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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072862
Recruitment Status : Active, not recruiting
First Posted : March 7, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Cochlear

Brief 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.

Condition or disease Intervention/treatment
Hearing Loss Device: Commercial Nucleus Cochlear Implant Systems

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cochlear Implant and Healthy Aging: A Multinational, Multicentre Observational Study
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072862


Locations
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France
Groupe Hospitalier de La Pitié Salpétrière
Paris, France
ENT Department-Hôpital Purpan
Toulouse, France
Israel
Bnai Zion Medical Center
Haifa, Israel
Rabin Medical Center (Beilinson)
Petah Tikva, Israel
Italy
ENT Otosurgery Department-Azienda Ospedaliera di Padova
Padova, Italy
ENT Department Ospedale Guglielmo da Saliceto
Piacenza, Italy
Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Sponsors and Collaborators
Cochlear
Investigators
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Study Director: Bart Volckaerts, PhD Cochlear
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT03072862    
Other Study ID Numbers: CEL5671
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cochlear:
Cochlear implant treatment, aging adults
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases