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.

抽象的 阿尔茨海默氏病和相关痴呆症（ADRD）及其前体，轻度认知障碍（MCI）是一个 对个人和家庭的主要公共卫生关注和改变生活的诊断。大多数人 ADRD或MCI也有听力损失。听力和认知障碍同时发生时， 部署认知资源来抑制分心的说话者，填写错过的单词或将上下文知识应用于 提高对扭曲信号的理解意味着ADRD的听众可能不太能够补偿 未经ADRD的听众，未经处理的听力损失。因此，听力损失和认知的结合 与单独的残疾相比，损伤导致功能局限性明显更大。 OTC 是 优势； 助听器 经过听力损失支持和老年保健小组的长期倡导之后，FDA批准了，并具有潜力 也就是说，低成本的助听器无需医生就诊，推荐和多个 听力学任命。然而， 和 结果 沟通 或者 临床 将要 目的 OTC AIDS具有技术限制，可能会限制其对佩戴者的利益 认知能力受损。损害水平不同的患者也可能有不同的治疗 与继承人遵守治疗的能力以及继承人认知水平的整体影响有关 能力。因此，需要直接评估ADRD成年人的OTC技术 MCI并确定OTC AIDS比其他干预措施的相对益处。这个R和 诊断为MCI或ADRD早期以及轻度听力损失后，将招募试验。参与者 随机分配为认知能力下降的成年人量身定制的OTC AIDS或通信策略。在 1，我们将衡量ADRD或MCI老年人的OTC助听器的沟通益处。 t 在 认识到沟通伙伴在治疗模型中的关键作用，并与我们关注 现实生活中的相关性，主要结果包括对二元交流的主观评估 听众的主要沟通合作伙伴。其他结果包括与听力相关的生活质量和 使用对话分析对沟通能力的客观评估。每个措施将在 基线和经过1个月的试验。在AIM 2中，我们将在各个阶段进行OTC助听器益处的特征 认知诊断（MCI与ADRD早期相比）。主要分析将采用多变量线性 回归模型比较武器之间主要结果的差异。这提出了基础科学 项目将提供基本证据，以指导MCI或早期老年人的治疗建议 ADRD，还将为将来的实用临床试验建立可行性数据。