DeafnessConnect ICNCT07117968
Benefit of Connected Care for Cochlear Implant Management
A study testing Standard-of-care and Experimental hybrid care pathway in people with Deafness, run by Hospices Civils de Lyon.
Trial summary
Some 30 hospitals in France are accredited to manage cochlear implant (CI) activity, which represents around 1,800 new patients implanted per year and an estimated active file of over 20,000 patients. The current patient pathway meets the requirements described in 2009 for this activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness
- What is being tested?
- Standard-of-care and Experimental hybrid care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2029
- 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
- Adult patients (aged 18 or over) eligible for a cochlear implant in primary implantation according to French National Authority for Health indications
- Patients suffering from severe to profound bilateral deafness with discrimination less than or equal to 50% on voice audiometry tests using the Fournier list (or equivalent).
- Patients affiliated to the public health insurance body
- Patients who benefit from a Cochlear® system with a processor compatible with Remote Care tools
- Patients using a smartphone compatible with the Nucleus Smart application.
- Patients who have given their written informed consent to the study
- French-speaking patients
Who cannot join
- Patients already implanted and candidates for implantation of the other ear (bilateralization), or previously implanted (re-implantation).
- Patients with concomitant illnesses that are incompatible with the use of remote monitoring,
- Pregnant women
- Patients suffering from unilateral deafness with incapacitating tinnitus
- Persons under legal protection (guardianship, curators).
- Subjects taking part in other interventional research with an exclusion period still in progress at the time of inclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Benefit of Integrating Connected Care to Reshape the Cochlear Implant Care Pathway: a Multicenter Randomized Non-inferiority Study
Some 30 hospitals in France are accredited to manage cochlear implant (CI) activity, which represents around 1,800 new patients implanted per year and an estimated active file of over 20,000 patients.
The current patient pathway meets the requirements described in 2009 for this activity. Today, however, it is inflexible, not scalable, and presents major constraints for both patients and the healthcare professionals in charge of them. In the first year post-implantation, a patient visits his or her center on average 9 times for routine follow-up. The growing demand for patients to be implanted and the need to continue monitoring patients who have already been implanted are putting a strain on the centers responsible for this activity, leading to a deterioration in the management of this condition. We need to propose a new care pathway that meets current needs, improves patient service and optimizes the workload of our teams in order to manage their entire implant cohort.
Read more
This project focuses on two areas in order to optimize the implant patient's care pathway. The first is to integrate telemonitoring into the follow-up process. Telemonitoring has already proved its worth in many therapeutic fields, and could clearly meet the needs of all those involved: Reduced time constraints, optimized on-site visits, flexibility in management, fewer people lost to follow-up... The second axis consists in optimizing the implant system activation stage, a cumbersome and complex step, by favoring early activation based on objective patient data collected intraoperatively. Reducing the variability of activation leads to earlier stabilization of settings, without compromising hearing performance.
These two approaches are currently used in some centers, but not in combination, and have been adopted routinely in some countries. The expected benefits are therefore well known, but this project has a key role to play in demonstrating the feasibility and medico-economic benefits of our French model.
This project will therefore jointly optimize early activation, made possible by objective intraoperative measurements, and patient management by integrating telemonitoring into the adult CI pathway to improve efficiency.
The aim of this project is to evaluate, in the first year of post-CI follow-up, the benefits of this new, adapted care pathway, both in terms of the organization of care and the patient's quality of life and performance.
The main hypothesis is that a new care pathway that integrates early activation and remote monitoring will enable the center to provide more flexible and adapted patient follow-up to optimize management, and thus improve quality of life without any deterioration in clinical effectiveness (hearing performance). The investigators aim to demonstrate the clinical non-inferiority of performance in noise (DTT Test) assessed at 12 months in patients benefiting from the new care pathway vs. current standard follow-up, while improving their quality of life, in a multicenter randomized controlled trial.
- Conditions
- Deafness
- Being tested
- Standard-of-care, Experimental hybrid care pathway
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-careOther
Management of the first year post-CI follow-up according to current center practices
Experimental hybrid care pathwayOther
First year post-CI follow-up including early activation of the implant and hybrid follow-up, including remote or in-center monitoring visits, adjustable according to the evolution of their hearing performance and comfort. In this new care pathway, compared with the Standard-of-care, the 2-week visit and the 9-month visit are omitted, due to early activation and remote follow-up. Visits at 1 and 6 months are the same as those in the conventional, on-site routine. Visits at 3 and 12 months will be carried out remotely by default via the remote monitoring application.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Cochlear implant patients will benefit from the current first year of post-CI follow-up care provided at their own center. Receives: Other: Standard-of-care |
| intervention group | Experimental | Cochlear implant patients will be integrated into the new care pathway. They will be offered early activation of the implant and hybrid follow-up, including remote or in-center monitoring visits, adjustable according to the evolution of their hearing performance and comfort. Receives: Other: Experimental hybrid care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing performance in noise
Hearing performance measured in noise using the Digit Triple Test (DTT). This value corresponds to the signal-to-noise ratio, expressed in decibel Single Number Rating, required for the subject to recognize 50% of the speech signal presented (50% intelligibility threshold in silence = Speech Reception Threshold 50 in decibel Single Number Rating).
