Optimizing Regulation of a Cochlear Implant in Patients W... | NCT03202797

Studies
Optimizing Regulation of a Cochlear Implant in Patients With Functional Contralateral Audition.

NCT03202797

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 6, 2026Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Functional Contralateral Audition
Cochlear Implant

Interventions

audiometric tests
Questionnaires
Settings of cochlear implants

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2017Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Jun 21, 2017

First Submission Date that Met QC Criteria

Jun 26, 2017

First Posted Date

Jun 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

360 million people in the world suffer from debilitating hearing deficiency. The cochlear implant is indicated in certain patients with severe profound deafness. The principle of the cochlear implant is to directly stimulate auditory nerve fibres by electrodes inserted in the cochlea. The steps in auditory rehabilitation are the surgical insertion of the cochlear implant, activation, and follow-up regulation. There is no formal consensus to define the exact modalities for regulation during activation or follow-up, but the principles are respected according to centres that regulate cochlear implant. Bimodal audition is the fact of having a cochlear implant and a contralateral hearing aid. In patients with cochlear implants, having binaural bimodal audition improves their auditory vocal performance in silence and in noisy environments. It needs to be considered when a second cochlear implant is not indicated for the contralateral ear. It has been shown that by allocating frequencies different from the default frequencies attributed by the manufacturer, intelligibility and perception of music are modified. The investigators therefore with to study this working hypothesis and to develop a simple protocol for the reallocation of frequencies in order to optimise auditory performance in the everyday lives of patients with implants by using an evolutionary algorithm.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients			Other: audiometric tests Other: Questionnaires Other: Settings of cochlear implants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
audiometric tests	Other	tone and speech audiometry	Patients
Questionnaires

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare the audiometric test performances (tone and speech audiometry) before and after the cochlear implant settings based on the evolutionary algorithm with a signal to noise ratio of +5dB		Baseline and 60 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have provided consent
Patients over 18 years old
Profound post-lingual deafness with a cochlear implant and a functional contralateral ear (normal audition or mild to severe deafness but with a hearing aid).
Patients fitted with one of the following cochlear implants with the most recent processor: Cochlear, Med-El, Neurelec Oticon or Advanced Bionics.
Patients with at least 6 months experience with the cochlear implant and using both aids for at least 6 hours per day.

Exclusion Criteria:

Persons without health insurance cover
Adults under guardianship
Pregnant or breast-feeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from Functional Contralateral Audition with Cochlear Implant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourgogne		Dijon		21000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35204015	Result	Saadoun A, Schein A, Pean V, Legrand P, Aho Glele LS, Bozorg Grayeli A. Frequency Fitting Optimization Using Evolutionary Algorithm in Cochlear Implant Users with Bimodal Binaural Hearing. Brain Sci. 2022 Feb 11;12(2):253. doi: 10.3390/brainsci12020253.

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms