Interventions for Cochlear Implant Users
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Are You a Good Fit for This Trial?
This trial is for adults who have been using a cochlear implant for more than 6 months. Participants should be experienced CI users and able to take part in hearing and cognitive tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo auditory, cognitive-linguistic, and functional neuroimaging assessments
Intervention
Participants receive either auditory or cognitive training, followed by crossover to the other intervention
Follow-up
Participants are monitored for speech processing improvements and quality of life outcomes
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two types of training: one focused on listening skills first, then thinking skills (AC group), and the other with the order reversed (CA group). The goal is to see which approach better improves speech understanding in adult cochlear implant users.
How Is the Trial Designed?
3
Treatment groups
Active Control
Those randomized to Group 1 will receive auditory training for 4 weeks prior to the crossover to the cognitive training.
Those randomized to Group 2 will receive cognitive training for 4 weeks prior to the crossover to the auditory training.
Group 3 will be the control group and not receive either training.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
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