Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT05532657
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
73 Years
Study:
NCT05532657
Study Brief:
Protocol Section:
NCT05532657