Cochlear Diseases Clinical Trial
Official title:
Remote Monitoring Applied to Cochlear Implant Patient Follow-up (TELESURVIC)
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.
The selection of the patients is made on study of the files of the cochlear implanted
patients with leading implant COCHLEARTM, compatible external processor with the research and
being able to potentially realize only the studied acts.
The unit proposes then during a consultation or by explanatory e-mail, to the patient to
participate in a training workshop. The information note will be presented to the patient
during the consultation, or sent by e-mail.
After checking the selection criteria and signing the consent by the patient, the patient
joins a training workshop.
During the workshop, bringing together 3 to 5 patients supervised by an ENT doctor of the +/-
adjuster team, a speech therapist and +/- a COCHLEARTM engineer, patients will be trained in
the handling of the tablet and software. Then, in a second step, each patient will have to
carry out the hearing and self-adjustment tests by themselves in a quiet room in the unit. He
will be able to reach a unit professional who can help him.
The patient will benefit from auditory evaluation by a consonants discrimination test and a
3-digit noise test and then an evaluation of the implant and processor parameters using
COCHLEARTM NFS tuning software.
It is at the end of this workshop that the unit professionals will judge whether the patient
is pursuing the research or not. If the patient continues the research, he will have an
appointment to return to the service 8 to 30 days later.
Patients pursuing the research will be invited to complete the end-of-workshop questionnaire.
The patient will return to the follow-up center and will repeat exactly the same acts, alone
in a room, 8 to 30 days after the first tests. He will also have the opportunity to be
assisted by someone of his choice.
At the end of this visit, the patient will be invited to complete the end-of-research
questionnaire.
This follow-up visit will mark the end of the patient's participation in this research,
unless there is a need to adjust the device.
Once the tests are completed, health professionals will analyze the data retrieved from the
tablet and if needed, will see the patient in adjustment within 8 days maximum if there is a
difference between the tests performed at the unit during the inclusion visit and those
performed by the patient alone in a distant evaluation.
Self-test data from the patient at the follow-up visit should be identical to the training
workshop. If this is not the case, it is therefore essential to know if the difference is due
to a poor control of the tests or rather to an anomaly appeared secondarily.
Patients will be reviewed as part of the care in case of need for new settings.
The professionals involved in the research (training workshop and self-test verification)
will be invited to complete an evaluation questionnaire
Our approach aims to make the patient aware of how the cochlear implant works, to empower him
and to make him responsible for his equipment.
By providing him with training not only in passing evaluation self-tests but also in certain
parameters of the setting, we want him to understand the interest of an annual follow-up.
And we want to show that a well-trained patient can participate actively in the follow-up of
his cochlear implant thanks to adapted tools and telemedicine.
Total number of subjects selected to participate in the workshop: 40. Inclusion period: 6
months, for 30 selected patients at the end of the workshop.
Duration of participation of each patient: 38 days maximum Total search time: 7 months and 8
days
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04183348 -
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
|
N/A | |
| Completed |
NCT05591807 -
Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract
|