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

August 2, 2023 updated by: Diane Brewer, Gallaudet University

Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Diane M Brewer, MA
  • Phone Number: 202 244-3538
  • Email: dmb@gwu.edu

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20002
    • New York
      • New York, New York, United States, 10004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Participant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)
Time Frame: Change from baseline AZBio Sentence Test scores at one-week post training. Change from baseline AZBio scores at 2 months post training.
Repeat sentences; % score of words repeated correctly; 0-100%; higher is better
Change from baseline AZBio Sentence Test scores at one-week post training. Change from baseline AZBio scores at 2 months post training.
Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)
Time Frame: Change from baseline COSI score at one-week post training. Change from baseline COSI score at 2 months post training.
Questionnaire rating for hearing ability pre and post treatment 10-95%; higher is better
Change from baseline COSI score at one-week post training. Change from baseline COSI score at 2 months post training.
Cochlear Implant Quality of Life (CIQOL) McRacken,T (2019) McRackan T, Hand B; Velozo CA, Dubno J. (2019) Cochlear Implant Quality of Life (CIQOL)(CIQOL-10 Global). J Speech Lang Hear Res. 62(9
Time Frame: Change from baseline CIQOL score at one-week post training. Change from baseline CIQOL score at 2 months post training.
Questionnaire measuring quality of life with hearing loss. Scores 1-5; higher is better
Change from baseline CIQOL score at one-week post training. Change from baseline CIQOL score at 2 months post training.
Raven Progressive Matrices Test. (2009).
Time Frame: Change from baseline Raven Progressive Matrices Test score at one-week post training. Change from baseline Raven Progressive Matrices Test score at 2 months post training.
Test of nonverbal reasoning. Scores number matrices completed from 0-60 matrices; higher is better.
Change from baseline Raven Progressive Matrices Test score at one-week post training. Change from baseline Raven Progressive Matrices Test score at 2 months post training.
Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H). Claes A, Mertens G, Gilles A et al. (2016).
Time Frame: Change from baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-H) scores at one-week post training. Change from RBANS-H baseline at 2 months.
Test of cognitive function adapted and normed for persons with hearing loss. Scores range from 40-160; higher is better.
Change from baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS-H) scores at one-week post training. Change from RBANS-H baseline at 2 months.
Revised Hearing Handicap Inventory and Screening Tool based on Psychometric Reevaluation of the Hearing Handicap Inventories for the Elderly and Adults (RHHI). Cassarly C, Matthews L, Simpson A et al.( 2020)
Time Frame: Change from baseline RHHI scores at 1-week post training. Change from baseline RHHI scores at 2 months post training.
Questionnaire to assess perceived hearing handicap associated with a hearing loss or effects of hearing loss on an individual's quality of life. Scores range from 0 to100 with 0-52 for emotional sub-scale and 0-48 for social-situational; lower scores are better.
Change from baseline RHHI scores at 1-week post training. Change from baseline RHHI scores at 2 months post training.
Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)
Time Frame: Change from baseline Trail Making Test scores at 1-week post training. Change from baseline Trail Making Test scores at 1-week post training. at 2 months post training. at 2 months post training
Test of cognitive abilities. Scores time to completion; lower is better.
Change from baseline Trail Making Test scores at 1-week post training. Change from baseline Trail Making Test scores at 1-week post training. at 2 months post training. at 2 months post training
Neural Response to sound Electrophysological response to sound.
Time Frame: Change in amplitude and latency scores at 1-week post training. Change from baseline at 2 months post training
Electrophysiological response to measure brain's electrical activity to sounds. Latency and amplitude changes recorded. Increased amplitude and reduced latency are better.
Change in amplitude and latency scores at 1-week post training. Change from baseline at 2 months post training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gallaudet University

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: Diane M Brewer, MA, Gallaudet University
  • Principal Investigator: Claire M Bernstein, PhD, Gallaudet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GallaudetU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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