Digital Biomarkers of Ulcerative Colitis Flare

这个项目将评估纵向收集的生理指标，重点是自主神经。 使用可穿戴设备的系统功能(心率变异性[HRV])。它将调查这些人的能力 用于识别和预测症状性溃疡性结肠炎(UC)发作的生理指标。它将探索 通过HRV指导的生物反馈干预对这些指标的可修改性及其对UC症状的影响。 应聘者：此应用程序的主要目标是支持Robert Hirten博士发展成为 数字健康和炎症性肠病(IBD)领域面向患者的独立研究人员 研究。Hirten博士的职业目标是成为一名独立的研究人员和利用密集的 在IBD研究中通过新的可穿戴技术获取的生理数据。Hirten博士提议的培训 活动涉及五个领域：(1)先进的统计方法，(2)数字健康，(3)临床试验设计，(4) 行为干预学，(5)职业发展。为了实现这些目标，希尔滕博士组装了一个 由西奈山医院消化科主任布鲁斯·桑兹博士领导的导师团队 擅长IBD的纵向和临床试验研究。环境：蒙特的伊坎医学院 西奈有着深厚的研究传统，是美国国立卫生研究院资助排名前20的医学院。西奈山师 消化内科是美国新闻和世界报道中排名前十的部门，也是IBD的领导者 研究和临床护理。西奈山的Hasso Plattner数字健康研究所是一家国际性的 该研究所拥有数据科学、生物医学和数字工程方面的专业知识。研究：UC是一种慢性疾病 一种影响结肠的炎症性疾病，症状为腹泻、直肠出血 还有腹痛。耀斑是经常发生的，每年至少有30%的患者会发生，并与 发病率和生活质量受损。目前识别和预测耀斑的方法不是最理想的，而且有限。如果 可以更早地识别耀斑，并可以制定预测的缓解或预防战略。最新进展 数字和可穿戴技术允许收集连续的、非侵入性的生理参数 可能与疾病活动有关。因此，我们的具体目标是(1)确定 包括心率变异性在内的生理指标，在UC出现症状发作时，(2)评估 生理指标，重点是心率变异性，用于UC症状性红斑的发展，(3)确定 对有症状的UC患者进行HRV生物反馈干预的可行性、可接受性和效果大小。至 为此，我们将进行一项纵向队列研究，招募160名UC缓解期和随访期的受试者 12个月或直到耀斑，从可穿戴设备(Apple Watch)收集生理指数，并 来自智能手机应用程序的调查指标。此外，我们还将进行HRV定向生物反馈 23例UC伴症状性闪光患者的干预。在此过程中获得的一般方法和技能 该奖项可以适用于未来的R01赠款，旨在建立在这项工作的发现。

This project will evaluate longitudinally collected physiological metrics, with a focus on autonomic nervous system function (heart rate variability [HRV]), using wearable devices. It will investigate the ability of these physiological metrics to identify and predict symptomatic ulcerative colitis (UC) flares. It will explore the modifiability of these metrics through a HRV directed biofeedback intervention and its impact on UC symptoms. Candidate: The primary objective of this application is to support the development of Dr. Robert Hirten into an independent patient-oriented researcher in the field of digital health and inflammatory bowel disease (IBD) research. Dr. Hirten’s career goal is to be an independent researcher and leader in leveraging the dense physiological data acquired through novel wearable technologies in IBD research. Dr. Hirten’s proposed training activities are in five areas: (1) Advanced statistical methodology, (2) Digital health, (3) Clinical trial design, (4) Behavioral intervention science, (5) Career development. To achieve these goals Dr. Hirten has assembled a mentorship team led by Dr. Bruce Sands, Chief of Gastroenterology at The Mount Sinai Hospital who has expertise in longitudinal and clinical trial research in IBD. Environment: The Icahn School of Medicine at Mount Sinai has a strong tradition of research and is a top 20 medical school in NIH funding. The Mount Sinai Division of Gastroenterology is a top 10 division in the country by US News and World Report and is a leader in IBD research and clinical care. The Hasso Plattner Institute for Digital Health at Mount Sinai is an international institute with expertise in data science, biomedical and digital engineering. Research: UC is a chronic inflammatory disease affecting the colon with symptomatic flares characterized by diarrhea, blood per rectum and abdominal pain. Flares are frequent, occurring in at least 30% of patients per year, and are associated with morbidity and impaired quality of life. Current methods to identify and predict flare are suboptimal and limited. If flares can be identified earlier and predicted strategies for mitigation or prevent could be instituted. Advances in digital and wearable technology allow for collection of continuous, non-invasive physiological parameters potentially linked with disease activity. Therefore, our specific aims are to (1) To determine the association of physiological metrics, including HRV, with symptomatic flare in UC, (2) To assess the predictive ability of physiological metrics, with a focus on HRV, for the development of symptomatic flare in UC, (3) Determine the feasibility, acceptability, and effect size of a HRV biofeedback intervention in subjects with symptomatic UC. To accomplish this we will perform a longitudinal cohort study enrolling 160 subjects with UC in remission and follow them for 12 months or until flare, collecting physiological indices from a wearable device (Apple Watch) and survey metrics from a smart phone application. In addition, we will perform a HRV directed biofeedback intervention in 23 subjects with UC and symptomatic flare. The general approach and skills acquired during this award can be applied to future R01 grants aimed at building upon the findings from this work.