Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

Hearing Loss Clinical Trial

— ARCog  

Official title:

Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176561
• Other study ID #: GallaudetU
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Gallaudet University
• Contact: Diane M Brewer, MA
• Phone: 202 244-3538
• Email: dmb[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Behavioral:
• Auditory-Cognitive Training
Participant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician.
• 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.

Locations

Country	Name	City	State
United States	Center for Hearing and Communication	New York	New York
United States	Gallaudet University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Gallaudet University	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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. Change from baseline Trail Making Test scores at 1-week post training. at 2 months post training. at 2 months post training
Primary	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