Early Age-Related Hearing Loss Investigation (EARHLI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorColumbia University
About this trial
Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).
Eligibility criteria
Qualifiers
Age 55-75 years of age
Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better hearing ear)
Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear
Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score >23, Clinical Dementia Rating (CDR) global score equivalent = 0.5, and ADNI3 criteria of Logical Memory II score of ≤6 if 0-7 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years
Disqualifiers
Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (<45 years old)
Prior dementia diagnosis
Reported disability in ≥ 2 activities of daily living (ADLs)
Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)
Trial design
Treatments tested in this trial
- Hearing Intervention
- Health Education Intervention
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
Johns Hopkins University
Collaborator
National Institute on Aging (NIA)
Collaborator
University of South Florida
Collaborator
University of Pittsburgh
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov