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

基本信息

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
项目类别：
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

项目摘要

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) 是最常见的儿童外科手术之一，美国每年进行超过 500,000 例手术，其中很大一部分是在原发性打鼾或轻度睡眠的儿童中进行的。 - 呼吸紊乱 (MSDB)，而不是患有明显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，因此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 的儿童可以受益。 AT 的定义是行为改善使用单盲、随机设计，我们的目标是从 5 个领先的儿科中心招募 460 名 3-9 岁儿童（50% 少数族裔），并接受多导睡眠图证实的 MSDB。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。问题：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， b) 检查 MSDB 风险增加的儿童（例如学龄前儿童、少数民族和患有哮喘或肥胖的儿童）的治疗反应差异；独特且及时的结果； d) 评估二手烟、睡眠不足、社会经济状况和家庭功能的调节影响研究结果将为 MSDB 儿童是否受益于手术提供证据，并确定最有可能受益的亚组，从而提供信息。这种常见儿科疾病的未来管理方法并帮助将资源分配给最有可能受益的儿童。