EarGenie: Assessment of a Minimum Viable Product

NCT05962814 | Completed Results

• 1 other identifier: 98058
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Impaired Children

Keywords

fNIRS; Early intervention

Outcome Measures

Primary Outcomes (1)

• 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".

  Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.

Secondary Outcomes (1)

• 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.

Study Arms (1)

fNIRS

EXPERIMENTAL

Infants who have a test completed with EarGenie MVP in a single test session

Device: EarGenie MVP test

Interventions

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.

fNIRS

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• The Bionics Institute of Australia: lead

Study Sites (1)

Bionics Institute

East Melbourne, Victoria, 3002, Australia

Location

Results Point of Contact

• Title: Prof Colette McKay
• Organization: Bionics Institute

cmckay@bionicsinstitute.org

+61 408698202

Study Officials

• Colette M McKay, PhD

  The Bionics Institute of Australia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leader, Translational Hearing Research and Principal Scientist

Model Details: A single group of infants without hearing impairment will be recruited so that safety and preliminary efficacy can be determined.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: August 14, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)