ClinicalTrials.gg
RecruitingNCT05325450OPERSAUpdated Sep 21, 2026

Optimization of Hearing Performance in the Subject Implanted

An interventional study of Program A and Program B in Hearing Loss, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Primary conditionDeafnessRegistry: Hearing LossReclassifiedWhy we changed it
Registry
Hearing Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Deafness
Why
  1. The study's title name Deafness, a narrower term within Hearing Loss.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hearing Loss

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Keywords

  • deafness, cochlear implant
03

In context

Deafness Reclassified

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's planned enrollment of 50 is above the median of 43 across 106 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Compared within Deafness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Training A

    Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates

    Procedure: Program A

  • Experimental
    Training B

    Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates

    Procedure: Program B

  • Active comparator
    Control

    Training in bilaterally postlingually-deafened adult cochlear implanted candidates

    Procedure: Control

Interventions

  • ProcedureProgram A

    Presentation of the sentence to the implant alone

  • ProcedureProgram B

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

  • ProcedureControl

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

06

What researchers measure

Primary outcomes

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

    Time frame: Month 12

07

Study locations

1 of 1 sites recruiting
  • Marx
    Toulouse, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Jan 2027, 44 months after the start.

Of 50 non-industry interventional studies with no phase under Deafness, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20. This study's planned 44 months is close to that.

Counting every sponsor, half of 58 studies reached it within 31 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2022
First posted
Apr 13, 2022
StartActual
May 18, 2023
Primary completionEst.
Jan 18, 2027
CompletionEst.
Jan 18, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05325450
Collaborators
Centre National de la Recherche Scientifique, France
Responsible party
Sponsor
First posted
Apr 13, 2022
Start date
May 18, 2023
Primary completion
Jan 18, 2027 (estimated)
Completion
Jan 18, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Mathieu MARX
Contact
marx.m@chu-toulouse.fr
0561777704
Nadege ALGANS
Contact
algans.n@chu-toulouse.fr
0561777204

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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