Optimization of Hearing Performance in the Subject Implanted

Not Applicable

Recruiting

• Conditions: Hearing Loss
• Interventions: Procedure: Program B; Procedure: Control; Procedure: Program A

• Registration Number: NCT05325450
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-13
• Study Start: 2023-05-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24
• Primary Completion: 2025-01-18
• Study Completion: 2025-01-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Training B	Program B	Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates
Control	Control	Training in bilaterally postlingually-deafened adult cochlear implanted candidates
Training A	Program A	Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates

Primary Outcome Measures

Name	Time	Method
The primary outcome is the percentage of correct speech recognition after training between the two training programs	Month 12

Trial Locations

Locations (1)

Marx; 🇫🇷 Toulouse, France