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 阿尔茨海默氏病和相关痴呆（ADRD）及其前兆轻度认知障碍（MCI）是一种严重的认知障碍。 这是一个重大的公共卫生问题，也是一个改变个人和家庭生活的诊断。大多数人 ADRD或MCI也有听力损失。当听力和认知障碍同时发生时， 部署认知资源，以抑制分心的谈话者，填补遗漏的单词，或应用上下文知识， 改善对失真信号的理解意味着患有ADRD的听众可能无法补偿 未治疗的听力损失比没有ADRD的听力损失更严重。因此，听力损失和认知功能的结合 损伤导致的功能限制明显大于单独的残疾。OTC 是 优势; 助听器 经过听力损失支持和老年人护理团体的长期倡导， 也就是说，低成本的助听器，而不需要医生的访问，转介， 听力预约然而，在这方面， 与 成果 通信 或 临床 将 目的 OTC辅助器具有技术限制，可能会限制其对佩戴者的益处 认知能力受损受损程度不同的患者也可能有不同的治疗方法 与其坚持治疗的能力以及其认知水平如何影响整体 能力因此，有必要对成人ADRD患者的OTC技术进行直接评估 MCI，并确定OTC辅助治疗相对于其他干预措施的相对获益。参加这次随机化的 试验将在诊断为MCI或早期ADRD沿着轻度听力损失后招募。参与者 随机接受OTC辅助治疗或为认知能力下降的成年人量身定制的沟通策略。在 1、我们将测量OTC助听器在患有ADRD或MCI的老年人中的沟通益处。 不 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， 现实生活中的相关性，主要结果包括主观评估的二元通信的 听众的主要交流伙伴。其他结果包括听力相关的生活质量， 使用会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助听器在不同阶段的益处， 认知诊断（MCI与早期ADRD相比）。主要分析将采用多变量线性回归分析。 回归模型，以比较两组之间主要结局的差异。这个提议的基础科学 该项目将提供基础证据，以指导MCI或早期MCI老年人的治疗建议。 ADRD，并将建立可行性数据，为未来务实的临床试验。