Clinical trial NCT03072862: Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population
Official title: Cochlear Implant and Healthy Aging: A Multinational, Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: Cochlear implant treatment, aging adults
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly routine clinical patients with permanent hearing loss seeking treatment with a commercial cochlear implant system.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Health Related Quality of Life Following Cochlear Implant Treatment
timeFrame: pre-implant surgery, 12 months post-surgery
measure: Change in Health Related Quality of Life Following Cochlear Implant Treatment
timeFrame: pre-implant surgery, 18 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier de La Pitié Salpétrière
city: Toulouse
country: France
facility: ENT Department-Hôpital Purpan
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center (Beilinson)
city: Padova
country: Italy
facility: ENT Otosurgery Department-Azienda Ospedaliera di Padova
city: Piacenza
country: Italy
facility: ENT Department Ospedale Guglielmo da Saliceto
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
Study officials:
affiliation: Cochlear
name: Bart Volckaerts, PhD
role: STUDY_DIRECTOR
References:
citation: 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.