Disrupted sleep architecture in adolescents with functional abdominal pain disorders

患有功能性腹痛疾病的青少年的睡眠结构被破坏

• 批准号: 10641146
• 负责人: Neha Richard Santucci
• 金额: $ 19.23万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10641146
• 关键词: Abdominal Pain; Absenteeism; Adolescent; Adult; Affect; Aftercare; Anxiety; Behavioral Medicine; Case/Control Studies; Center for Translational Science Activities; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Cranial Nerves; Data; Dedications; Development; Devices; Environment; Eye; Foundations; Frequencies; Funding Opportunities; Gastroenterologist; Gastroenterology; Gastrointestinal tract structure; Goals; Grant; Health; Health Care Costs; Institution; Intervention Trial; Intestines; Learning; Master of Science; Measures; Mediating; Mediation; Medical center; Mental Depression; Mentors; Monitor; Movement; Nausea; Nerve; Nociception; Nociceptors; Outcome; Pain; Pain Disorder; Pain Measurement; Pathway interactions; Patient Outcomes Assessments; Patient Self-Report; Patients; Pediatric Hospitals; Pediatrics; Persons; Pharmaceutical Preparations; Physicians; Physiological Processes; Polysomnography; Predictive Factor; Questionnaires; Records; Reporting; Research; Research Design; Research Personnel; Research Training; Resources; Risk Factors; Role; Schools; Scientist; Severities; Sleep; Sleep Architecture; Sleep Fragmentations; Sleep Stages; Sleep disturbances; Sleeplessness; Slow-Wave Sleep; Statistical Data Interpretation; Statistical Methods; Symptoms; Time; Training; Translational Research; Treatment outcome; Vagus nerve structure; Visit; Work; Wrist; Youth; actigraphy; central pain; chronic pain; chronic painful condition; clinical efficacy; clinical translation; cohort; diaries; disability; disorders of gut-brain interaction; effective therapy; gastrointestinal; gastrointestinal symptom; improved; improved outcome; improvement on sleep; innovation; non rapid eye movement; novel; pain processing; predicting response; professor; programs; psychologic; response; sleep pattern; sleep physiology; sleep quality; treatment response; treatment strategy; trend

Project Summary Functional abdominal pain disorders (FAPD) constitute one of the most common pediatric chronic pain conditions. FAPD is associated with significant disability, school absenteeism and suboptimal treatment outcomes. Treatment is hampered by an incomplete understanding of contributing factors like sleep disturbances. Subjective sleep disturbances have been reported in FAPD but the role of sleep architecture and its relationship to gastrointestinal (GI) symptoms has not been established. Preliminary data by the candidate has shown decreased slow wave sleep (%NREM3) measured via polysomnography (PSG) in FAPD patients vs. controls. Percutaneous Electrical Nerve Field Stimulation (PENFS) is an FDA cleared therapy for pediatric FAPD. Preliminary data indicates that PENFS improves sleep in addition to symptoms of FAPD. However, there is limited data on factors predicting response, effects on sleep architecture and underlying mechanisms. The primary aims of this K23 training application are to: (1) Determine the relationship of sleep architecture (NREM3 and other variables measured via PSG) with abdominal pain and other patient-reported outcomes in a case-control study of adolescents with FAPD. (2) Compare changes in sleep architecture before and after PENFS, associate with patient reported outcomes. This is the first study to objectively characterize sleep architecture in pediatric FAPD and changes with PENFS. Comprehensive measures of sleep physiology such as sleep questionnaires, daily diaries and actigraphy will be employed in addition to PSG to associate with GI measures. The primary objective is for the candidate to acquire advanced research training through a Master of Science in Clinical and Translational Research, learn sleep (PSG and actigraphy) and pain assessments, and advanced statistical methods. The long-term goal is to build an independent research program to study risk factors in pediatric FAPD and identify novel treatment targets to improve outcomes. The K23 candidate is an Assistant Professor of Pediatrics, and a pediatric gastroenterologist at Cincinnati Children's Hospital Medical Center (CCHMC). This application integrates a thoughtfully designed research and training plan developed in conjunction with mentors and collaborators who are leading scientists and clinical experts in pain, GI, sleep and behavioral medicine. CCHMC provides a rich collaborative research environment and is deeply dedicated to the development of young investigators with significant institutional funding opportunities, support in developing clinical trials, study monitoring, and statistical analysis through core resources at the Digestive Health Center, and Clinical Translation Research Center. This environment will be conducive to the candidate to complete the proposed research and training to achieve full research independence. Results will build the foundation for a subsequent R01 trial to further optimize PENFS outcomes and determine the relationship of central pain processing with NREM3 sleep.

项目摘要 功能性腹痛障碍是儿科最常见的慢性疼痛之一 条件FAPD与严重残疾、缺课和次优治疗相关 结果。对睡眠等影响因素的不完全理解阻碍了治疗 干扰.在FAPD中已经报道了主观睡眠障碍，但是睡眠结构和 其与胃肠道（GI）症状的关系尚未确定。候选人的初步数据 在FAPD患者中，通过多导睡眠图（PSG）测量的慢波睡眠（%NREM 3）减少 vs.对照经皮神经电场刺激（PENFS）是FDA批准的儿科治疗方法 FAPD。初步数据表明，PENFS除了改善FAPD的症状外，还改善了睡眠。然而，在这方面， 关于预测反应的因素、对睡眠结构的影响和潜在机制的数据有限。 此K23培训应用程序的主要目的是： (1)确定睡眠结构（NREM 3和通过PSG测量的其他变量）与 腹痛和其他患者报告的结果在青少年FAPD病例对照研究。 (2)比较PENFS前后睡眠结构的变化，并与患者报告的结果相关联。 这是第一项客观描述儿童FAPD睡眠结构和PENFS变化的研究。 睡眠生理学的综合测量，如睡眠问卷调查、每日日记和活动记录仪， 除PSG外，还可用于GI测量。主要目标是让候选人 通过临床和转化研究理学硕士获得高级研究培训，学习 睡眠（PSG和活动记录）和疼痛评估，以及先进的统计方法。长期目标是 建立一个独立的研究项目，研究儿科FAPD的风险因素，并确定新的治疗方法 目标是改善结果。K23候选人是儿科助理教授，也是儿科 辛辛那提儿童医院医疗中心（CCHMC）的胃肠病学家。此应用程序集成了 精心设计的研究和培训计划，与导师和合作者一起制定， 是疼痛、胃肠道、睡眠和行为医学领域的领先科学家和临床专家。CCHMC提供丰富的 合作研究环境，并致力于发展年轻的研究人员， 重要的机构资助机会，支持开展临床试验，研究监测，以及 通过消化健康中心和临床翻译研究的核心资源进行统计分析 中心这样的环境将有利于候选人完成拟进行的研究和培训， 实现完全的研究独立。结果将为后续的R01试验奠定基础， 优化PENFS结果并确定中枢疼痛处理与NREM 3睡眠的关系。