Optimization of Hearing Performance in the Subject Implanted

NCT ID: NCT05325450

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-18

Study Completion Date

2025-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Training A

Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates

Group Type EXPERIMENTAL

Program A

Intervention Type PROCEDURE

Presentation of the sentence to the implant alone

Training B

Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates

Group Type EXPERIMENTAL

Program B

Intervention Type PROCEDURE

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

Control

Training in bilaterally postlingually-deafened adult cochlear implanted candidates

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

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

Interventions

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Program A

Presentation of the sentence to the implant alone

Intervention Type PROCEDURE

Program B

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

Intervention Type PROCEDURE

Control

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marx

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathieu MARX

Role: CONTACT

0561777704

Nadege ALGANS

Role: CONTACT

0561777204

Other Identifiers

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RC31/21/0125

Identifier Type: -

Identifier Source: org_study_id

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