Early Age-Related Hearing Loss Investigation (EARHLI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorColumbia University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Hearing Intervention
DeviceThe 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
BehavioralThe 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Hearing InterventionOther 1 intervention
Group B: Health Education InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
Free and Cued Selective Reminding Test (FC-SRT) Score
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.
Time frame
Week 0, Week 28, Week 522
Delayed Recall Log Memory IIa, (DRLM) Score
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.
Time frame
Week 0, Week 28, Week 523
Digit Symbol Substitution Test, (DSST) Score
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.
Time frame
Week 0, Week 28, Week 524
Mini-Mental State Examination 2, (MMSE-2) Score
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.
Time frame
Week 0, Week 28, Week 52Other outcomes
1
Hearing Handicap Index for Adults and the Elderly-Short (HHIS) Score
This test evaluates self perceived hearing handicap. Score ranges from 0 - 48, a higher score indicates higher perception of problems secondary to hearing loss.
Time frame
Week 0, Week 28, Week 522
Hearing Handicap Index-Short-Significant Other (HHIO) Score
This test evaluates hearing handicap perceived by subjects significant other. Score ranges from 0 - 48, a higher score indicates higher perception of problems secondary to hearing loss.
Time frame
Week 0, Week 28, Week 523
Speech, Spatial and Qualities of Hearing Scale (SSQ12) Score
This test evaluates a range of hearing disabilities across several domains. Scored from 0 - 120, a higher score indicates better hearing.
Time frame
Week 0, Week 28, Week 524
Vanderbilt Fatigue Scale (VFS) Score
This test evaluates listening-related fatigue in individuals with hearing loss and other communication-based difficulties. Scored from 0 - 40, a higher score indicates more symptoms of fatigue related to hearing loss.
Time frame
Week 0, Week 28, Week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Johns Hopkins University
Collaborator
National Institute on Aging (NIA)
Collaborator
University of South Florida
Collaborator
University of Pittsburgh
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov