Hearing Aid Intervention for Cognitive Decline

(ACHIEVE-BHFU Trial)

Not currently recruiting at 3 trial locations

Overseen By Christine Mitchell

Age: 65+

Sex: Any

Trial Phase: Phase 3

Sponsor: Johns Hopkins University

Disqualifiers: Disability in ADLs, Vision impairment, Hearing aid use, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if wearing hearing aids can slow cognitive decline, such as memory and thinking problems, in older adults. Participants will either receive a hearing aid with personalized care from an audiologist or join a healthy aging education program before receiving a hearing aid later. The trial is best suited for individuals with adult-onset hearing impairment who haven't recently used a hearing aid and are willing to participate for three years. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to important research that could lead to new treatment options.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that hearing aids and similar treatments improved thinking and memory in older adults. This suggests that hearing aids might safely aid cognitive functions. No evidence links these devices to serious health problems, indicating they are generally well-tolerated by users.

For the successful aging/delayed hearing intervention, research mainly focuses on educating participants about healthy aging. This approach is not expected to cause any safety issues. Neither treatment in this trial has shown serious side effects in past studies, suggesting they are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the hearing intervention for cognitive decline because it incorporates a comprehensive and individualized approach to hearing rehabilitation. Unlike standard care, which often involves basic hearing aid fittings, this treatment includes personalized sessions with an audiologist and ongoing support through semi-annual booster sessions. This method not only addresses hearing loss but also aims to enhance cognitive health by providing continuous, tailored support. Additionally, the successful aging/delayed hearing intervention offers a unique opportunity to study the impact of hearing care on healthy aging, offering participants a robust health education program before introducing the hearing intervention. This dual approach could provide valuable insights into the relationship between hearing health and cognitive function over time.

What evidence suggests that this hearing intervention could be effective for cognitive decline?

Research has shown that using hearing aids can help slow mental decline and lower the risk of mild cognitive impairment (MCI) or dementia. In this trial, participants in the Hearing Intervention (HI) group will receive a best practices hearing rehabilitation treatment program, which includes fitting with hearing aids and other assistive technologies. Studies have found that people who use hearing aids are less likely to experience cognitive problems compared to those who don't. One study linked long-term use of hearing aids to either reduced mental decline or improvements in thinking skills. Another analysis found that hearing aids and cochlear implants are associated with a lower risk of mental decline. These findings suggest that hearing treatments might help maintain mental health as people age. ^{4 6 7 8 9}

Who Is on the Research Team?

Frank R Lin, MD, PhD

Principal Investigator

Johns Hopkins University

Josef Coresh, MD, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults aged 70-84 with adult-onset hearing loss who previously participated in the ACHIEVE trial. They must be able to follow the study for three years, live in the community, speak fluent English, and have a certain level of cognitive function as measured by MMSE. Those using hearing aids in the past year or unable to wear them daily are excluded.

Inclusion Criteria

You need to score 23 or higher on a test to join the study if you have a high school degree or less, and 25 or higher if you have some college education or more.

You have moderate to severe hearing loss in your better ear.

It seems like "Original ACHIEVE" might be a specific term or acronym related to a clinical trial. Without additional context, it's difficult to provide a plain language summary. If you could provide more information or clarify, I'd be happy to help summarize it for you!

Exclusion Criteria

You have used a hearing aid in the past year.

I cannot use hearing aids due to a medical issue like a draining ear.

I am not willing to wear hearing aids every day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hearing intervention or successful aging education control intervention

3 years

Semi-annual visits

Follow-up

Participants are monitored for long-term effects of hearing intervention on cognitive and brain health outcomes

3 years

Semi-annual visits

Open-label extension

Participants in the successful aging group are offered hearing intervention and continue to receive semi-annual booster sessions

3 years

Semi-annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Hearing intervention
• Successful aging/delayed hearing intervention

Trial Overview The study examines long-term effects on brain health from two strategies: immediate hearing intervention versus successful aging with delayed hearing intervention. It aims to see which approach better slows down cognitive decline or prevents mild cognitive impairment/dementia over three years.

