Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults (PROGRESS)

October 10, 2023 updated by: Cochlear

Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study

The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult Cochlear Implants recipients who are using currently a Nucleus cochlear implant with moderately severe to profound bilateral sensorineural hearing loss.

Description

Inclusion Criteria:

  • Adult subjects, 18 years or older
  • Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.
  • Subjects who have been implanted between January 2016 and December 2021.
  • Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 off-the-ear types.
  • Subjects who are fluent in French (language used in the questionnaire and speech tests)
  • Subjects who are not opposed to participating in the study
  • Subjects for who the medical record data is available throughout the defined data search period.

Exclusion Criteria:

  • Subjects with single-sided deafness (SSD).
  • Subjects who are not affiliated to the French Social Security.
  • Subjects who are under legal protection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of the French MBAA2 Sentence Recognition Test in Quiet
Time Frame: 1 month post activation
Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of <90/100 correct sentence.
1 month post activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Collaborators

EVAMED

Investigators

  • Principal Investigator: Mathieu Marx, MD, Hôpital Pierre-Paul Riquet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

September 20, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMEA5798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sensorineural Hearing Loss, Bilateral

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