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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cohens Social Network Index (SNI) Score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hearing Intervention
Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take ~75 minutes.
干预措施: Hearing Intervention (Device)
Health Education 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.
干预措施: Health Education Intervention (Behavioral)
结局指标
主要结局
Cohens Social Network Index (SNI) Score
时间窗: Week 0, Week 28, Week 52
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.
Delayed Recall Log Memory IIa, (DRLM) Score
时间窗: Week 0, Week 28, Week 52
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.
Trail Making Test Part B, (TMTB) Score
时间窗: Week 0, Week 28, Week 52
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.
Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score
时间窗: Week 0, Week 28, Week 52
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
Social Activity Frequency
时间窗: Week 0, Week 28, Week 52
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
Brain MRI Measures
时间窗: Week 0, Week 52
Approximately 50% of all participants (random selection) will have a functional brain MRI.
Free and Cued Selective Reminding Test (FC-SRT) Score
时间窗: Week 0, Week 28, Week 52
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.
Digit Symbol Substitution Test, (DSST) Score
时间窗: Week 0, Week 28, Week 52
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.
Mini-Mental State Examination 2, (MMSE-2) Score
时间窗: Week 0, Week 28, Week 52
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.
University of California Loneliness Scale (ULS) Score
时间窗: Week 0, Week 28, Week 52
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.
Ability to Participate in Social Roles and Activities (APSR) Score
时间窗: Week 0, Week 28, Week 52
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.
Community Integration Measure (CIM) Score
时间窗: Week 0, Week 28, Week 52
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.
次要结局
未报告次要终点
研究者
Justin S. Golub
Associate Professor of Otolaryngology/Head and Neck Surgery
Columbia University