How Is the Trial Designed?

Group I: Hearing intervention (HI) group Active Control 1 Intervention

Participants in this group were randomized to the hearing intervention (HI) group at ACHIEVE trial baseline and received a best practices hearing rehabilitation treatment program, consisting of fitting with hearing aids and other hearing assistive technologies along with comprehensive, individualized hearing rehabilitation sessions with a study audiologist spaced over the 2-3 months post-fitting designed to provide all the active components of the intervention. Participants also received semi-annual booster sessions with the study audiologist. These participants will continue to receive hearing healthcare from the study audiologist and complete semi-annual sessions for 3 additional years.

Group II: Successful aging/Delayed hearing intervention (SA/DHI) group Active Control 1 Intervention

Participants in this active control group were randomized to the successful aging (SA) group at ACHIEVE trial baseline and received a successful aging health education program, following the protocol and materials developed for the 10 Keys to Healthy Aging program. The program involved individualized sessions with a study health educator to control for staff-participant time and attention between the two groups. Upon completion of the ACHIEVE trial, these participants are offered the best practices hearing rehabilitative treatment program with comprehensive, individualized sessions post-fitting and will receive semi-annual booster sessions with the study audiologist for 3 years.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Published Research Related to This Trial

Adults with mild cognitive impairment or Alzheimer's disease face significant cognitive barriers that affect their ability to use hearing aids effectively, as revealed through interviews with 10 participants aged 75-86.

Despite recognizing the benefits of hearing aids, participants expressed ambivalence towards their use, indicating a need for targeted strategies to enhance hearing aid adoption and support in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of hearing aid use among patients with mild cognitive impairment and Alzheimer's disease dementia: A qualitative study. Gregory, S., Billings, J., Wilson, D., et al.[2022]

The SMART study involves 145 participants aged 50 and older, assessing the impact of hearing aids and cochlear implants on various health outcomes related to hearing loss.

Participants with cochlear implants reported higher levels of loneliness and social isolation, as well as poorer hearing and communication abilities compared to those using hearing aids, highlighting the need for effective rehabilitative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Studying Multiple Outcomes After Aural Rehabilitative Treatment Study: Study Design and Baseline Results. Li, L., Blake, C., Sung, Y., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11882528/

Prediction of hearing aid cognitive outcomes in age-related ... More recently, longitudinal studies have demonstrated reduced cognitive decline or cognitive gains following prolonged use of hearing aids ( ...

2. medrxiv.org medrxiv.org/content/10.1101/2025.03.25.25324637v1.full-text

Hearing aid interventions to mitigate cognitive impairment Cognitive outcomes assessed at 6 months were Digit Symbol Substitution, Phonemic Fluency and Vocabulary testing. Hearing aid use was at least an ...

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12248

The impact of hearing impairment and hearing aid use on ... Hearing aid use is associated with lower risk of MCI and slower cognitive decline. People with normal hearing and hearing aid users have similar ...

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2799139

Association of Hearing Aids and Cochlear Implants With ... Meaning In this meta-analysis, the usage of hearing aids and cochlear implants is associated with a decreased risk of subsequent cognitive ...

5. academic.oup.com academic.oup.com/ageing/article/54/1/afaf004/7965371

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12078761/

Cognitive benefits of hearing intervention vary by risk ... Among ACHIEVE participants in the top quartile of predicted risk, 3‐year cognitive decline in the hearing intervention was 61.6% (95% confidence ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6197326/

Hearing treatment for reducing cognitive decline Primary study outcome is 3-year change in global cognitive function. Secondary outcomes include domain-specific cognitive decline, incident dementia, brain ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826555

A Hearing Intervention and Health-Related Quality of Life ... In a secondary analysis of the ACHIEVE study, hearing intervention was not associated with physical and mental health-related quality of life ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824287

Hearing Loss, Hearing Aids, and Cognition | Otolaryngology The odds of cognitive impairment did not differ significantly between participants with hearing aid use and participants with disabling hearing ...