Early Age-Related Hearing Loss Investigation (EARHLI)

Alzheimer Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174038
• Other study ID #: AAAU1896
• Secondary ID: R01AG075083
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: February 1, 2028

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Michael Gomez
• Phone: 646-317-3252
• Email: mg4432[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Impairment
• Deafness
• Hearing Loss
• Presbycusis

Intervention

Device:
• Hearing 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.

Behavioral:
• Health Education Intervention
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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
Columbia University	Johns Hopkins University, National Institute on Aging (NIA), University of Pittsburgh, University of South Florida, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	Week 0, Week 28, Week 52
Other	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
Other	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
Other	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
Other	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
Other	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
Other	RAND Short-Form 36 (SF36)	This is a general measure of quality of life	Week 0, Week 28, Week 52
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Week 0, Week 28, Week 52
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Brain MRI Measures	Approximately 50% of all participants (random selection) will have a functional brain MRI.	Week 0, Week 52