Evaluation of the Changes in Cochlear Implant Patients Care Pathway With the Use of Telemonitoring

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University Hospital Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Frédéric Venail, PhD, MD
f-venail@chu-montpellier.fr
+33467336890
Backup
Olivier Deguine, PhD, MD
deguine.o@chu-toulouse.fr
+33561772211
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2025-06-20
Participants
Target number of participants: 78
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation, Foundation maladies rares, France, University Hospital, Toulouse, Cochlear
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov