Actively Recruiting
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
Eligibility Criteria
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)
You will not qualify if you...
- Developmental disorders
- Unwillingness of the subject to participate further
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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