Remote Monitoring Applied to Cochlear Implant Patient Follow-up

NCT03874533 | Unknown

• 1 other identifier: APHP180004
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 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. 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

Keywords

Cochlear Implantation; telemonitoring; training workshop

Outcome Measures

Primary Outcomes (2)

• The degree of auditory rehabilitation achieved with the cochlear implant.

  Comparison of the data collected (The hearing tests 3 digits test and VCV) during the usual evaluations in the department, then in auditory self-test and of the parameters of reaction just after an apprenticeship and at a distance, between 8 to 30 days, of this learning

  Between day +8 to +30 after the training session

• The degree of auditory rehabilitation achieved with the cochlear implant.

  Comparison of the data collected (the electrophysiological measures) during the usual evaluations in the department, then in auditory self-test and of the parameters of reaction just after an apprenticeship and at a distance, between 8 to 30 days, of this learning

  Between day +8 to +30 after the training session

Secondary Outcomes (5)

• Estimate the degree of patients satisfaction, on the use of new tools that will be used for remote monitoring

  Between day +8 to +30 after the training session

• Estimate the degree of satisfaction professionals, on the use of new tools that will be used for remote monitoring

  Between day +8 to +30 after the training session

• Estimate the necessary adaptations of the medical team and patients

  Between day +8 to +30 after the training session

• Estimate time savings for professionals

  Between day +8 to +30 after the training session

• Estimate time savings for patients

  Between day +8 to +30 after the training session

Study Arms (1)

self-adjustment tests

EXPERIMENTAL

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

Device: Self-adjustment tests

Interventions

Self-adjustment tests DEVICE

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

self-adjustment tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old
• Cochlear implantation older than 6 months (with a COCHLEAR implant and processor allowing wireless connection), followed by CRIC or IFIC,
• Fluent in the French language,
• Possibility of carrying out the acts alone in person in the service within a short time (less than 30 days).
• Patients affiliated to a social security scheme or entitled to it
• Patient who has signed informed consent form

You may not qualify if:

• Difficulty mastering the tests alone or handling the tablet that will be entrusted to him
• Persons deprived of their liberty by judicial or administrative decision
• Persons hospitalized without consent and without legal protection, and persons admitted to a health or social institution for purposes other than research.
• Adults who are subject to a legal protection measure (guardianship, trusteeship or judicial protection), adults who are unable to express their consent and are not subject to a protection measure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Cochlear Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Christine PONCET WALLET, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine PONCET WALLET, MD

CONTACT

+33 1 40 19 36 61; christine.poncet@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: March 14, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share