Hearing LossNCT03072862
Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population
An observational study of Hearing Loss, run by Cochlear at 8 sites in 4 countries.
Trial summary
The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Commercial Nucleus Cochlear Implant Systems
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 6 Nov 2017to 21 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly routine clinical patients with permanent hearing loss seeking treatment with a commercial cochlear implant system.
Who may be able to join
- Unilateral CI candidates with bilateral post-lingual deafness with intention to treat
- ≥ 60 years at first unilateral cochlear implant
- Implant ear: meets all local criteria for cochlear implant treatment
- Contralateral ear: average pure tone thresholds indicate a moderately-severe to profound hearing loss (4 freq. average: 0.5, 1, 2 and 3 or 4 kHz > 56 dBHL).
- Willingness to participate in and to comply with all study procedures
- Fluency in languages used to assess clinical performance
- Appropriate expectations from routine cochlear implant treatment
- Able to decide on study participation personally and independently sign their consent
Who cannot join
- Significantly/severely dependent or fragile
- Unable to provide consent personally
- Unable to complete questionnaires for self-assessment independently
- Unilateral hearing loss
- Sequential and simultaneous bilateral cochlear implant recipients
- Ossification or other cochlear anomalies preventing full electrode insertion
Show all 11Show fewer
- Retro cochlear or central origins of hearing impairment.
- Significant comorbidities preventing study participation (e.g. blindness, immobility or in a wheel chair, severe aphasia)
- Medical contraindications to surgery
- Clinic Standard fail criteria for cochlear implant candidacy in regards to chronic depression, dementia, and cognitive disorders.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
France2 sites
Groupe Hospitalier de La Pitié Salpétrière
Paris
ENT Department-Hôpital Purpan
Toulouse
Israel2 sites
Bnai Zion Medical Center
Haifa
Rabin Medical Center (Beilinson)
Petah Tikva
Italy2 sites
ENT Otosurgery Department-Azienda Ospedaliera di Padova
Padova
ENT Department Ospedale Guglielmo da Saliceto
Piacenza
Spain2 sites
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria
Clinica Universitaria de Navarra
Pamplona
About this study
Official title: Cochlear Implant and Healthy Aging: A Multinational, Multicentre Observational Study
The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.
Read the detailed description
The study is designed as an observational prospective repeated measures study with each subject acting as his/her own control. Subjects are evaluated subjectively at pre- and post-operative intervals that coincide with their routine visits to the clinic. Outcomes from routine practice and application of cochlear implant intervention are recorded through observational measures using clinical standards scales used widely in geriatrics and audiology. The study is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company Cochlear. Patients are approached for study participation prior to surgery by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.
- Conditions
- Hearing Loss
- Being tested
- Commercial Nucleus Cochlear Implant Systems
- Keywords
- Cochlear implant treatment, aging adults
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial Nucleus Cochlear Implant SystemsDevice
Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
| Study group | Role | What they receive |
|---|---|---|
| Commercial Nucleus Cochlear Implant Systems | Not described Receives: Device: Commercial Nucleus Cochlear Implant Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Related Quality of Life Following Cochlear Implant Treatment
Assessed via the Health Utilities Index Mark III (HUI 3) questionnaire. HUI-3 classification system consists of 8 attributes including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. HUI-3 values range from -0.36 to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Measured: pre-implant surgery, 12 months post-surgery
Change in Health Related Quality of Life Following Cochlear Implant Treatment
Assessed via the Health Utilities Index Mark III (HUI 3) questionnaire. HUI-3 classification system consists of 8 attributes including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. HUI-3 values range from -0.36 to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores will be presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Measured: pre-implant surgery, 18 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start6 Nov 2017
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Volckaerts, PhD, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072862
- Sponsor's protocol ID
- CEL5671
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2017
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cuda D, Manrique M, Ramos A, Marx M, Bovo R, Khnifes R, Hilly O, Belmin J, Stripeikyte G, Graham PL, James CJ, Greenham PV, Mosnier I. Improving quality of life in the elderly: hearing loss treatment with cochlear implants. BMC Geriatr. 2024 Jan 4;24(1):16. doi: 10.1186/s12877-023-04642-2.
