Clinical Trial

Patient-Oriented Research to Optimize Cochlear Implant Outcomes

Not Yet Recruiting
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Summary
The rationale is that only through understanding how individual Cochlear Implant (CI) patients respond to interventions investigators further develop precision-medicine approaches to optimize outcomes. In the proposed research study to investigate the hypotheses, investigators will address two Specific Aims: Specific Aim #1: Define the auditory (bottom-up), cognitive-linguistic (top-down), and functional neuroimaging profiles of adult CI users. Investigators will enroll experienced CI users (\> 6 months of CI use). Specific Aim #2: Determine the feasibility of "auditory" (bottom-up) and "cognitive" (top-down) interventions to improve speech processing in adult CI users. The main hypothesis is that the two interventions are feasible. Investigators also hypothesize that our study protocol will detect the variance in auditory processing profiles and that investigators will show promise in improving both speech processing (using speech recognition and Functional Near-Infrared Spectroscopy (fNIRS) responses)) and real-world functioning (using patient-reported measures), compared with no intervention. Additional hypotheses to be explored are that baseline profile (as defined in Aim #1) will impact the magnitude of participants' responses to the interventions, as will order of interventions (Auditory-Cognitive vs. Cognitive-Auditory, AC vs CA).
Trial Details
NCT Number NCT07678879
Lead Sponsor Vanderbilt University Medical Center
Conditions Cochlear Implant, Cochlear Implant Users, Cochlear Implant Recipients, Cochlear Implant Listeners
Enrollment 100 participants
Start Date 2026-07
Primary Completion 2031-06 (estimated)
Study Completion 2032-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-01