EarGenie: Assessment of a Minimum Viable Product

Hearing Impaired Children Clinical Trial

Official title:

EarGenie: Assessment of a Minimum Viable Product

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05962814
• Other study ID #: 98058
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: The Bionics Institute of Australia
• Contact: Colette M McKay, PhD
• Phone: +61 408698202
• Email: cmckay[@]bionicsinstitute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 30, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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 exclusion criteria other than not meeting the inclusion criteria.

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired Children
• Hearing Loss

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Bionics Institute of Australia

Outcome

Type	Measure	Description	Time frame	Safety issue
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".	Through study completion, up to 3.5 months
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.	Through study completion, up to 3.5 months