Optimizing Speech Recognition and Cognitive Outcomes for Older Cochlear Implant Users
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Control group will be told that their treatment might improve attention and concentration which in turn might improve communication ability.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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%.
排除标准
- •Single-sided deafness
- •Non-fluent English
研究组 & 干预措施
Treatment: Auditory-Cognitive Training
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.
干预措施: Auditory-Cognitive Training (Behavioral)
Control: Non-auditory Cognitive Training
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.
干预措施: Non-auditory Cognitive Training (Behavioral)
结局指标
主要结局
Trail Making Test (TMT) Sánchez-Cubillo I, Periáñez JA, Adrover-Roig D, et al. (2009)
时间窗: Change from baseline Trail Making Test scores at 1-week post training, at 2 months post training. at 2 months post training.
Test of cognitive abilities. Scores time to completion; lower 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)
时间窗: Change from baseline RHHI scores at 1-week post training. Change from baseline RHHI scores at 2 months post training.
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.
Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)
时间窗: Change from baseline COSI score at one-week post training. Change from baseline COSI score at 2 months post training.
Questionnaire rating for hearing ability pre and post treatment 10-95%; higher is better
Raven Progressive Matrices Test. (2009).
时间窗: 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.
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).
时间窗: 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.
Test of cognitive function adapted and normed for persons with hearing loss. Scores range from 40-160; higher is better.
Neural Response to sound Electrophysological response to sound.
时间窗: Change in amplitude and latency scores at 1-week post training. Change from baseline at 2 months post training
Electrophysiological response to measure brain's electrical activity to sounds. Latency and amplitude changes recorded. Increased amplitude and reduced latency are 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
时间窗: Change from baseline CIQOL score at one-week post training. Change from baseline CIQOL score at 2 months post training.
Questionnaire measuring quality of life with hearing loss. Scores 1-5; higher is better
AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)
时间窗: Change from baseline AZBio Sentence Test scores at one-week post training. Change from baseline AZBio scores at 2 months post training.
Repeat sentences; % score of words repeated correctly; 0-100%; higher is better
次要结局
未报告次要终点
研究者
Diane Brewer
C0-Principal Investigator
Gallaudet University