Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment
ConditionHearing Impaired Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-36
SponsorIRCCS Burlo Garofolo
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Developmental disorders
Unwillingness of the subject to participate further
Trial population
Participants with and without hearing impairment
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Stimuli
Other interventionAuditory 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.
Treatment groups
180 Participants
are divided into 4 treatment groupsGroup A: Hearing threshold without aids1 intervention
Group B: Hearing threshold with cochlear implant1 intervention
Group C: Hearing threshold with aids1 intervention
Group D: Control group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 30 minutes from enrolmentSponsors and contacts
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Source ClinicalTrials.gov