Hearing Aid Intervention for Cognitive Decline

(ACHIEVE-BHFU Trial)

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

629 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if giving hearing aids to older adults with untreated hearing loss can help slow down memory and thinking problems. It compares this to just giving general health advice. The idea is that better hearing keeps the brain active, which might help prevent cognitive decline. Hearing aids have been shown to improve cognitive function and offset declines in neural function in older adults.

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 Hearing intervention, Successful aging/delayed hearing intervention for cognitive decline?

Research suggests that using hearing aids may help improve cognitive functions in people with mild hearing loss, as seen in improvements on cognitive tests like the Clock Drawing Test. However, the evidence is mixed, with some studies showing benefits and others showing no impact, indicating that more research is needed to fully understand the effects. ^{1 2 3 4 5}

Is the hearing aid intervention safe for humans?

The studies reviewed do not report any specific safety concerns related to the use of hearing aids or cochlear implants in older adults, suggesting that these interventions are generally safe for human use. ^{3 6 7 8 9}

How does the hearing aid intervention treatment for cognitive decline differ from other treatments?

The hearing aid intervention is unique because it targets hearing loss, a modifiable risk factor for dementia, to potentially delay cognitive decline. Unlike other treatments that may focus directly on cognitive symptoms, this approach improves hearing, which in turn can enhance cognitive function and quality of life. ^{6 10 11 12 13}

Research Team

Frank R Lin, MD, PhD

Principal Investigator

Johns Hopkins University

Josef Coresh, MD, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Hearing interventions to prevent dementia. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Neuropsychological profile of hearing-impaired patients and the effect of hearing aid on cognitive functions: an exploratory study. [2021]

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

The Studying Multiple Outcomes After Aural Rehabilitative Treatment Study: Study Design and Baseline Results. [2020]

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

A Deterioration in Hearing Is Associated With Functional and Cognitive Impairments, Difficulty With Communication, and Greater Health Instability. [2021]

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

Hearing Loss Treatment in Older Adults With Cognitive Impairment: A Systematic Review. [2020]

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

Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial. [2023]

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

Do hearing loss interventions prevent dementia? [2023]

8. England pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of hearing aids to improve mood and cognition in older adults. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial. [2023]

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

Assisting Older Persons With Adjusting to Hearing Aids. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Experiences of hearing aid use among patients with mild cognitive impairment and Alzheimer's disease dementia: A qualitative study. [2022]

12. Brazil pubmed.ncbi.nlm.nih.gov

Cognition and benefit obtained with hearing aids: a study in elderly people. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Hearing Aid Use on Cognition in Older Adults: Can We Delay Decline or Even Improve Cognitive Function? [2020]