RecruitingNot Applicable

Early Age-Related Hearing Loss Investigation (EARHLI)

United States150 participantsStarted 2024-08-01

Plain-language summary

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).

Who can participate

Age range

55 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention Instrument (ADCS-ADL-PI) * Community-dwelling * Fluent in English or Spanish * Availability of participant in area for study duration Exclusion Criteria: * 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) * Unwillingness to wear hearing aids regularly (≥8 hours/day) * Medical contraindications to the use of hearing aids (e.g., actively draining ear) * Corrected vision impairment (worse than 20/63 on MNRead Acuity Chart in worse eye) * Untreatable conducti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Free and Cued Selective Reminding Test (FC-SRT) Score

Timeframe: Week 0, Week 28, Week 52

Delayed Recall Log Memory IIa, (DRLM) Score

Timeframe: Week 0, Week 28, Week 52

Digit Symbol Substitution Test, (DSST) Score

Timeframe: Week 0, Week 28, Week 52

Mini-Mental State Examination 2, (MMSE-2) Score

Timeframe: Week 0, Week 28, Week 52

Trail Making Test Part B, (TMTB) Score

Timeframe: Week 0, Week 28, Week 52

Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score

Timeframe: Week 0, Week 28, Week 52

Social Activity Frequency

Timeframe: Week 0, Week 28, Week 52

Trial details

NCT IDNCT06174038

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Larry Tapia

646-317-3252 earhli@cumc.columbia.edu

View on ClinicalTrials.gov More Alzheimer Disease trials

Plain-language summary

Who can participate

Age range

55 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Free and Cued Selective Reminding Test (FC-SRT) Score

Timeframe: Week 0, Week 28, Week 52

Delayed Recall Log Memory IIa, (DRLM) Score

Timeframe: Week 0, Week 28, Week 52

Digit Symbol Substitution Test, (DSST) Score

Timeframe: Week 0, Week 28, Week 52

Mini-Mental State Examination 2, (MMSE-2) Score

Timeframe: Week 0, Week 28, Week 52

Trail Making Test Part B, (TMTB) Score

Timeframe: Week 0, Week 28, Week 52

Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score

Timeframe: Week 0, Week 28, Week 52

Social Activity Frequency

Timeframe: Week 0, Week 28, Week 52