Sensorineural Hearing LossTIMAGINGNCT05402969
Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools
An observational study of Sensorineural Hearing Loss and Fibrosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Cochlear fibrosis development can compromise the success and the outcomes of the cochlear implantation (CI) thus affecting the quality of life of the implanted patient. Correlating the results of the Transimpedance Matrix (TIM) measurements to the implant electrode location determined by the Cone Beam Computer… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Sensorineural Hearing Loss, Fibrosis
- What is being tested?
- Transimedance Matrix measurements, Depth sounding and spectroscopy and Cone Beam Computer Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2023to 29 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 160 patients undergone CI more than 6 months ago will be enrolled during their routine checks-up at the University Hospital, Montpellier. This group will include 80 individuals with perimodiolar electrode (Contour Advanced or Slim Modiolar) and 80 individuals with lateral electrode (Slim Straight Array). 20 patients scheduled for CI will be enrolled during their pre-op appointment.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT
Cochlear fibrosis development can compromise the success and the outcomes of the cochlear implantation (CI) thus affecting the quality of life of the implanted patient. Correlating the results of the Transimpedance Matrix (TIM) measurements to the implant electrode location determined by the Cone Beam Computer Tomography (CBCT), this study aims to identify a range of TIM profiles within the implanted population, certain profiles suggesting the growth of the fibrosis tissue in cochlea
Read the detailed description
Fibrosis tissue growth after the CI is an inflammatory reaction to a foreign body occurring around the electrode array. It is considered responsible for a larger current diffusion, less precise stimulation of auditory nerve fibres and elevated electrical impedances thus affecting the functioning and the battery life of an implant. Fibrosis has been also proposed as a factor reducing residual hearing. Hence, its early detection and prevention can significantly improve the outcomes of CI.
To date, no reliable technique to visualise cochlear fibrosis in vivo exists. However, the TIM measurement developed by Cochlear® including depth sounding and spectroscopy tools could possibly provide a better "view" of the fibrosis apparition after CI. This approach has been already successfully applied in the University Hospital of Montpellier, France, to the patients-users of the Advanced Bionics cochlear implants.
One of the factors provoking the fibrosis tissue development is an electrode positioning into the scala vestibule (SV) versus scala tympani (ST). CBCT will be used to visualise the electrode location as well as possible damages of the inner ear caused by CI. The imaging data will be then linked to the TIM measurements results.
Potential participants will be recruited from the French population of the Cochlear® implant users either coming for their regular checks-up at the ENT service of the University Hospital of Montpellier and implanted for more than 6 month (time necessary for the fibrosis tissue to develop) or recently implanted at the same hospital.
For the patients with long-term implantation (160 participants planned) the TIM measurements will be performed only once whereas the newly implanted group (20 participants planned) will require these measurements to be repeated several times: on the day of the surgery as well as 15 days, 1 month, 2 months, 3 months and 6 months after it. For the first group the post operational CBCT imaging file will be extracted from the patient medical record; for the second group CBCT will be performed during the surgery.
The main objective of this study is:
For the group with long-term implantation - to show the difference in TIM profiles according to the electrode scala position (ST or SV) determined by CBCT 6 months or more after the implantation For the group with recent implantation - to evaluate the changes in TIM profiles with time according to the electrode scala position (ST or SV) determined by CBCT
The secondary objectives are common for both groups:
- To analyse various patient subgroups defined by the electrode type (Contour Advanced - only for long-term implantation, Slim Straight, Slim Modiolar) and the inner ear access (round window, enlarged round window or cochleostomy)
- To identify the TIM profile threshold values, potential indicators of the cochlear fibrosis apparition, depending on the electrode type
- To evaluate the depth sounding tool accuracy for the measurement of the distance between the electrode and the spiral ganglion in comparison to CBCT depending on the type of the electrode array.
- To evaluate the spectroscopy tool accuracy for fibrosis detection in specific cochlear areas (around electrodes dislocated to SV or basal electrodes in case of cohleostomy)
- Conditions
- Sensorineural Hearing Loss, Fibrosis
- Being tested
- Transimedance Matrix measurements, Depth sounding and spectroscopy, Cone Beam Computer Tomography
- Keywords
- Cochlear implantation, Cochlear fibrosis, Transimpedance matrix measurement, Cochlear implant
- Medical subject headings
- Hearing Loss, Sensorineural, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transimedance Matrix measurementsProcedure or surgery
Also called TIM measurements
TIM measurements are based on cochlear implant back-telemetry function. Each electrode contact is stimulated in monopolar mode. Transimpedance is represented by the ratio between the voltage measured at each recording electrode and the current injected at the stimulation contact. The result of the measurements is a matrix of 21x21 transimpedances. Stimulation current cannot be perceived by a patient thus making TIM measurements a non-invasive and painless procedure. The test duration is only 2-3 minutes
Depth sounding and spectroscopyProcedure or surgery
Depth sounding and spectroscopy are based on the matrixes obtained after TIM imaging. Deep sounding measures the capacitances throughout the electrode array whereas spectroscopy determines the phase of every transimpedance value. These tests take 10 to 15 minutes together. The stimulation intensity used by depth sounding technique can be perceived by a patient. If it is considered as unpleasant, the test will be stopped.
