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

NCT05586555 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-03-29

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Isabelle Mosnier · Centre de Recherche en Audiologie adulte - CreA- GH Pitié Salpêtrière (APHP)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2023-11-06
Completion
2023-11-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586555 on ClinicalTrials.gov