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Enrolling by invitationNCT05176561ARCogUpdated Mar 30, 2026

Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

An interventional study of Auditory-Cognitive Training and Non-auditory Cognitive Training in Hearing Loss and Deafness, sponsored by Gallaudet University. Enrolling by invitation at 3 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.

Primary conditionDeafnessRegistry: Hearing LossReclassifiedWhy we changed it
Registry
Hearing Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Deafness
Why
  1. The study's listed conditions name Deafness, a narrower term within Hearing Loss.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Gallaudet University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hearing Loss
  • Deafness

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Keywords

  • Older Adult
  • Auditory Training
  • Speech recognition
  • Cognitive function
  • Quality of Life
  • Post-lingual
  • Cochlear Implant
  • Electrophysiologic response
03

In context

Deafness Reclassified

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's planned enrollment of 30 is below the median of 43 across 106 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

Gallaudet University is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Compared within Deafness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Single-sided deafness
  • Non-fluent English
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

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).

06

What researchers measure

Primary outcomes

  1. AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)

    Repeat sentences; % score of words repeated correctly; 0-100%; higher is better

    Time frame: Change from baseline AZBio Sentence Test scores at one-week post training. Change from baseline AZBio scores at 2 months post training.

  2. Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)

    Questionnaire rating for hearing ability pre and post treatment 10-95%; higher is better

    Time frame: Change from baseline COSI score at one-week post training. Change from baseline COSI score at 2 months post training.

  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

    Questionnaire measuring quality of life with hearing loss. Scores 1-5; higher is better

    Time frame: Change from baseline CIQOL score at one-week post training. Change from baseline CIQOL score at 2 months post training.

  4. Raven Progressive Matrices Test. (2009).

    Test of nonverbal reasoning. Scores number matrices completed from 0-60 matrices; higher is better.

    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.

  5. Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H). Claes A, Mertens G, Gilles A et al. (2016).

    Test of cognitive function adapted and normed for persons with hearing loss. Scores range from 40-160; higher is better.

    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.

  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)

    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.

    Time frame: Change from baseline RHHI scores at 1-week post training. Change from baseline RHHI scores at 2 months post training.

  7. Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)

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

    Time frame: Change from baseline Trail Making Test scores at 1-week post training, at 2 months post training. at 2 months post training.

  8. Neural Response to sound Electrophysological response to sound.

    Electrophysiological response to measure brain's electrical activity to sounds. Latency and amplitude changes recorded. Increased amplitude and reduced latency are better.

    Time frame: Change in amplitude and latency scores at 1-week post training. Change from baseline at 2 months post training

07

Study locations

3 sites
  • Gallaudet University
    Washington D.C., District of Columbia 20002, United States
  • Center for Hearing and Communication
    New York, New York 10004, United States
  • Vanderbilt University
    Nashville, Tennessee 37203-8820, United States
08

References and documents

Publications

  • 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. PubMed 24273377 ↗
  • 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. PubMed 16888038 ↗
  • 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. PubMed 21829134 ↗
  • 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. PubMed 27895549 ↗
  • 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. PubMed 19402930 ↗
  • Raven, J. (2009). The Raven Progressive Matrices and measuring aptitude constructs. The International Journal of Educational and Psychological Assessment, 2, 2-38.
  • 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. PubMed 31479616 ↗
  • 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. PubMed 9046067 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05176561
Lead sponsor
Gallaudet University
Collaborators
Department of Health and Human Services
Responsible party
Diane Brewer (C0-Principal Investigator, Gallaudet University) — Principal investigator
First posted
Jan 4, 2022
Start date
May 1, 2022
Primary completion
Nov 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Mar 30, 2026

Study contacts

Diane M Brewer, MA
principal investigator · Gallaudet University
Claire M Bernstein, PhD
principal investigator · Gallaudet University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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