Cone Beam Computer TomographyProcedure or surgery
Also called CBCT
CBCT is a routine postoperative assessment after CI, non-invasive and painless for patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients with long-term implantation | Patients undergone CI more than 6 months ago. After the study is presented to the patient and the egligibility criterias are verified, the patient is proposed to sign a consent form (visit 0). Once the consent form is signed, the visit 1 is scheduled (0 to 90 days after the visit 0). During the visit 1 TIM measurements are performed, including depth sounding and spectroscopy, and adversed affects if any are collected. Receives: Procedure: Transimedance Matrix measurements; Procedure: Depth sounding and spectroscopy; Procedure: Cone Beam Computer Tomography | |
| Recently implanted patients | Patients enrolled at their pre-op appointments (visit 0 - egligibilty criterias are verified and the consent collected). Visit 1 (0 to 90 days after visit 0) is a surgery. TIM measurements, icluding deep sound and spectroscopy, are performed after the CI and all adverse events are noted. CBCT is routinely done the next day after CI. TIM measurements (as well as adverse event collection) are repeated during visits 2, 3, 4, 5 and 6 (appoitments 15 days, 1, 2, 3 and 6 months after the surgery). Receives: Procedure: Transimedance Matrix measurements; Procedure: Depth sounding and spectroscopy; Procedure: Cone Beam Computer Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIM profiles in patients with long-term implantation
Comparison of TIM profiles of patients with ST electrode position versus patients with SV electrode dislocateon in the long-term implantation group
Measured: Visit 1 (0 to 90 days after inclusion)
TIM profiles time dynamics in the recently implanted patients
Assessment of the TIM profile changes with time and depending on electrode scala position in newly-implanted patients
Measured: Visit 1 - surgery (0 to 90 days after inclusion), visit 3, 4, 5, 6 (1, 2, 3 and 6 months after surgery)
Secondary outcomes (3)
TIM profiles depending on electrode array and inner ear access
Comparison of the TIM profiles depending on the electrode array type and inner ear access
Measured: Visit 1 (0 to 90 days after inclusion)
Depth sounding versus the distance electrode - spiral ganglion
Correlation of the depth sounding measures with the electrode-spiral ganglion distance assesed through CBCT imaging
Measured: Visit 1 (0 to 90 days after inclusion)
Spectroscopy of the specific electrode insertion zones
Comparison of the spectroscopy measures in the specific zones prone to electrode insertion damages (180° turn and basal part) between groups with ST electrode positioning and SV electrode dislocation
Measured: Visit 1 (0 to 90 days after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start6 Jan 2023
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402969
- Sponsor's protocol ID
- RECHMPL20_0666
- Acronym
- TIMAGING
- Status last verified
- Jul 2026
- First submitted
- 23 May 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT
- ClinicalTrials.gov ID
- NCT05402969
- Acronym / sponsor ID
- TIMAGING / RECHMPL20_0666
- Conditions
- Sensorineural Hearing Loss, Fibrosis
- Keywords
- Cochlear implantation, Cochlear fibrosis, Transimpedance matrix measurement, Cochlear implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cochlear fibrosis development can compromise the success and the outcomes of the cochlear implantation (CI) thus affecting the quality of life of the implanted patient. Correlating the results of the Transimpedance Matrix (TIM) measurements to the implant electrode location determined by the Cone Beam Computer Tomography (CBCT), this study aims to identify a range of TIM profiles within the implanted population, certain profiles suggesting the growth of the fibrosis tissue in cochlea
Detailed description
Fibrosis tissue growth after the CI is an inflammatory reaction to a foreign body occurring around the electrode array. It is considered responsible for a larger current diffusion, less precise stimulation of auditory nerve fibres and elevated electrical impedances thus affecting the functioning and the battery life of an implant. Fibrosis has been also proposed as a factor reducing residual hearing. Hence, its early detection and prevention can significantly improve the outcomes of CI.
To date, no reliable technique to visualise cochlear fibrosis in vivo exists. However, the TIM measurement developed by Cochlear® including depth sounding and spectroscopy tools could possibly provide a better "view" of the fibrosis apparition after CI. This approach has been already successfully applied in the University Hospital of Montpellier, France, to the patients-users of the Advanced Bionics cochlear implants.
One of the factors provoking the fibrosis tissue development is an electrode positioning into the scala vestibule (SV) versus scala tympani (ST). CBCT will be used to visualise the electrode location as well as possible damages of the inner ear caused by CI. The imaging data will be then linked to the TIM measurements results.
Potential participants will be recruited from the French population of the Cochlear® implant users either coming for their regular checks-up at the ENT service of the University Hospital of Montpellier and implanted for more than 6 month (time necessary for the fibrosis tissue to develop) or recently implanted at the same hospital.
