Auditory-Cognitive Training for Hearing Loss

(ARCog Trial)

Recruiting at 2 trial locations

Overseen By Claire M Bernstein, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gallaudet University

Disqualifiers: Single-sided deafness, Non-fluent English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Auditory-Cognitive Training for Hearing Loss?

Research shows that auditory-cognitive training can improve both auditory and cognitive skills, which are important for language development and speech perception in cochlear implant users. Additionally, studies indicate that such training can enhance memory and executive functions, which are crucial for understanding speech in noisy environments. ^{1 2 3 4 5}

Is auditory-cognitive training safe for humans?

Auditory-cognitive training, often used in cochlear implant rehabilitation, is generally considered safe as it involves listening exercises to improve hearing and cognitive skills. No specific safety concerns have been reported in the studies reviewed. ^{6 7 8 9 10}

How is Auditory-Cognitive Training different from other treatments for hearing loss?

Auditory-Cognitive Training is unique because it combines listening exercises with cognitive tasks to improve both hearing and mental processing, which is especially beneficial for cochlear implant users who may struggle with understanding speech. Unlike other treatments that focus solely on hearing, this approach also enhances working memory, helping users better comprehend language in challenging listening environments. ^{3 6 7 8 9}

Research Team

Claire M Bernstein, PhD

Principal Investigator

Gallaudet University

Diane M Brewer, MA

Principal Investigator

Gallaudet University

Eligibility Criteria

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.

Inclusion Criteria

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

I am 60 years old or older.

Your ability to understand speech (using the AZBio test) falls between 10% and 85%.

Exclusion Criteria

You are deaf in one ear.

I am not fluent in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete auditory-cognitive or non-auditory cognitive training sessions at home or office, with weekly virtual clinician meetings

8 weeks

8 virtual visits

Follow-up

Participants are monitored for changes in cognitive and auditory performance post-training

8 weeks

3 assessment appointments

Treatment Details

Interventions

• Auditory-Cognitive Training
• Non-auditory Cognitive Training

Trial Overview 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.

Participant Groups

Group I: Treatment: Auditory-Cognitive Training Experimental Treatment 1 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 Training Placebo Group 1 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.

Auditory-Cognitive Training is already approved in United States, European Union for the following indications:

Approved in United States as Auditory Brain Training for:

• Rehabilitation of hearing communication through cochlear implantation in elderly patients
• Improvement of cognitive abilities in older CI users

Approved in European Union as Cochlear Implant Rehabilitation for:

• Enhancement of speech perception and cognitive abilities in older CI users
• Improvement of quality of life in older CI users

Who Is Running the Clinical Trial?

Gallaudet University

Lead Sponsor

Trials

3

Recruited

250+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Findings from Research

In a study of older patients (ages 65-86) who received unilateral cochlear implants, significant improvements in cognitive function were observed within 6 months, particularly in verbal skills and processing speed.

The dementia screening test (DemTect) scores increased significantly (p=0.049), and processing speed on the trail making test improved notably (TMT A: p=0.003; TMT B: p=0.001), suggesting that cochlear implants can positively impact cognitive domains in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Hearing Rehabilitation Using Cochlear Implants on Cognitive Function in Older Patients. Issing, C., Baumann, U., Pantel, J., et al.[2022]

Cochlear implants have significantly improved hearing and speech perception in prelingually deafened children, but many still do not achieve spoken language skills comparable to their normal hearing peers, indicating a need for additional behavioral interventions.

Research suggests that enhancing auditory and cognitive skills through targeted training could lead to better language development outcomes for children with cochlear implants, highlighting the importance of comprehensive support beyond just the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training to improve language outcomes in cochlear implant recipients. Ingvalson, EM., Wong, PC.[2022]

Adult cochlear implant users can significantly improve their language comprehension through auditory-cognitive training, which helps enhance their working memory capacity during rehabilitation.

Working memory is crucial for CI users, especially in challenging listening conditions, as it aids in disambiguating speech signals that may be difficult for them to process due to their hearing history or age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How Working Memory Supports Language Comprehension after Cochlear Implantation]. Fengler, A., Fuchs, M., Tretbar, K.[2023]

A study involving 44 bilaterally deaf patients over 60 years old showed that both cochlear implants (CIs) and hearing aids (HAs) significantly improved speech recognition and cognitive functions, particularly memory and executive functions, after 6-12 months of auditory rehabilitation.

