Early Age-Related Hearing Loss Investigation (EARHLI)

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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 d
• Поведенческое 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.

Первичные конечные точки

• Free and Cued Selective Reminding Test (FC-SRT) Score [Срок оценки: Week 0, Week 28, Week 52]
• Delayed Recall Log Memory IIa, (DRLM) Score [Срок оценки: Week 0, Week 28, Week 52]
• Digit Symbol Substitution Test, (DSST) Score [Срок оценки: Week 0, Week 28, Week 52]
• Mini-Mental State Examination 2, (MMSE-2) Score [Срок оценки: Week 0, Week 28, Week 52]
• Trail Making Test Part B, (TMTB) Score [Срок оценки: Week 0, Week 28, Week 52]
• Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score [Срок оценки: Week 0, Week 28, Week 52]
• Social Activity Frequency [Срок оценки: Week 0, Week 28, Week 52]
• Ability to Participate in Social Roles and Activities (APSR) Score [Срок оценки: Week 0, Week 28, Week 52]
• Community Integration Measure (CIM) Score [Срок оценки: Week 0, Week 28, Week 52]
• Cohens Social Network Index (SNI) Score [Срок оценки: Week 0, Week 28, Week 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Columbia University Medical Center — New York

Публикации

• 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. PMID 38728564

Идентификаторы

NCT: NCT06174038 · AAAU1896 · R01AG075083

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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