Vanderbilt Clinical Trials

Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

Purpose

The proposed study will investigate whether an auditory brain training program can improve cochlear implant (CI) outcomes in older post-lingually deafened CI users. The study will evaluate the potential benefit of training on speech recognition performance, psychosocial and cognitive function.

Conditions

Hearing Loss
Deafness

Eligibility

Eligible Ages: Over 60 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

60 years of age and over; - Between 3 months and 3 years post cochlear implant activation; - Passing score an cognitive screener (Callahan et al, 2002); - Speech recognition scores on AZBio between 10% and 85%.

Exclusion Criteria

Single-sided deafness - Non-fluent English

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two randomly assigned treatment groups with each receiving a different treatment that is parallel for time.
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Control group will be told that their treatment might improve attention and concentration which in turn might improve communication ability.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Treatment: Auditory-Cognitive Training	Behavioral: AR Group will complete sessions in their home or office via internet. Sessions will include independent work using computer software two hours per week and one hour meeting with the clinician each week. One half of the training is devoted to auditory training and one half to auditory cognitive activities. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with cochlear implant.	Behavioral: Auditory-Cognitive Training Treatment Participants will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician. Participants with spend 1 hour auditory training use Angel Sound and one hour of auditory cognitive training using auditory portions of Posit Science. A clinical paradigm including reviewing results, providing strategies and positive feedback and strategies in the 1 hour virtual meeting of clinician and participant. Practice for next week is assigned. Control group intervention follows the same time and procedure but the materials are non-auditory puzzles (Sudoku, Cross Word Puzzles, Spot the Difference, Ken-Ken and Word Search).
Sham Comparator Control: Non-auditory Cognitive Training	Behavioral: The CT Group will complete two hours of training in their home or office via internet. Sessions will include independent work using computer software two hours per week. Training exercises will be chosen from: Ken-Ken, Sudoku, Crosswords, Word Search, Spot the Differences. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with cochlear implant.	Behavioral: Non-auditory Cognitive Training Participant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician. Control group intervention follows the same time and clinical paradigm, but the materials are non-auditory puzzles (Sudoku, Cross Word Puzzles, Spot the Difference, Ken-Ken and Word Search).

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37203-8820

Contact:
Terrin Tamati, PhD
615-322-5000
terrin.tamati@vumc.org

More Details

Status: Recruiting
Sponsor: Gallaudet University

Study Contact

Diane M Brewer, MA
202 244-3538
dmb@gwu.edu

Detailed Description

Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users with Auditory-Brain Training is evaluating the performance of older cochlear implant users completing a customized auditory-cognitive brain training program. The goal is to determine the effectiveness of training based on speech recognition, neural responses, cognitive, and psychosocial function. Successful training could result in improved outcomes for communication and cognition, new client-centered care models, and better consumer access to effective training. Specifically, investigators will assess two training programs to determine whether participants can improve speech understanding and speed, attention and memory, and communication in daily life. Thirty participants will be randomly assigned to one of two treatment groups: auditory-brain training or non-auditory brain training. Participants will complete two hours of training online at home or office. Participants will meet virtually with a clinician weekly to discuss progress.The study will help determine the best training methods for older adult cochlear implant users.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.