Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment - Trial NCT06317493
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Study Focus
Sponsor & Location
IRCCS Burlo Garofolo
Timeline & Enrollment
N/A
Jan 03, 2021
Dec 31, 2024
Primary Outcome
Sensitivity index of pupillometry test
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06317493
Non-Device Trial