Over-The-Counter Hearing Aid Treatment For Adults With Cognitive Decline Due To Alzheimer's Disease And Related Dementias

针对因阿尔茨海默病和相关痴呆症而导致认知能力下降的成年人的非处方助听器治疗

• 批准号: 10740008
• 负责人: PAMELA E. SOUZA
• 金额: $ 44.38万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10740008
• 关键词: Adherence; Adult; Advocacy; Age Years; Alzheimer' s Disease; Alzheimer' s disease related dementia; Appointment; Audiology; Auditory; Basic Science; Caring; Climacteric; Clinic; Clinical; Cognitive; Communication; Communication Disability; Communication impairment; Compensation; Data; Dementia; Devices; Diagnosis; Discourse analysis; Elderly; Enrollment; Ensure; FDA approved; Family; Family member; Friends; Future; Geriatrics; Hearing; Hearing Aids; Heterogeneity; Hour; Impaired cognition; Impairment; Individual; Intervention; Knowledge; Life; Linear Regressions; Long-Term Care for Elderly; Marketing; Measures; Memory; Modeling; Motivation; Outcome; Participant; Partner Communications; Patients; Persons; Physicians; Population; Pragmatic clinical trial; Presbycusis; Public Health; Qualifying; Quality of life; Randomized; Recommendation; Reporting; Research Personnel; Resources; Sensorineural Hearing Loss; Signal Transduction; Technology; Testing; Time; Training; Treatment outcome; Visit; Work; arm; cognitive ability; cognitive disability; cost; cost effective; design; disability; family support; health management; hearing impairment; hearing loss treatment; improved; mild cognitive impairment; primary outcome; randomized, clinical trials; recruit; remediation; social relationships; treatment arm; treatment effect; two-arm trial; underserved community; usability

Abstract Alzheimer's disease and related dementias (ADRD) and their precursor, mild cognitive impairment (MCI), are a major public health concern and a life-changing diagnosis for individuals and families. Most individuals with ADRD or MCI also have hearing loss. When hearing and cognitive impairments co-occur, reduced ability to deploy cognitive resources to inhibit distracting talkers, fill in missed words, or apply contextual knowledge to improve understanding of a distorted signal means that listeners with ADRD may be less able to compensate for untreated hearing loss than listeners without ADRD. Therefore, the combination of hearing loss and cognitive impairment results in significantly greater functional limitations than either disability alone. OTC were advantages; hearing aids approved by the FDA after long advocacy by hearing loss support and eldercare groups and have potential namely, lower-cost hearing aids without the need for physician visits, referrals, and multiple audiology appointments. However, with outcomes communication or clinical will Aim OTC aids have technology constraints that may limit their benefit for wearers impaired cognitive ability. Patients with different levels of impairment may also have different treatment related to t heir ability to adhere to treatment and how heir cognitive level impacts overall ability. Therefore, there is a need for direct assessment of OTC t echnology for adults with ADRD MCI and to determine the relative benefit of OTC aids over other interventions. Participants in this r andomized trial will be recruited after diagnosis of either MCI or early ADRD along with mild hearing loss. Participants be randomized to receive OTC aids or communication strategies tailored for adults with cognitive decline. In 1, we will measure communication benefit for OTC hearing aids in older adults with ADRD or MCI. t In recognition of the key role of communication partners in the treatment model and in keeping with our focus on real-life relevance, the primary outcome consists of subjective assessment of dyadic communication by the listener's primary communication partner. Additional outcomes include hearing-related quality of life and objective assessment of communication ability using conversation analysis. Each measure will be conducted at baseline and after a 1-month trial. In Aim 2, we will characterize OTC hearing aid benefit across stages of cognitive diagnosis (MCI compared to early ADRD). Primary analyses will employ a multivariable linear regression model to compare the difference in primary outcome between arms. This proposed basic science project will provide foundational evidence to guide treatment recommendations in older adults with MCI or early ADRD, and will also establish feasibility data for future pragmatic clinical trials.

摘要 阿尔茨海默病和相关痴呆(ADRD)及其前驱--轻度认知障碍(MCI)是一种 对个人和家庭的重大公共卫生问题和改变生活的诊断。大多数人都有 ADRD或MCI也有听力损失。当听力和认知障碍同时出现时， 部署认知资源以抑制分心的说话者，填补遗漏的单词，或将上下文知识应用于 提高对失真信号的理解意味着患有ADRD的听众可能无法补偿 未经治疗的听力损失比没有ADRD的听众要好。因此，听力损失和认知能力的结合 功能障碍导致的功能限制比任何一种单独的残疾都要大得多。场外交易 是 优势； 助听器 经过失聪支持和老年护理团体的长期倡导，得到了FDA的批准，并具有潜力 即，无需医生就诊、转诊和多次使用的低成本助听器 听力学预约。然而， 使用 结果 沟通 或 临床 将要 目标 非处方药辅助设备的技术限制可能会限制佩戴者获得的好处 认知能力受损。不同程度损害的患者也可能有不同的治疗方法 与继承人坚持治疗的能力以及继承人的认知水平对整体的影响有关 才能。因此，有必要对成人ADRD的非处方药技术进行直接评估 并确定非处方药辅助相对于其他干预措施的相对益处。本次调查的参与者被随机 试验将在诊断为MCI或早期ADRD并伴有轻度听力损失后招募。参与者 随机接受非处方药辅助或为认知功能减退的成年人量身定做的沟通策略。在……里面 1，我们将衡量患有ADRD或MCI的老年人使用OTC助听器的沟通益处。 T 在……里面 认识到沟通伙伴在治疗模式中的关键作用，并与我们对 与现实生活的相关性，主要结果包括由 听众的主要沟通伙伴。其他结果包括与听力相关的生活质量和 运用会话分析客观评价学生的交际能力。每项措施将在 基线和1个月的试验后。在目标2中，我们将描述OTC助听器在以下几个阶段的优势 认知诊断(MCI与早期ADRD比较)。初步分析将采用多变量线性 建立回归模型，比较两组患者主要结局的差异。这项提出的基础科学 该项目将提供基础证据，指导患有MCI或早期的老年人的治疗建议 ADRD，并将为未来的务实临床试验建立可行性数据。