Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population

March 29, 2023 updated by: Cochlear

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Groupe Hospitalier de La Pitié Salpétrière
      • Toulouse, France
        • ENT Department-Hôpital Purpan
  • Israel
      • Haifa, Israel
        • Bnai Zion Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center (Beilinson)
  • Italy
      • Padova, Italy
        • ENT Otosurgery Department-Azienda Ospedaliera di Padova
      • Piacenza, Italy
        • ENT Department Ospedale Guglielmo da Saliceto
  • Spain
      • Las Palmas de Gran Canaria, Spain
        • Complejo Hospitalario Universitario Insular Materno Infantil
      • Pamplona, Spain
        • Clinica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly routine clinical patients with permanent hearing loss seeking treatment with a commercial cochlear implant system.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Commercial Nucleus Cochlear Implant Systems
Device: Commercial Nucleus Cochlear Implant Systems
Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-implant surgery, 12 months post-surgery
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.
pre-implant surgery, 18 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Director: Bart Volckaerts, PhD, Cochlear

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2017

Primary Completion (Actual)

March 21, 2022

Study Completion (Actual)

March 21, 2022

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 2, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEL5671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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