Treating insomnia to reduce inflammation in HIV

治疗失眠以减少艾滋病毒炎症

基本信息

批准号：
10414994
负责人：
SAMIR KUMAR GUPTA
金额：
$ 19.3万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-06-01 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10414994
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

项目摘要

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.

项目摘要严重的非艾滋病事件 (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 HIV 相关的 SNAE 发病率和死亡率的重要因素。与艾滋病毒感染者（PWH）相比，这可能是由全身炎症引起的尽管病毒学受到抑制，但 HIV 阴性者的全身循环标志物仍升高。炎症[高敏 C 反应蛋白 (hsCRP)、白细胞介素 6 (IL-6)] 和单核细胞证据激活[sCD14、sCD163、CD14+CD16+中间单核细胞]与更大的 SNAE 风险相关。失眠是普通人群健康状况不佳的一个已知危险因素，可能是通过它与幸运的是，失眠是可以改变的，并且明确的一线治疗方法已经存在。 2016 年美国医师学会指南得出的结论是，首选治疗方法是：成人慢性失眠不是药物治疗，而是 CBT 治疗失眠 (CBT-I)，因为它具有很强的有证据表明它是安全、有效、广泛适用并具有持久效益的可行且有效的互联网。名为“使用互联网健康睡眠”(SHUTi) 的 CBT-I 工具是由该应用程序的开发和验证的顾问 Lee Ritterband 博士在多项随机对照试验中证明，SHUTi 对于治疗失眠症有效。据我们所知，此前尚未对艾滋病毒感染者中的互联网 CBT-I 进行过研究。该提案代表了现有干预技术在新患者身上的创新应用该应用程序的中心目标是评估 SHUTI 减少系统性人口的能力。我们将通过解决以下问题来实现这一目标。以下具体目标：评估失眠认知行为疗法 (CBT-I) 对失眠的影响对患有失眠症的病毒学抑制的艾滋病毒阳性成人的全身炎症进行测量。将进行单中心 II 期随机对照试验，将 SHUTi 与接受睡眠的主动比较组进行比较对 50 名患有失眠症的病毒学抑制的感染者进行卫生教育计划，以减少生物标志物炎症和单核细胞激活的积极的 II 期试验将提供概念验证数据和需要对效应大小进行估计，以证明和正确设计多中心 III 期随机对照试验，以建立长期效果 SHUTi（一种实用且易于扩展的干预措施）对 HIV 相关炎症和预防的影响 SNAE。