Auditory-Cognitive Training for Hearing Loss

(ARCog Trial)

Recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an auditory brain training program can enhance speech understanding and improve mental and social well-being in individuals with cochlear implants. Participants will engage in either the auditory-cognitive training, a specialized program for hearing and brain function, or a non-auditory version to compare outcomes. The training involves using computer software at home and meeting with a clinician online. It suits those over 60 who have had a cochlear implant for at least three months and struggle with recognizing speech. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve the quality of life for cochlear implant users.

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 prior data suggests that this auditory-cognitive training is safe for cochlear implant users?

Research has shown that auditory-cognitive training is generally well-tolerated by adults, including those with cochlear implants. This training involves computer-based activities at home to improve memory and thinking skills. Studies have found no significant side effects, indicating that this method is safe for enhancing cognitive function in adults with hearing loss.

The ongoing trial will examine these findings more closely, especially in older adults who lost their hearing later in life and now use cochlear implants. Overall, current evidence supports the safety of auditory-cognitive training, making it a promising option for those interested in improving speech recognition and thinking abilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Auditory-Cognitive Training for hearing loss because it uniquely combines auditory exercises with cognitive challenges. Unlike traditional treatments like hearing aids or cochlear implants that focus on amplifying sound, this approach aims to enhance the brain's ability to process auditory information. By integrating cognitive tasks, it targets the underlying cognitive aspects of hearing, potentially improving overall hearing performance and quality of life for individuals with hearing loss. This dual focus on auditory and cognitive skills could offer a more comprehensive improvement in hearing function compared to conventional methods.

What evidence suggests that this trial's treatments could be effective for improving cochlear implant outcomes?

Studies have shown that training focused on listening and thinking can help adults with cochlear implants improve their speech and listening skills. In this trial, participants in the Auditory-Cognitive Training arm will engage in such training, which research indicates makes it easier to understand speech in noisy places and boosts mental abilities like memory and thinking. A review of studies found that adults who did listening training had better speech results. Additionally, computer-based listening programs have led to improvements in hearing that last both in the short term and long term. Overall, the evidence suggests that listening and thinking training is promising for adults with cochlear implants who want to enhance their hearing and mental skills. Meanwhile, participants in the Non-auditory Cognitive Training arm will engage in activities like Sudoku and crosswords to evaluate the benefit of non-auditory cognitive training on performance with cochlear implants. ^{2 6 7 8 9}

Who Is on the Research Team?

Diane M Brewer, MA

Principal Investigator

Gallaudet University

Claire M Bernstein, PhD

Principal Investigator

Gallaudet University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12286825/

Cognitive function and speech outcomes after cochlear ... These findings suggest that cochlear implant use contributes to long-term stability in speech and auditory performance (19, 20). However, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8488513/

Effectiveness of Computer-Based Auditory Training for Adult ... The aim of this study was to assess whether a computer-based speech-in-noise auditory training (AT) program would lead to short- and long-term changes in ...

3. mdpi.com mdpi.com/2077-0383/13/2/400

Systematic Review of Auditory Training Outcomes in Adult ... Systematic review of auditory training outcomes in adult cochlear implant recipients and meta-analysis of outcomes.

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05714-7

Auditory-cognitive training for adult cochlear implant recipients This study aims to determine if completing at-home computer-based brain training activities improve memory and thinking skills in adults following their first ...

5. pubs.asha.org pubs.asha.org/doi/10.1044/2019_JSLHR-H-18-0252

Systematic Review of Auditory Training in Pediatric ... Children receiving the intervention showed significant improvements in vowel, consonant, and tone recognition. The authors suggested that moderate amounts of AT ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34772432/

Auditory-cognitive training for adult cochlear implant ... This study aims to determine if completing at-home computer-based brain training activities improve memory and thinking skills in adults following their first ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8588651/

Auditory-cognitive training for adult cochlear implant ... This study aims to determine if completing at-home computer-based brain training activities improve memory and thinking skills in adults following their first ...

8. withpower.com withpower.com/trial/phase-deafness-2022-fa3cc

Auditory-Cognitive Training for Hearing Loss (ARCog Trial) The proposed study will investigate whether an auditory brain training program can improve cochlear implant (CI) outcomes in older post-lingually deafened ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1672293016300022

Safety and outcomes of cochlear implantation in the elderly In this study, auditory rehabilitation using traditional amplification (hearing aids) was associated with better DSST performance (Lin, 2011). While a complete ...