Personalized OSA treatment and effects on AD biomarkers and cognition among blacks

个性化 OSA 治疗及其对黑人 AD 生物标志物和认知的影响

• 批准号: 10525595
• 负责人: Girardin Jean-Louis
• 金额: $ 78.68万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10525595
• 关键词: Address; Adherence; Alzheimer' s Disease; Alzheimer’s disease biomarker; Amyloid beta-Protein; Attention; Behavioral Model; Biological Markers; Black Populations; Blood Pressure; Caring; Clinic; Cognition; Cognitive; Collaborations; Communities; Data; Ecological momentary assessment; Education; Effectiveness; Effectiveness of Interventions; Enrollment; Evaluation; Exposure to; Failure; Focus Groups; Fostering; Glean; Glial Fibrillary Acidic Protein; Glucose; Glycosylated hemoglobin A; Goals; Health; Health Educators; Health Policy; Health education; Home; Impairment; Inflammatory; Infrastructure; Interleukin-10; Interleukin-6; Intervention; Joints; Language; Lipids; Lipoproteins; Measures; Mediating; Medical; Memory; Modality; Modeling; Molecular; Motivation; Newly Diagnosed; Obesity; Obstructive Sleep Apnea; Online Systems; Outcome; Pathway interactions; Patient-Focused Outcomes; Patients; Physicians; Public Health; Readiness; Risk; Schedule; Self Efficacy; Serum; Shoulder; Sleep; Sleep Apnea Syndromes; Strategic Planning; System; TNF gene; Techniques; Telemetry; Time; United States National Institutes of Health; base; black patient; brain health; clinical center; cognitive function; comparative effectiveness; effectiveness evaluation; executive function; health data; health literacy; health related quality of life; human centered design; human very old age (85+); improved; innovation; insulin sensitivity; literacy; molecular marker; novel; personalized approach; positive airway pressure; post intervention; prevent; response; sleep health; sleep quality; success; system-level barriers; systemic inflammatory response; tau Proteins; treatment adherence; treatment effect; vascular contributions; video delivery; vigilance; web site; web-based intervention; β-amyloid burden

Project Summary Evidence shows increased tau and amyloid-β burden among patients with obstructive sleep apnea (OSA). Impairment in memory, executive function, attention, and vigilance is also common among those patients. Fortunately, OSA treatment can normalize these biomarkers of Alzheimer’s disease (AD) and improve cognitive function. Treatment can also reduce systemic inflammation and improve insulin sensitivity, blood pressure, and serum lipids and lipoproteins. Notwithstanding such compelling data, little is known about the impact of OSA treatment among blacks, a group shouldering a disproportionate burden of OSA and AD. Failure to benefit from these medical advances is due in part to a dearth of data explaining poor access to adequate OSA care, limiting our ability to implement health policies guiding aggressive OSA control among blacks. We propose an RCT to assess the effectiveness of our innovative Personalized OSA Treatment Adherence Model in enhancing adherence to OSA treatment among blacks. We will implement an effective and scalable intervention to ascertain effects of OSA treatment on AD biomarkers and cognitive function as well as patient-centered outcomes. First, we will leverage a stakeholder-endorsed, web-based sleep education platform (TASHE) we developed, featuring journeys of black patients with OSA. Second, we will use a personalized approach for delivering video messages (OSA content & coaching advice) to increase OSA treatment self-efficacy. Messages will be personalized based on patients’ idiographic profile to nudge and navigate them in their preferred OSA care pathway. Profiles will integrate patients’ baseline data (e.g., demographic, medical, health literacy, motivation, readiness to change) and the emergent barriers gleaned from responses to ecological momentary assessment. Coaching messages about strategies to overcome system-level barriers, impeding successful navigation of the OSA care pathway will be delivered using Motivational Enhancement. Newly diagnosed blacks (n=330, 60-85 years) will be randomly exposed to either the personalized or standard OSA messages (e.g., AASM & NSF). We will capture adherence data via telemetry, enabling real-time application of data-driven decision rules to optimize message delivery. We will ascertain biomarker and cognitive outcomes at baseline and at 6 months post-enrollment. The study team will: 1) assess the comparative effectiveness of the personalized, web-based intervention in increasing adherence to OSA treatment with Positive Airway Pressure among newly diagnosed blacks; 2) determine whether OSA treatment improves a) molecular AD biomarkers (Hcy, NFL, GFAP, Tau and Aβ) and b) cognitive function (attention, language, memory, and executive function); and 3) determine whether OSA treatment improves patients’ health-related quality of life, daytime functioning, and sleep quality. We expect the Personalized OSA Treatment Adherence Model (PRAISE) will have a significant impact on OSA treatment adherence, leading to improved OSA-related clinical and patient-centered outcomes.

项目摘要 有证据表明，阻塞性睡眠呼吸暂停（OSA）患者的tau蛋白和淀粉样蛋白-β负担增加。 在这些患者中，记忆力、执行功能、注意力和警惕性的损害也很常见。 幸运的是，OSA治疗可以使阿尔茨海默病（AD）的这些生物标志物正常化，并改善阿尔茨海默病的发病率。 认知功能治疗还可以减少全身炎症，改善胰岛素敏感性，血液 血压和血清脂质和脂蛋白。尽管有这些令人信服的数据，但人们对这些数据知之甚少。 OSA治疗在黑人中的影响，一个承担着不成比例的OSA和AD负担的群体。 未能从这些医学进步中受益的部分原因是缺乏数据解释难以获得 足够的OSA护理，限制了我们实施健康政策的能力，这些政策指导积极的OSA控制， 黑人我们提出了一项随机对照试验，以评估我们的创新个性化OSA治疗的有效性 在黑人中增强对OSA治疗依从性的依从性模型。我们将实施有效的 和可扩展的干预，以确定OSA治疗对AD生物标志物和认知功能的影响， 以及以病人为中心的结果。首先，我们将利用一个由企业主认可的、基于网络的睡眠 我们开发了一个教育平台（TASHE），以OSA黑人患者的旅程为特色。二是 使用个性化的方法传递视频信息（OSA内容和指导建议）， OSA治疗自我效能消息将根据患者的具体情况进行个性化设置， 并引导他们进入他们的首选OSA护理路径。配置文件将整合患者的基线数据（例如， 人口统计学、医学、健康素养、动机、改变的准备）和收集到的紧急障碍 从反应到生态瞬时评估。关于克服策略的指导信息 阻碍OSA护理路径成功导航的系统级障碍将使用 动机增强。新诊断的黑人（n=330，60-85岁）将随机暴露于 个性化或标准OSA消息（例如，AASM & NSF）。我们将收集依从性数据 通过遥感勘测，实现数据驱动决策规则的实时应用，以优化消息传递。我们 将确定基线和入组后6个月的生物标志物和认知结局。研究 小组将：1）评估个性化的、基于网络的干预措施在增加 在新诊断的黑人中坚持使用气道正压通气治疗OSA; 2）确定 OSA治疗是否改善a）分子AD生物标志物（Hcy、NFL、GFAP、Tau和Aβ）和B） 认知功能（注意力、语言、记忆和执行功能）;以及3）确定OSA是否 治疗改善了患者与健康相关的生活质量、日间功能和睡眠质量。我们预计 个性化OSA治疗依从性模型（PRAISE）将对OSA产生重大影响 治疗依从性，从而改善OSA相关的临床和以患者为中心的结局。