Assessing hearing and pupil response in children with hearing impairment
Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment
This study is testing if measuring how much children's pupils dilate can help us understand their hearing abilities better, especially for those using cochlear implants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 4 Months to 36 Months |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 5 sites (Padova and 4 other locations) |
| Trial ID | NCT06317493 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between pupil dilation and hearing thresholds in children with hearing impairments, particularly those using cochlear implants. The researchers hypothesize that perceived sounds will cause greater pupil dilation compared to non-perceived sounds, and that these responses will correlate with hearing thresholds measured through pure tone audiometry. By confirming these hypotheses, the study aims to develop a standardized procedure for auditory signal detection using pupillometry, which could enhance the assessment and rehabilitation of young children with hearing aids or cochlear implants.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 36 months with normal or corrected-to-normal vision and no relevant neurological or psychiatric conditions.
Not a fit: Patients with developmental disorders or those unwilling to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of auditory thresholds in young children, improving their post-operative care and rehabilitation.
How similar studies have performed: While this approach is innovative, similar studies have shown promising results in using pupillometry for auditory assessments, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Normal or corrected-to-normal vision * No history of relevant neurological or psychiatric concomitant disease * Age: 4-36 months * At least 1 months of more after initial fitting of the CI or hearing aid (only for aided subjects) Exclusion Criteria: * Developmental disorders * Unwillingness of the subject to participate further
Where this trial is running
Padova and 4 other locations
- UOC Otorinolaringoiatria — Padova, Italy (Active_not_recruiting)
- Università degli Studi di Perugia — Perugia, Italy (Active_not_recruiting)
- Ospedale Martini — Torino, Italy (Active_not_recruiting)
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
- Univeristy Medical Center — Ljubljana, Slovenia (Active_not_recruiting)
Study contacts
- Study coordinator: Eva Orzan, MD
- Email: eva.orzan@burlo.trieste.it
- Phone: +39.040.3785.537
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.