Optimization of Hearing Performance in the Subject Implanted

NCT05325450 | Unknown

• 1 other identifier: RC31/21/0125
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

deafness, cochlear implant

Outcome Measures

Primary Outcomes (1)

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

  Month 12

Study Arms (3)

Training A

EXPERIMENTAL

Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates

Procedure: Program A

Training B

EXPERIMENTAL

Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates

Procedure: Program B

Control

ACTIVE COMPARATOR

Training in bilaterally postlingually-deafened adult cochlear implanted candidates

Procedure: Control

Interventions

Program A PROCEDURE

Presentation of the sentence to the implant alone

Training A

Program B PROCEDURE

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

Training B

Control PROCEDURE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Marx

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss; Deafness

Interventions

Medicare Part A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Medicare; Medical Assistance; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Insurance, Health; Insurance; Legislation as Topic; Social Control, Formal

Central Study Contacts

Mathieu MARX

CONTACT

0561777704; marx.m@chu-toulouse.fr

Nadege ALGANS

CONTACT

0561777204; algans.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: April 13, 2022
• Study Start: May 18, 2023
• Primary Completion: January 18, 2025
• Study Completion: January 18, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)