Optimization of Hearing Performance in the Subject Implanted
ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
- 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 design
Design model
Crossover
Treatments tested in this trial
Program A
Procedure/SurgeryPresentation of the sentence to the implant alone
Program B
Procedure/SurgeryPresentation of the sentence to the implanted ear, associated for the non-implanted ear
Control
Procedure/SurgeryPresentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Training AExperimental treatment 1 intervention
Group B: Training BExperimental treatment 1 intervention
Group C: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The primary outcome is the percentage of correct speech recognition after training between the two training programs
Time frame
Month 12Sponsors and contacts
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University Hospital, Toulouse
Lead sponsor
Centre National de la Recherche Scientifique, France
Collaborator
Source ClinicalTrials.gov