CochlearRCIVELDONCT05992779
Cochlear Implantation in the Elderly
An observational study of Cochlear and Implant, run by Hospices Civils de Lyon at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 80 years and older
- What is being tested?
- Measuring the vocal audiometry of patients. and Measuring data loging
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2023to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- Older adult
Study population: Patients 80 years or more
Who may be able to join
- 80 years or more
- Primo-implantation
Who cannot join
- Under 80 years
- Bilateralisation
- Explantation or re-implantation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Edouard Herriot
Lyon, 69007
Thomas BOCQUILLON, 642381137 ext. +33, thomas.bocquillon@chu-lyon.fr
Marjolaine BEAUDOIN, Marjolaine.beaudoin@chu-lyon.fr
About this study
Official title: 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
- Being tested
- Measuring the vocal audiometry of patients., Measuring data loging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring the vocal audiometry of patients.Other
Measuring vocal audiometry at 6 months, 1 year and annually until the last date of follow-up
Measuring data logingOther
Measuring data loging at 6 months, 1 year and then annually until last date of follow-up
| Study group | Role | What they receive |
|---|---|---|
| Patient elderly implanted | Patients over 80 years old, primo implanted between 2011 and 2021 Receives: Other: Measuring the vocal audiometry of patients.; Other: Measuring data loging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal audiometry
Measured: Through study completion, an average of 1 year
Data Loging
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start3 Apr 2023
- Primary completion3 May 2023
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CochlearStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992779
- Sponsor's protocol ID
- 69HCL23_0758
- Acronym
- RCIVELDO
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELEVANCE OF COCHLEAR IMPLANTATION IN THE VERY ELDERLY: LENGTH OF DURATION AND OUTCOMES
- ClinicalTrials.gov ID
- NCT05992779
- Acronym / sponsor ID
- RCIVELDO / 69HCL23_0758
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient elderly implanted | – | Other: Measuring the vocal audiometry of patients., Other: Measuring data logingPatients over 80 years old, primo implanted between 2011 and 2021 |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients 80 years or more
Key inclusion criteria (2 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measuring the vocal audiometry of patients.Measuring vocal audiometry at 6 months, 1 year and annually until the last date of follow-up | Other | Patient elderly implanted |
| Measuring data logingMeasuring data loging at 6 months, 1 year and then annually until last date of follow-up | Other | Patient elderly implanted |
Primary outcome
Vocal audiometry
Time frame: Through study completion, an average of 1 year
Data Loging
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear and Implant, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal audiometry (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.