Recruiting

Hearing Loss

Sponsor:

Columbia University

Code:

NCT06174038

Conditions

Alzheimer Disease

Hearing Loss

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Hearing Intervention

Health Education Intervention

Study Details

Brief 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).

Conditions

Alzheimer Disease

Hearing Loss

Cognitive Impairment

Study ID

NCT06174038

Start date

Aug 1, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Hearing Intervention

Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take \~75 minutes.

other: Health Education Intervention

Participants will receive a modified health education program on healthy aging. It will match the number and length of sessions as the hearing intervention, including compliance/phone checks. Participants will be on a waitlist to obtain hearing aids without fee at the end of their 12-month participation.

Interventions

Hearing Intervention

The hearing intervention includes an auditory needs assessment, hearing aid fitting, establishing Bluetooth connectivity from hearing aids to devices such as smartphones and computers, systematic orientation and instruction in device use, and provision and discussion of hearing "toolkit" materials for self-management and communication strategies. The hearing intervention is person-centered, focusing on identification of individual needs, setting of specific goals, engagement in shared-informed decision-making, and development of self-management abilities. Intervention-centric outcomes (e.g., hearing aid data logging, real ear measures) to verify the best-practices intervention will be gathered at all 5 intervention sessions as well as weeks 16 and 52. Additional visits to troubleshoot hearing aids or address concerns will be scheduled as needed.

Health Education Intervention

The evidence-based interactive health education program is designed for older adults and addresses chronic disease and disability prevention. Session content will be individualized for each participant based on a "key," depending on his/her goals/interests. The curriculum includes didactics, activities, and goal setting led by staff trained/certified to deliver the intervention.

Primary outcome measure

  • Free and Cued Selective Reminding Test (FC-SRT) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Delayed Recall Log Memory IIa, (DRLM) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Digit Symbol Substitution Test, (DSST) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Mini-Mental State Examination 2, (MMSE-2) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Trail Making Test Part B, (TMTB) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Social Activity Frequency [ Time Frame: Week 0, Week 28, Week 52 ]
  • Ability to Participate in Social Roles and Activities (APSR) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Community Integration Measure (CIM) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Cohens Social Network Index (SNI) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • University of California Loneliness Scale (ULS) Score [ Time Frame: Week 0, Week 28, Week 52 ]
  • Brain MRI Measures [ Time Frame: Week 0, Week 52 ]

Central Contacts and Locations

Central contacts

Larry Tapia

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

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Larry Tapia

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

Principal Investigator:

Justin S Golub, MD

More Information

Sponsor

Columbia University

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Hearing Loss
  • Alzheimer's
  • Alzheimer
  • Hearing Aid
  • Memory Loss
  • Memory
  • Audiogram
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-08-12.