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Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear (IROS)

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ClinicalTrials.gov Identifier: NCT02004353
Recruitment Status : Terminated (Original study purpose accomplished)
First Posted : December 9, 2013
Results First Posted : November 8, 2021
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Cochlear

Tracking Information
First Submitted Date November 26, 2013
First Posted Date December 9, 2013
Results First Submitted Date September 2, 2021
Results First Posted Date November 8, 2021
Last Update Posted Date November 8, 2021
Study Start Date July 2011
Actual Primary Completion Date June 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2021)
  • Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire [ Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year ]
    A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 1 year is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
  • Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire [ Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years ]
    A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 2 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
  • Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire [ Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years ]
    A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 3 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
  • Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire [ Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year ]
    A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 1 year is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
  • Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire [ Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years ]
    A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 2 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
  • Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire [ Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years ]
    A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 3 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Original Primary Outcome Measures
 (submitted: December 3, 2013)
  • Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [ Time Frame: Baseline (i.e. pre-implanted status) assessed prior to 1st switch-on ]
  • Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [ Time Frame: post-implant at 1 year ]
  • Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [ Time Frame: post-implant at 2 years ]
  • Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [ Time Frame: Baseline (i.e. pre-implanted status) assessed prior to 1st switch-on ]
  • Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [ Time Frame: post-implant at 1year ]
  • Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [ Time Frame: post-implant at 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: October 8, 2021)
  • Unaided Hearing Thresholds [ Time Frame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 500 Hz and 4000 Hz
  • Unaided Hearing Thresholds [ Time Frame: post-implant at 1 year ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 500 and 4000 Hz
  • Unaided Hearing Thresholds [ Time Frame: immediately post-implant ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
  • Unaided Hearing Thresholds [ Time Frame: post-implant at 2 years ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
Original Secondary Outcome Measures
 (submitted: December 3, 2013)
  • Unaided hearing thresholds [ Time Frame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
  • Unaided hearing thresholds [ Time Frame: immediately post-implant (optional) ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
  • Unaided hearing thresholds [ Time Frame: post-implant at 1 year ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
  • Unaided hearing thresholds [ Time Frame: post-implant at 2 years ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: December 3, 2013)
  • General Patient Hearing Profile Information [ Time Frame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on ]
    General Patient Hearing Profile Information related to hearing history and daily hearing device use
  • General Patient Hearing Profile Information [ Time Frame: post-implant at 1 year ]
    General Patient Hearing Profile Information related to hearing history and daily hearing device use
  • General Patient Hearing Profile Information [ Time Frame: post-implant at 2 years ]
    General Patient Hearing Profile Information related to hearing history and daily hearing device use
 
Descriptive Information
Brief Title Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
Official Title Cochlear-Implanted Recipient Observational Study
Brief Summary

The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment.

Assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.

Detailed Description

The clinical investigation is designed as a prospective repeated measures longitudinal study with intra-subject controls, using a selection of subjective evaluation tools to assess patient related benefits from hearing implant treatment of permanent hearing loss.

Clinically standard self-assessment scales, threshold measures and a general hearing history profile questionnaires for the clinician and implant recipient are made available for selection through an interface to a central electronic platform.

The registry 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 registry participation following implant by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.

Monitoring of data entry is included through automated reminders via e-platform and through inherent audit trail.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care routine clinical patients, with permanent hearing loss seeking implant treatment for hearing rehabilitation. Adolescent and Adult patients have limited or no benefit from conventional acoustic hearing aids.
Condition Hearing Loss
Intervention Device: Cochlear® Hearing Implants
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants
Study Groups/Cohorts Cochlear® Hearing Implants, hearing loss
Implanted Adolescents and Adults with permanent hearing loss
Intervention: Device: Cochlear® Hearing Implants
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: November 5, 2020)
1518
Original Estimated Enrollment
 (submitted: December 3, 2013)
500
Actual Study Completion Date July 31, 2020
Actual Primary Completion Date June 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Post-lingually deafened adults and adolescents who are newly implanted AND prior to first switch-on of their external device
  • Unilateral, bilateral simultaneous recipients of any implant device(s) available with market approval from the company Cochlear®
  • Children 10 years or older and in accordance with local regulations and product labelling
  • Mentally capable to respond to self-administered assessment scales
  • Willingness to participate and sign the Patient Informed Consent form

Exclusion Criteria:

  • Individuals excluded from participation in a registry according to national or local regulations
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Austria,   Belgium,   Brazil,   Colombia,   France,   Germany,   Hungary,   Netherlands,   Poland,   Portugal,   Slovenia,   South Africa,   Spain,   Sweden,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT02004353
Other Study ID Numbers CEL 5277
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Cochlear
Study Sponsor Cochlear
Collaborators Not Provided
Investigators
Study Director: Bart Volckaerts Cochlear
PRS Account Cochlear
Verification Date November 2020