The findings suggest that addressing hearing loss in older adults can be a modifiable risk factor for cognitive decline, as improvements in hearing led to better cognitive performance and quality of life, indicating that restoring hearing may help reallocate brain resources affected by hearing deprivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of Cognitive Functions After Rehabilitation With Cochlear Implant or Hearing Aids: Preliminary Results of a Multicentric Study on Elderly Patients. Anzivino, R., Conti, G., Di Nardo, W., et al.[2020]

Auditory training can improve specific listening tasks for adults with hearing loss, but the benefits may not always translate to real-world situations, indicating a need for more effective training methods.

Incorporating cognitive training into auditory training programs may enhance overall listening abilities by targeting executive functions like attention and memory, potentially leading to better communication in challenging environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Does Auditory Training Work? Joined-Up Thinking and Listening. Ferguson, M., Henshaw, H.[2020]

A study involving 15 adult cochlear implant (CI) users showed that a computer-based auditory training program significantly improved their ability to discriminate between phonemes, particularly consonants, over a 3-week period.

The training specifically enhanced discrimination skills for both voiced and unvoiced consonants, indicating that such programs can be effective tools for auditory rehabilitation in CI listeners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phoneme discrimination training with experienced cochlear implant listeners]. Schumann, A., Liebscher, T., Hoppe, U.[2018]

Group interventions for adult cochlear implant users, such as Auditory Training Groups and Thematic Group Workshops, are well accepted and rated positively by participants, indicating their effectiveness in rehabilitation.

Participants highlighted the importance of training in speech perception in noise and communicative exchange, suggesting that these group settings can enhance both auditory skills and social interaction among CI users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Auditory group therapy in adult cochlear implant rehabilitation]. Glaubitz, C., Lehmann, EK., Weber, L., et al.[2020]

Auditory training using computer-based methods showed improvements in specific tasks for adults with hearing loss, with 9 out of 10 studies reporting positive outcomes for trained tasks.

However, while some general improvements in untrained speech intelligibility and cognition were noted, these were small and not consistent, indicating that the current evidence for the effectiveness of this intervention is not strong enough to guide clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of individual computer-based auditory training for people with hearing loss: a systematic review of the evidence. Henshaw, H., Ferguson, MA.[2022]

A study involving 29 adult cochlear implant users with partial deafness found that while the proposed auditory training was deemed useful for rehabilitation, it was also considered difficult, particularly for identifying mid- and high-frequency sounds.

Women reported significantly more difficulties than men in performing the auditory training exercises, highlighting the need for tailored support in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of the auditory training of the subjects presenting with partial deafness following cochlear implantation as reported by the patients and speech therapists]. Solnitsa, I., Kobosko, I., Pankovska, A., et al.[2014]

This study will evaluate the effectiveness of combining auditory training with adaptive computer-based cognitive training to enhance cognitive function and quality of life in adults who have received cochlear implants, using a randomized controlled trial design.

The trial aims to determine if this combined approach leads to greater improvements in memory, sound and speech perception, and mood compared to a placebo cognitive training, potentially influencing future clinical practices for cochlear implant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory-cognitive training for adult cochlear implant recipients: a study protocol for a randomised controlled trial. Lawrence, BJ., Eikelboom, RH., Jayakody, DMP.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Hearing Rehabilitation Using Cochlear Implants on Cognitive Function in Older Patients. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Training to improve language outcomes in cochlear implant recipients. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[How Working Memory Supports Language Comprehension after Cochlear Implantation]. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of Cognitive Functions After Rehabilitation With Cochlear Implant or Hearing Aids: Preliminary Results of a Multicentric Study on Elderly Patients. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

How Does Auditory Training Work? Joined-Up Thinking and Listening. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

[Phoneme discrimination training with experienced cochlear implant listeners]. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

[Auditory group therapy in adult cochlear implant rehabilitation]. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of individual computer-based auditory training for people with hearing loss: a systematic review of the evidence. [2022]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effectiveness of the auditory training of the subjects presenting with partial deafness following cochlear implantation as reported by the patients and speech therapists]. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Auditory-cognitive training for adult cochlear implant recipients: a study protocol for a randomised controlled trial. [2021]