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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
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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.
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I am not willing to wear hearing aids every day.
Select...
I need help with two or more daily activities like eating or dressing.
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I have hearing loss where sounds don't travel well to my inner ear in both ears.

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)
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.

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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthOTHER
1,415 Previous Clinical Trials
855,448 Total Patients Enrolled
16 Trials studying Hearing Loss
1,575 Patients Enrolled for Hearing Loss
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,002 Total Patients Enrolled
12 Trials studying Hearing Loss
4,059 Patients Enrolled for Hearing Loss
University of North CarolinaOTHER
170 Previous Clinical Trials
1,454,835 Total Patients Enrolled
3 Trials studying Hearing Loss
406 Patients Enrolled for Hearing Loss
University of South FloridaOTHER
427 Previous Clinical Trials
192,002 Total Patients Enrolled
8 Trials studying Hearing Loss
864 Patients Enrolled for Hearing Loss
University of MinnesotaOTHER
1,439 Previous Clinical Trials
1,621,329 Total Patients Enrolled
5 Trials studying Hearing Loss
924 Patients Enrolled for Hearing Loss
Wake Forest UniversityOTHER
192 Previous Clinical Trials
165,607 Total Patients Enrolled
2 Trials studying Hearing Loss
30,339 Patients Enrolled for Hearing Loss
Mayo ClinicOTHER
3,362 Previous Clinical Trials
3,065,495 Total Patients Enrolled
6 Trials studying Hearing Loss
690 Patients Enrolled for Hearing Loss
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,194,228 Total Patients Enrolled
8 Trials studying Hearing Loss
1,986 Patients Enrolled for Hearing Loss
University of Mississippi Medical CenterOTHER
182 Previous Clinical Trials
196,475 Total Patients Enrolled
1 Trials studying Hearing Loss
339 Patients Enrolled for Hearing Loss
Frank R Lin, MD, PhDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
1,467 Total Patients Enrolled
2 Trials studying Hearing Loss
490 Patients Enrolled for Hearing Loss

Media Library

Hearing intervention Clinical Trial Eligibility Overview. Trial Name: NCT05532657 — Phase 3
Hearing Loss Research Study Groups: Hearing intervention (HI) group, Successful aging/Delayed hearing intervention (SA/DHI) group
Hearing Loss Clinical Trial 2023: Hearing intervention Highlights & Side Effects. Trial Name: NCT05532657 — Phase 3
Hearing intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05532657 — Phase 3
Hearing Loss Patient Testimony for trial: Trial Name: NCT05532657 — Phase 3
~276 spots leftby Jun 2026
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