Sensorineural Hearing LossPERILOTONCT05670158
Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss
A study testing Blood sampling and Perilymph sampling in people with Sensorineural Hearing Loss, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- Blood sampling and Perilymph sampling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or more
- Indication for the cochlear implantation surgery according to the criteria of French National Authority for Health (Severe to profound sensorineural deafness with indication for cochlear implant surgery: Intelligibility less than or equal to 50% when performing vocal audiometry tests with Fournier's list in free field with recent devices.)
- Presence of "useful" residual hearing ≤ 80 dB on at least 2 consecutive frequencies (in air conduction) from the range 125, 250, 500, 1000 kHz on pure-tone audiometry
- Patients given their free and informed written consent
- Patients affiliated to a French social security system
- Patients aged 18 years or more
Show all 10Show fewer
- Indication for otological surgery of the middle ear (excluding active infectious or inflammatory pathology e.g. myringoplasty, ossiculoplasty, cure for otosclerosis)
- Normal hearing (non affected inner ear): average hearing loss (mean threshold for the frequencies 500, 1000, 2000, 4000 Hz) ≤ 35 dB in bone conduction
- Patients given their free and informed written consent
- Patients affiliated to a French social security system
Who cannot join
- Contraindication to surgery detected during the preoperative assessment
- Pre-implantation cochlear assessment unfavorable to the implantation surgery
- Absence of residual hearing shown by preoperative audiometry
- History of bacterial labyrinthitis or bacterial meningitis
- Cochlear ossification shown on preoperative imaging
- Homozygous pathogenic mutations identified by molecular diagnosis of the SCL26A5 (prestin), TECTB (Beta-Tectorin) genes, and heterozygous of the COCH gene (Cochlin) prior to implantation (if available)
Show all 17Show fewer
- Vulnerable subject: minors, protected adults as defined by the Public Health Code, pregnant or breastfeeding women, subject under guardianship or subject deprived of liberty
- Participation in another pharmacological therapeutic interventional clinical research
- Contraindication to surgery detected during the preoperative assessment
- Fluctuating hearing = fluctuating hearing thresholds on at least one ear (shown by past bone conduction pure-tone audiometries)
- History of bacterial labyrinthitis or bacterial meningitis
- Middle ear infection or inflammation on the day of the surgery
- Chronical immune or inflammatory disease
- Active viral or bacterial infection on the day of inclusion visit or surgery
- Fever on the day of the first blood sample
- Vulnerable subject: minors, protected adults as defined by the Public Health Code, pregnant or breastfeeding women, subject under guardianship or subject deprived of liberty
- Participation in another pharmacological therapeutic interventional clinical research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
Akil KARDEBAY, MD, +33467336890, a-kaderbay@chu-montpellier.fr
About this study
Official title: Study on the Inner Ear Immunisation Post-cohlear Implantation and Perilymph Molecular Profiling in Sensorineural Hearing Loss
Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation. Although the mechanisms involved in the residual audition loss remain unknown, animal experiments suggest the role of inflammatory or immune reaction in the cochlea. The goal of this project is to search in the perilymph (a fluid which fills the scala vestibuli and scala tympani of the cochlea) some predictive biomarkers of the residual hearing loss using modern proteomics and immunological techniques. A parallel search for blood biomarkers of post-implantation residual hearing loss and for molecular and cellular evidences of immune response to cochlear implantation will be performed.
The study will recruit 50 subjects-candidates for cochlear implantation surgery; 30 normally hearing individuals eligible for other types of otological interventions will form a control group. For all the participants blood samples will be collected and preserved. In addition, the perilymph sampling will be performed during cochlear implantation surgery.
Read more
This project relies on the calculation that from 50 patients post-cochlear implantation, 15 patients will form a group with maintained residual hearing and 15 will display delayed hearing loss. For these 30 subjects together with the control group the blood biomarkers search will be performed.
For the group of implanted patients, the follow-up will last for 12 months with 6 visits in total :
- the inclusion visit V0 during which the study will be presented and the consent form will be signed
- the surgery visit V1 with blood sample and perilymph collection
- the activation visit V2, 1 month ± 1 week after V1, visit V3 3 months ± 7 days after V1, V4 6 months ± 7 days after V1, V5 12 months ± 1 month after V1. During each of this visit blood sampling will be performed.
