Impact of treatment of mild sleep-disordered breathing on children's health-DCC

治疗轻度睡眠呼吸障碍对儿童健康的影响-DCC

• 批准号: 9325560
• 负责人: Susan S. Redline
• 金额: $ 84.59万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 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/9325560
• 关键词: Address; Adherence; Adverse event; Ancillary Study; Archives; Area; Asthma; Attention; Behavior; Biometry; Breathing; Case Report Form; Child; Child health care; Childhood; Clinical; Clinical Trials; Collaborations; Collection; Communication; Communities; Companions; Controlled Study; Cotinine; Custom; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Files; Data Quality; Data Reporting; Data Set; Databases; Development; Documentation; Eligibility Determination; Ensure; Environmental Tobacco Smoke; Epidemiologist; Epidemiology; Evaluation; Family; Future; Goals; Health Care Costs; Healthcare Systems; Hospitals; Informatics; Laboratories; Leadership; Manuals; Manuscripts; Medicine; Minority; Monitor; Morbidity - disease rate; Multicenter Studies; Neuropsychology; Obesity; Obstructive Sleep Apnea; Online Systems; Operative Surgical Procedures; Otolaryngology; Outcome; Participant; Patient Outcomes Assessments; Patient observation; Patients; Phase; Physiological; Polysomnography; Preparation; Preschool Child; Procedures; Protocols documentation; Publications; Quality Control; Quality of life; Randomized; Randomized Clinical Trials; Reading; Recruitment Activity; Reporting; Research; Research Design; Research Training; Resolution; Resources; Risk; Role; Safety; School-Age Population; Secure; Services; Single-Blind Study; Site; Sleep; Sleep Apnea Syndromes; Sleep disturbances; Snoring; Socioeconomic Status; Standardization; Statistical Data Interpretation; Subgroup; Summary Reports; Support System; Supportive care; Symptoms; System; Time; Uncertainty; United States National Institutes of Health; Validation; Woman; Work; Writing; actigraphy; aged; atopy; behavioral outcome; data management; data sharing; design; distributed data; electronic data capture system; experience; geographic difference; health care service utilization; improved; innovation; member; minority children; operation; primary outcome; programs; public health relevance; quality assurance; signal processing; treatment response; urinary; web site; web-accessible

 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 behaviour 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）：腺样体扁桃体切除术（AT）是儿童最常见的外科手术之一，在美国每年进行超过50万例手术。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，而不是在患有明显阻塞性睡眠呼吸暂停的儿童中进行的。虽然AT已被证明可以改善学龄儿童睡眠呼吸暂停的行为和生活质量，但这种常见手术在MSDB儿童中的作用尚不清楚，导致其使用存在较大的实践和地理差异。考虑到AT的发病率和医疗保健成本，确定手术对患者和医疗保健系统有价值的结局的影响至关重要。我们建议利用睡眠医学，耳鼻喉科，神经心理学和临床试验的领导者的成功合作，对MSDB进行AT的随机临床试验。该建议的总体假设是，患有MSDB的儿童受益于AT，其定义为改善行为和注意力（主要结果）以及降低医疗保健利用率。采用单盲、随机设计，我们的目标是从5家领先的儿科中心招募460名3-9岁经多导睡眠图证实的MSDB儿童（50%为少数民族）。受试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，生活质量和卫生保健利用的标准化评估 还有12个月将评估体型、尿可替宁水平、活动记录、家庭功能、特应性和社会经济地位，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几个关键问题来解决儿科MSDB初始管理方法的现有不确定性：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MSD B风险增加的儿童（如学龄前儿童、少数民族和哮喘或肥胖儿童）中治疗反应的差异; c）评估卫生保健利用作为独特和及时的结果; 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。研究结果将提供证据证明患有多发性硬化症的儿童是否从手术中受益，并将确定最有可能受益的亚组，从而为这种常见儿科疾病的未来管理方法提供信息，并帮助将资源引导到最有可能受益的儿童身上。