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 阿尔茨海默病和相关痴呆症 (ADRD) 及其前兆轻度认知障碍 (MCI) 是一种 重大公共卫生问题以及改变个人和家庭生活的诊断。大多数人患有 ADRD 或 MCI 也有听力损失。当听力和认知障碍同时发生时，识别能力会降低 部署认知资源来阻止分散注意力的谈话者、填写遗漏的单词或应用上下文知识 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 的听众要高。因此，听力损失和认知能力的结合 与单独的残疾相比，损伤会导致更大的功能限制。场外交易 是 优点； 助听器 经过听力损失支持和老年护理团体的长期倡导，获得 FDA 批准，具有潜力 即，无需医生就诊、转诊和多次就诊的低成本助听器 听力学预约。然而， 和 结果 沟通 或者 临床 将要 目的 非处方辅助用品的技术限制可能会限制其对佩戴者的益处 认知能力受损。不同程度的损伤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如何影响整体有关 能力。因此，需要对成人 ADRD 患者的 OTC 技术进行直接评估 MCI 并确定非处方药援助相对于其他干预措施的相对益处。本次随机分组的参与者 在诊断出 MCI 或早期 ADRD 并伴有轻度听力损失后，将招募试验。参加者 被随机接受非处方药援助或为认知能力下降的成年人量身定制的沟通策略。在 1，我们将衡量 OTC 助听器对患有 ADRD 或 MCI 的老年人的沟通益处。 t 在 认识到沟通伙伴在治疗模式中的关键作用，并与我们的重点保持一致 现实生活的相关性，主要结果包括对二元沟通的主观评估 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 使用对话分析客观评估沟通能力。每项措施将在 基线和 1 个月试验后。在目标 2 中，我们将描述 OTC 助听器在各个阶段的益处 认知诊断（MCI 与早期 ADRD 相比）。初步分析将采用多变量线性 回归模型来比较各组之间主要结果的差异。本提议的基础科学 该项目将提供基础证据来指导患有 MCI 或早期的老年人的治疗建议 ADRD，还将为未来的实用临床试验建立可行性数据。