For the control group, the follow up will be 6 months long with 4 visits in total arranged during the routine follow-up appointments:
- the inclusion visit V0 during which the study will be presented and the consent form will be signed
- the surgery visit V1, the 1 month visit V2 and the 6 months visit V3 during which the blood sampling will be performed.
Read the detailed description
With the progress of technologies and surgical methods, cochlear implantation, initially proposed only to patients with completely non-functional inner ear, can be now performed on individuals with still some measurable hearing left in some frequencies. Such patients can additionally benefit from a special treatment by electric-acoustic stimulation (EAS). Combining the electric stimulation with cochlear implant (CI) and acoustic amplification of residual hearing using a conventional hearing aid (HA) can drastically improve one's quality of life and ameliorate the performance in noisy environment as well as music perception.
Since the main condition for EAS is the residual hearing preservation, it is important to understand the reasons of its loss post-cochlear implantation. This loss can occur in 2 periods:
- Early after surgery (˂ 1 month): mainly due to the trauma from electrode insertion. This risk decreases with the development of surgical techniques. Another possible reason is early inflammation processes in the cochleae.
- Later after surgery (˃ 1 month): occurs mainly about 3 months post-implantation in 30-40 % of patients. This loss is the main reason for dropping out the EAS leaving the patient to rely on CI only.
Animal studies suggest that the delayed residual hearing loss might happen as consequence of cochlear fibrosis development, supposedly due to the inflammation and foreign body response to the CI materials within the cochlea. In its natural state, the cochlea does not contain any immune cells and is well protected from immune stimulation by infectious agents. Cochlear implantation, however, provides a single clinical cause for infectious or autoimmune fibrosis. Such immune response might be provoked by autoantigens against cochlear proteins like Cochline or TectB. This study aims to search blood markers of immunisation against inner ear proteins after cochlear implantation. Another goal is to seek potential biomarkers of delayed residual hearing loss directly in perilymph. Proteomic analysis will be performed using Liquid Chromatography - High Resolution Mass Spectroscopy (HRMS) technique.
The main objective of this study is
- to identify, in the perilymph of implanted patients, biomarkers predictive of the delayed residual hearing loss
- to identify blood biomarkers predictive of delayed residual hearing loss in implanted patients
The secondary objectives are
- to describe qualitatively and quantitatively the time evolution for blood biomarkers of interest after cochlear implantation
- to correlate quantitative values of identified biomarkers with clinical data of implanted patients
- to identify perilymph and blood biomarkers of early residual hearing loss post-cochlear implantation
- depending on molecular profiles identified, to study metabolic pathways and mechanisms involved in delayed residual hearing loss post-cochlear implantation
- to seek for blood indicators in favour of anti-cochlear immunisation through screening for peripheral blood mononuclear cells (PBMC)
- to create a bio collection of human perilymph and blood serum biobank of cochlear implants users for future proteomics/molecular studies
- Conditions
- Sensorineural Hearing Loss
- Being tested
- Blood sampling, Perilymph sampling
- Keywords
- Perilymph, Proteomics, Metabolomics, Sensorineural hearing loss, Residual hearing, Cochlear implantation
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood will be collected into 2 EDTA and 1 heparin tube. The 2 EDTA tubes (4ml of blood in each) will be transported on ice to the proteomics platform in the next three hours, centrifuged and stored on -80 degrees Celcius in low-binding tubes for further molecular analysis. 1 heparin tube (5mL) will be sent to the Bacteriology-Virology Department for the active PBMC counting.
