Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

NCT05176561 | Enrolling By Invitation

• 1 other identifier: GallaudetU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Hearing Loss; Deafness

Keywords

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

Outcome Measures

Primary Outcomes (8)

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

  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)

  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

  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).

  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).

  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)

  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)

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

  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.

  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

Study Arms (2)

Treatment: Auditory-Cognitive Training

EXPERIMENTAL

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

Control: Non-auditory Cognitive Training

SHAM COMPARATOR

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

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).

Treatment: Auditory-Cognitive Training

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).

Control: Non-auditory Cognitive Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• Single-sided deafness
• Non-fluent English

Sponsors & Collaborators

• Department of Health and Human Services: collaborator
• Gallaudet University: lead

Study Sites (3)

Gallaudet University

Washington D.C., District of Columbia, 20002, United States

Location

Center for Hearing and Communication

New York, New York, 10004, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203-8820, United States

Location

Related Publications (8)

• 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.

  PMID: 24273377 BACKGROUND

• 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.

  PMID: 16888038 BACKGROUND

• 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.

  PMID: 21829134 BACKGROUND

• 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.

  PMID: 27895549 BACKGROUND

• 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.

  PMID: 19402930 BACKGROUND

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

  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.

  PMID: 31479616 BACKGROUND

• 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.

  PMID: 9046067 BACKGROUND

MeSH Terms

Conditions

Hearing Loss; Deafness

Condition Hierarchy (Ancestors)

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

Study Officials

• Diane M Brewer, MA

  Gallaudet University

  PRINCIPAL INVESTIGATOR

• Claire M Bernstein, PhD

  Gallaudet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Control group will be told that their treatment might improve attention and concentration which in turn might improve communication ability.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: C0-Principal Investigator

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

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: January 4, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)