Treating insomnia to reduce inflammation in HIV

治疗失眠以减少艾滋病毒炎症

• 批准号: 10252447
• 负责人: SAMIR KUMAR GUPTA
• 金额: $ 23.26万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10252447
• 关键词: Address; Adult; Aging; American College of Physicians; Biological Markers; Blood; C-reactive protein; CD14 gene; Cardiovascular Diseases; Chronic Insomnia; Clinical; Cognitive Therapy; Cohort Studies; Data; Development; Diabetes Mellitus; Disease; Education; Enrollment; Event; FCGR3B gene; Funding; General Population; Goals; Guidelines; HIV; HIV Seronegativity; HIV Seropositivity; Health; Heart failure; Impaired cognition; Inflammation; Inflammatory; Interleukin-6; Internet; Intervention; Knowledge; Lead; Link; Long-Term Effects; Measures; Mental Depression; Mental disorders; Modeling; Morbidity - disease rate; Myocardial Infarction; Osteoporosis; Outcome; Participant; Pathologic; Patients; Persons; Phase; Population; Prevention; Primary Insomnia; Publishing; Pulmonary Emphysema; Randomized Controlled Trials; Resources; Risk; Risk Factors; Secondary Insomnia; Severities; Shapes; Site; Sleep; Sleeplessness; Symptoms; Technology; Testing; Therapeutic; Time; Training; Translating; Veterans; active comparator; antiretroviral therapy; circulating biomarkers; clinically relevant; comparison group; depressive symptoms; design; epidemiology study; follow-up; high risk; improved; indexing; innovation; monocyte; mortality; multidisciplinary; patient population; phase II trial; programs; restraint; screening; sleep health; systemic inflammatory response; tool; treatment as usual; trial comparing; virology

PROJECT ABSTRACT Serious non-AIDS events (SNAE), including emphysema, diabetes, osteoporosis, cardiovascular disease, and cognitive impairment, have emerged as important contributors to HIV-related morbidity and mortality. SNAE are likely driven by systemic inflammation, which remains heightened in people with HIV (PWH), compared to HIV-negative persons, despite virologic suppression. Specifically, elevated circulating markers of systemic inflammation [high sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6)] and evidence of monocyte activation [sCD14, sCD163, CD14+CD16+ intermediate monocytes] are associated with greater risks of SNAE. Insomnia is a known risk factor for poor health outcomes in the general population, perhaps via its link with greater systemic inflammation. Fortunately, insomnia is modifiable, and the clear first-line treatment has been identified. The 2016 American College of Physicians guideline concluded that the preferred treatment for chronic insomnia in adults is not pharmacologic therapy but rather CBT for insomnia (CBT-I), given the strong evidence that it is safe, effective, and broadly applicable with durable benefits. A feasible and effective internet CBT-I tool called Sleep Healthy Using The Internet (SHUTi) was developed and validated by this application’s consultant, Dr. Lee Ritterband. In multiple RCTs, SHUTi has proven effective for treating insomnia in the general population. To our knowledge, internet CBT-I in PWH has not previously been studied. Thus, our proposal represents an innovative application of an established intervention technology in a new patient population. The central objective of this application is to evaluate SHUTI’s ability to reduce systemic inflammation, and, in particular, monocyte activation in PWH. We will meet this objective by addressing the following Specific Aim: To evaluate the effects of cognitive-behavioral therapy for insomnia (CBT-I) on measures of systemic inflammation in virologically-suppressed, HIV-positive adults with insomnia disorder. We will conduct a single-site, phase II RCT comparing SHUTi to an Active Comparator group receiving sleep hygiene education program in 50 virologically-suppressed PWH with insomnia disorder to reduce biomarkers of inflammation and monocyte activation. A positive phase II trial would provide the proof-of-concept data and effect size estimates needed to justify and properly design a multisite, phase III RCT to establish the long-term effects of SHUTi (a practical and readily scalable intervention) on HIV-related inflammation and prevention of SNAE.

项目摘要 严重的非辅助事件（SNAE），包括肺气肿，糖尿病，骨质疏松症，心血管疾病和 认知障碍已成为与HIV相关的发病率和死亡率的重要贡献者。 snae 与艾滋病毒（PWH）相比，全身性炎症的驱动 HIV阴性人，目的地病毒学抑制。具体而言，全身性的循环标记升高 炎症[高灵敏度C反应蛋白（HSCRP），白介素6（IL-6）和单核细胞的证据 激活[SCD14，SCD163，CD14+ CD16+中间单核细胞]与SNAE风险更大有关。 失眠是普通人群健康状况不佳的已知危险因素，也许是通过其与 更大的系统性炎症。幸运的是，失眠是可修改的，清晰的一线治疗已经 确定。 2016年美国医师学院指南得出结论，首选的治疗方法 成人的慢性失眠不是药物治疗，而是CBT的失眠症（CBT-I），鉴于强大 证据表明它是安全，有效且广泛适用的，具有持久的好处。可行有效的互联网 CBT-I工具称为使用Internet（shuti）的“健康睡眠健康”工具是由本应用程序的 顾问Lee Ritterband博士。在多个RCT中，Shuti已证明对治疗失眠有效 一般人口。据我们所知，PWH中的Internet CBT-I以前从未研究过。那，我们的 提案代表了已建立干预技术在新患者中的创新应用 人口。该应用程序的核心目的是评估Shuti降低全身性的能力 炎症，尤其是PWH中的单核细胞激活。我们将通过解决这个目标来实现这一目标 遵循特定目的：评估认知行为疗法对失眠（CBT-I）对 病毒学抑制的HIV阳性成年人患有失眠症的全身性炎症的度量。我们 将进行单点II阶段RCT，将Suthi与接收睡眠的主动比较组进行比较 50种病毒学抑制的PWH和失眠症疾病的卫生教育计划可减少生物标志物 炎症和单核细胞激活。积极的II期试验将提供概念证明数据，并且 效应尺寸估计值为合理和正确设计多站点的合理性，以建立长期 Shuti（一种实用且易于扩展的干预措施）对HIV相关的炎症和预防的影响 snae。