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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG075083 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| National Institute on Aging (NIA) | NIH |
| University of South Florida | OTHER |
| University of Pittsburgh |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing Intervention | Other | Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take ~75 minutes. |
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| Health Education Intervention | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Intervention | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, Week 28, Week 52 |
| Hearing Handicap Index-Short-Significant Other (HHIO) Score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larry Tapia | Contact | 646-317-3252 | earhli@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Justin S Golub, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38728564 | Derived | Denham MW, Arnold ML, Sanchez VA, Lin FR, Tucker LH, Gomez MC, Fernandez K, Arpi P, Neil H, Boyle S, Selevan S, Sussman TJ, Gmelin T, Fine I, Glynn NW, Teresi J, Noble JM, Goldberg T, Luchsinger JA, Golub JS. Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial. Otol Neurotol. 2024 Jun 1;45(5):594-601. doi: 10.1097/MAO.0000000000004093. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D034381 | Hearing Loss |
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| University of Washington | OTHER |
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| Health Education Intervention | Behavioral | 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. |
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| 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 | 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. | 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. | 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. | 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. | Week 0, Week 28, Week 52 |
| Brain MRI Measures | Approximately 50% of all participants (random selection) will have a functional brain MRI. | Week 0, Week 52 |
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. |
| 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. | 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. | 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. | 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. | 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 | Week 0, Week 28, Week 52 |
| RAND Short-Form 36 (SF36) | This is a general measure of quality of life | Week 0, Week 28, Week 52 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019954 | Neurobehavioral Manifestations |