Optimization of Hearing Performance in the Subject Implanted

Hearing Loss Clinical Trial

— OPERSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325450
• Other study ID #: RC31/21/0125
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: January 18, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Toulouse
• Contact: Mathieu MARX
• Phone: 0561777704
• Email: marx.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 18, 2025
• Est. primary completion date: January 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Procedure:
• Program A
Presentation of the sentence to the implant alone
• Program B
Presentation of the sentence to the implanted ear, associated for the non-implanted ear
• Control
Presentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time

Locations

Country	Name	City	State
France	Marx	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the percentage of correct speech recognition after training between the two training programs		Month 12