Remote Monitoring Applied to Cochlear Implant Patient Follow-up

NCT03874533 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-14

No results posted yet for this study

Summary

The cochlear implant (CI) is a device to compensate severe or profound deafness. The CI has a lifetime implanted part and an external processor. Regular monitoring is necessary because the device can generate complications and when the device is dysfunctional, the patient becomes deaf again. Our center, the CRIC, is a center for monitoring and fitting CI. Follow-up requires face-to-face procedures and some patients have difficulty accessing the center.

Our cohort of patients is growing steadily and now exceeds 750 patients. Provision should be made for sustained steady growth and enabling means. Telemedicine may be a response for the follow-up of some patients.

Currently, cochlear implanted patients benefit once a year from: an ENT (Ear Nose and Throat) medical consultation, a speech-language assessment, physical verification of the external processor, an audiometric test, a fitting of the external processor. This makes it possible to check the absence of medical complication, the use and the correct functioning of the external and internal parts.

Provision should be made for sustained steady growth and enabling means. With the development of new hearing tests, technical possibilities of some speech processors and software for their fitting, telemedicine may be a response for the follow-up of some patients.

TELESURVIC will study the feasibility for patients implanted with an implant Cochlear™ to carry out a complete test of their equipment by themselves.

For this project we will use a tablet device, without simultaneous contact with CRIC professionals. On this tablet are installed calibrated hearing tests, tutorials of good maintenance of the processor and a software of adjustment allowing the realization of the operations desired for an inspection of the implant.

Patients selected to participate, (on a voluntary basis), in this protocol will follow the following steps:

1. They will first be trained in the use of the tablet at the CRIC by professionals. Patients will only be included if they are autonomous in handling the tablet and specific software;
2. They will carry out the various tests at the hospital on the tablet: audiometry test in quiet and in noise then checking of the data logging, self-fitting thanks to the Cochlear software (NFS);
3. Between one week and one month later, they will come back to the center and will do the same tests alone in a quiet room of the center.
4. Outside the patient's presence, the data will be analyzed and compared with the data collected in step 2, in order to validate or not, the feasibility of these self-administrated tests without any help by the team.

Conditions

  • Cochlear Diseases

Interventions

DEVICE

Self-adjustment tests

For patients with an implant Cochlear™, we will be trained during workshop, to use a tablet how to do some tests ; They will do alone, by themselves the tests, just after the workshop and 8 to 30 days later. Self audiometric test : digit triplet test, consonants discrimination test, Self-fitting of cochlear implant

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Christine PONCET WALLET, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2019-03-31
Completion
2019-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874533 on ClinicalTrials.gov