Early Age-Related Hearing Loss Investigation (EARHLI)

Not Applicable

Recruiting

• Conditions: Hearing Loss; Cognitive Impairment; Alzheimer Disease

• Registration Number: NCT06174038
• Lead Sponsor: Columbia University

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).

Detailed Description

EARHLI will be a phase II 1:1 randomized controlled trial of a hearing intervention (including prescription hearing aids) versus a health education program. Participants must be 55-75 years old and have early-stage age-related hearing loss and amnestic mild cognitive impairment. The trial will last 1 year and occur at a single site (Columbia University Irving Medical Center). Outcome measurements will include cognition, social engagement, and change in brain organization/connectivity. Assessments will occur at study start, 6 months, and 12 months. A total of 150 participants will be enrolled (75 per intervention group). Participants will also have a hearing test and a blood test. Approximately half of participants will have two MRI scans. As part of participating, all participants will get prescription hearing aids, either at study start or end.

Study Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Study Start: 2024-04-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-21
• Last Update Posted: 2025-06-26
• Primary Completion: 2028-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cohens Social Network Index (SNI) Score	Week 0, Week 28, Week 52	This is the Social Engagement and Related Socialization test # 4: Evaluates Social Relationships. Scored from 1 - 12. Higher score indicates a larger number of social roles in which the respondent has regular contact.
Delayed Recall Log Memory IIa, (DRLM) Score	Week 0, Week 28, Week 52	This is the Cognitive Performance Test # 2 ADCS-PACC 2: Evaluates Episodic Memory. Scoring from 0 - 25 and a higher score translates into a preserved function of the episodic memory.
Trail Making Test Part B, (TMTB) Score	Week 0, Week 28, Week 52	This is the Cognitive Performance test # 5 Evaluates Episodic Memory. Scored in terms of the time, in seconds, required to complete the trail. 300 seconds = maximum amount of time. The less seconds it takes to complete the trail, the better performance/ episodic memory.
Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score	Week 0, Week 28, Week 52	This is the Cognitive Performance test # 6: Evaluates the ability of patients to perform Activities of Daily Living. Section a. Scored from 0 - 45: Items 1 to 15. Higher score for each activity equals better performance. Section b. Scored from 0 - 5. Item 16 to 20. Higher score equals better performance
Social Activity Frequency	Week 0, Week 28, Week 52	This is the Social Engagement and Related Socialization test # 1: Evaluates frequency of social activity participation. Participants are asked on a 5-point scale how often during the past 6 months they engaged in 6 common activities involving socialization. A composite score is created
Brain MRI Measures	Week 0, Week 52	Approximately 50% of all participants (random selection) will have a functional brain MRI.
Free and Cued Selective Reminding Test (FC-SRT) Score	Week 0, Week 28, Week 52	This is the Cognitive Performance Test # 1 ADCS-PACC 1: Evaluates Episodic Memory. Scoring from 0 - 48 and a higher score translates into a preserved function of the episodic memory.
Digit Symbol Substitution Test, (DSST) Score	Week 0, Week 28, Week 52	This it the Cognitive Performance test # 3 ADCS-PACC 3: Evaluates speed of processing. Scoring from 0 - 91 and a higher score relates to better performance and speed of processing.
Mini-Mental State Examination 2, (MMSE-2) Score	Week 0, Week 28, Week 52	This is the Cognitive Performance test # 4 ADCS-PACC 4: Evaluates Global Cognition. Scoring from 0 - 30 and a higher score relates to preserved Global Cognition.
University of California Loneliness Scale (ULS) Score	Week 0, Week 28, Week 52	This is the Social Engagement and Related Socialization test # 5: Evaluates Individuals perception of loneliness. The total score ranges from 20 - 80. Higher scores indicate higher loneliness.
Ability to Participate in Social Roles and Activities (APSR) Score	Week 0, Week 28, Week 52	This is the Social Engagement and Related Socialization test # 2: Evaluates Social Activity Participation. Scored from 8 - 40 a higher score translates into higher levels of social participation.
Community Integration Measure (CIM) Score	Week 0, Week 28, Week 52	This is the Social Engagement and Related Socialization test # 3: Evaluates Community Integration/Participation. Scored from 10 - 50. Higher scores indicate higher levels of community integration and participation.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States