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NCT Number: NCT05325450

Optimization of Hearing Performance in the Subject Implanted

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.

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Key information

Conditions

Hearing Loss Deafness Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marx

Toulouse, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Program A

Procedure

Presentation of the sentence to the implant alone

Program B

Procedure

Presentation of the sentence to the implanted ear, associated for the non-implanted ear

Control

Procedure

Presentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time

Primary outcomes

  1. The primary outcome is the percentage of correct speech recognition after training between the two training programs

    Time frame: Month 12

Study contacts

Contact information is provided by the study sponsor or research team.

Mathieu MARX

CONTACT

[email protected]

0561777704

Nadege ALGANS

CONTACT

[email protected]

0561777204

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Centre National de la Recherche Scientifique, France

Registry information

Official study title

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

Acronym: OPERSA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2022
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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