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Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05176561
Acronym
ARCog
Enrollment
30
Registered
2022-01-04
Start date
2022-05-01
Completion date
2027-04-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness, Hearing Loss

Keywords

Older Adult, Auditory Training, Speech recognition, Cognitive function, Quality of Life, Post-lingual, Cochlear Implant, Electrophysiologic response

Brief summary

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.

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.

Interventions

BEHAVIORALAuditory-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).

BEHAVIORALNon-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).

Sponsors

Gallaudet University
Lead SponsorOTHER
Department of Health and Human Services
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.

Intervention model description

Two randomly assigned treatment groups with each receiving a different treatment that is parallel for time.

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)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
Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)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
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(9Change 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
Raven Progressive Matrices Test. (2009).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.
Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H). Claes A, Mertens G, Gilles A et al. (2016).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.
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)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.
Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)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.
Neural Response to sound Electrophysological response to sound.Change in amplitude and latency scores at 1-week post training. Change from baseline at 2 months post trainingElectrophysiological response to measure brain's electrical activity to sounds. Latency and amplitude changes recorded. Increased amplitude and reduced latency are better.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDiane M Brewer, MA

Gallaudet University

PRINCIPAL_INVESTIGATORClaire M Bernstein, PhD

Gallaudet University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026