NCT05532657 · Phase 3 · ACTIVE NOT RECRUITING
ACHIEVE Brain Health Follow-Up Study
This trial is a 3-year follow-up to a completed study called ACHIEVE. It is tracking whether older adults who received hearing aids earlier show less cognitive decline over time compared to those who got them later. It is a Phase 3 study, meaning it is testing a real-world question at scale. Only people who were already enrolled in the original ACHIEVE trial can participate in this follow-up.
Eligibility criteria
To be eligible for ACHIEVE-BHFU, participants must meet the following criteria: * Eligible for and participated in the ACHIEVE trial (see original criteria below) * Agree to participate and are able and willing to comply with study procedures for three years in the follow-up study Original ACHIEVE Inclusion Criteria (during 2018-2019 enrollment): * Age 70-84 years * Community dwelling, fluent English speaker * Availability of participant in area for study duration * Adult-onset hearing impairment, defined as four-frequency pure tone average (PTA, 0.5-4 kilohertz (kHz), better ear) ≥ 30 decibels hearing level (dB HL) \& ≤ 70 dB HL * Speech recognition scores in quiet ≥ 60% in better ear * Mini-Mental State Exam (MMSE) score ≥ 23 for high school degree or less; ≥ 25 for some college or more Original ACHIEVE Exclusion Criteria: * Reported disability in ≥ 2 activities of daily living (ADLs) * Vision impairment (worse than 20/63 on the Minnesota Near Vision Card) * Self-reported use of a hearing aid in the past 1 year * Medical contraindication to use of hearing aids (e.g., draining ear) * Unwilling to wear hearing aids on a daily basis * Conductive hearing impairment with air-bone gap > 15 dB (decibels) in two or more contiguous frequencies in both ears
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-11-10