RECRUITING

Early Age-Related Hearing Loss Investigation (EARHLI)

Conditions

Alzheimer Disease Hearing Loss Cognitive Impairment Alzheimer's Alzheimer Hearing Aid Memory Loss Memory Audiogram Cognition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-04-01

Study Completion:2028-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06174038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Michael Gomez

CONTACT

646-317-3252

mg4432@cumc.columbia.edu

Principal Investigator

Justin S Golub, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Justin S Golub, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01

Study Completion Date2028-02-01

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2028-02-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Alzheimer Disease
Hearing Loss
Cognitive Impairment