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

March 27, 2024 updated by: Oticon Medical

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75013
        • Centre de Recherche en Audiologie adulte GH Pitié-Salpêtrière, APHP Sorbonne Université, Unité Fonctionnelle Implants auditifs et Explorations Fonctionnelles, 52 Bd Vincent Auriol, 75013 Paris, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Both groups:

    • Adult (≥ 18 years old)
    • Fluent in French language
    • Affiliation to social security
    • Information and signature of a written consent prior to any study-specific procedure

  • Control group (normal hearing in regards of age):

    • Normal hearing participants according to pure tone hearing levels defined for age and tested frequency (audiometry ISO 7029 and Wand & Puel, 2020 recommendations for hearing loss at the tested frequencies)

  • CI group (cochlear implant subjects):

    • Bilateral, severe-to-profound sensorineural hearing loss, with at least one cochlear implant system
    • Using Oticon Medical Neuro Cochlear Implant System (NCIS) or Digisonic Cochlear Implant system (DCIS), unilateral or bilateral
    • Duration of cochlear implant experience ≥ 6 months (period from cochlear implant activation to study enrolment)
    • Pure Tone Audiometry must be strictly below 50 dBA, CI aided.

Exclusion Criteria:

  • Both groups, according to the best practices for pupillometry (Winn et al., 2018):

    • Eye diseases: nystagmus, amblyopia, and macular degeneration
    • Severe head injury or any history of significant neurological problems: These issues can affect gaze stability, congruence of eye movements, and pupil dilation
    • Concomitant medication that can impact the parasympathetic autonomic nervous system
    • Person under State Medical Assistance (AME for "Aide medical d'état" in French)
    • Use of one of the following treatments: Trihexyphenidyl, Biperiden or Tropatepine (anticholinergics, commonly used in the treatment of Parkinson's disease)
    • Person under legal protection (guardianship, curators, other, etc.) or under family authorization
    • Unwillingness or inability to comply with all investigational requirements
    • Additional cognitive, medical, or social handicaps that would prevent completion of all study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group (normal hearing in regards of age)
Normal hearing participants according to pure tone hearing levels defined for age and tested frequency (audiometry ISO 7029 and Wang & Puel, 2020 recommendations for hearing loss at the tested frequencies). Total of 32 subjects in this arm.
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.
Experimental: CI group (cochlear implanted subjects)

Cochlear implanted subjects with bilateral, severe-to-profound sensorineural hearing loss, with at least one Oticon Medical cochlear implant system .

Up to 40 subjects in this arm:

  • 20 subjects will perform experiment 1 & 2

  • 20 subjects will perform experiment 3

    • The subjects of the experiment 3 ore either those taken part to experiment 1 and 2, or subjects who only take port to the experiment 3
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the pupil dilation response to a range of auditory stimuli (acoustic and electric).
Time Frame: At Visit 2 (Month 1)
Pupil dilation response for each intensity and frequency [Mean pupil dilatation in milimeters]
At Visit 2 (Month 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the loudness perception of the subjects regarding the different auditory stimuli (acoustic and electric) to correlate the results to the pupil dilation response.
Time Frame: At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done]
Loudness score corresponding to each pupil dilation response. [Using Oticon Medical Loudness scale: scale from 0 to 10 following the ISO 16832. 0 (zero) corresponding to inaudible level and 10 to extremely loud (intolerable) sounds.]
At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oticon Medical

Investigators

  • Principal Investigator: Isabelle Mosnier, Centre de Recherche en Audiologie adulte - CreA- GH Pitié Salpêtrière (APHP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

November 6, 2023

Study Completion (Actual)

November 6, 2023

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OM29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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