Auditory-Cognitive Training to Optimize Outcomes for Older CI Users (ARCog)

Gallaudet University

Status: Enrolling

Conditions: Hearing Loss; Deafness

Treatments: Behavioral: Non-auditory Cognitive Training; Behavioral: Auditory-Cognitive Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05176561

GallaudetU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Treatment: Auditory-Cognitive Training

Experimental group

Description:

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.

Treatment:

Behavioral: Auditory-Cognitive Training

Control: Non-auditory Cognitive Training

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Non-auditory Cognitive Training