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

Hearing Loss Clinical Trial

Official title:

Cochlear Implant and Healthy Aging: A Multinational, Multicentre Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072862
• Other study ID #: CEL5671
• Status: Completed
• Start date: November 6, 2017
• Est. completion date: March 21, 2022

Study information

• Verified date: March 2023
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Commercial Nucleus Cochlear Implant Systems
Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Countries where clinical trial is conducted

France,  Israel,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	pre-implant surgery, 12 months post-surgery
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.	pre-implant surgery, 18 months post-surgery