NCT05586555

A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings

A Monocentric Study Evaluating Pupillometry as an Objective Measurement for Cochlear Implant (CI) Fittings

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.

Detailed description

The purpose of the clinical investigation is to explore the pupil dilation response of subjects with a cochlear implant and to provide proof of concept that it is possible to perform the adaptation of a cochlear implant using pupillometry. The population of this study is divided in 2 group: * A control group with normal-hearing listeners. * An Cl group with subjects with bilateral, severe-to-profound sensorineural hearing loss, with at least one cochlear implant for more than 6 months. Mainly used in audiology to evaluate listening effort, pupillometry is an objective measure that could also be used for fittings. Studies have shown that sound intensity influence pupil dilation. indeed, normal hearing and hearing aids subjects exhibit larger pupil responses with increasing intensity/loudness. The purpose of this study is to explore the pupil dilation response of cochlear implant subjects and to provide a proof of concept that we can perform cochlear implant fitting using pupillometry. Implanted subjects (Cl group) will undergo up to 3 visits: 1. Visit 1 or V1(inclusion) on day 1, 2. Visit 2 or V2 (Experiment 1-+2+3 or Experiment 1+2 or Experiment 3 )\* up to 1 month after V1 3. Visit 3 or V3 (Experiment 1+2 or Experiment 3, optional)\* up to 1 month after V2 \*lt is up to investigator decision to conduct experiment 1+2 and experiment 3 the same day or in on independent visit (no matter in which order) Normal-hearing listeners (control group) will undergo up to 2 visits: 1. Visit 1 or Va (inclusion) on day 1, 2. Visit 2 or V2 (experiment) up to 1 month after V1

Conditions

• Hearing Loss, Sensorineural
• Hearing Loss, Bilateral
• Cochlear Hearing Loss
• Hearing Loss, Cochlear

Interventions

Type	Name	Description
OTHER	Pupillometry (Eve-tracking measurements)	Pupillometry measurements are carried out by a dedicated device (eye tracker), which includes cameras allowing the measurement of pupillary dilation. The subject stands in front of a screen and fixes a point in the center of the screen, the cameras placed on the screen allowing a measurement of the pupillary dilation in a non-invasive way. These eye-tracking measurements are performed simultaneously with an auditory task and allow to study the pupil's response to different stimuli.

Timeline

• Start date: 2023-05-02
• Primary completion: 2023-11-06
• Completion: 2023-11-06
• First posted: 2022-10-19
• Last updated: 2024-03-29

Locations

1 site across 1 country: France