NCT05566353

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

September 29, 2022

Last Update Submit

May 24, 2024

Conditions

Hearing Loss

Keywords

Remote monitoringCochlear implantTelemedicineHealthcare system

Outcome Measures

Primary Outcomes (1)

  • 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

    24 months from the start of the study

Secondary Outcomes (6)

  • Scheduled and unscheduled visits during 1 year

    24 months from the start of the study

  • Compliance measures

    24 months from the start of the study

  • Equipment failures and dysfunctions

    24 months from the start of the study

  • Time spent in MyCochlear for each patient

    24 months from the start of the study

  • Patient satisfaction

    24 months from the start of the study

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Remote Check

Interventions

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,

Patients followed at the implantation reference centers

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Frédéric Venail, PhD, MD

CONTACT

+33467336890f-venail@chu-montpellier.fr

Olivier Deguine, PhD, MD

CONTACT

+33561772211deguine.o@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 4, 2022

Study Start

December 20, 2022

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

FR(1)