Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

Study Overview
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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.

Official Title
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Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users

Conditions
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Hearing Loss, Deafness

Intervention / Treatment
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* Behavioral: Auditory-Cognitive Training
* Behavioral: Non-auditory Cognitive Training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two randomly assigned treatment groups with each receiving a different treatment that is parallel for time.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment: Auditory-Cognitive Training<br>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<br>* Participant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician.<br>|
| Sham Comparator: Control: Non-auditory Cognitive Training<br>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<br>* Participant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older Adult, Auditory Training, Speech recognition, Cognitive function, Quality of Life, Post-lingual, Cochlear Implant, Electrophysiologic response