Clinical trial NCT05962814: EarGenie: Assessment of a Minimum Viable Product
Official title: EarGenie: Assessment of a Minimum Viable Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impaired Children
Keywords: fNIRS
Early intervention
Lead sponsor: The Bionics Institute of Australia
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group of infants without hearing impairment will be recruited so that safety and preliminary efficacy can be determined.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Significant fNIRS Detection and Discrimination Responses
timeFrame: Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 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.
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Bionics Institute
state: Victoria
Study officials:
affiliation: The Bionics Institute of Australia
name: Colette M McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References: