Hearing Care Program for Mild Cognitive Impairment
(K-HEARS MCI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new hearing care program for Korean American older adults with mild cognitive impairment (MCI). It examines whether an affordable hearing device and rehabilitation, called the K-HEARS Intervention, can improve hearing and cognitive health. Participants will begin the program either immediately or after a delay. Ideal participants are Korean American seniors who speak Korean, have some hearing loss, do not currently use hearing aids, and have a care partner involved in their daily lives. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance hearing and cognitive health for the Korean American community.
Will I have to stop taking my current medications?
The trial requires that your medication regimen be stable, meaning you should have been on the same dose for at least 2 weeks. You don't need to stop your current medications, but they should not change during the study.
What prior data suggests that this hearing care intervention is safe for older adults with mild cognitive impairment?
Research shows that the K-HEARS program, which includes a sound amplifier and hearing assistance, appears safe for participants. In past studies on similar hearing aids, researchers reported no major side effects, suggesting that the treatment is generally well-tolerated. For instance, the ACHIEVE study, which examined the mental benefits of hearing aids, found no significant safety issues over three years.
Additionally, the sound amplifier used in the K-HEARS program is designed to be affordable and easy to use, making it suitable for everyday use without causing harm. While specific side effects of the K-HEARS program haven't been noted, the lack of negative reports in related research and the non-invasive nature of hearing aids suggest a reassuring safety profile.
In summary, based on current research, the K-HEARS program appears safe for older adults with mild memory problems. However, as with any treatment, monitoring for any unexpected issues during the trial is important.12345Why are researchers excited about this trial?
Researchers are excited about the K-HEARS intervention for mild cognitive impairment because it offers a unique approach by addressing hearing care to potentially improve cognitive health. Unlike traditional treatments that focus primarily on cognitive training or medication, K-HEARS integrates sound amplification technology to enhance auditory input, which is thought to play a role in cognitive function. This approach is particularly promising because it targets a sensory pathway that may influence cognitive processes, offering a different angle from typical cognitive impairment therapies. By improving hearing, researchers hope to see a corresponding positive impact on cognitive abilities, paving the way for a more holistic treatment strategy.
What evidence suggests that the K-HEARS intervention could be effective for mild cognitive impairment?
Research has shown that hearing treatments can slow memory and thinking problems in older adults at high risk. The Ageing and Cognitive Health Evaluation in Elders study found that hearing aids helped reduce these issues. In this trial, participants may receive the K-HEARS Intervention or the K-HEARS Sound Amplifier, both affordable options for hearing care, which could benefit people with mild memory and thinking problems. Additionally, evidence suggests that managing hearing loss with these treatments might prevent further decline and help maintain mental sharpness. Overall, these treatments could be valuable for managing mild cognitive impairment effectively.56789
Who Is on the Research Team?
Hae-Ra Han, PhD, RN
Principal Investigator
JHU School Of Nursing
Are You a Good Fit for This Trial?
This trial is for Korean American adults over 60 with mild cognitive impairment and hearing loss, who can read and speak Korean. They must not be using a hearing aid but have a care partner willing to join the study. Participants should also be on stable medication regimens.Inclusion Criteria
Timeline for a Trial Participant
Development
Development of the intervention through exploratory focus groups and/or semi-structured interviews and prototyping via open-labeled trial
Randomized Controlled Pilot Study
Randomized, controlled pilot study with participants randomized to an immediate treatment group versus a 6-month delayed treatment group
Non-randomized Pragmatic-focused Trial
Non-randomized pragmatic-focused trial of community-dwelling older Korean Americans with hearing loss but without MCI
Qualitative Evaluation
Qualitative evaluation of the experience and supplemental feedback through exploratory focus groups and/or semi-structured interviews
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- K-HEARS Intervention
- K-HEARS Sound Amplifier Intervention
Trial Overview
The K-HEARS intervention being tested includes an affordable sound amplifier device and hearing rehabilitation tailored for first-generation Korean American older adults with MCI. The study will assess its feasibility, acceptability, and preliminary effectiveness through a randomized pilot study.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Immediate treatment with K-HEARS intervention
Immediate treatment with K-HEARS intervention
6-month delayed treatment with K-HEARS intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Citations
Early detection and management of hearing loss to reduce ...
The Ageing and Cognitive Health Evaluation in Elders randomised controlled trial (RCT) found hearing aids reduce cognitive decline in high-risk older adults ...
Hearing Care Program for Mild Cognitive Impairment · Info ...
... K-HEARS Intervention and K-HEARS Sound Amplifier Intervention will have tolerable side effects & efficacy for patients with Hearing Loss, Hearing Loss, ...
Hearing intervention for decreasing risk of developing ...
The primary outcome of our study is the rate of progression to dementia among the two groups of participants. Additionally, various evaluations ...
4.
frontiersin.org
frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2024.1380145/fullCorrelation between hearing loss and mild cognitive ...
The findings suggest that hearing interventions may reduce cognitive change over 3 years in an older population at increased risk of cognitive ...
5.
trialsjournal.biomedcentral.com
trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07813-zHearing intervention for decreasing risk of developing ...
Our findings may demonstrate that hearing rehabilitation can be a valuable tool in managing ARHL and preventing cognitive decline.
6.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT06068933/hearing-health-for-korean-american-older-adults-with-mild-cognitive-impairmentHearing Health for Korean American Older Adults With Mild ...
The objective of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy of a community-delivered, ...
Behavioral Interventions in Mild Cognitive Impairment (MCI)
Meta-analysis of non-cognitive effects of cognitive interventions in pwMCI demonstrates significant though small effects for activities of daily living (ADLs; ...
Effect of Multimodal Intervention in Individuals with Mild ...
This trial aims to investigate the efficacy, safety, and potential mechanism of a multimodal intervention on cognitive function in individuals with MCI living ...
Effects of Home Based Serious Game Training (Brain Talk ...
Serious games may be effective in improving cognitive function in patients with MCI; however, research on their effects remains insufficient.
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