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Auditory Training for Cochlear Implant Recipients
N/A
Recruiting
Led By Matthew Carlson, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients with a diagnosis of bilateral moderate-to-profound sensorineural hearing loss who are undergoing unilateral or simultaneous bilateral cochlear implantation at the Mayo Clinic in Rochester MN.
Be older than 18 years old
Must not have
Patients will be excluded if they speak a language not supported by the Sound Success platform. Sound Success is available in English, Spanish, French, Italian, Dutch, Polish, and Danish.
Patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 12 months
Summary
This trial aims to see if a new computer-based auditory training program called Sound Success is better than the current standard patient-directed auditory training in helping new adult cochlear implant recipients improve their speech recognition and quality
Who is the study for?
This trial is for adults who have recently received a cochlear implant and are in their first year post-activation. They should be looking to improve speech recognition and quality of life with their new implant.
What is being tested?
The study compares Sound Success, a free computer-based auditory training program, with the standard patient-directed auditory training to see which one better improves speech recognition and quality-of-life for new adult cochlear implant users.
What are the potential side effects?
Since this trial involves non-invasive auditory training programs rather than medication or surgery, there are no direct physical side effects expected from participating.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe hearing loss in both ears and am getting a cochlear implant at Mayo Clinic.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I speak a language supported by Sound Success (English, Spanish, French, Italian, Dutch, Polish, Danish).
Select...
I am not getting a cochlear implant for the first time or for both ears at once.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cochlear Implant Quality of Life-35 Profile
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental GroupExperimental Treatment1 Intervention
Group II: Control GroupPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,881 Total Patients Enrolled
Matthew Carlson, M.D.Principal InvestigatorMayo Clinic