Evaluation of the EarGenie MVP for detecting sounds in infants
EarGenie Minimum Viable Product (MVP) Performance Evaluation: Sensitivity and Specificity of a Test of Sound Detection and Discrimination Using Functional Near-infrared Spectroscopy (fNIRS) in a Single Group Trial of Normal Hearing Infants
This study is testing a new device called EarGenie to see if it can accurately detect sounds in babies aged 1 to 24 months who have normal hearing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Month to 24 Months |
| Sex | All |
| Sponsor | The Bionics Institute of Australia Academic / other |
| Locations | 1 site (Fitzroy, Victoria) |
| Trial ID | NCT06406088 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the performance of the EarGenie minimum viable product (MVP) in detecting and discriminating sounds in normal hearing infants aged 1 to 24 months. The trial involves a single test session where infants undergo standard audiological procedures, including otoscopy and tympanometry, before participating in fNIRS tests. Qualified pediatric audiologists will administer the tests while monitoring the infants for comfort and distress. The study aims to estimate the sensitivity and specificity of the EarGenie MVP across various sound levels and speech sound contrasts.
Who should consider this trial
Good fit: Ideal candidates are infants aged 1 to 24 months who have passed hearing screenings and have no known hearing loss.
Not a fit: Infants with skin conditions on the head or those who do not meet the age and hearing criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection of hearing impairments in infants, leading to timely interventions.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using fNIRS for auditory assessments, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Each infant must meet all of the following criteria to be enrolled in this trial: * Is between the ages of 1 and 24 months at the time of fNIRS testing. * Has no known hearing loss, having either passed newborn hearing screening or diagnostic audiological assessment. * Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Exclusion Criteria: * Infants with skin conditions such as cradle cap, eczema, or other skin conditions on the head will be excluded. There are no additional exclusion criteria other than not meeting the inclusion criteria.
Where this trial is running
Fitzroy, Victoria
- Bionics Institute — Fitzroy, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Colette McKay, PhD — The Bionics Institute of Australia
- Study coordinator: Colette M McKay, PhD
- Email: cmckay@bionicsinstitute.org
- Phone: +61 408698202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.