Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea

腺样体扁桃体切除术治疗儿童睡眠呼吸暂停的随机对照研究

• 批准号: 7137147
• 负责人: Susan S. Redline
• 金额: $ 156.51万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-25 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7137147
• 关键词: anthropometry; attention; behavior test; blood pressure; body weight; child physical development; clinical research; clinical trials; cooperative study; executive function; human subject; human therapy evaluation; inflammation; insulin sensitivity /resistance; lymphatic tissue surgery; middle childhood (6-11); neuropsychological tests; neuropsychology; otorhinolaryngologic surgery; outcomes research; patient oriented research; polysomnography; quality of life; respiratory function; sleep; sleep apnea

DESCRIPTION (provided by applicant): Pediatric obstructive sleep apnea (OSA) is a prevalent disorder, with a high burden among minority children. There is growing evidence that when untreated, it is associated with numerous adverse health outcomes, including neurocognitive and behavioral deficits, impaired quality of life, and cardiovascular and metabolic sequelae. The first line treatment is adenotonsillectomy (AT), which is the second most common pediatric operation, accounting for $500 million of annual health care costs. Despite the prevalence of OSA, its broad range of co-morbidity, and the frequency of surgical treatments, there has not been a single rigorously controlled trial that has addressed either the efficacy of the procedure or potential differences in treatment responses among vulnerable groups such as overweight children and ethnic minorities. To address this critical gap, we have assembled a group of expert centers in pediatric OSA, with a range of sleep medicine, otolaryngology, neurobehavioral, epidemiological, and biostatistical expertise to address the hypothesis that AT for treatment of OSA in children aged 5 to 9 years will result in improvements in health outcomes determined 6 months following AT. Over a 2.5 year recruitment period, we will enroll 460 children (50% minorities) with OSA from the otolaryngology and sleep referral clinics of four clinical sites (Children's Hospital of Philadelphia, Cinncinatti Children's Hospital, Kosair Children's Hospital, Rainbow Babies and Children's Hospital), randomizing 50% to early AT and 50% to deferred surgery (with treatment decisions reevaluated after a 7 month observation period). At baseline and 7 months later, we will obtain standardized overnight polysomnography, morning and evening blood pressures, anthropometry, a fasting blood sample, and perform a comprehensive assessment of neurocognitive and behavioral functions. Selected clinical endpoints also will be re-evaluated at 12 months. Quality assurance for polysomnography, surgery, and neurobehavioral measurements will be directed by centralized cores at Case School of Medicine and the University of Michigan. Analyses will address whether AT is associated with improvement in attention and neurocognitive executive functions and sleep-related breathing disturbances, and whether changes in indices of OSA correlate with changes in other outcomes. Secondary analyses will address treatment effects on learning/memory, behavior, quality of life, growth, blood pressure, and biochemical indices of insulin resistance and inflammation. These will be the first data from a randomized controlled study, with geographic and ethnic representation, to address treatment efficacy for a common pediatric condition and to identify sub-groups, such as overweight children, with potential differential treatment responses. These data will be critical for defining treatment indications for a common surgical procedure, for identifying subgroups who require more intensive monitoring, and for understanding the co-morbidity of OSA.

描述（由申请人提供）： 小儿阻塞性睡眠呼吸暂停（OSA）是一种普遍的疾病，少数儿童负担很大。越来越多的证据表明，如果不进行治疗，它与许多不良健康结果有关，包括神经认知和行为缺陷，生活质量受损以及心血管和代谢后遗症。第一线治疗是腺孔切除术（AT），这是第二大的儿科手术，占年度医疗保健费用的5亿美元。尽管OSA的普遍存在，其合并症的广泛范围以及手术治疗的频率，但尚未进行一项严格控制的试验，该试验既可以解决该程序的疗效或弱势群体（例如超重儿童和少数民族）的治疗反应的潜在差异。为了解决这一关键差距，我们组建了一组儿科OSA的专家中心，并通过多种睡眠医学，耳鼻喉科，神经性毛虫，流行病学和生物统计学专业知识来解决以下假设，以解决5至9岁儿童治疗5至9岁儿童的假设，这将导致5至9岁的健康状况，这将导致6个月的健康远离确定的健康。在2。5年的招聘期内，我们将与四个临床部位的耳鼻喉科和睡眠转介诊所（费城儿童医院，Cinncinatti儿童医院，Kosair Kosair儿童医院，Kosair儿童医院，Rainbow Baby and Children Hospital）在50％和50％后期进行治疗（在A A I IMPERRED）中，招募了460名儿童（50％少数群体）（50％少数群体）（50％少数群体）（50％） 时期）。在基线和7个月后，我们将获得标准化的隔夜多摄影术，早晨和晚上的血压，人体测量法，禁食样本，并对神经认知和行为功能进行全面评估。选定的临床终点也将在12个月后重新评估。多个学术，手术和神经行为测量的质量保证将由案例医学院和密歇根大学的集中核心指导。分析将解决AT是否与注意力和神经认知的执行功能和与睡眠有关的呼吸障碍的改善以及OSA指数的变化是否与其他结果的变化相关。次要分析将解决对学习/记忆，行为，生活质量，生长，血压以及胰岛素抵抗和炎症的生化指数的影响。这些将是一项随机对照研究的第一个数据，具有地理和种族代表，以解决常见儿科状况的治疗效率，并确定具有潜在差异治疗反应的超重儿童的亚组。这些数据对于定义常见手术程序的治疗指示至关重要，对于确定需要更密集监控的亚组以及了解OSA的合并症。