Clinical trial NCT06174038: Early Age-Related Hearing Loss Investigation (EARHLI)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Hearing Loss
Cognitive Impairment
Keywords: Hearing Loss
Alzheimer's
Alzheimer
Hearing Aid
Memory Loss
Memory
Audiogram
Cognition
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Institute on Aging (NIA)
name: University of South Florida
name: University of Pittsburgh
name: University of Washington
First posted: 2023-12-18
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Free and Cued Selective Reminding Test (FC-SRT) Score
timeFrame: Week 0, Week 28, Week 52
measure: Delayed Recall Log Memory IIa, (DRLM) Score
timeFrame: Week 0, Week 28, Week 52
measure: Digit Symbol Substitution Test, (DSST) Score
timeFrame: Week 0, Week 28, Week 52
measure: Mini-Mental State Examination 2, (MMSE-2) Score
timeFrame: Week 0, Week 28, Week 52
measure: Trail Making Test Part B, (TMTB) Score
timeFrame: Week 0, Week 28, Week 52
measure: Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score
timeFrame: Week 0, Week 28, Week 52
measure: Social Activity Frequency
timeFrame: Week 0, Week 28, Week 52
measure: Ability to Participate in Social Roles and Activities (APSR) Score
timeFrame: Week 0, Week 28, Week 52
measure: Community Integration Measure (CIM) Score
timeFrame: Week 0, Week 28, Week 52
measure: Cohens Social Network Index (SNI) Score
timeFrame: Week 0, Week 28, Week 52
measure: University of California Loneliness Scale (ULS) Score
timeFrame: Week 0, Week 28, Week 52
measure: Brain MRI Measures
timeFrame: Week 0, Week 52
Secondary outcomes:
Other outcomes:
measure: Hearing Handicap Index for Adults and the Elderly-Short (HHIS) Score
timeFrame: Week 0, Week 28, Week 52
measure: Hearing Handicap Index-Short-Significant Other (HHIO) Score
timeFrame: Week 0, Week 28, Week 52
measure: Speech, Spatial and Qualities of Hearing Scale (SSQ12) Score
timeFrame: Week 0, Week 28, Week 52
measure: Vanderbilt Fatigue Scale (VFS) Score
timeFrame: Week 0, Week 28, Week 52
measure: Pittsburgh Fatigability Scale (PFS) Score
timeFrame: Week 0, Week 28, Week 52
measure: Quick Inventory of Depressive Symptoms (QIDS) Score
timeFrame: Week 0, Week 28, Week 52
measure: CESD-12 Depression (CES) Score
timeFrame: Week 0, Week 28, Week 52
measure: RAND Short-Form 36 (SF36)
timeFrame: Week 0, Week 28, Week 52
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Justin S Golub, MD
role: PRINCIPAL_INVESTIGATOR
References: