Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment

Hearing Impaired Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317493
• Other study ID #: RC 15/2021
• Status: Recruiting
• Start date: January 3, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: IRCCS Burlo Garofolo
• Contact: Eva Orzan, MD
• Phone: +39.040.3785.537
• Email: eva.orzan[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired Children
• Hearing Loss

Intervention

Other:
• Stimuli
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.

Locations

Country	Name	City	State
Italy	UOC Otorinolaringoiatria	Padova
Italy	Università degli Studi di Perugia	Perugia
Italy	Ospedale Martini	Torino
Italy	Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"	Trieste
Slovenia	Univeristy Medical Center	Lubiana

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Countries where clinical trial is conducted

Italy,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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