Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Impaired Children
- Sponsor
- IRCCS Burlo Garofolo
- Enrollment
- 180
- Locations
- 5
- Primary Endpoint
- Sensitivity index of pupillometry test
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Sensitivity index of pupillometry test
Time Frame: 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.