RCIVELDO: Cochlear Implantation in the Elderly

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05992779
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 6.9
• Patients Per Site Per Month: 21.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Cochlear; Implant	Other: Measuring the vocal audiometry of patients.; Other: Measuring data loging

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: RELEVANCE OF COCHLEAR IMPLANTATION IN THE VERY ELDERLY: LENGTH OF DURATION AND OUTCOMES
• Actual Study Start Date: Apr 3, 2023
• Actual Primary Completion Date: May 3, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Vocal audiometry [Through study completion, an average of 1 year]

2. Data Loging [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 80 Years and Older
• Sexes Eligible for Study: All

• Inclusion Criteria :

• 80 years or more

• Primo-implantation

• Exclusion Criteria :

• Under 80 years

• Bilateralisation

• Explantation or re-implantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Edouard Herriot	Lyon		France	69007

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT05992779
• Other Study ID Numbers: 69HCL23_0758
• First Posted: Aug 15, 2023
• Last Update Posted: Aug 15, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 15, 2023