Perilymph samplingProcedure or surgery
The perilymph collection will be performed during the cochlear implantation surgery at the same time as the round window opening. 5 to 15 microliters will be aspirated using an atraumatic spinal needle mounted onto 1 ml insulin syringe.
| Study group | Role | What they receive |
|---|---|---|
| "Cochlear Implantation" group | Experimental | 50 patients with sensorineural hearing loss eligible for cochlear implantation surgery. The blood and perilymph sampling will be performed during surgery (visit V1). The blood sampling will be additionally done during the visits V2, V3 and V4. After the visit V4, this arm will be subdivided into 2 groups: group 1, 15 patients with the delayed residual hearing loss, and group 2,15 patients with preserved residual hearing. For these 30 patients, blood sampling will be also performed during the visit V5. Receives: Biological: Blood sampling; Procedure: Perilymph sampling |
| Control group | Other | 30 normally hearing patients who will undergo through an otological surgery other than cochlear implantation. A blood sampling will be performed during surgery (visit V1) as well as during the visits V2 and V3. Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of proteins and metabolites in the perilymph before surgery in the 2 groups of implanted patients
Expression levels of proteins and metabolites identified by high-resolution mass spectrometry (Lc-HRMS) in the perilymph of group 1, "delayed residual hearing loss" and group 2, "maintained residual hearing" patients, collected before cochlear implantation surgery
Measured: Before cochlear implantation surgery (V1)
Expression levels of proteins and metabolites in the blood before surgery in the 2 groups of implanted patients
Expression levels of proteins and metabolites identified by high-resolution mass spectrometry (Lc-HRMS) in the blood of group 1 "delayed residual hearing loss" and group 2 "maintained residual hearing" patients, collected before cochlear implantation surgery
Measured: Before cochlear implantation surgery (V1)
Secondary outcomes (9)
PBMC cell counting
Counting of activated blood immune cells, using FACS technique after the PBMC cells culture is performed
Measured: Before cochlear implantation surgery (V1)
PBMC cell counting
Counting of activated blood immune cells, using FACS technique after the PBMC cells culture is performed
Measured: At 1 month post-implantation (V2)
PBMC cell counting
Counting of activated blood immune cells, using FACS technique after the PBMC cells culture is performed
Measured: At 3 months post-implantation (V3)
PBMC cell counting
Counting of activated blood immune cells, using FACS technique after the PBMC cells culture is performed
Measured: At 6 months post-implantation (V4)
PBMC cell counting
Counting of activated blood immune cells, using FACS technique after the PBMC cells culture is performed
Measured: At 12 months post-implantation (V5)
Expression levels of identified molecules in the 2 groups of implanted patients after the surgery
Expression levels of identified molecules for each group over time
Measured: At 1 month post-implantation (V2)
Expression levels of identified molecules in the 2 groups of implanted patients after the surgery
Expression levels of identified molecules for each group over time
Measured: At 3 months post-implantation (V3)
Expression levels of identified molecules in the 2 groups of implanted patients after the surgery
Expression levels of identified molecules for each group over time
Measured: At 6 months post-implantation (V4)
Expression levels of identified molecules in the 2 groups of implanted patients after the surgery
Expression levels of identified molecules for each group over time
Measured: At 12 months post-implantation (V5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start7 Dec 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will recruit individuals eligible for cochlear implantation surgery. In parallel, the control group will be formed from normal hearing patients - candidates for other otological interventions. The two groups will be matched by age and gender of participants.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670158
- Sponsor's protocol ID
- RECHMPL21_0380
- Acronym
- PERILOTO
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Inner Ear Immunisation Post-cohlear Implantation and Perilymph Molecular Profiling in Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT05670158
- Acronym / sponsor ID
- PERILOTO / RECHMPL21_0380
- Conditions
- Sensorineural Hearing Loss
- Keywords
- Perilymph, Proteomics, Metabolomics, Sensorineural hearing loss, Residual hearing, Cochlear implantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Jan 2023 (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.
Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation. Although the mechanisms involved in the residual audition loss remain unknown, animal experiments suggest the role of inflammatory or immune reaction in the cochlea. The goal of this project is to search in the perilymph (a fluid which fills the scala vestibuli and scala tympani of the cochlea) some predictive biomarkers of the residual hearing loss using modern proteomics and immunological techniques. A parallel search for blood biomarkers of post-implantation residual hearing loss and for molecular and cellular evidences of immune response to cochlear implantation will be performed.
The study will recruit 50 subjects-candidates for cochlear implantation surgery; 30 normally hearing individuals eligible for other types of otological interventions will form a control group. For all the participants blood samples will be collected and preserved. In addition, the perilymph sampling will be performed during cochlear implantation surgery.
