Sensorineural Hearing Loss, BilateralPROGRESSNCT05265260
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults
An observational study of Sensorineural Hearing Loss, Bilateral, run by Cochlear at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2022to 20 Sep 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Cochlear Implants recipients who are using currently a Nucleus cochlear implant with moderately severe to profound bilateral sensorineural hearing loss.
Who may be able to join
- 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.
Who cannot join
- Subjects with single-sided deafness (SSD).
- Subjects who are not affiliated to the French Social Security.
- Subjects who are under legal protection.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique
Toulouse, 31059
About this study
Official title: 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.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- Cochlear implant, Sentence recognition, Cognitive processing, Electrophysiology
- Medical subject headings
- Hearing Loss, Sensorineural
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the French MBAA2 Sentence Recognition Test in Quiet
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.
Measured: 1 month post activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start21 Apr 2022
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Mathieu Marx, MD, Principal investigator, Hôpital Pierre-Paul Riquet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265260
- Sponsor's protocol ID
- EMEA5798
- Acronym
- PROGRESS
- Status last verified
- Oct 2023
- First submitted
- 23 Feb 2022
- Last updated
- 5 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study
- ClinicalTrials.gov ID
- NCT05265260
- Acronym / sponsor ID
- PROGRESS / EMEA5798
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- Cochlear implant, Sentence recognition, Cognitive processing, Electrophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Posted 5 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Cochlear Implants recipients who are using currently a Nucleus cochlear implant with moderately severe to profound bilateral sensorineural hearing loss.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- Subjects with single-sided deafness (SSD).
- Subjects who are not affiliated to the French Social Security.
- Subjects who are under legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu Marx, MD principal investigator
Hôpital Pierre-Paul Riquet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss, Bilateral, run by Cochlear at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the French MBAA2 Sentence Recognition Test in Quiet (time frame: 1 month post activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.