Clinical trial NCT05176561: Auditory-Cognitive Training to Optimize Outcomes for Older CI Users
Official title: Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Deafness
Keywords: Older Adult
Auditory Training
Speech recognition
Cognitive function
Quality of Life
Post-lingual
Cochlear Implant
Electrophysiologic response
Lead sponsor: Gallaudet University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2022-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomly assigned treatment groups with each receiving a different treatment that is parallel for time.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)
timeFrame: Change from baseline AZBio Sentence Test scores at one-week post training. Change from baseline AZBio scores at 2 months post training.
measure: Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)
timeFrame: Change from baseline COSI score at one-week post training. Change from baseline COSI score at 2 months post training.
measure: 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
timeFrame: Change from baseline CIQOL score at one-week post training. Change from baseline CIQOL score at 2 months post training.
measure: Raven Progressive Matrices Test. (2009).
timeFrame: 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.
measure: Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H). Claes A, Mertens G, Gilles A et al. (2016).
timeFrame: 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.
measure: 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)
timeFrame: Change from baseline RHHI scores at 1-week post training. Change from baseline RHHI scores at 2 months post training.
measure: Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)
timeFrame: Change from baseline Trail Making Test scores at 1-week post training, at 2 months post training. at 2 months post training.
measure: Neural Response to sound Electrophysological response to sound.
timeFrame: Change in amplitude and latency scores at 1-week post training. Change from baseline at 2 months post training
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Gallaudet University
state: District of Columbia
city: New York
country: United States
facility: Center for Hearing and Communication
state: New York
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Gallaudet University
name: Diane M Brewer, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Gallaudet University
name: Claire M Bernstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
citation: 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.
citation: Raven, J. (2009). The Raven Progressive Matrices and measuring aptitude constructs. The International Journal of Educational and Psychological Assessment, 2, 2-38.
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.
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.