Hearing LossEMPSICOTNCT05566353
Telemonitoring in Cochlear Implant Patient Care
A study testing Remote Check in people with Hearing Loss, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Following a sufficient delay after the cochlear implantation and initial implant activation, the patient will return to the hospital for follow-up visits for equipment maintenance and auditory performance evaluation only once per year. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Remote Check
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2022to 20 Jun 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects-users of uni- or bilateral cochlear implants (Cl24RE, series 400, 500 and 600) and Cochlear Nucleus processor CP1000 or CP1150 during one year minimum
- Subjects who have already renewed their processor at least once
- Subjects implanted for more than 5 years
- Over 20 years old
- Subjects with Apple or Android smartphones compatible with Remote Check
Who cannot join
- Associated physical (visual, motor...) or severe cognitive (dementia, specific language development troubles) making impossible the use of smartphone software and the conduction of hearing tests
- Patients unable to give oral informed consent
- Patients residing in geographical zones with limited internet access
- Subjects deprived of liberty by juridical or administrative decision
- Patients subjected to legal protection measures (guardianship or curatorship)
- Subjects for whom French is not a native language
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Montpellier
Montpellier
Frédéric Venail
About this study
Official title: Evaluation of the Changes in Cochlear Implant Patients Care Pathway With the Use of Telemonitoring
Following a sufficient delay after the cochlear implantation and initial implant activation, the patient will return to the hospital for follow-up visits for equipment maintenance and auditory performance evaluation only once per year. This frequency might appear either insufficient, in which case an additional patient check-up will be arranged, or excessive if patient performances and implant adjustments are stable. Using at-home testing tool for remote hearing performance monitoring can thus appear advantageous for both patients and clinicians, allowing to avoid an unnecessary journey to the implantation reference center for the first and to diminish a number of unscheduled medical appointments for the second.
Read the detailed description
In December 2020, the French Medical Device and Health Technology Evaluation Committee (CNEDiMTS) voted in favour of the integration of telemonitoring in cochlear implant users' follow-up thus adding a range of new possibilities to a standard health care routine.
According to the official recommendations of the French National Authority for Health, a patient implanted for a sufficiently long time should be seen annually at the implantation reference center. This periodicity might appear too low, in which case a patient will have to organise an unscheduled check-up appointment. Such appointments are a source of various problems: firstly, they disorganise the routine of the reference centers not adapted for emergency and semi-emergency situations; secondly, the patient might encounter substantial travelling fees (only 22 refence centers in France), especially if an implant component to replace is out of stock. Having an utility of remote patient monitoring is also beneficial in situations where the access to health care system is restricted, for example, the recent pandemic of Covid 19.
Cochlear™ has recently designed an at-home based patient testing tool, Remote Check application, permitting to complete a series of hearing test from a compatible smartphone. The results are then sent to the implantation reference center and evaluated by healthcare professionals. The data is securely stored on Cloud accessible to authorised clinicians via MyCochlear site.
Although the feasibility and the accuracy in detecting technical problems of remote follow-up of people with cochlear implant had been already assessed, its impact on health care system is still unknown. Hence, this project will be the first to evaluate an interest of implementing remote monitoring in following adults with cochlear implantation.
The main objective of the study is - to determine if the use of telemonitoring through Remote Check application reduces significantly a number of unscheduled check-up appointments in the reference centre during 1 year follow-up period for a patient with a cochlear implant Cochlear™ in comparison to traditional health care approach.
The secondary objectives are:
- To compare a number of scheduled appointments during a period of Remote Check use versus a historical period of a traditional follow-up
- To compare a number of indispensable unscheduled visits (unavoidable with or without Remote Check use) with a number of unnecessary ones (avoidable with Remote Check)
- To measure the compliance of the Remote Check application use
- To assess quantitatively and qualitatively a number of implant failures/dysfunctions identified with Remote Check
- To evaluate for each study participant time spent by clinician to treat Remote Check analysis data uploaded to My Cochlear data base
- To assess patients satisfaction of Remote Check implementation in their healthcare routine
- To evaluate the quality of life specific to the Deaf before and after Remote Check use The study implies four visits for each patient. The inclusion visit (V0) is a routine check-up appointment in the implantation reference center. After the patient is informed and his/her consent is collected, the Remote Check application will be activated on his/her processor. Two next follow-up visits, V1 (V0+ 5 mois (± 0.5 mois)) and V2 (V0 + 11 mois (± 0.5 mois)), are remote visits with hearing test performed through Remote Check application. Final visit, V3 (V0 + 12 mois (± 0.5 mois)), corresponds to patient's annual check-up appointment. In case a problem with processor's functioning is detected during V2, it will be resolved at V3. Equipment verification will be also performed to detect failures missed by Remote Check.
