Back to resultsOptimization of Hearing Performance in the Subject Implanted (OPERSA)
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Program A
Program B
Control
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring deafness, cochlear implant
Eligibility Criteria
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
Sites / Locations
- MarxRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Training A
Training B
Control
Arm Description
Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates
Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates
Training in bilaterally postlingually-deafened adult cochlear implanted candidates
Outcomes
Primary Outcome Measures
The primary outcome is the percentage of correct speech recognition after training between the two training programs
Secondary Outcome Measures
Full Information
NCT ID
NCT05325450
First Posted
March 1, 2022
Last Updated
August 22, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France
1. Study Identification
Unique Protocol Identification Number
NCT05325450
Brief Title
Optimization of Hearing Performance in the Subject Implanted
Acronym
OPERSA
Official Title
Optimization of Hearing Performance in the Subject Implanted With Profound Asymmetric Deafness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
January 18, 2025 (Anticipated)
Study Completion Date
January 18, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
deafness, cochlear implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training A
Arm Type
Experimental
Arm Description
Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates
Arm Title
Training B
Arm Type
Experimental
Arm Description
Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Training in bilaterally postlingually-deafened adult cochlear implanted candidates
Intervention Type
Procedure
Intervention Name(s)
Program A
Intervention Description
Presentation of the sentence to the implant alone
Intervention Type
Procedure
Intervention Name(s)
Program B
Intervention Description
Presentation of the sentence to the implanted ear, associated for the non-implanted ear
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Presentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time
Primary Outcome Measure Information:
Title
The primary outcome is the percentage of correct speech recognition after training between the two training programs
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu MARX
Phone
0561777704
Email
marx.m@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nadege ALGANS
Phone
0561777204
Email
algans.n@chu-toulouse.fr
Facility Information:
Facility Name
Marx
City
Toulouse
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimization of Hearing Performance in the Subject Implanted
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