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Clinical Trials/NCT06607146
NCT06607146
Recruiting
Not Applicable

Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes

Mayo Clinic1 site in 1 country80 target enrollmentMay 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cochlear Implants
Sponsor
Mayo Clinic
Enrollment
80
Locations
1
Primary Endpoint
Change in Cochlear Implant Quality of Life-35 Profile
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

The purpose of this study is to compare the effectiveness of a free computer-based auditory training program, Sound Success (Advanced Bionics, Valencia, CA), with the current standard of care of patient-directed auditory training in improving common measures of speech recognition and cochlear implant (CI) specific quality-of-life in new adult CI recipients in their first year post-activation.

Registry
clinicaltrials.gov
Start Date
May 9, 2023
End Date
December 31, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew L. Carlson, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment
  • Patients unable or unwilling to use a computer or similar device will be excluded from enrollment.
  • 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.

Outcomes

Primary Outcomes

Change in Cochlear Implant Quality of Life-35 Profile

Time Frame: Baseline, 3 months, 6 months, 12 months

The Cochlear Implant Quality of Life-35 (CIQOL-35) Profile is a patient reported questiornaire that assesses the functional abilities of adult cochlear implant recipients within 6 domains: communication, assessing communication ability in different circumstances; emotional, assessing the impact of hearing on emotional well-being; entertainment, assessing the ability to enjoy television, radio, and music; environmental, assessing the ability to distinguish and localize environmental sounds; listening effort, assessing effort and fatigue associated with receptive communication; and social, assessing the ability to interact and enjoy interaction with groups. Scores are calculated for each domain and ranged from 0 (poorest Quality of Life) to 100 (highest Quality of Life).

Study Sites (1)

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