Cochlear Implantation in the Elderly (RCIVELDO)

August 11, 2023 updated by: Hospices Civils de Lyon

RELEVANCE OF COCHLEAR IMPLANTATION IN THE VERY ELDERLY: LENGTH OF DURATION AND OUTCOMES

The goal of this study is to demonstrate that cochlear implantation is an effective, reasonable, and viable long-term option within a very elderly population

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients 80 years or more

Description

  • Inclusion Criteria :

    • 80 years or more
    • Primo-implantation

  • Exclusion Criteria :

    • Under 80 years
    • Bilateralisation
    • Explantation or re-implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient elderly implanted
Patients over 80 years old, primo implanted between 2011 and 2021
Other: Measuring the vocal audiometry of patients.
Measuring vocal audiometry at 6 months, 1 year and annually until the last date of follow-up
Other: Measuring data loging
Measuring data loging at 6 months, 1 year and then annually until last date of follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vocal audiometry
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Data Loging
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Actual)

May 3, 2023

Study Completion (Estimated)

October 31, 2023

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 69HCL23_0758

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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