What side effects are associated with this type of intervention?

Common treatments for hearing loss include hearing aids, cochlear implants, and certain medications. Hearing aids are generally safe but can cause minor issues such as earwax buildup, discomfort, and feedback noise. Cochlear implants, while effective, carry risks such as surgical complications, infections, and device malfunction. Medications like corticosteroids used for sudden hearing loss can lead to side effects such as increased blood pressure, mood swings, and weight gain. These treatments aim to improve auditory input, which may enhance cognitive function and potentially slow cognitive decline.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of hearing loss. Current interventions primarily include hearing aids and cochlear implants, which are designed to improve auditory input. These devices are similar to the interventions being studied in the ACHIEVE Brain Health Follow-Up Study, which aims to enhance cognitive function by improving hearing. Emerging therapeutic strategies, such as antioxidants and other compounds, are still in the trial phase and have not yet received FDA approval.

What other types of research exist?

Promising, novel alternatives to traditional hearing interventions for hearing loss patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in enhancing naming accuracy and is being evaluated for primary progressive aphasia. 2) Cognitive Behavioral Therapy (CBT) delivered via the internet, which has been effective in managing tinnitus and could be adapted for hearing loss-related cognitive decline. 3) Cochlear implants, which have been used for tinnitus suppression and may offer cognitive benefits by improving auditory input. These alternatives are still under research but show promise for future treatment options.

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Hearing Aid Intervention for Cognitive Decline (ACHIEVE-BHFU Trial)

Phase 3

Waitlist Available

Led By Frank R Lin, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 70-84 years

Be older than 65 years old

Must not have

Medical contraindication to use of hearing aids (e.g., draining ear)

Unwilling to wear hearing aids on a daily basis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up if in achieve-mri: achieve baseline, achieve-bhfu year 3 (~6 years); if not in achieve-mri: achieve-bhfu baseline, achieve-bhfu year 3 (~2.5 years)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive interventions like wearing hearing aids and lifestyle guidance rather than medication, side effects are minimal but may include discomfort from wearing devices or frustration if no improvement in cognition is perceived.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 70 and 84 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am not willing to wear hearing aids every day.

Select...

I need help with two or more daily activities like eating or dressing.

Select...

I have hearing loss where sounds don't travel well to my inner ear in both ears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ if in achieve-mri: achieve baseline, achieve-bhfu year 3 (~6 years); if not in achieve-mri: achieve-bhfu baseline, achieve-bhfu year 3 (~2.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~if in achieve-mri: achieve baseline, achieve-bhfu year 3 (~6 years); if not in achieve-mri: achieve-bhfu baseline, achieve-bhfu year 3 (~2.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and if in achieve-mri: achieve baseline, achieve-bhfu year 3 (~6 years); if not in achieve-mri: achieve-bhfu baseline, achieve-bhfu year 3 (~2.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in global cognition

Mild cognitive impairment (MCI) / dementia

Secondary study objectives

Change in cognition executive function domain

Change in cognition language domain

Change in cognition memory domain

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Hearing intervention (HI) groupActive Control1 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) groupActive Control1 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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hearing loss include hearing aids, cochlear implants, and auditory training. Hearing aids amplify sound, making it easier for the brain to process auditory information. Cochlear implants bypass damaged parts of the ear and directly stimulate the auditory nerve, providing a sense of sound to the user. Auditory training involves exercises that improve the brain's ability to interpret sounds. These treatments are crucial as they not only improve hearing but also potentially slow cognitive decline by maintaining auditory input, which is essential for cognitive health.

Hearing Loss in the Elderly.Glial cell line-derived neurotrophic factor and chronic electrical stimulation prevent VIII cranial nerve degeneration following denervation.