- Conditions
- Hearing Loss
- Being tested
- Remote Check
- Keywords
- Remote monitoring, Cochlear implant, Telemedicine, Healthcare system
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote CheckOther
Remote Check is a remote monitoring tool which permits patients with Cochlear Nucleus CP1000 or CP1150 processors to complete hearing tests (pure-tone and speech-in-voice audiometry, electrode impedance measures, implant functioning assessment) at home,
| Study group | Role | What they receive |
|---|---|---|
| Patients followed at the implantation reference centers | Experimental | Patients eligible for implant processor renewal in 2 years and corresponding to inclusion criteria will be enrolled during their routine check-up appointment at the implantation reference centers of the University Hospitals of Montpellier and Toulouse. Patients will be their own controls through the use of their medical history data. Receives: Other: Remote Check |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with at least one unscheduled follow-up visit
Annual percentage of patients-cochlear implant users having at least one unscheduled appointment at the reference center
Measured: 24 months from the start of the study
Secondary outcomes (6)
Scheduled and unscheduled visits during 1 year
The number of scheduled and unscheduled (avoidable and unavoidable) visits during 1 year
Measured: 24 months from the start of the study
Compliance measures
The compliance will be measured by the number of Remote Check assessments in one year after the start of remote monitoring. Assessments performed within the timeframe and after the deadline will be identified.
Measured: 24 months from the start of the study
Equipment failures and dysfunctions
The number and the type of failures/dysfunctions identified by Remote Check
Measured: 24 months from the start of the study
Time spent in MyCochlear for each patient
Clinician login time spent on each subject's file on MyCochlear data base during the year of follow up
Measured: 24 months from the start of the study
Patient satisfaction
Patient satisfaction measured by the questionnaire validated in French language: "the Service User Technology Acceptability (SUTAQ)". Score will be assessed by 5 options from "Strongly disagree" (worse outcome), "Disagree somewhat", "Neither agree nor disagree", "agree somewhat" to "strongly agree" (better outcome)
Measured: 24 months from the start of the study
Patient's Quality of Life
Patient's quality of life score linked to deafness will be measured by the questionnaire Speech, Spatial and Qualities of Hearing scale (Sp-SSQ12) validated in french. Score will run from 0 (worse outcome) to 10 (better outcome)
Measured: 24 months from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start20 Dec 2022
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Toulouse, Groupement Interrégional de Recherche Clinique et d'Innovation, Foundation maladies rares, France, Cochlear
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566353
- Sponsor's protocol ID
- RECHMPL21_0519
- Acronym
- EMPSICOT
- Status last verified
- May 2024
- First submitted
- 29 Sep 2022
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Changes in Cochlear Implant Patients Care Pathway With the Use of Telemonitoring
- ClinicalTrials.gov ID
- NCT05566353
- Acronym / sponsor ID
- EMPSICOT / RECHMPL21_0519
- Conditions
- Hearing Loss
- Keywords
- Remote monitoring, Cochlear implant, Telemedicine, Healthcare system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Toulouse, Groupement Interrégional de Recherche Clinique et d'Innovation, Foundation maladies rares, France, Cochlear
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 4 Oct 2022 (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.
Following a sufficient delay after the cochlear implantation and initial implant activation, the patient will return to the hospital for follow-up visits for equipment maintenance and auditory performance evaluation only once per year. This frequency might appear either insufficient, in which case an additional patient check-up will be arranged, or excessive if patient performances and implant adjustments are stable. Using at-home testing tool for remote hearing performance monitoring can thus appear advantageous for both patients and clinicians, allowing to avoid an unnecessary journey to the implantation reference center for the first and to diminish a number of unscheduled medical appointments for the second.
Detailed description
In December 2020, the French Medical Device and Health Technology Evaluation Committee (CNEDiMTS) voted in favour of the integration of telemonitoring in cochlear implant users' follow-up thus adding a range of new possibilities to a standard health care routine.
According to the official recommendations of the French National Authority for Health, a patient implanted for a sufficiently long time should be seen annually at the implantation reference center. This periodicity might appear too low, in which case a patient will have to organise an unscheduled check-up appointment. Such appointments are a source of various problems: firstly, they disorganise the routine of the reference centers not adapted for emergency and semi-emergency situations; secondly, the patient might encounter substantial travelling fees (only 22 refence centers in France), especially if an implant component to replace is out of stock. Having an utility of remote patient monitoring is also beneficial in situations where the access to health care system is restricted, for example, the recent pandemic of Covid 19.
