Predictive Study on Hearing Rehabilitation After Cochlear Implant

October 10, 2023 updated by: University Hospital, Grenoble

Predictive Factors of Hearing Rehabilitation After Cochlear Implant Surgery in Deaf Patients

The aim of this study is to display the predictive factors of hearing rehabilitation after cochlear implant surgery in severely to profoundly deaf adults.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cochlear implants are indicated in France in cases of severe to profound bilateral sensorineural hearing loss with an audiometric threshold of less than or equal to 50% speech discrimination in silence in the Fournier list (or equivalent) at 60 dB, in the free field, with well-fitted hearing aids. Cochlear implant represents a major advance in the management of severe to profoundly deaf patients and has also shown a benefit in the prevention of neurodegenerative diseases.

An average of 1800 cochlear implants are placed in France per year, 58% of which are placed in patients over 18 years of age.

The results of cochlear implants are in favour of a benefit in speech comprehension compared to hearing aids in cases of severe to profound deafness. However, there is a strong disparity in hearing performance after cochlear implantation from one patient to another, whether in silence or in noise.

Several factors influencing the results of the implant have been identified. Some of them are linked to the patient: etiology of the deafness, duration of auditory deprivation, age at implantation, residual hearing, pre- or post-lingual status of the deafness, some others are related to implant surgery (insertion of the electrode in the tympanic ramp, complete insertion, presence of a translocation, depth of electrode insertion).

Finally, there are factors related to the quality of the settings of the implant and to the brain plasticity of the patients.The 4 main factors seem to be the duration of the deafness, the age of onset of the deafness, its etiology and the duration of the patient's experience with the implant. It is assumed that the performance of cochlear implantation is strongly related to the individual's auditory processing abilities and the integrity of the central nervous system from the auditory nerve to the cortex.

At present, it is very difficult to predict the outcome of cochlear implants in deaf patients with a cochlear implant indication prior to implantation. The results remain variable from one patient to another and, to date, both the etiology and the state of the central auditory pathways are not taken into account in the indication for cochlear implantation. Animal studies have demonstrated anterograde degenerative neural damage in cochlear deafness (presbycusis, endolymphatic hydrops) and such damage is likely to explain the functional variability observed in humans in the case of neural stimulation with cochlear implants. Multiple integration of clinical data to propose a predictive model can now be done using both supervised (Deep Learning) and unsupervised (Manifold Learning) Machine Learning techniques, including for predicting auditory recovery. It is now possible to extend machine learning models to include quantitative data from diffusion MRI with the goal of providing an objective functional parameter from the central auditory pathways, then combined with clinical parameters and genetic to obtain a predictive model of hearing recovery after cochlear implantation. This study will allow us, through the study of brain tractography, to specify the role of the central auditory pathways in the results of cochlear implantation, a role that has not been determined to date, and to evaluate their correlation with clinical and genetic in order to create a predictive model of good auditory rehabilitation in artificial intelligence. The objective is to better select patients who can benefit from a cochlear implant in order to implant them in an optimal timing and to improve indications for cochlear implant.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Severely to profoundly deaf patients consulting in Grenoble University Hospital with cochlear implantation indication.

Description

Inclusion Criteria:

Patient severely to profoundly deafed according French National Authority for Health (HAS) recommendations followed in Grenoble University Hospital.

Exclusion Criteria:

  • cochlear malformation making impossible the cochlear implantation
  • IRM contraindications
  • Patient opposed to the use of their data in the context of the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
severely to profoundly deaf patients with cochlear implantation indication

Severely to profoundly deaf patients consulting in Grenoble University Hospital with cochlear implantation indication.

Patients are followed according to current care during 1 year after cochlear implantation.
Procedure: cochlear implant
cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of the predictive factors of hearing rehabilitation after cochlear implantation in severely to profoundly deaf adults.
Time Frame: 1 year post-surgery
Correlation between a diffusion MRI biomarker extracted from preoperative brain tractography (fractional anisotropy) and the postoperative hearing performance in silence and noise after cochlear implantation.
1 year post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the correlation between several predictive factors like clinical parameters, genetics ... with the MRI biomarker.
Time Frame: 3 months, 6 months and 1 year post-surgery.
Correlation between clinical predictive factors (age, age at onset of deafness , etiology and genetic) and the postoperative hearing performance in silence and noise after cochlear implantation.
3 months, 6 months and 1 year post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: raphaële QUATRE, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC23.0020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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