NCT05992779

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 3, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

August 15, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

July 26, 2023

Last Update Submit

August 11, 2023

Conditions

CochlearImplant

Outcome Measures

Primary Outcomes (2)

  • Vocal audiometry

    Through study completion, an average of 1 year

  • Data Loging

    Through study completion, an average of 1 year

Study Arms (1)

Patient elderly implanted

Patients over 80 years old, primo implanted between 2011 and 2021

Other: Measuring the vocal audiometry of patients.Other: Measuring data loging

Interventions

Measuring the vocal audiometry of patients.OTHER

Measuring vocal audiometry at 6 months, 1 year and annually until the last date of follow-up

Patient elderly implanted
Measuring data logingOTHER

Measuring data loging at 6 months, 1 year and then annually until last date of follow-up

Patient elderly implanted

Eligibility Criteria

Age80 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 80 years or more

You may qualify if:

  • years or more
  • Primo-implantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69007, France

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 15, 2023

Study Start

April 3, 2023

Primary Completion

May 3, 2023

Study Completion

October 31, 2023

Last Updated

August 15, 2023

Record last verified: 2023-07

Locations

FR(1)