← Back to Search

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
Age 70-84 years
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

ACHIEVE-BHFU Trial Summary

This trial will help researchers understand if hearing aid intervention can help prevent cognitive decline 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.Check my eligibility
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.See study design
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.

ACHIEVE-BHFU Trial 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.
Select...
I am between 70 and 84 years old.

ACHIEVE-BHFU Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in global cognition
Mild cognitive impairment (MCI) / dementia
Secondary outcome measures
Change in cognition executive function domain
Change in cognition language domain
Change in cognition memory domain
+2 more

ACHIEVE-BHFU 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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,815,778 Total Patients Enrolled
12 Trials studying Hearing Loss
4,016 Patients Enrolled for Hearing Loss
University of North CarolinaOTHER
164 Previous Clinical Trials
1,438,716 Total Patients Enrolled
3 Trials studying Hearing Loss
406 Patients Enrolled for Hearing Loss
University of South FloridaOTHER
403 Previous Clinical Trials
184,335 Total Patients Enrolled
7 Trials studying Hearing Loss
743 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research looking for more participants?

"Unfortunately, this particular trial is not accepting any more participants at this time. The trial was posted on November 7th, 2022 and updated on October 7th, 2022. Although this trial might not be right for you, there are 1263 other trials that might be a better fit."

Answered by AI

Would I be a good candidate for this research project?

"This medical trial is enrolling 859 individuals, all of whom are over the age of 73 and suffer from dementia. Furthermore, it is crucial that participants meet the following additional requirements: Be willing and able to comply with study procedures for a three-year period, Be between the ages of 70 and 84, Be a community dwelling individual, Be a fluent English speaker, Be available in the area for the duration of the study, Have adult-onset hearing impairment (as defined by a four-frequency pure tone average (PTA) of 0.5-4 kHz that is no worse than 70 dB HL in the better"

Answered by AI

In how many different medical facilities is this medical study taking place?

"At the moment, this study is focusing on enrolling patients at Johns Hopkins Comstock Center for Public Health Research and Prevention in Hagerstown, Maryland, University of Minnesota in Minneapolis, Minnesota, and University of Mississippi Medical Center in Jackson, Mississippi. There are 4 other potential sites for recruitment."

Answered by AI

If an older person wanted to participate in this research, would they be allowed to?

"Out of the 1185 clinical trials currently taking place, 96 are for minors and this particular one is for elderly patients aged 73 to 89."

Answered by AI

Could you please clarify the risks associated with the Hearing intervention (HI) group?

"The team at Power has HI group's safety at a 3 because it is a Phase 3 trial. This suggests that there is data affirming HI group's efficacy as well as multiple rounds of data that support HI group's safety."

Answered by AI

What do researchers hope to learn from this clinical trial?

"The goal of this trial is to study the effects of the medication on mild cognitive impairment (MCI) / dementia, over a period of 6 years. Secondary outcomes that will be measured include change in regional brain volumes, change in cognition in the memory domain, and change in cognition in the language domain."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Pennsylvania
North Carolina
Georgia
How many prior treatments have patients received?
0
What site did they apply to?
Wake Forest University

Why did patients apply to this trial?

I have definitely lost some of my hearing and have tinnitus. Diagnosed with Mild Cognitive Impairment and want to prevent progression.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Wake Forest University: < 24 hours
Average response time
  • < 1 Day
~566 spots leftby Jun 2026