Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

NCT ID: NCT05176561

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Hearing Loss Deafness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Control group will be told that their treatment might improve attention and concentration which in turn might improve communication ability.

Study Groups

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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.

Group Type EXPERIMENTAL

Auditory-Cognitive Training

Intervention Type 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).

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.

Group Type SHAM_COMPARATOR

Non-auditory Cognitive Training

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

Gallaudet University

OTHER

Sponsor Role lead

Responsible Party

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Diane Brewer

C0-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diane M Brewer, MA

Role: PRINCIPAL_INVESTIGATOR

Gallaudet University

Claire M Bernstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Gallaudet University

Locations

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Gallaudet University

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

Site Status RECRUITING

Center for Hearing and Communication

New York, New York, United States

Site Status RECRUITING

Vanderbilt University

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Diane M Brewer, MA

Role: CONTACT

202 256 8343

Claire M Bernstein, PhD

Role: CONTACT

301 509 0722

Facility Contacts

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Claire Bernstein, PhD

Role: primary

301-509-0722

Diane Brewer, MA

Role: backup

202-256-8343

Laurie Hanin, PhD

Role: primary

917 305-7760

Dominique Calandrillo, MA

Role: backup

917 305 7758

Terrin Tamati, PhD

Role: primary

615-322-5000

Morgan Zupkus, AuD

Role: backup

847-702-3783

References

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Fu QJ, Galvin JJ 3rd. Computer-Assisted Speech Training for Cochlear Implant Patients: Feasibility, Outcomes, and Future Directions. Semin Hear. 2007 May 1;28(2):10.1055/s-2007-973440. doi: 10.1055/s-2007-973440.

Reference Type BACKGROUND
PMID: 24273377 (View on PubMed)

Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.

Reference Type BACKGROUND
PMID: 16888038 (View on PubMed)

Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.

Reference Type BACKGROUND
PMID: 21829134 (View on PubMed)

Claes AJ, Mertens G, Gilles A, Hofkens-Van den Brandt A, Fransen E, Van Rompaey V, Van de Heyning P. The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) before and after Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study. Front Neurosci. 2016 Nov 15;10:512. doi: 10.3389/fnins.2016.00512. eCollection 2016.

Reference Type BACKGROUND
PMID: 27895549 (View on PubMed)

Sanchez-Cubillo I, Perianez JA, Adrover-Roig D, Rodriguez-Sanchez JM, Rios-Lago M, Tirapu J, Barcelo F. Construct validity of the Trail Making Test: role of task-switching, working memory, inhibition/interference control, and visuomotor abilities. J Int Neuropsychol Soc. 2009 May;15(3):438-50. doi: 10.1017/S1355617709090626.

Reference Type BACKGROUND
PMID: 19402930 (View on PubMed)

Raven, J. (2009). The Raven Progressive Matrices and measuring aptitude constructs. The International Journal of Educational and Psychological Assessment, 2, 2-38.

Reference Type BACKGROUND

McRackan TR, Hand BN; Cochlear Implant Quality of Life Development Consortium; Velozo CA, Dubno JR. Cochlear Implant Quality of Life (CIQOL): Development of a Profile Instrument (CIQOL-35 Profile) and a Global Measure (CIQOL-10 Global). J Speech Lang Hear Res. 2019 Sep 20;62(9):3554-3563. doi: 10.1044/2019_JSLHR-H-19-0142. Epub 2019 Sep 4.

Reference Type BACKGROUND
PMID: 31479616 (View on PubMed)

Dillon H, James A, Ginis J. Client Oriented Scale of Improvement (COSI) and its relationship to several other measures of benefit and satisfaction provided by hearing aids. J Am Acad Audiol. 1997 Feb;8(1):27-43.

Reference Type BACKGROUND
PMID: 9046067 (View on PubMed)

Other Identifiers

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GallaudetU

Identifier Type: -

Identifier Source: org_study_id

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