Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Impaired Children
• Intervention / Treatment: Other: Stimuli

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Eva Orzan, MD; Phone Number: +39.040.3785.537; Email: eva.orzan@burlo.trieste.it
• Study Contact Backup: Name: Amanda Saksida; Phone Number: +39.040.3785.537; Email: eva.orzan@burlo.trieste.it

Study Locations

• Italy
  • Padova, Italy
    • Active, not recruiting
    • UOC Otorinolaringoiatria
  • Perugia, Italy
    • Active, not recruiting
    • Università degli Studi di Perugia
  • Torino, Italy
    • Active, not recruiting
    • Ospedale Martini
  • Trieste, Italy, 34137
    • Recruiting
    • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
    • Contact: Eva Orzan, MD; Phone Number: +39.040.3785.537; Email: eva.orzan@burlo.trieste.it
    • Sub-Investigator: Amanda Saksida
• Slovenia
  • Lubiana, Slovenia
    • Active, not recruiting
    • Univeristy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with and without hearing impairment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hearing threshold without aids; Case group with hearing impairment (HI) (hearing threshold >35 dB) without aids	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.
Hearing threshold with cochlear implant; Case group with hearing threshold corrected with cochlear implant (CI)	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.
Hearing threshold with aids; Case group with hearing threshold corrected with hearing aids	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.
Control group; Control group of normally hearing age-matched children	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity index of pupillometry test	The peak and the average pupil dilation will be defined for each trial and the difference between trials below and above the threshold will be defined within each block. The difference between the trials with and without audible stimuli will be assessed using the multiple corrected t- tests. The sensitivity index of the pupillometric exam compared to the audiometry results will be computed for the whole group using a signal detection analysis.	Within 30 minutes from enrolment

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pupillometry; Hearing threshold; Pediatric cochlear implants
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: RC 15/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No