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NCT05992779 Clinical Trial

Cochlear Implantation in the Elderly

Implant Clinical Trial

— RCIVELDO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05992779
Other study ID # 69HCL23_0758
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 3, 2023
Est. completion date October 31, 2023

Study information
Verified date July 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date October 31, 2023
Est. primary completion date May 3, 2023
Accepts healthy volunteers
Gender All
Age group 80 Years and older
Eligibility - Inclusion Criteria : - 80 years or more - Primo-implantation - Exclusion Criteria : - Under 80 years - Bilateralisation - Explantation or re-implantation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Measuring the vocal audiometry of patients.
Measuring vocal audiometry at 6 months, 1 year and annually until the last date of follow-up
• Measuring data loging
Measuring data loging at 6 months, 1 year and then annually until last date of follow-up

Locations
Country Name City State
France Hôpital Edouard Herriot Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vocal audiometry Through study completion, an average of 1 year
Primary Data Loging Through study completion, an average of 1 year
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