Actively Recruiting

Age: 4Months - 36Months
All Genders
NCT06317493

Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

Led by IRCCS Burlo Garofolo · Updated on 2024-06-13

180

Participants Needed

5

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

Who Can Participate

Age: 4Months - 36Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • Developmental disorders
  • Unwillingness of the subject to participate further

AI-Screening

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Trial Site Locations

Total: 5 locations

1

UOC Otorinolaringoiatria

Padova, Italy

Active, Not Recruiting

2

Università degli Studi di Perugia

Perugia, Italy

Active, Not Recruiting

3

Ospedale Martini

Torino, Italy

Active, Not Recruiting

4

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, Italy, 34137

Actively Recruiting

5

Univeristy Medical Center

Ljubljana, Slovenia

Active, Not Recruiting

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Research Team

E

Eva Orzan, MD

CONTACT

A

Amanda Saksida

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment | DecenTrialz