An interventional study of Hearing Intervention and Health Education Intervention in Alzheimer Disease, Hearing Loss and Cognitive Impairment, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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).
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take \~75 minutes.
Device: Hearing 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.
Behavioral: Health Education 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.
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.
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 52
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 52
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 52
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 52
Trail Making Test Part B, (TMTB) Score
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.
Time frame: Week 0, Week 28, Week 52
Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score
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
Time frame: Week 0, Week 28, Week 52
Social Activity Frequency
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
Time frame: Week 0, Week 28, Week 52
Ability to Participate in Social Roles and Activities (APSR) Score
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.
Time frame: Week 0, Week 28, Week 52
Community Integration Measure (CIM) Score
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.
Time frame: Week 0, Week 28, Week 52
Cohens Social Network Index (SNI) Score
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.
Time frame: Week 0, Week 28, Week 52
University of California Loneliness Scale (ULS) Score
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.
Time frame: Week 0, Week 28, Week 52
Brain MRI Measures
Approximately 50% of all participants (random selection) will have a functional brain MRI.
Time frame: Week 0, Week 52
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 52
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 52
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 52
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 52
Pittsburgh Fatigability Scale (PFS) Score
This test evaluates self-report whole-body physical and mental tiredness related to activities of fixed intensity and duration in adults. Scored from 0 - 50, a higher score indicates more symptoms of fatigue.
Time frame: Week 0, Week 28, Week 52
Quick Inventory of Depressive Symptoms (QIDS) Score
Assesses the 9 criterion domains used to diagnose a depressive disorder. Scored 0 - 27 This is the Depression/Depressive Symptom Measure #1: Higher score indicates the presence of more depressive symptoms.
Time frame: Week 0, Week 28, Week 52
CESD-12 Depression (CES) Score
This is the Depression/Depressive Symptom Measure # 2: Evaluates symptoms of depression. Possible range of scores is 0 -26, with the higher scores indicating the presence of more symptomatology
Time frame: Week 0, Week 28, Week 52
RAND Short-Form 36 (SF36)
This is a general measure of quality of life
Time frame: Week 0, Week 28, Week 52
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