Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

NCT06317493 | Recruiting

• 1 other identifier: RC 15/2021
• Study Type: observational
• Target: 180
• Locations: 2 countries
• Sites: 5

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.

Conditions

Hearing Impaired Children

Keywords

Pupillometry; Hearing threshold; Pediatric cochlear implants

Outcome Measures

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.

  Within 30 minutes from enrolment

Study Arms (4)

Hearing threshold without aids

Case group with hearing impairment (HI) (hearing threshold \>35 dB) without aids

Other: Stimuli

Hearing threshold with cochlear implant

Case group with hearing threshold corrected with cochlear implant (CI)

Other: Stimuli

Hearing threshold with aids

Case group with hearing threshold corrected with hearing aids

Other: Stimuli

Control group

Control group of normally hearing age-matched children

Other: Stimuli

Interventions

Stimuli OTHER

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.

Control group; Hearing threshold with aids; Hearing threshold with cochlear implant; Hearing threshold without aids

Eligibility Criteria

• Age: 4 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants with and without hearing impairment

You may qualify if:

• 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)

You may not qualify if:

• Developmental disorders
• Unwillingness of the subject to participate further

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (5)

UOC Otorinolaringoiatria

Padua, Italy

ACTIVE NOT RECRUITING

Università degli Studi di Perugia

Perugia, Italy

ACTIVE NOT RECRUITING

Ospedale Martini

Torino, Italy

ACTIVE NOT RECRUITING

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

RECRUITING

Univeristy Medical Center

Ljubljana, Slovenia

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Stimuli Responsive Polymers

Intervention Hierarchy (Ancestors)

Polymers; Macromolecular Substances; Smart Materials; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Eva Orzan, MD

CONTACT

+39.040.3785.537; eva.orzan@burlo.trieste.it

Amanda Saksida

CONTACT

+39.040.3785.537; eva.orzan@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: January 3, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

IT (4); SL (1)