Remote Monitoring Applied to Cochlear Implant Patient Follow-up
NCT03874533 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2019-03-14
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
More Related Trials
-
Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
NCT02004353 ·Status: TERMINATED
-
Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
NCT05451628 ·Status: RECRUITING ·Phase: NA
-
Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)
NCT06235073 ·Status: COMPLETED
-
Telephone vs. Voice Over IP Speech Comprehension in Hearing Aided Subjects.
NCT03005912 ·Status: TERMINATED ·Phase: NA
-
Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App
NCT06543953 ·Status: COMPLETED ·Phase: NA
-
The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping
NCT06051006 ·Status: RECRUITING
-
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
NCT07139327 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Pediatric Image-Guided Cochlear Implant Programming
NCT03886168 ·Status: COMPLETED ·Phase: NA
-
Vestibular Cochlear Implant Hearing Impaired Child
NCT03599804 ·Status: UNKNOWN
-
Image-guided Cochlear Implant Programming (IGCIP)
NCT03306082 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation
NCT05552118 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Cochlear Implantation in the Elderly
NCT05992779 ·Status: UNKNOWN
-
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
NCT07287124 ·Status: RECRUITING ·Phase: NA
-
Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology
NCT03157492 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Therapy Via Telemedicine Following Cochlear Implants
NCT02497690 ·Status: COMPLETED ·Phase: PHASE2
-
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
NCT06021132 ·Status: ACTIVE_NOT_RECRUITING
-
Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
NCT02644343 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Middle Ear Implantation
NCT00451503 ·Status: COMPLETED ·Phase: NA
-
Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments
NCT06305039 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Remote Care: The Future of Cochlear Implants
NCT04721327 ·Status: COMPLETED ·Phase: NA
-
Optimization of Hearing Performance in the Subject Implanted
NCT05325450 ·Status: UNKNOWN ·Phase: NA
-
An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients
NCT04987021 ·Status: COMPLETED ·Phase: NA
-
Early Cochlear Implant Use
NCT07114744 ·Status: RECRUITING
-
Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients
NCT06841900 ·Status: NOT_YET_RECRUITING
-
Team-based Virtual Pediatric Cochlear Implant Clinic
NCT05030961 ·Status: COMPLETED ·Phase: NA