Hearing LossOPERSANCT05325450
Optimization of Hearing Performance in the Subject Implanted
A study testing Program A and Program B in people with Hearing Loss, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Program A and Program B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2023to 18 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimization of Hearing Performance in the Subject Implanted With Profound Asymmetric Deafness
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
- Being tested
- Program A, Program B, Control
- Keywords
- deafness, cochlear implant
- Medical subject headings
- Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program AProcedure or surgery
Presentation of the sentence to the implant alone
Program BProcedure or surgery
Presentation of the sentence to the implanted ear, associated for the non-implanted ear
ControlProcedure or surgery
Presentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time
| Study group | Role | What they receive |
|---|---|---|
| Training A | Experimental | Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates Receives: Procedure: Program A |
| Training B | Experimental | Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates Receives: Procedure: Program B |
| Control | Active comparator | Training in bilaterally postlingually-deafened adult cochlear implanted candidates Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the percentage of correct speech recognition after training between the two training programs
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start18 May 2023
- Primary completion18 Jan 2027 (estimated)
- Study completion18 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325450
- Sponsor's protocol ID
- RC31/21/0125
- Acronym
- OPERSA
- Status last verified
- Sep 2026
- First submitted
- 1 Mar 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Hearing Performance in the Subject Implanted With Profound Asymmetric Deafness
- ClinicalTrials.gov ID
- NCT05325450
- Acronym / sponsor ID
- OPERSA / RC31/21/0125
- Conditions
- Hearing Loss
- Keywords
- deafness, cochlear implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 18 May 2023 (actual)
- Primary completion
- 18 Jan 2027 (estimated)
- Study completion
- 18 Jan 2027 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Training A | Experimental | Procedure: Program ATraining A in Unilaterally postlingually-deafened adult cochlear implanted candidates |
| Training B | Experimental | Procedure: Program BTraining B in Unilaterally postlingually-deafened adult cochlear implanted candidates |
| Control | Active comparator | Procedure: ControlTraining in bilaterally postlingually-deafened adult cochlear implanted candidates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program APresentation of the sentence to the implant alone | Procedure or surgery | Training A |
| Program BPresentation of the sentence to the implanted ear, associated for the non-implanted ear | Procedure or surgery | Training B |
| ControlPresentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time | Procedure or surgery | Control |
Primary outcome
The primary outcome is the percentage of correct speech recognition after training between the two training programs
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program A and Program B in people with Hearing Loss, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu MARX (0561777704, marx.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the percentage of correct speech recognition after training between the two training programs (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.