NCT06317493

Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment
IRCCS Burlo Garofolo·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Hearing Impaired Children
Drug/Device/Intervention
Stimuli
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
IRCCS Burlo Garofolo
Location
Trieste, Italy
Timeline & enrollment
Phase
N/A
Start date
Jan 03, 2021
End date
Dec 31, 2024
Enrollment
180 participants
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
Hearing loss, unspecifiedOther hearing lossOther specified hearing lossFamily history of deafness and hearing lossCongenital malformations of ear causing impairment of hearing
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06317493
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06317493 through Pure Global AI's free database. This phase not specified trial is sponsored by IRCCS Burlo Garofolo and is currently Recruiting. The study focuses on Hearing Impaired Children. Target enrollment is 180 participants.

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