Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 3
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
UOC Otorinolaringoiatria
ACTIVE_NOT_RECRUITING
Padua
Università degli Studi di Perugia
ACTIVE_NOT_RECRUITING
Perugia
Ospedale Martini
ACTIVE_NOT_RECRUITING
Torino
Institute for Maternal and Child Health - IRCCS Burlo Garofolo
RECRUITING
Trieste
Slovenia
Univeristy Medical Center
ACTIVE_NOT_RECRUITING
Ljubljana
Contact Information
Primary
Eva Orzan, MD
eva.orzan@burlo.trieste.it
+39.040.3785.537
Backup
Amanda Saksida
eva.orzan@burlo.trieste.it
+39.040.3785.537
Time Frame
Start Date: 2021-01-03
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 180
Treatments
Hearing threshold without aids
Case group with hearing impairment (HI) (hearing threshold \>35 dB) without aids
Hearing threshold with cochlear implant
Case group with hearing threshold corrected with cochlear implant (CI)
Hearing threshold with aids
Case group with hearing threshold corrected with hearing aids
Control group
Control group of normally hearing age-matched children
Related Therapeutic Areas
Sponsors
Leads: IRCCS Burlo Garofolo

This content was sourced from clinicaltrials.gov