Trial Outcomes & Findings for Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population (NCT NCT03072862)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

pre-implant surgery, 12 months post-surgery

Results posted on

2024-01-08

Participant Flow

100 participants were recruited in 8 centres from 06 November 2017 to 21 March 2022.

Participant milestones

Participant milestones
Measure	Commercial Nucleus Cochlear Implant Systems Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
Overall Study STARTED	100
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Commercial Nucleus Cochlear Implant Systems Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	6
Overall Study Protocol Violation	4
Overall Study Physician Decision	2
Overall Study Death	1
Overall Study Adverse Event	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Commercial Nucleus Cochlear Implant Systems n=98 Participants Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
Age, Continuous	71.7 years STANDARD_DEVIATION 7.6 • n=98 Participants
Sex: Female, Male Female	43 Participants n=98 Participants
Sex: Female, Male Male	55 Participants n=98 Participants
Region of Enrollment Italy	35 participants n=98 Participants
Region of Enrollment Israel	7 participants n=98 Participants
Region of Enrollment France	35 participants n=98 Participants
Region of Enrollment Spain	21 participants n=98 Participants

PRIMARY outcome

Timeframe: pre-implant surgery, 12 months post-surgery

Population: Data were available for 85 participants for analysis.

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.

Outcome measures

Outcome measures
Measure	Commercial Nucleus Cochlear Implant Systems n=85 Participants Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
Change in Health Related Quality of Life Following Cochlear Implant Treatment Multi-attribute score	0.14 units on a scale Interval 0.08 to 0.19
Change in Health Related Quality of Life Following Cochlear Implant Treatment Hearing single-attribute	0.22 units on a scale Interval 0.16 to 0.29
Change in Health Related Quality of Life Following Cochlear Implant Treatment Speech single-attribute	0.08 units on a scale Interval 0.03 to 0.12

PRIMARY outcome

Timeframe: pre-implant surgery, 18 months post-surgery

Population: Data were available for 82 participants for analysis.

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.

Outcome measures

Outcome measures
Measure	Commercial Nucleus Cochlear Implant Systems n=82 Participants Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
Change in Health Related Quality of Life Following Cochlear Implant Treatment Hearing single-attribute	0.25 units on a scale Interval 0.18 to 0.31
Change in Health Related Quality of Life Following Cochlear Implant Treatment Speech single-attribute	0.08 units on a scale Interval 0.03 to 0.14
Change in Health Related Quality of Life Following Cochlear Implant Treatment Multi-attribute	0.13 units on a scale Interval 0.07 to 0.18

Adverse Events

Commercial Nucleus Cochlear Implant Systems

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Commercial Nucleus Cochlear Implant Systems n=100 participants at risk Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
Product Issues Magnet dislocation after MRI (Magnetic Resonance Imaging)	2.0% 2/100 • Number of events 100 • 20 months Incidents defined as "any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, any inadequacy in the information supplied by the manufacturer as well as any undesirable side-effect" were collected. One participant died; the cause of death was not related to the device.

Other adverse events

Adverse event data not reported

Additional Information

PRS Specialist, Clinical Affairs

Cochlear

Phone: +61 2 9428 6555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee It is planned to generate at least two joint publications by the clinical investigator(s), with support from the sponsor using collective data. Publications are requested to be reviewed by the sponsor at least 30 days in advance to submission for publication. Investigators are able to publish their local data separately. The sponsor kindly requests a copy of manuscripts intended for submission for publication least 60 days in advance of submission.
Publication restrictions are in place

Restriction type: OTHER