Optimization of Hearing Performance in the Subject Implanted (OPERSA)

August 22, 2023 updated by: University Hospital, Toulouse

Optimization of Hearing Performance in the Subject Implanted With Profound Asymmetric Deafness

In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear. However, contralateral hearing is often not considered in rehabilitation programs, mainly due to the lack of scientific evidence on the role it may play. The present project aims to better understand the mechanisms of perceptual learning of CI-processed speech after implantation and to develop and test rehabilitation strategies for CI users.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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
      • Toulouse, France
        • Recruiting
        • Marx

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

No

Description

Inclusion Criteria:

  • Age>18
  • Unilaterally postlingually-deafened adult cochlear implanted candidates (IC-Uni)
  • Person with almost normal or moderate contralateral hearing ( under 60dB)
  • Cochlear implanted person whose activation has not yet been performed
  • Cochlear implanted subjects with bilateral post-lingual profound deafness, who already benefit from a unilateral cochlear implant and candidates to a bilateral cochlear implant
  • Affiliated to social security

Exclusion Criteria:

  • - Subjects under juridical protections or tutelage measure
  • Subjects with associated neurological or neurodegenerative conditions
  • Significant anatomical changes on CT scan of the temporal bone that may interfere with the insertion of the cochlear implant

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training A
Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates
Procedure: Program A
Presentation of the sentence to the implant alone
Experimental: Training B
Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates
Procedure: Program B
Presentation of the sentence to the implanted ear, associated for the non-implanted ear
Active Comparator: Control
Training in bilaterally postlingually-deafened adult cochlear implanted candidates
Procedure: Control
Presentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is the percentage of correct speech recognition after training between the two training programs
Time Frame: Month 12
Month 12

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Collaborators

Centre National de la Recherche Scientifique, France

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 18, 2023

Primary Completion (Estimated)

January 18, 2025

Study Completion (Estimated)

January 18, 2025

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0125

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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