Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm. (Algo Fréq)
Primary Purpose
Profound Deafness
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaires
Evolutionary algorithm
Sponsored by
About this trial
This is an interventional other trial for Profound Deafness
Eligibility Criteria
Inclusion Criteria:
- Person having given his or her non-opposition
- Implanted post lingual profound deafness and one functional contralateral ear (normal hearing or mild to severe hearing loss with hearing aids)
- Have more than 6 months of experience with cochlear implants
- Daily use of their two hearing aids for more than 6 hours a day
Exclusion Criteria:
- person subject to a legal protection measure (guardianship, tutorship)
- person subject to a measure of judicial control
- pregnant, parturient or breastfeeding woman
- adult unable to express consent
- minor
Sites / Locations
- Chu Dijon Bourgogne
Outcomes
Primary Outcome Measures
percentage of words recognized
Measurement of intelligibility in noise in bimodal situations
Secondary Outcome Measures
Full Information
NCT ID
NCT04888143
First Posted
May 11, 2021
Last Updated
November 24, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT04888143
Brief Title
Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.
Acronym
Algo Fréq
Official Title
Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
November 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have profound or total impairment.
Cochlear implants are indicated in severe to profound deafness in some cases. The principle of the cochlear implant is to directly stimulate the fibres of the auditory nerve via electrodes inserted into the cochlea. It stimulates the auditory nerve and sends electrical impulses to the brain where they are interpreted as sounds.
The steps in hearing rehabilitation are surgical placement of the cochlear implant, activation, and follow-up adjustments.
There is no formal consensus on the exact adjustment procedures during activation or follow-up, but principles are followed depending on the cochlear implant adjustment centers (jack). All centers focus on sound intensity adjustments to achieve the goals of tonal audiometry in open-field silence with cochlear implant alone between 20 and 40 db (30 db most frequently). However, it is common practice to observe that this means of assessment does not really represent the performance of the individual because hearing a sound does not mean that someone will be able to recognize it and interpret it. Some of the patients who achieve these goals have difficulty hearing well in a noisy environment. Speech audiometry in silence and especially in noise would be a better reflection of patient needs.
Bimodal hearing is having a cochlear implant and a contralateral hearing aid. In cochlear implants, having bimodal binaural hearing improves the patients ability to understand speech in silent and noisy contexts. It should thus be considered when a second cochlear implant is not indicated in the contralateral ear.
It has been shown that intelligibility and musical perception are altered when the frequency allocations are different from the manufacturer's default frequency allocations. The possible redundancy between the acoustic and electrical information on the contralateral ear can lead to metallic distortion of the voice, which is perceived as less natural. This is due to a different stimulation of the cochlear tonotopic zones concerning conversational frequencies, between the implanted side and the device side. However, the frequency distribution is not subject to adjustment in current practice. A modification of the frequency distribution is possible on cochlear implants, which could improve the intelligibility and comfort of the implanted patient.
This working hypothesis will be studied, and a simple protocol for frequency reallocation of the cochlear implant will be developed to optimize the daily hearing performance of the implanted patients. An evolutionary algorithm will be used. The search for new adjustment solutions will be carried out within the safety limits imposed by the adjusters (detection and comfort loudness threshold).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Profound Deafness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
questionnaires
Intervention Description
evaluation of hearing performance and quality of life questionnaires
Intervention Type
Other
Intervention Name(s)
Evolutionary algorithm
Intervention Description
application of the evolutionary algorithm and customized frequency allocation on a separate program.
Primary Outcome Measure Information:
Title
percentage of words recognized
Description
Measurement of intelligibility in noise in bimodal situations
Time Frame
Through study completion, an average of 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Person having given his or her non-opposition
Implanted post lingual profound deafness and one functional contralateral ear (normal hearing or mild to severe hearing loss with hearing aids)
Have more than 6 months of experience with cochlear implants
Daily use of their two hearing aids for more than 6 hours a day
Exclusion Criteria:
person subject to a legal protection measure (guardianship, tutorship)
person subject to a measure of judicial control
pregnant, parturient or breastfeeding woman
adult unable to express consent
minor
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.
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