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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06317493
Other study ID # RC 15/2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 3, 2021
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source IRCCS Burlo Garofolo
Contact Eva Orzan, MD
Phone +39.040.3785.537
Email eva.orzan@burlo.trieste.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Months to 36 Months
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Stimuli
Auditory Stimuli: Pure tone bursts with main frequencies of 500, 1000, 2000, and 4000 Hz. Each tone will be presented at 10dB above the estimated individual threshold per frequency and compared to the responses to trials without auditory stimuli. Auditory stimulus duration: 25ms, there is 200ms baseline period before each trial, and 2000 ms interstimulus interval. Visual stimuli: an animated movie adapted for the age and controlled for luminosity levels. Pupil data will be collected through a "Tobii PRO" screen-based eye-tracker that measures eye-movements and pupil dilation using the infrared light cameras.

Locations

Country Name City State
Italy UOC Otorinolaringoiatria Padova
Italy Università degli Studi di Perugia Perugia
Italy Ospedale Martini Torino
Italy Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" Trieste
Slovenia Univeristy Medical Center Lubiana

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Countries where clinical trial is conducted

Italy,  Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity index of pupillometry test 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. Within 30 minutes from enrolment
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