Measured: At 12 months post-activation of the CI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator will conduct a randomized, comparative, multicenter study. Two prospective follow-up groups of CI patients will be set up for comparison, and each patient will be followed until their 12-month post-implantation check-up. Patients in the control group will benefit from the current follow-up, as performed in their center, and those in the experimental group will integrate the new care pathway.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117968
- Sponsor's protocol ID
- 69HCL24_0756
- Acronym
- Connect IC
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 11 Sep 2025
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Benefit of Integrating Connected Care to Reshape the Cochlear Implant Care Pathway: a Multicenter Randomized Non-inferiority Study
- ClinicalTrials.gov ID
- NCT07117968
- Acronym / sponsor ID
- Connect IC / 69HCL24_0756
- Conditions
- Deafness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 12 Aug 2025 (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.
Some 30 hospitals in France are accredited to manage cochlear implant (CI) activity, which represents around 1,800 new patients implanted per year and an estimated active file of over 20,000 patients.
The current patient pathway meets the requirements described in 2009 for this activity. Today, however, it is inflexible, not scalable, and presents major constraints for both patients and the healthcare professionals in charge of them. In the first year post-implantation, a patient visits his or her center on average 9 times for routine follow-up. The growing demand for patients to be implanted and the need to continue monitoring patients who have already been implanted are putting a strain on the centers responsible for this activity, leading to a deterioration in the management of this condition. We need to propose a new care pathway that meets current needs, improves patient service and optimizes the workload of our teams in order to manage their entire implant cohort.
This project focuses on two areas in order to optimize the implant patient's care pathway. The first is to integrate telemonitoring into the follow-up process. Telemonitoring has already proved its worth in many therapeutic fields, and could clearly meet the needs of all those involved: Reduced time constraints, optimized on-site visits, flexibility in management, fewer people lost to follow-up... The second axis consists in optimizing the implant system activation stage, a cumbersome and complex step, by favoring early activation based on objective patient data collected intraoperatively. Reducing the variability of activation leads to earlier stabilization of settings, without compromising hearing performance.
These two approaches are currently used in some centers, but not in combination, and have been adopted routinely in some countries. The expected benefits are therefore well known, but this project has a key role to play in demonstrating the feasibility and medico-economic benefits of our French model.
This project will therefore jointly optimize early activation, made possible by objective intraoperative measurements, and patient management by integrating telemonitoring into the adult CI pathway to improve efficiency.
The aim of this project is to evaluate, in the first year of post-CI follow-up, the benefits of this new, adapted care pathway, both in terms of the organization of care and the patient's quality of life and performance.
The main hypothesis is that a new care pathway that integrates early activation and remote monitoring will enable the center to provide more flexible and adapted patient follow-up to optimize management, and thus improve quality of life without any deterioration in clinical effectiveness (hearing performance). The investigators aim to demonstrate the clinical non-inferiority of performance in noise (DTT Test) assessed at 12 months in patients benefiting from the new care pathway vs. current standard follow-up, while improving their quality of life, in a multicenter randomized controlled trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigator will conduct a randomized, comparative, multicenter study. Two prospective follow-up groups of CI patients will be set up for comparison, and each patient will be followed until their 12-month post-implantation check-up. Patients in the control group will benefit from the current follow-up, as performed in their center, and those in the experimental group will integrate the new care pathway.
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: Standard-of-careCochlear implant patients will benefit from the current first year of post-CI follow-up care provided at their own center. |
| intervention group | Experimental | Other: Experimental hybrid care pathwayCochlear implant patients will be integrated into the new care pathway. They will be offered early activation of the implant and hybrid follow-up, including remote or in-center monitoring visits, adjustable according to the evolution of their hearing performance and comfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients (aged 18 or over) eligible for a cochlear implant in primary implantation according to French National Authority for Health indications
- Patients suffering from severe to profound bilateral deafness with discrimination less than or equal to 50% on voice audiometry tests using the Fournier list (or equivalent).
- Patients affiliated to the public health insurance body
- Patients who benefit from a Cochlear® system with a processor compatible with Remote Care tools
- Patients using a smartphone compatible with the Nucleus Smart application.
Key exclusion criteria (6 listed)
- Patients already implanted and candidates for implantation of the other ear (bilateralization), or previously implanted (re-implantation).
- Patients with concomitant illnesses that are incompatible with the use of remote monitoring,
- Pregnant women
- Patients suffering from unilateral deafness with incapacitating tinnitus
- Persons under legal protection (guardianship, curators).
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 |
|---|---|---|
| Standard-of-careManagement of the first year post-CI follow-up according to current center practices | Other | control group |
| Experimental hybrid care pathwayFirst year post-CI follow-up including early activation of the implant and hybrid follow-up, including remote or in-center monitoring visits, adjustable according to the evolution of their hearing performance and comfort. In this new care pathway, compared with the Standard-of-care, the 2-week visit and the 9-month visit are omitted, due to early activation and remote follow-up. Visits at 1 and 6 months are the same as those in the conventional, on-site routine. Visits at 3 and 12 months will be carried out remotely by default via the remote monitoring application. | Other | intervention group |
Primary outcome
Hearing performance in noise
Time frame: At 12 months post-activation of the CI
Hearing performance measured in noise using the Digit Triple Test (DTT). This value corresponds to the signal-to-noise ratio, expressed in decibel Single Number Rating, required for the subject to recognize 50% of the speech signal presented (50% intelligibility threshold in silence = Speech Reception Threshold 50 in decibel Single Number Rating).
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 11 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Deafness
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard-of-care and Experimental hybrid care pathway in people with Deafness, run by Hospices Civils de Lyon.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hung THAI VAN (0472110525 ext. +33, hung.thai-van@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing performance in noise (time frame: At 12 months post-activation of the CI). 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 11 Sep 2025.