NCT06317493

Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 4 Months – 36 Months
• Healthy volunteers: Not accepted

Summary

The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient.

Conditions

• Hearing Impaired Children

Interventions

Type	Name	Description
OTHER	Stimuli	Auditory Stimuli: Pure tone bursts with main frequencies of 500, 1000, 2000, and 4000 Hz. Each tone will be presented at 10dB above the estimated individual threshold per frequency and compared to the responses to trials without auditory stimuli. Auditory stimulus duration: 25ms, there is 200ms baseline period before each trial, and 2000 ms interstimulus interval. Visual stimuli: an animated movie adapted for the age and controlled for luminosity levels. Pupil data will be collected through a "Tobii PRO" screen-based eye-tracker that measures eye-movements and pupil dilation using the infrared light cameras.

Timeline

• Start date: 2021-01-03
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-19
• Last updated: 2024-06-13

Locations

5 sites across 2 countries: Italy, Slovenia