Telemonitoring in Cochlear Implant Patient Care

NCT ID: NCT05566353

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2025-06-20

Brief Summary

Following a sufficient delay after the cochlear implantation and initial implant activation, the patient will return to the hospital for follow-up visits for equipment maintenance and auditory performance evaluation only once per year. This frequency might appear either insufficient, in which case an additional patient check-up will be arranged, or excessive if patient performances and implant adjustments are stable. Using at-home testing tool for remote hearing performance monitoring can thus appear advantageous for both patients and clinicians, allowing to avoid an unnecessary journey to the implantation reference center for the first and to diminish a number of unscheduled medical appointments for the second.

Detailed Description

In December 2020, the French Medical Device and Health Technology Evaluation Committee (CNEDiMTS) voted in favour of the integration of telemonitoring in cochlear implant users' follow-up thus adding a range of new possibilities to a standard health care routine.

According to the official recommendations of the French National Authority for Health, a patient implanted for a sufficiently long time should be seen annually at the implantation reference center. This periodicity might appear too low, in which case a patient will have to organise an unscheduled check-up appointment. Such appointments are a source of various problems: firstly, they disorganise the routine of the reference centers not adapted for emergency and semi-emergency situations; secondly, the patient might encounter substantial travelling fees (only 22 refence centers in France), especially if an implant component to replace is out of stock. Having an utility of remote patient monitoring is also beneficial in situations where the access to health care system is restricted, for example, the recent pandemic of Covid 19.

Cochlear™ has recently designed an at-home based patient testing tool, Remote Check application, permitting to complete a series of hearing test from a compatible smartphone. The results are then sent to the implantation reference center and evaluated by healthcare professionals. The data is securely stored on Cloud accessible to authorised clinicians via MyCochlear site.

Although the feasibility and the accuracy in detecting technical problems of remote follow-up of people with cochlear implant had been already assessed, its impact on health care system is still unknown. Hence, this project will be the first to evaluate an interest of implementing remote monitoring in following adults with cochlear implantation.

The main objective of the study is - to determine if the use of telemonitoring through Remote Check application reduces significantly a number of unscheduled check-up appointments in the reference centre during 1 year follow-up period for a patient with a cochlear implant Cochlear™ in comparison to traditional health care approach.

The secondary objectives are:

• To compare a number of scheduled appointments during a period of Remote Check use versus a historical period of a traditional follow-up
• To compare a number of indispensable unscheduled visits (unavoidable with or without Remote Check use) with a number of unnecessary ones (avoidable with Remote Check)
• To measure the compliance of the Remote Check application use
• To assess quantitatively and qualitatively a number of implant failures/dysfunctions identified with Remote Check
• To evaluate for each study participant time spent by clinician to treat Remote Check analysis data uploaded to My Cochlear data base
• To assess patients satisfaction of Remote Check implementation in their healthcare routine
• To evaluate the quality of life specific to the Deaf before and after Remote Check use The study implies four visits for each patient. The inclusion visit (V0) is a routine check-up appointment in the implantation reference center. After the patient is informed and his/her consent is collected, the Remote Check application will be activated on his/her processor. Two next follow-up visits, V1 (V0+ 5 mois (± 0.5 mois)) and V2 (V0 + 11 mois (± 0.5 mois)), are remote visits with hearing test performed through Remote Check application. Final visit, V3 (V0 + 12 mois (± 0.5 mois)), corresponds to patient's annual check-up appointment. In case a problem with processor's functioning is detected during V2, it will be resolved at V3. Equipment verification will be also performed to detect failures missed by Remote Check.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients followed at the implantation reference centers

Patients eligible for implant processor renewal in 2 years and corresponding to inclusion criteria will be enrolled during their routine check-up appointment at the implantation reference centers of the University Hospitals of Montpellier and Toulouse. Patients will be their own controls through the use of their medical history data.

Group Type: EXPERIMENTAL

Remote Check

Intervention Type: OTHER

Remote Check is a remote monitoring tool which permits patients with Cochlear Nucleus CP1000 or CP1150 processors to complete hearing tests (pure-tone and speech-in-voice audiometry, electrode impedance measures, implant functioning assessment) at home,

Interventions

Remote Check

Remote Check is a remote monitoring tool which permits patients with Cochlear Nucleus CP1000 or CP1150 processors to complete hearing tests (pure-tone and speech-in-voice audiometry, electrode impedance measures, implant functioning assessment) at home,

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects-users of uni- or bilateral cochlear implants (Cl24RE, series 400, 500 and 600) and Cochlear Nucleus processor CP1000 or CP1150 during one year minimum
• Subjects who have already renewed their processor at least once
• Subjects implanted for more than 5 years
• Over 20 years old
• Subjects with Apple or Android smartphones compatible with Remote Check

Exclusion Criteria

• Associated physical (visual, motor...) or severe cognitive (dementia, specific language development troubles) making impossible the use of smartphone software and the conduction of hearing tests
• Patients unable to give oral informed consent
• Patients residing in geographical zones with limited internet access
• Subjects deprived of liberty by juridical or administrative decision
• Patients subjected to legal protection measures (guardianship or curatorship)
• Subjects for whom French is not a native language

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

Groupement Interrégional de Recherche Clinique et d'Innovation

OTHER

Sponsor Role: collaborator

Foundation maladies rares, France

UNKNOWN

Sponsor Role: collaborator

Cochlear

INDUSTRY

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Frédéric Venail, PhD, MD

Role: CONTACT

f-venail@chu-montpellier.fr

+33467336890

Olivier Deguine, PhD, MD

Role: CONTACT

deguine.o@chu-toulouse.fr

+33561772211

Facility Contacts

Frédéric Venail

Role: primary

Other Identifiers

RECHMPL21_0519

Identifier Type: -

Identifier Source: org_study_id