Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-26 @ 7:21 PM
Study NCT ID:
NCT07117968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit of Connected Care for Cochlear Implant Management
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Evaluating the Benefit of Integrating Connected Care to Reshape the Cochlear Implant Care Pathway: a Multicenter Randomized Non-inferiority Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Connect IC
Brief 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. 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: