IMPACT OF TREATMENT OF MILD SLEEP-DISORDERED BREATHING ON CHILDREN'S HEALTH-CCC

治疗轻度睡眠呼吸障碍对儿童健康的影响-CCC

• 批准号: 9137713
• 负责人: CAROLE L MARCUS
• 金额: $ 152.84万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-04 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9137713
• 关键词: Academy; Accounting; Address; African American; Age; American; Asthma; Attention; Attenuated; Behavior; Breathing; Cessation of life; Child; Child health care; Childhood; Clinical Trials; Collaborations; Cotinine; Data; Diagnosis; Disease Management; Environmental Tobacco Smoke; Equilibrium; Evaluation; Family; Future; Gases; General Anesthesia; Guidelines; Hand; Health; Health Care Costs; Healthcare Systems; Hemorrhage; Hospitalization; Infection; Israel; Measures; Medical Societies; Medicine; Minority; Morbidity - disease rate; Neurocognitive; Neuropsychology; Obesity; Obstruction; Obstructive Sleep Apnea; Office Visits; Operative Surgical Procedures; Otolaryngology; Outcome; Participant; Patient Outcomes Assessments; Patient observation; Patients; Pediatrics; Pharmaceutical Preparations; Phenotype; Polysomnography; Population; Prevalence; Public Health; Publishing; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Research; Resources; Risk; Role; Schedule; School-Age Population; Schools; Severities; Single-Blind Study; Sleep; Sleep Apnea Syndromes; Sleep disturbances; Snoring; Socioeconomic Status; Subgroup; Supportive care; Symptoms; Time; Tobacco smoke; Uncertainty; actigraphy; aged; atopy; behavioral health; cost; design; executive function; experience; geographic difference; health care service utilization; improved; minority children; operation; primary outcome; response; symptomatic improvement; treatment response; urinary; vigilance

 DESCRIPTION (provided by applicant): Adenotonsillectomy (AT) is one of the most common surgical procedures performed in children, with more than 500,000 operations performed annually in the US. A large proportion of these are performed in children with primary snoring, or mild sleep-disordered breathing (MSDB) rather than in children with frank obstructive sleep apnea. Although AT has been shown to improve behavior and quality of life in school-aged children with sleep apnea, the role of this common surgery in children with MSDB is not known, resulting in large practice and geographic variation in its use. Considering the morbidity and health care costs of AT, it is crucial to determine the impact of the surgery on outcomes of value to patients and the healthcare system. We propose to take advantage of a successful collaboration of leaders in sleep medicine, otolaryngology, neuropsychology and clinical trials to conduct a randomized clinical trial of AT for MSDB. The overall hypothesis of this proposal is that children with MSDB benefit from AT as defined by improved behaviour and attention (primary outcomes) and decreased health care utilization. Using a single-blinded, randomized design, we aim to recruit 460 children (50% minority), aged 3-9 years, with polysomnographically-confirmed MSDB from 5 leading pediatric centers. Participants will be randomized to early AT or watchful waiting with supportive care, and undergo standardized evaluations of sleep, behavior, attention, quality of life, and health care utilization at baseline and 12 months. Body habitus, urinary cotinine levels, actigraphy, family functioning, atopy and socioeconomic status will be assessed to identify potential moderating influences. This rigorous design and comprehensive study will resolve existing uncertainties on initial management approaches for pediatric MSDB by addressing several critical issues: a) assess outcomes of importance to children and their families, particularly the patient- reported outcomes of behavior, quality of life, and sleep disturbances); b) examine differences in treatment responses among children who are at increased risk for MSDB, such as pre-school children, minorities, and children with asthma or obesity; c) evaluate health care utilization as a unique and timely outcome; d) assess moderating influences of second hand smoke, insufficient sleep, socioeconomic status and family functioning. Study results will provide evidence on whether children with MSDB benefit from surgery and will identify subgroups who are most likely to benefit, thus informing future management approaches of this common pediatric condition and helping to direct resources to those children most likely to benefit.

 描述（由申请人提供）：腺样扁桃体切除术 (AT) 是儿童最常见的外科手术之一，美国每年进行超过 500,000 例手术。其中很大一部分是在患有原发性打鼾或轻度睡眠呼吸障碍（MSDB）的儿童中进行的，而不是患有明显的阻塞性睡眠呼吸暂停的儿童。尽管 AT 已被证明可以改善患有睡眠呼吸暂停的学龄儿童的行为和生活质量，但这种常见手术在 MSDB 儿童中的作用尚不清楚，导致其使用存在很大的实践和地域差异。考虑到 AT 的发病率和医疗保健费用，确定手术对患者和医疗保健系统有价值的结果的影响至关重要。我们建议利用睡眠医学、耳鼻喉科、神经心理学和临床试验领域领先者的成功合作，开展一项针对 MSDB 的 AT 随机临床试验。该提案的总体假设是，患有 MSDB 的儿童从 AT 中受益，定义为行为和注意力的改善（主要结果）以及医疗保健利用率的降低。我们的目标是采用单盲、随机设计，从 5 个领先的儿科中心招募 460 名年龄在 3-9 岁且经多导睡眠图证实的 MSDB 的儿童（50% 为少数族裔）。参与者将被随机分配到早期 AT 或支持性护理的观察等待，并在基线时接受睡眠、行为、注意力、生活质量和医疗保健利用率的标准化评估 和12个月。将评估身体习惯、尿可替宁水平、体动记录、家庭功能、特应性和社会经济状况，以确定潜在的调节影响。这项严格的设计和全面的研究将通过解决以下几个关键问题来解决儿科 MSDB 初始管理方法中现有的不确定性：a) 评估对儿童及其家庭重要的结果，特别是患者报告的行为结果， 生活质量和睡眠障碍）； b) 检查 MSDB 风险增加的儿童（例如学龄前儿童、少数民族以及患有哮喘或肥胖的儿童）治疗反应的差异； c) 将医疗保健利用情况作为独特且及时的结果进行评估； d) 评估二手烟、睡眠不足、社会经济地位和家庭功能的调节影响。研究结果将提供关于 MSDB 儿童是否能从手术中受益的证据，并将确定最有可能受益的亚组，从而为未来这种常见儿科疾病的管理方法提供信息，并帮助将资源分配给最有可能受益的儿童。