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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach

4 countries

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

First Submitted

Initial submission to the registry

March 2, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed

8 months until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

January 8, 2024

Completed

Last Updated

January 8, 2024

Status Verified

March 1, 2023

Enrollment Period

4.4 years

First QC Date

March 2, 2017

Results QC Date

March 29, 2023

Last Update Submit

March 29, 2023

Conditions

Hearing Loss

Keywords

Cochlear implant treatment, aging adults

Outcome Measures

Primary Outcomes (2)

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

Study Arms (1)

Commercial Nucleus Cochlear Implant Systems

Device: Commercial Nucleus Cochlear Implant Systems

Interventions

Commercial Nucleus Cochlear Implant SystemsDEVICE

Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality

Commercial Nucleus Cochlear Implant Systems

Eligibility Criteria

Age60 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Cochlearlead

Study Sites (8)

Groupe Hospitalier de La Pitié Salpétrière

Paris, France

Location

ENT Department-Hôpital Purpan

Toulouse, France

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Rabin Medical Center (Beilinson)

Petah Tikva, Israel

Location

ENT Otosurgery Department-Azienda Ospedaliera di Padova

Padua, Italy

Location

ENT Department Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Related Publications (2)

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.
PMID: 38178036DERIVED
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.
PMID: 32703167DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: PRS Specialist, Clinical Affairs
Organization: Cochlear

Study Officials

Bart Volckaerts, PhD
Cochlear
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 7, 2017

Study Start

November 6, 2017

Primary Completion

March 21, 2022

Study Completion

March 21, 2022

Last Updated

January 8, 2024

Results First Posted

January 8, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing: Will not share

Locations

ES(2)IT(2)FR(2)IL(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Commercial Nucleus Cochlear Implant Systems

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations