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Completed

NCT Number: NCT05962814

EarGenie: Assessment of a Minimum Viable Product

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.

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Key information

Conditions

Hearing Impaired Children

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bionics Institute

East Melbourne, Victoria, 3002, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EarGenie MVP test

Device

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.

Primary outcomes

  1. Prevalence of Significant fNIRS Detection and Discrimination Responses

    Time frame: 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 outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    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.

    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.

Sponsors and collaborators

Lead sponsor

The Bionics Institute of Australia

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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