This project relies on the calculation that from 50 patients post-cochlear implantation, 15 patients will form a group with maintained residual hearing and 15 will display delayed hearing loss. For these 30 subjects together with the control group the blood biomarkers search will be performed.
For the group of implanted patients, the follow-up will last for 12 months with 6 visits in total :
- the inclusion visit V0 during which the study will be presented and the consent form will be signed
- the surgery visit V1 with blood sample and perilymph collection
- the activation visit V2, 1 month ± 1 week after V1, visit V3 3 months ± 7 days after V1, V4 6 months ± 7 days after V1, V5 12 months ± 1 month after V1. During each of this visit blood sampling will be performed.
For the control group, the follow up will be 6 months long with 4 visits in total arranged during the routine follow-up appointments:
- the inclusion visit V0 during which the study will be presented and the consent form will be signed
- the surgery visit V1, the 1 month visit V2 and the 6 months visit V3 during which the blood sampling will be performed.
Detailed description
With the progress of technologies and surgical methods, cochlear implantation, initially proposed only to patients with completely non-functional inner ear, can be now performed on individuals with still some measurable hearing left in some frequencies. Such patients can additionally benefit from a special treatment by electric-acoustic stimulation (EAS). Combining the electric stimulation with cochlear implant (CI) and acoustic amplification of residual hearing using a conventional hearing aid (HA) can drastically improve one's quality of life and ameliorate the performance in noisy environment as well as music perception.
Since the main condition for EAS is the residual hearing preservation, it is important to understand the reasons of its loss post-cochlear implantation. This loss can occur in 2 periods:
- Early after surgery (˂ 1 month): mainly due to the trauma from electrode insertion. This risk decreases with the development of surgical techniques. Another possible reason is early inflammation processes in the cochleae.
- Later after surgery (˃ 1 month): occurs mainly about 3 months post-implantation in 30-40 % of patients. This loss is the main reason for dropping out the EAS leaving the patient to rely on CI only.
Animal studies suggest that the delayed residual hearing loss might happen as consequence of cochlear fibrosis development, supposedly due to the inflammation and foreign body response to the CI materials within the cochlea. In its natural state, the cochlea does not contain any immune cells and is well protected from immune stimulation by infectious agents. Cochlear implantation, however, provides a single clinical cause for infectious or autoimmune fibrosis. Such immune response might be provoked by autoantigens against cochlear proteins like Cochline or TectB. This study aims to search blood markers of immunisation against inner ear proteins after cochlear implantation. Another goal is to seek potential biomarkers of delayed residual hearing loss directly in perilymph. Proteomic analysis will be performed using Liquid Chromatography - High Resolution Mass Spectroscopy (HRMS) technique.
The main objective of this study is
- to identify, in the perilymph of implanted patients, biomarkers predictive of the delayed residual hearing loss
- to identify blood biomarkers predictive of delayed residual hearing loss in implanted patients
The secondary objectives are
- to describe qualitatively and quantitatively the time evolution for blood biomarkers of interest after cochlear implantation
- to correlate quantitative values of identified biomarkers with clinical data of implanted patients
- to identify perilymph and blood biomarkers of early residual hearing loss post-cochlear implantation
- depending on molecular profiles identified, to study metabolic pathways and mechanisms involved in delayed residual hearing loss post-cochlear implantation
- to seek for blood indicators in favour of anti-cochlear immunisation through screening for peripheral blood mononuclear cells (PBMC)
- to create a bio collection of human perilymph and blood serum biobank of cochlear implants users for future proteomics/molecular studies
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will recruit individuals eligible for cochlear implantation surgery. In parallel, the control group will be formed from normal hearing patients - candidates for other otological interventions. The two groups will be matched by age and gender of participants.