For the patients with long-term implantation (160 participants planned) the TIM measurements will be performed only once whereas the newly implanted group (20 participants planned) will require these measurements to be repeated several times: on the day of the surgery as well as 15 days, 1 month, 2 months, 3 months and 6 months after it. For the first group the post operational CBCT imaging file will be extracted from the patient medical record; for the second group CBCT will be performed during the surgery.
The main objective of this study is:
For the group with long-term implantation - to show the difference in TIM profiles according to the electrode scala position (ST or SV) determined by CBCT 6 months or more after the implantation For the group with recent implantation - to evaluate the changes in TIM profiles with time according to the electrode scala position (ST or SV) determined by CBCT
The secondary objectives are common for both groups:
- To analyse various patient subgroups defined by the electrode type (Contour Advanced - only for long-term implantation, Slim Straight, Slim Modiolar) and the inner ear access (round window, enlarged round window or cochleostomy)
- To identify the TIM profile threshold values, potential indicators of the cochlear fibrosis apparition, depending on the electrode type
- To evaluate the depth sounding tool accuracy for the measurement of the distance between the electrode and the spiral ganglion in comparison to CBCT depending on the type of the electrode array.
- To evaluate the spectroscopy tool accuracy for fibrosis detection in specific cochlear areas (around electrodes dislocated to SV or basal electrodes in case of cohleostomy)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with long-term implantation | – | Procedure: Transimedance Matrix measurements, Procedure: Depth sounding and spectroscopy, Procedure: Cone Beam Computer TomographyPatients undergone CI more than 6 months ago. After the study is presented to the patient and the egligibility criterias are verified, the patient is proposed to sign a consent form (visit 0). Once the consent form is signed, the visit 1 is scheduled (0 to 90 days after the visit 0). During the visit 1 TIM measurements are performed, including depth sounding and spectroscopy, and adversed affects if any are collected. |
| Recently implanted patients | – | Procedure: Transimedance Matrix measurements, Procedure: Depth sounding and spectroscopy, Procedure: Cone Beam Computer TomographyPatients enrolled at their pre-op appointments (visit 0 - egligibilty criterias are verified and the consent collected). Visit 1 (0 to 90 days after visit 0) is a surgery. TIM measurements, icluding deep sound and spectroscopy, are performed after the CI and all adverse events are noted. CBCT is routinely done the next day after CI. TIM measurements (as well as adverse event collection) are repeated during visits 2, 3, 4, 5 and 6 (appoitments 15 days, 1, 2, 3 and 6 months after the surgery). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 160 patients undergone CI more than 6 months ago will be enrolled during their routine checks-up at the University Hospital, Montpellier. This group will include 80 individuals with perimodiolar electrode (Contour Advanced or Slim Modiolar) and 80 individuals with lateral electrode (Slim Straight Array). 20 patients scheduled for CI will be enrolled during their pre-op appointment.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transimedance Matrix measurementsAlso: TIM measurementsTIM measurements are based on cochlear implant back-telemetry function. Each electrode contact is stimulated in monopolar mode. Transimpedance is represented by the ratio between the voltage measured at each recording electrode and the current injected at the stimulation contact. The result of the measurements is a matrix of 21x21 transimpedances. Stimulation current cannot be perceived by a patient thus making TIM measurements a non-invasive and painless procedure. The test duration is only 2-3 minutes | Procedure or surgery | Patients with long-term implantation, Recently implanted patients |
| Depth sounding and spectroscopyDepth sounding and spectroscopy are based on the matrixes obtained after TIM imaging. Deep sounding measures the capacitances throughout the electrode array whereas spectroscopy determines the phase of every transimpedance value. These tests take 10 to 15 minutes together. The stimulation intensity used by depth sounding technique can be perceived by a patient. If it is considered as unpleasant, the test will be stopped. | Procedure or surgery | Patients with long-term implantation, Recently implanted patients |
| Cone Beam Computer TomographyAlso: CBCTCBCT is a routine postoperative assessment after CI, non-invasive and painless for patients. | Procedure or surgery | Patients with long-term implantation, Recently implanted patients |
Primary outcome
TIM profiles in patients with long-term implantation
Time frame: Visit 1 (0 to 90 days after inclusion)
Comparison of TIM profiles of patients with ST electrode position versus patients with SV electrode dislocateon in the long-term implantation group
TIM profiles time dynamics in the recently implanted patients
Time frame: Visit 1 - surgery (0 to 90 days after inclusion), visit 3, 4, 5, 6 (1, 2, 3 and 6 months after surgery)
Assessment of the TIM profile changes with time and depending on electrode scala position in newly-implanted patients
3 secondary outcomes
TIM profiles depending on electrode array and inner ear access
Time frame: Visit 1 (0 to 90 days after inclusion)
Depth sounding versus the distance electrode - spiral ganglion
Time frame: Visit 1 (0 to 90 days after inclusion)
Spectroscopy of the specific electrode insertion zones
Time frame: Visit 1 (0 to 90 days after inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss and Fibrosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIM profiles in patients with long-term implantation (time frame: Visit 1 (0 to 90 days after inclusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.