PubMed 38178036Marx M, Mosnier I, Belmin J, Wyss J, Coudert-Koall C, Ramos A, Manrique Huarte R, Khnifes R, Hilly O, Martini A, Cuda D. Healthy aging in elderly cochlear implant recipients: a multinational observational study. BMC Geriatr. 2020 Jul 23;20(1):252. doi: 10.1186/s12877-020-01628-2.
PubMed 32703167
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Implant and Healthy Aging: A Multinational, Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT03072862
- Acronym / sponsor ID
- CEL5671
- Conditions
- Hearing Loss
- Keywords
- Cochlear implant treatment, aging adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Posted 8 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.
Detailed description
The study is designed as an observational prospective repeated measures study with each subject acting as his/her own control. Subjects are evaluated subjectively at pre- and post-operative intervals that coincide with their routine visits to the clinic. Outcomes from routine practice and application of cochlear implant intervention are recorded through observational measures using clinical standards scales used widely in geriatrics and audiology. The study is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company Cochlear. Patients are approached for study participation prior to surgery by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Commercial Nucleus Cochlear Implant Systems | – | Device: Commercial Nucleus Cochlear Implant Systems |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly routine clinical patients with permanent hearing loss seeking treatment with a commercial cochlear implant system.
Key inclusion criteria (8 listed)
- Unilateral CI candidates with bilateral post-lingual deafness with intention to treat
- ≥ 60 years at first unilateral cochlear implant
- Implant ear: meets all local criteria for cochlear implant treatment
- Contralateral ear: average pure tone thresholds indicate a moderately-severe to profound hearing loss (4 freq. average: 0.5, 1, 2 and 3 or 4 kHz > 56 dBHL).
- Willingness to participate in and to comply with all study procedures
Key exclusion criteria (11 listed)
- Significantly/severely dependent or fragile
- Unable to provide consent personally
- Unable to complete questionnaires for self-assessment independently
- Unilateral hearing loss
- Sequential and simultaneous bilateral cochlear implant recipients
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 |
|---|---|---|
| Commercial Nucleus Cochlear Implant SystemsCommercially available Nucleus Cochlear Implant Systems, including Data Logging functionality | Device | Commercial Nucleus Cochlear Implant Systems |
Primary outcome
Change in Health Related Quality of Life Following Cochlear Implant Treatment
Time frame: pre-implant surgery, 12 months post-surgery
Assessed via the Health Utilities Index Mark III (HUI 3) questionnaire. HUI-3 classification system consists of 8 attributes including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. HUI-3 values range from -0.36 to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Change in Health Related Quality of Life Following Cochlear Implant Treatment
Time frame: pre-implant surgery, 18 months post-surgery
Assessed via the Health Utilities Index Mark III (HUI 3) questionnaire. HUI-3 classification system consists of 8 attributes including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. HUI-3 values range from -0.36 to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores will be presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38178036Cuda D, Manrique M, Ramos A, Marx M, Bovo R, Khnifes R, Hilly O, Belmin J, Stripeikyte G, Graham PL, James CJ, Greenham PV, Mosnier I. Improving quality of life in the elderly: hearing loss treatment with cochlear implants. BMC Geriatr. 2024 Jan 4;24(1):16. doi: 10.1186/s12877-023-04642-2.
- Derived from this study: PubMed 32703167Marx M, Mosnier I, Belmin J, Wyss J, Coudert-Koall C, Ramos A, Manrique Huarte R, Khnifes R, Hilly O, Martini A, Cuda D. Healthy aging in elderly cochlear implant recipients: a multinational observational study. BMC Geriatr. 2020 Jul 23;20(1):252. doi: 10.1186/s12877-020-01628-2.
- Individual participant dataSharing planned: No
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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.
Bart Volckaerts, PhD study director
Cochlear
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Cochlear at 8 sites in 4 countries.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Israel, Italy, Spain. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Related Quality of Life Following Cochlear Implant Treatment (time frame: pre-implant surgery, 12 months post-surgery). 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?
On the ClinicalTrials.gov record for NCT03072862, which also lists 2 linked publications.
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 8 Jan 2024.