Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06317493

Enrollment

180

Registered

2024-03-19

Start date

2021-01-03

Completion date

2024-12-31

Last updated

2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Impaired Children

Keywords

Pupillometry, Hearing threshold, Pediatric cochlear implants

Brief 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.

Interventions

OTHERStimuli

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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Months to 36 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity index of pupillometry test	Within 30 minutes from enrolment	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.

Countries

Italy, Slovenia

Contacts

Primary ContactEva Orzan, MD

eva.orzan@burlo.trieste.it+39.040.3785.537

Backup ContactAmanda Saksida