Evaluating cochlear fibrosis and electrode placement in hearing loss patients
Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT
University Hospital, Montpellier · NCT05402969
This study is trying to see if the way cochlear implant electrodes are placed affects the growth of scar tissue in the ear, which could help improve hearing for people who have had implants for over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05402969 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between electrode positioning in cochlear implants and the development of cochlear fibrosis, which can negatively impact hearing outcomes. By utilizing Transimpedance Matrix (TIM) measurements alongside Cone Beam Computer Tomography (CBCT), researchers will identify specific TIM profiles that may indicate fibrosis growth. Participants will include cochlear implant users from the University Hospital of Montpellier, with a focus on those who have been implanted for over six months. The study seeks to improve early detection and prevention of fibrosis to enhance cochlear implant performance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been using cochlear implants for more than six months and have available post-operation CBCT imaging results.
Not a fit: Patients who have not been using their cochlear implants regularly or those with implant dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for cochlear implant patients by enabling early detection and management of cochlear fibrosis.
How similar studies have performed: This approach has shown success in previous applications at the University Hospital of Montpellier, indicating potential for effective outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Group with long-term implantation: * Age18 years or older * Affiliation to the French social security * Signed and dated informed consent form * Users of uni or bilateral cochlear implants for more than 6 months (CI24CA, CI422, CI512, CI522, CI532, CI612; CI622; CI632), in primo-implantation or reimplantation, with more than 18 electrodes active * Postoperation CBCT imaging results available Recently-implanted group: * Age18 years or older * Affiliation to the French social security * Signed and dated informed consent form * Indication for CI622 or CI632 cochlear implants * Postoperation CBCT imaging results available Exclusion Criteria: * Vulnerable individuals (minors, adults protected in accordance to the French Public Health code, patients deprived of liberty by court decision) * Daily usage of the cochlear implant for less than 4 hours or weekly usage for less than 5 days * Failure or disfunction of the cochlear implant
Where this trial is running
Montpellier
- University Hospital Montpellier — Montpellier, France (RECRUITING)
Study contacts
- Study coordinator: Venail Frederic, MD, PhD
- Email: f-venail@chu-montpellier.fr
- Phone: +33467336890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sensorineural Hearing Loss, Fibrosis, Cochlear implantation, Cochlear fibrosis, Transimpedance matrix measurement, Cochlear implant