Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

Recruiting

• Conditions: Hearing Impaired Children
• Interventions: Other: Stimuli

• Registration Number: NCT06317493
• Lead Sponsor: IRCCS Burlo Garofolo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hearing threshold without aids	Stimuli	Case group with hearing impairment (HI) (hearing threshold \>35 dB) without aids
Hearing threshold with aids	Stimuli	Case group with hearing threshold corrected with hearing aids
Hearing threshold with cochlear implant	Stimuli	Case group with hearing threshold corrected with cochlear implant (CI)
Control group	Stimuli	Control group of normally hearing age-matched children

Primary Outcome Measures

Name	Time	Method
Sensitivity index of pupillometry test	Within 30 minutes from enrolment	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.

Trial Locations

Locations (5)

Università degli Studi di Perugia; 🇮🇹 Perugia, Italy

UOC Otorinolaringoiatria; 🇮🇹 Padova, Italy

Ospedale Martini; 🇮🇹 Torino, Italy

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"; 🇮🇹 Trieste, Italy

Univeristy Medical Center; 🇸🇮 Lubiana, Slovenia