early intervention, functional near-infrared spectroscopy

Eligibility Criteria

24 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bionics InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Provision of standard audiological + fNIRS test results

Provision of standard audiological test results only

Arm 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: At diagnosis: unaided Auditory Brainstem Response results; After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials; After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2); After initial cochlear implant programming: behavioural observations.

The standard audiology information available to the audiologists includes: At diagnosis: unaided Auditory Brainstem Response results; After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials; After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2); After initial cochlear implant programming: behavioural observations.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 27, 2023
Last Updated
July 26, 2023
Sponsor
The Bionics Institute of Australia
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1. Study Identification

Unique Protocol Identification Number
NCT05847426
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
April 28, 2028 (Anticipated)
Study Completion Date
April 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Bionics Institute of Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment
Keywords
Infants, Early intervention, functional near-infrared spectroscopy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Provision of standard audiological + fNIRS test results
Arm Type
Experimental
Arm 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: At diagnosis: unaided Auditory Brainstem Response results; After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials; After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2); After initial cochlear implant programming: behavioural observations.
Arm Title
Provision of standard audiological test results only
Arm Type
Active Comparator
Arm Description
The standard audiology information available to the audiologists includes: At diagnosis: unaided Auditory Brainstem Response results; After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials; After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2); After initial cochlear implant programming: behavioural observations.
Intervention Type
Other
Intervention Name(s)
Provision of standard audiological + fNIRS test results
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Provision of standard audiological test results only
Intervention Description
The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Between each infant's completed fNIRS testing session and 2 months after
Secondary Outcome Measure Information:
Title
Parental/Guardian perception of acceptability of fNIRS test process and usefulness of fNIRS test results
Description
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.
Time Frame
Within 2 weeks after their child's fNIRS testing session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Colette McKay
Phone
+61 3 9667 7541
Email
cmckay@bionicsinstitute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Julia Wunderlich
Phone
+61 3 9667 7500
Email
hearingstudy@bionicsinstitute.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Colette McKay
Organizational Affiliation
Bionics Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bionics Institute
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Colette McKay
Phone
+61 3 9667 7541
Email
cmckay@bionicsinstitute.org
First Name & Middle Initial & Last Name & Degree
Dr Julia Wunderlich
Phone
+61 3 9667 7500
Email
hearingstudy@bionicsinstitute.org
First Name & Middle Initial & Last Name & Degree
Prof Colette McKay
First Name & Middle Initial & Last Name & Degree
Dr Julia Wunderlich
First Name & Middle Initial & Last Name & Degree
Dr Darren Mao
First Name & Middle Initial & Last Name & Degree
Dr Gautam Balasubramanian
First Name & Middle Initial & Last Name & Degree
Mr Ohn Wah (Steven) Lee

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Beginning 1 month following analysis and article publication, the following data will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept Bionics Institute's conditions for access: Raw anonymized confidence rating scores linked to the questionnaire question, infant subgroup (type and degree of hearing loss categories), and point in clinical care pathway. study protocol and statistical analysis plan if not already clear in the publication
IPD Sharing Time Frame
Data, study protocol, and statistical analysis plan will be available from one month following trial analysis and article publication, for a period of 10 years.
IPD Sharing Access Criteria
Data can only be accessed if the researchers are from a recognized research institution, the proposed use of the data has been ethically reviewed and approved by an independent committee, and the researchers accept Bionics Institute's conditions for access.
Citations:
PubMed Identifier
34907273
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.
Results Reference
background
PubMed Identifier
35071689
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.
Results Reference
background
PubMed Identifier
34051607
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.
Results Reference
background
PubMed Identifier
33362260
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.
Results Reference
background
PubMed Identifier
31985534
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.
Results Reference
background
PubMed Identifier
29633049
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.
Results Reference
background

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

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