Cochlear DiseasesTELESURVICNCT03874533
Remote Monitoring Applied to Cochlear Implant Patient Follow-up
A study testing Self-adjustment tests in people with Cochlear Diseases, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Diseases
- What is being tested?
- Self-adjustment tests
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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:
- 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;
- 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);
- 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.
- 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.
Read the detailed description
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
- Conditions
- Cochlear Diseases
- Being tested
- Self-adjustment tests
- Keywords
- Cochlear Implantation, telemonitoring, training workshop
- Medical subject headings
- Cochlear Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-adjustment testsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Self-adjustment tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
For the patients: The results of Qualitative Self questionnaire, EVA scale, and free comments, according to the scoring manual, will be aggregated to estimate the degree of satisfaction.
Measured: 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
For the professionals: The results of Qualitative Self questionnaire, EVA scale, and free comments, according to the scoring manual, will be aggregated to estimate the degree of satisfaction.
Measured: Between day +8 to +30 after the training session
Estimate the necessary adaptations of the medical team and patients
When the patients come back (between Day +8 to Day+30), they do the same tests alone, by themselves. The staff checks if the results are the same as those of the tests at day 0, (without any medical or technical intercurrent event).
We note the time spent for each test by the patient. Each professional involved in the process of teaching, coaching and assessing the patient through the study will fill a chart detailing his/her actions and keep a record of his/her dedicated time.
By this approach, we hope building a team adapted to the remote monitoring applied to cochlear implant patient follow-up.
Measured: Between day +8 to +30 after the training session
Estimate time savings for professionals
Comparison of the time spent for acts realized in a traditional way and the way according to the protocol, for professionals.
Measured: Between day +8 to +30 after the training session
Estimate time savings for patients
Comparison of the time spent for acts realized in a traditional way and the way according to the protocol, for patients.
Measured: Between day +8 to +30 after the training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study startMar 2019 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine PONCET WALLET, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874533
- Sponsor's protocol ID
- APHP180004
- Acronym
- TELESURVIC
- Status last verified
- Mar 2019
- First submitted
- 30 Aug 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring Applied to Cochlear Implant Patient Follow-up (TELESURVIC)
- ClinicalTrials.gov ID
- NCT03874533
- Acronym / sponsor ID
- TELESURVIC / APHP180004
- Conditions
- Cochlear Diseases
- Keywords
- Cochlear Implantation, telemonitoring, training workshop
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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);
- 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.
- 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.
Detailed description
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| self-adjustment tests | Experimental | Device: Self-adjustment testsFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-adjustment testsFor 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 |
Primary outcome
The degree of auditory rehabilitation achieved with the cochlear implant.
Time frame: Between day +8 to +30 after the training session
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
The degree of auditory rehabilitation achieved with the cochlear implant.
Time frame: Between day +8 to +30 after the training session
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
5 secondary outcomes
Estimate the degree of patients satisfaction, on the use of new tools that will be used for remote monitoring
Time frame: 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
Time frame: Between day +8 to +30 after the training session
Estimate the necessary adaptations of the medical team and patients
Time frame: Between day +8 to +30 after the training session
Estimate time savings for professionals
Time frame: Between day +8 to +30 after the training session
Estimate time savings for patients
Time frame: Between day +8 to +30 after the training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Cochlear Diseases
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine PONCET WALLET, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Self-adjustment tests in people with Cochlear Diseases, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine PONCET WALLET, MD (+33 1 40 19 36 61, christine.poncet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of auditory rehabilitation achieved with the cochlear implant. (time frame: Between day +8 to +30 after the training session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.