Predictive Study on Hearing Rehabilitation After Cochlear Implant
NCT ID: NCT06086041
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2022-01-17
2025-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
NCT06420921
Telemonitoring in Cochlear Implant Patient Care
NCT05566353
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
NCT02904187
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
NCT06021132
Neuroplastic Changes Seen in Cochlear Implants With Preserved Hearing
NCT02407587
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
cochlear implant
cochlear implant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cochlear implant
cochlear implant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* IRM contraindications
* Patient opposed to the use of their data in the context of the research
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
raphaële QUATRE
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Grenoble University hospital
Grenoble, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Blamey P, Artieres F, Baskent D, Bergeron F, Beynon A, Burke E, Dillier N, Dowell R, Fraysse B, Gallego S, Govaerts PJ, Green K, Huber AM, Kleine-Punte A, Maat B, Marx M, Mawman D, Mosnier I, O'Connor AF, O'Leary S, Rousset A, Schauwers K, Skarzynski H, Skarzynski PH, Sterkers O, Terranti A, Truy E, Van de Heyning P, Venail F, Vincent C, Lazard DS. Factors affecting auditory performance of postlinguistically deaf adults using cochlear implants: an update with 2251 patients. Audiol Neurootol. 2013;18(1):36-47. doi: 10.1159/000343189. Epub 2012 Oct 19.
Attye A, Renard F, Baciu M, Roger E, Lamalle L, Dehail P, Cassoudesalle H, Calamante F. TractLearn: A geodesic learning framework for quantitative analysis of brain bundles. Neuroimage. 2021 Jun;233:117927. doi: 10.1016/j.neuroimage.2021.117927. Epub 2021 Mar 6.
Blamey PJ, Pyman BC, Gordon M, Clark GM, Brown AM, Dowell RC, Hollow RD. Factors predicting postoperative sentence scores in postlinguistically deaf adult cochlear implant patients. Ann Otol Rhinol Laryngol. 1992 Apr;101(4):342-8. doi: 10.1177/000348949210100410.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
38RC23.0020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.