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Early Age-Related Hearing Loss Investigation (EARHLI)

Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Blood draws, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for 1 year."
  • "Participants will also have a hearing test and a blood test."
  • "Approximately half of participants will have two MRI scans."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether hearing care, including hearing aids, may help slow loss of memory and thinking skills compared with health education. It is for adults ages 55–75 with hearing loss and mild memory problems who are at risk for Alzheimer's disease and related dementias. Participants are assigned by chance to a group and followed for 1 year.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 55–75 years old.
  • Have mild to moderate hearing loss that began in adulthood, based on a hearing test.
  • Have hearing loss that hearing aids can help, with at least 60% word recognition in quiet in the better-hearing ear.
  • Have mild memory problems, called amnestic mild cognitive impairment, and meet the study's memory and thinking test rules.
  • Have a study partner who can help with questions about your memory, thinking, and daily activities.
  • Live in the community, rather than in a care facility.
  • Speak English or Spanish fluently.
  • Be available in the study area for the full year.

Who can't join

  • Have hearing loss from birth, from a known gene change, or that began before age 45.
  • Have a past diagnosis of dementia.
  • Report difficulty doing at least 2 basic daily activities.
  • Use hearing aids regularly now or have done so in the past, including use in the past 6 months beyond brief trials.
  • Be unwilling to wear hearing aids for at least 8 hours a day.
  • Have a medical reason you cannot use hearing aids, such as fluid actively draining from an ear.
  • Have vision worse than 20/63 in the worse eye, even with glasses or other vision correction.
  • Have hearing loss in both ears caused by problems carrying sound through the outer or middle ear that cannot be treated and meets the study's hearing test limits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 conductive hearing loss with air-bone gap \> 15 dB in two or more contiguous octave frequencies in both ears

Study sites (1)

NY