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Auditory-Cognitive Training to Optimize Outcomes for Older CI Users (ARCog)

Primary Purpose

Hearing Loss, Deafness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auditory-Cognitive Training
Non-auditory Cognitive Training
Sponsored by
Gallaudet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Older Adult, Auditory Training, Speech recognition, Cognitive function, Quality of Life, Post-lingual, Cochlear Implant, Electrophysiologic response

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gallaudet UniversityRecruiting
  • Center for Hearing and Communication

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment: Auditory-Cognitive Training

Control: Non-auditory Cognitive Training

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)
Repeat sentences; % score of words repeated correctly; 0-100%; higher is better
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
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
Raven Progressive Matrices Test. (2009).
Test of nonverbal reasoning. Scores number matrices completed from 0-60 matrices; higher is better.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2021
Last Updated
August 2, 2023
Sponsor
Gallaudet University
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT05176561
Brief Title
Auditory-Cognitive Training to Optimize Outcomes for Older CI Users
Acronym
ARCog
Official Title
Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gallaudet University
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Deafness
Keywords
Older Adult, Auditory Training, Speech recognition, Cognitive function, Quality of Life, Post-lingual, Cochlear Implant, Electrophysiologic response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two randomly assigned treatment groups with each receiving a different treatment that is parallel for time.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Control group will be told that their treatment might improve attention and concentration which in turn might improve communication ability.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment: Auditory-Cognitive Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: Non-auditory Cognitive Training
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Auditory-Cognitive Training
Intervention Description
Participant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician.
Intervention Type
Behavioral
Intervention Name(s)
Non-auditory Cognitive Training
Intervention Description
Participant will complete 8 weeks of training for 2 hours per week and participate in a 1 hour meeting with clinician.
Primary Outcome Measure Information:
Title
AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)
Description
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.
Title
Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)
Description
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.
Title
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
Description
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.
Title
Raven Progressive Matrices Test. (2009).
Description
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.
Title
Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H). Claes A, Mertens G, Gilles A et al. (2016).
Description
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.
Title
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)
Description
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.
Title
Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)
Description
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. Change from baseline Trail Making Test scores at 1-week post training. at 2 months post training. at 2 months post training
Title
Neural Response to sound Electrophysological response to sound.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane M Brewer, MA
Phone
202 244-3538
Email
dmb@gwu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Claire M Bernstein, PhD
Phone
301 509 0722
Email
Claire.bernstein@gallaudet.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane M Brewer, MA
Organizational Affiliation
Gallaudet University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire M Bernstein, PhD
Organizational Affiliation
Gallaudet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gallaudet University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Bernstein, PhD
Phone
301-509-0722
Email
claire.bernstein@gallaudet.edu
First Name & Middle Initial & Last Name & Degree
Diane Brewer, MA
Phone
2022568343
Email
dmb@gwu.edu
Facility Name
Center for Hearing and Communication
City
New York
State/Province
New York
ZIP/Postal Code
10004
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Hanin, PhD
Phone
917-305-7760
Email
lhanin@chchearing.org
First Name & Middle Initial & Last Name & Degree
Dominique Calandrillo, MA
Phone
917 305 7758
Email
dcalandrillo@chchearing.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24273377
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.
Results Reference
background
PubMed Identifier
16888038
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.
Results Reference
background
PubMed Identifier
21829134
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.
Results Reference
background
PubMed Identifier
27895549
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.
Results Reference
background
PubMed Identifier
19402930
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.
Results Reference
background
Citation
Raven, J. (2009). The Raven Progressive Matrices and measuring aptitude constructs. The International Journal of Educational and Psychological Assessment, 2, 2-38.
Results Reference
background
PubMed Identifier
31479616
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.
Results Reference
background
PubMed Identifier
9046067
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.
Results Reference
background

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Auditory-Cognitive Training to Optimize Outcomes for Older CI Users

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