| Arm | Type | Receives |
|---|---|---|
| "Cochlear Implantation" group | Experimental | Biological: Blood sampling, Procedure: Perilymph sampling50 patients with sensorineural hearing loss eligible for cochlear implantation surgery. The blood and perilymph sampling will be performed during surgery (visit V1). The blood sampling will be additionally done during the visits V2, V3 and V4. After the visit V4, this arm will be subdivided into 2 groups: group 1, 15 patients with the delayed residual hearing loss, and group 2,15 patients with preserved residual hearing. For these 30 patients, blood sampling will be also performed during the visit V5. |
| Control group | Other | Biological: Blood sampling30 normally hearing patients who will undergo through an otological surgery other than cochlear implantation. A blood sampling will be performed during surgery (visit V1) as well as during the visits V2 and V3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 18 years or more
- Indication for the cochlear implantation surgery according to the criteria of French National Authority for Health (Severe to profound sensorineural deafness with indication for cochlear implant surgery: Intelligibility less than or equal to 50% when performing vocal audiometry tests with Fournier's list in free field with recent devices.)
- Presence of "useful" residual hearing ≤ 80 dB on at least 2 consecutive frequencies (in air conduction) from the range 125, 250, 500, 1000 kHz on pure-tone audiometry
- Patients given their free and informed written consent
- Patients affiliated to a French social security system
Key exclusion criteria (17 listed)
- Contraindication to surgery detected during the preoperative assessment
- Pre-implantation cochlear assessment unfavorable to the implantation surgery
- Absence of residual hearing shown by preoperative audiometry
- History of bacterial labyrinthitis or bacterial meningitis
- Cochlear ossification shown on preoperative imaging
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 |
|---|---|---|
| Blood samplingBlood will be collected into 2 EDTA and 1 heparin tube. The 2 EDTA tubes (4ml of blood in each) will be transported on ice to the proteomics platform in the next three hours, centrifuged and stored on -80 degrees Celcius in low-binding tubes for further molecular analysis. 1 heparin tube (5mL) will be sent to the Bacteriology-Virology Department for the active PBMC counting. | Biological | "Cochlear Implantation" group, Control group |
| Perilymph samplingThe perilymph collection will be performed during the cochlear implantation surgery at the same time as the round window opening. 5 to 15 microliters will be aspirated using an atraumatic spinal needle mounted onto 1 ml insulin syringe. | Procedure or surgery | "Cochlear Implantation" group |
Primary outcome
Expression levels of proteins and metabolites in the perilymph before surgery in the 2 groups of implanted patients
Time frame: Before cochlear implantation surgery (V1)
Expression levels of proteins and metabolites identified by high-resolution mass spectrometry (Lc-HRMS) in the perilymph of group 1, "delayed residual hearing loss" and group 2, "maintained residual hearing" patients, collected before cochlear implantation surgery
Expression levels of proteins and metabolites in the blood before surgery in the 2 groups of implanted patients
Time frame: Before cochlear implantation surgery (V1)
Expression levels of proteins and metabolites identified by high-resolution mass spectrometry (Lc-HRMS) in the blood of group 1 "delayed residual hearing loss" and group 2 "maintained residual hearing" patients, collected before cochlear implantation surgery
9 secondary outcomes
PBMC cell counting
Time frame: Before cochlear implantation surgery (V1)
PBMC cell counting
Time frame: At 1 month post-implantation (V2)
PBMC cell counting
Time frame: At 3 months post-implantation (V3)
PBMC cell counting
Time frame: At 6 months post-implantation (V4)
PBMC cell counting
Time frame: At 12 months post-implantation (V5)
Expression levels of identified molecules in the 2 groups of implanted patients after the surgery
Time frame: At 1 month post-implantation (V2)
Expression levels of identified molecules in the 2 groups of implanted patients after the surgery
Time frame: At 3 months post-implantation (V3)
Expression levels of identified molecules in the 2 groups of implanted patients after the surgery
Time frame: At 6 months post-implantation (V4)
Expression levels of identified molecules in the 2 groups of implanted patients after the surgery
Time frame: At 12 months post-implantation (V5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Perilymph sampling in people with Sensorineural Hearing Loss, 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 10 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 18 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akil Kaderbay, MD (+33467336890, a-kaderbay@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of proteins and metabolites in the perilymph before surgery in the 2 groups of implanted patients (time frame: Before cochlear implantation surgery (V1)). 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 18 Jan 2024.