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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial Nucleus Cochlear Implant Systems |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial Nucleus Cochlear Implant Systems | Device | Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | pre-implant surgery, 18 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly routine clinical patients with permanent hearing loss seeking treatment with a commercial cochlear implant system.
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| Name | Affiliation | Role |
|---|---|---|
| Bart Volckaerts, PhD | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier de La Pitié Salpétrière | Paris | France | ||||
| ENT Department-Hôpital Purpan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38178036 | Derived | 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. | |
| 32703167 | Derived |
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100 participants were recruited in 8 centres from 06 November 2017 to 21 March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Commercial Nucleus Cochlear Implant Systems | Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 participants did not meet the inclusion/exclusion criteria and were excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Commercial Nucleus Cochlear Implant Systems | Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data were available for 85 participants for analysis. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | pre-implant surgery, 12 months post-surgery |
|
20 months
Incidents defined as "any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, any inadequacy in the information supplied by the manufacturer as well as any undesirable side-effect" were collected. One participant died; the cause of death was not related to the device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Commercial Nucleus Cochlear Implant Systems | Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Magnet dislocation after MRI (Magnetic Resonance Imaging) | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2019 | Mar 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 21, 2018 | Mar 21, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Toulouse |
| France |
| Bnai Zion Medical Center | Haifa | Israel |
| Rabin Medical Center (Beilinson) | Petah Tikva | Israel |
| ENT Otosurgery Department-Azienda Ospedaliera di Padova | Padova | Italy |
| ENT Department Ospedale Guglielmo da Saliceto | Piacenza | Italy |
| Complejo Hospitalario Universitario Insular Materno Infantil | Las Palmas de Gran Canaria | Spain |
| Clinica Universitaria de Navarra | Pamplona | Spain |
| Marx 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. |
| Physician Decision |
|
| Death |
|
| Adverse Event |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Data were available for 82 participants for analysis. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | pre-implant surgery, 18 months post-surgery |
|
|
|
| 1 |
| 100 |
| 2 |
| 100 |
| 0 |
| 100 |
It is planned to generate at least two joint publications by the clinical investigator(s), with support from the sponsor using collective data. Publications are requested to be reviewed by the sponsor at least 30 days in advance to submission for publication.
Investigators are able to publish their local data separately. The sponsor kindly requests a copy of manuscripts intended for submission for publication least 60 days in advance of submission.
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|