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Enrolling by Invitation

NCT Number: NCT05176561

Auditory-Cognitive Training to Optimize Outcomes for Older CI 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.

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Key information

Conditions

Hearing Loss Deafness Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gallaudet University, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory-Cognitive Training

Behavioral

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).

Non-auditory Cognitive Training

Behavioral

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).

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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, at 2 months post training. at 2 months post training.

    Test of cognitive abilities. Scores time to completion; lower is better.

  8. 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.

Sponsors and collaborators

Lead sponsor

Gallaudet University

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users

Acronym: ARCog

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 4, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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