Cochlear™ has recently designed an at-home based patient testing tool, Remote Check application, permitting to complete a series of hearing test from a compatible smartphone. The results are then sent to the implantation reference center and evaluated by healthcare professionals. The data is securely stored on Cloud accessible to authorised clinicians via MyCochlear site.
Although the feasibility and the accuracy in detecting technical problems of remote follow-up of people with cochlear implant had been already assessed, its impact on health care system is still unknown. Hence, this project will be the first to evaluate an interest of implementing remote monitoring in following adults with cochlear implantation.
The main objective of the study is - to determine if the use of telemonitoring through Remote Check application reduces significantly a number of unscheduled check-up appointments in the reference centre during 1 year follow-up period for a patient with a cochlear implant Cochlear™ in comparison to traditional health care approach.
The secondary objectives are:
- To compare a number of scheduled appointments during a period of Remote Check use versus a historical period of a traditional follow-up
- To compare a number of indispensable unscheduled visits (unavoidable with or without Remote Check use) with a number of unnecessary ones (avoidable with Remote Check)
- To measure the compliance of the Remote Check application use
- To assess quantitatively and qualitatively a number of implant failures/dysfunctions identified with Remote Check
- To evaluate for each study participant time spent by clinician to treat Remote Check analysis data uploaded to My Cochlear data base
- To assess patients satisfaction of Remote Check implementation in their healthcare routine
- To evaluate the quality of life specific to the Deaf before and after Remote Check use The study implies four visits for each patient. The inclusion visit (V0) is a routine check-up appointment in the implantation reference center. After the patient is informed and his/her consent is collected, the Remote Check application will be activated on his/her processor. Two next follow-up visits, V1 (V0+ 5 mois (± 0.5 mois)) and V2 (V0 + 11 mois (± 0.5 mois)), are remote visits with hearing test performed through Remote Check application. Final visit, V3 (V0 + 12 mois (± 0.5 mois)), corresponds to patient's annual check-up appointment. In case a problem with processor's functioning is detected during V2, it will be resolved at V3. Equipment verification will be also performed to detect failures missed by Remote Check.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients followed at the implantation reference centers | Experimental | Other: Remote CheckPatients eligible for implant processor renewal in 2 years and corresponding to inclusion criteria will be enrolled during their routine check-up appointment at the implantation reference centers of the University Hospitals of Montpellier and Toulouse. Patients will be their own controls through the use of their medical history data. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects-users of uni- or bilateral cochlear implants (Cl24RE, series 400, 500 and 600) and Cochlear Nucleus processor CP1000 or CP1150 during one year minimum
- Subjects who have already renewed their processor at least once
- Subjects implanted for more than 5 years
- Over 20 years old
- Subjects with Apple or Android smartphones compatible with Remote Check
Key exclusion criteria (6 listed)
- Associated physical (visual, motor...) or severe cognitive (dementia, specific language development troubles) making impossible the use of smartphone software and the conduction of hearing tests
- Patients unable to give oral informed consent
- Patients residing in geographical zones with limited internet access
- Subjects deprived of liberty by juridical or administrative decision
- Patients subjected to legal protection measures (guardianship or curatorship)
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 |
|---|---|---|
| Remote CheckRemote Check is a remote monitoring tool which permits patients with Cochlear Nucleus CP1000 or CP1150 processors to complete hearing tests (pure-tone and speech-in-voice audiometry, electrode impedance measures, implant functioning assessment) at home, | Other | Patients followed at the implantation reference centers |
Primary outcome
Patients with at least one unscheduled follow-up visit
Time frame: 24 months from the start of the study
Annual percentage of patients-cochlear implant users having at least one unscheduled appointment at the reference center
6 secondary outcomes
Scheduled and unscheduled visits during 1 year
Time frame: 24 months from the start of the study
Compliance measures
Time frame: 24 months from the start of the study
Equipment failures and dysfunctions
Time frame: 24 months from the start of the study
Time spent in MyCochlear for each patient
Time frame: 24 months from the start of the study
Patient satisfaction
Time frame: 24 months from the start of the study
Patient's Quality of Life
Time frame: 24 months from the start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Check in people with Hearing Loss, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 6 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Frédéric Venail, PhD, MD (+33467336890, f-venail@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with at least one unscheduled follow-up visit (time frame: 24 months from the start of the study). 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 28 May 2024.