Skip to content

Optimization of Hearing Performance in the Subject Implanted

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05325450
Acronym
OPERSA
Enrollment
50
Registered
2022-04-13
Start date
2023-05-18
Completion date
2025-01-18
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

deafness, cochlear implant

Brief summary

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.

Interventions

PROCEDUREProgram A

Presentation of the sentence to the implant alone

PROCEDUREProgram B

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

PROCEDUREControl

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

Sponsors

Centre National de la Recherche Scientifique, France
CollaboratorOTHER
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

two within-subject crossover experiments (short-term and long-term) where each subject will follow two phases of the protocol (training A and training B).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The primary outcome is the percentage of correct speech recognition after training between the two training programsMonth 12

Countries

France

Contacts

Primary ContactMathieu MARX
marx.m@chu-toulouse.fr0561777704
Backup ContactNadege ALGANS
algans.n@chu-toulouse.fr0561777204

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026