← Back to all trials
Not Yet Recruiting
NCT07678879
Patient-Oriented Research to Optimize Cochlear Implant Outcomes
Conditions: Cochlear Implant, Cochlear Implant Users, Cochlear Implant Recipients, Cochlear Implant Listeners
Sex: All
Ages: 18 Years – 95 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Vanderbilt University Medical Center
Location: Vanderbilt University Medical Center Nashville Tennessee
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).
Eligibility Criteria
Inclusion Criteria:
1. Adults between ages of 18 years and 95 years
2. Native language is American English
3. Have one or two CIs from any of the three FDA-approved CI manufacturers (Cochlear Americas, Advanced Bionics, MED-EL).
4. Experience of \>6 of CI use.
Exclusion Criteria:
1. Score 24 or below on a visual Mini-Mental State Exam (MMSE; Folstein et al., 1975) to rule out dementia
2. Known diagnosis of dementia
3. Under the age of 18 years
4. Unable to read and write in English (WRAT score \
Source: ClinicalTrials.gov (NCT07678879). StuddyBuddy aggregates publicly available trial information.