Hearing Impaired Children
Conditions
Keywords
fNIRS, Early intervention
Brief summary
The goal of this clinical trial is to evaluate safety and preliminary efficacy of a novel device (EarGenie MVP) to assess hearing function in infants, using a small number of infants with normal hearing. The main questions it aims to answer are: * Is our device safe? * Does the device provide preliminary results consistent with previous results from a commercial functional Near Infrared Spectroscopy (fNIRS) research device? Participants will attend one test session and have their hearing assessed with the EarGenie MVP device.
Detailed description
This is a first-in-human study to evaluate safety and preliminary efficacy of our prototype hearing assessment system (EarGenie MVP). EarGenie MVP uses fNIRS technology to assess an infant's brain response to hearing speech sounds, or discriminating between different speech sounds. It includes software to automatically run analysis in real time, and has a user interface allowing clinicians to operate the tests and receive result reports. The test methods and analysis software have been developed using our commercial fNIRS research system, but the EarGenie MVP has been designed for easy use in paediatric audiology clinics. 10 infants with normal hearing will be recruited for the study, and undergo one test session each with the EarGenie MVP. Safety data will be documented and the results of the tests examined to see if they are consistent with the results expected from our experience using the commercial device in 36 infants with normal hearing.
Interventions
DEVICEEarGenie MVP test
The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests via the user interface. Blocks of speech sounds are presented to the infant via earphones or via speaker, and the EarGenie MVP measures changes in the blood oxygenation. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
Sponsors
The Bionics Institute of Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
A single group of infants without hearing impairment will be recruited so that safety and preliminary efficacy can be determined.
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Is between the ages of 1 and 24 months at the time of fNIRS testing. * Has no known hearing loss * Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Significant fNIRS Detection and Discrimination Responses | Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested. | Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants. PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm). For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the response waveform is consistent with those found in the previous data set. We will consider the feasibility as confirmed if not more than 1(/10) infants (or 10%) have an absent detection response at 65 dB SPL, and not more than 3 (/10) babies (or 30%) show an absent discrimination response for Ba versus Ga. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse effects are noted during, and for 24 hours following the single test session of the infant. Incidence of events is calculated after the last infant is tested. | Safety assessment will be undertaken as follows. Any adverse event (as defined using standard definitions) will be documented in each infant's case report, and reported using standard required procedures. Each infant's case report will also include details of any minor non-reportable occurrences only relevant to comfort of use such as discomfort signs in the infant, or any temporary visual skin marks left by the headgear after the test. If any major adverse effect occurs, the trial will be stopped until the such time as the issue is resolved. |
Countries
Australia
Participant flow
Recruitment details
11 Participants were recruited via word of mouth between August 2023 and February 2024.
Pre-assignment details
One infant was found to have middle ear disfunction on the tympanometry test, and so was excluded from the study and did not complete an fNIRS test
Participants by arm
| Arm | Count |
|---|---|
| fNIRS Infants who have a test completed with EarGenie MVP in a single test session
EarGenie MVP test: The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests via the user interface. Blocks of speech sounds are presented to the infant via earphones or via speaker, and the EarGenie MVP measures changes in the blood oxygenation. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | failed eligibility | 1 |
Baseline characteristics
| Characteristic | fNIRS | — |
|---|---|---|
| Age, Customized 1-24 months | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 10 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Prevalence of Significant fNIRS Detection and Discrimination Responses
Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants. PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm). For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the response waveform is consistent with those found in the previous data set. We will consider the feasibility as confirmed if not more than 1(/10) infants (or 10%) have an absent detection response at 65 dB SPL, and not more than 3 (/10) babies (or 30%) show an absent discrimination response for Ba versus Ga.
Time frame: Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| fNIRS | Prevalence of Significant fNIRS Detection and Discrimination Responses | significant detection response to BA at 65 dB SPL | with | 4 Participants |
| fNIRS | Prevalence of Significant fNIRS Detection and Discrimination Responses | significant detection response to BA at 65 dB SPL | without | 6 Participants |
| fNIRS | Prevalence of Significant fNIRS Detection and Discrimination Responses | significant discrimination response to BA/GA contrast | with | 1 Participants |
| fNIRS | Prevalence of Significant fNIRS Detection and Discrimination Responses | significant discrimination response to BA/GA contrast | without | 9 Participants |
| fNIRS | Prevalence of Significant fNIRS Detection and Discrimination Responses | Response morphologies consitent with morphologies of research device | with | 10 Participants |
| fNIRS | Prevalence of Significant fNIRS Detection and Discrimination Responses | Response morphologies consitent with morphologies of research device | without | 0 Participants |
Secondary
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety assessment will be undertaken as follows. Any adverse event (as defined using standard definitions) will be documented in each infant's case report, and reported using standard required procedures. Each infant's case report will also include details of any minor non-reportable occurrences only relevant to comfort of use such as discomfort signs in the infant, or any temporary visual skin marks left by the headgear after the test. If any major adverse effect occurs, the trial will be stopped until the such time as the issue is resolved.
Time frame: Adverse effects are noted during, and for 24 hours following the single test session of the infant. Incidence of events is calculated after the last infant is tested.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| fNIRS | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse events | with | 0 Participants |
| fNIRS | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse events | without | 10 Participants |
| fNIRS | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | no impression marks on skin, or impression marks that resolved within 3 hours | with | 10 Participants |
| fNIRS | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | no impression marks on skin, or impression marks that resolved within 3 hours | without | 0 Participants |
| fNIRS | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | signs of distress during test such as crying | with | 0 Participants |
| fNIRS | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | signs of distress during test such as crying | without | 10 Participants |