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Auditory-Cognitive Training for Hearing Loss (ARCog Trial)

N/A

Recruiting

Led By Claire M Bernstein, PhD

Research Sponsored by Gallaudet University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 3 months and 3 years post cochlear implant activation

60 years of age and over

Must not have

Non-fluent English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline rhhi scores at 1-week post training. change from baseline rhhi scores at 2 months post training.

Summary

This trial will investigate whether an auditory brain training program can improve cochlear implant 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.

Who is the study for?

This trial is for older individuals, aged 60 and above, who have had a cochlear implant activated between 3 months to 3 years ago. They must pass a cognitive test and have speech recognition scores within a specific range. People with single-sided deafness or non-fluent English speakers cannot participate.

What is being tested?

The study tests if an auditory brain training program can help improve outcomes for older people with cochlear implants. It looks at how the training affects their ability to recognize speech, as well as their social and mental functions.

What are the potential side effects?

Since this trial involves cognitive training programs rather than drugs or medical procedures, traditional side effects are not expected; however, participants may experience fatigue or frustration during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cochlear implant was activated between 3 months and 3 years ago.

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I am 60 years old or older.

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I passed a test that checks for thinking problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline trail making test scores at 1-week post training, at 2 months post training. at 2 months post training.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline trail making test scores at 1-week post training, at 2 months post training. at 2 months post training.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline trail making test scores at 1-week post training, at 2 months post training. at 2 months post training. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AZBio Sentence Test (Spahr A, Dorman M, Gilles,A et al (2012)

Client Orientated Scale of Improvement (COSI) Dillon H, James A , Ginis J, et al.(1997)

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

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment: Auditory-Cognitive TrainingExperimental Treatment1 Intervention

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.

Group II: Control: Non-auditory Cognitive TrainingPlacebo Group1 Intervention

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.

0 / 4Eligibility criteria met