Sleep-Disordered Breathing and CPAP after Adenotonsillectomy in Children

儿童腺样体扁桃体切除术后睡眠呼吸障碍和 CPAP

• 批准号: 8633056
• 负责人: RONALD D CHERVIN
• 金额: $ 68.7万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-12-01 至 2016-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8633056
• 关键词: 12 year old; Address; Adherence; Adult; Advocate; Affect; Aftercare; Attention; Behavior; Behavioral; Body mass index; Child; Childhood; Clinical; Clinical Research; Cognition; Continuous Positive Airway Pressure; Control Groups; Data; Enrollment; Epidemic; Evaluation; Family; Funding; Goals; Health; Home environment; Hyperactive behavior; Investigation; Laboratories; Link; Measures; Monitor; Morbidity - disease rate; Neuropsychological Tests; Obesity; Operative Surgical Procedures; Outcome; Parents; Participant; Patients; Play; Polysomnography; Postoperative Period; Protocols documentation; Publishing; Questionnaires; Randomized; Randomized Clinical Trials; Research; Research Personnel; Residual state; Resources; Risk Factors; Role; Sampling; Sleep; Sleep Apnea Syndromes; Specialist; Symptoms; Testing; Time; Titrations; United States National Institutes of Health; base; candidate identification; clinical care; follow-up; improved; inattention; innovation; instrument; neurobehavioral; neurobehavioral test; novel; novel strategies

DESCRIPTION (provided by applicant): Obstructive sleep-disordered breathing (SDB) affects at least 2-3% of children and is a frequent reason for adenotonsillectomy, the second most common surgical procedure performed in childhood. Among consequences of SDB, neurobehavioral problems such as inattention, hyperactivity, and daytime sleepiness are some of the most important and have been linked to levels of SDB that would otherwise be considered mild. Although adenotonsillectomy was once thought highly effective, recent studies in the midst of epidemic obesity show that more than half of operated patients still have residual SDB, though usually at mild levels, after surgery. Many sleep specialists now advocate for routine evaluation, by polysomnography or otherwise, after SDB is treated by adenotonsillectomy. However, this is far from usual practice, in part because evaluation results that would merit further treatment remain poorly defined, and the potential clinical benefit of continuous positive airway pressure (CPAP), the mainstay of treatment for adult SDB, has not been well documented in children who have undergone adenotonsillectomy. The main goals of the research now proposed, therefore, are to examine neurobehavioral benefits of CPAP after adenotonsillectomy for SDB, and to determine what role a well-validated symptom-based questionnaire and polysomnography can play in post- operative determination of which patients may benefit from CPAP. Four months after adenotonsillectomy, 120 children will be assessed with sleep laboratory-based polysomnography, sleep questionnaires, Multiple Sleep Latency Tests of daytime sleepiness, standard parental behavioral ratings, and neuropsychological testing. Results will show that after adenotonsillectomy, an SDB questionnaire can help identify children who should have polysomnography to assess for residual SDB, and that residual SDB is associated with persistent neurobehavioral morbidity. The investigators will then randomize 80 subjects to receive CPAP and 40 to receive no CPAP, treat the first group and monitor adherence, and after 6 months re-assess all 120 participants with parental sleep questionnaires, polysomnography, Multiple Sleep Latency Tests, parent behavioral ratings, and neuropsychological testing. Results will document that polysomnography identifies children who benefit from further treatment for SDB; implicate residual SDB after adenotonsillectomy as a cause of persistent neurobehavioral problems; and suggest that successful treatment of residual SDB can provide tangible clinical benefits. The investigators have a long and successful track record of clinical research on childhood SDB; novel approaches to its subjective and objective assessment; and neurobehavioral benefits of its treatment. Results of the critical, timely, and innovative protocol now proposed are likely to have substantial impact: they will help to inform common and consequential clinical decisions, guide allocation of costly resources, justify subsequent large multicenter randomized clinical trials, and improve the health, cognition, and behavior of many children.

描述(申请人提供)：阻塞性睡眠呼吸障碍(SDB)影响至少2%-3%的儿童，是扁桃体切除术的常见原因，这是儿童时期第二常见的外科手术。在SDB的后果中，注意力不集中、多动和白天嗜睡等神经行为问题是最重要的，并且与SDB水平有关，否则SDB水平将被认为是轻微的。尽管扁桃体切除术一度被认为是非常有效的，但最近在肥胖症流行期间进行的研究表明，超过一半的手术患者术后仍有残余的SDB，尽管通常处于轻微水平。许多睡眠专家现在主张在SDB经腺扁桃体切除术治疗后，通过多导睡眠图或其他方法进行常规评估。然而，这与通常的做法相去甚远，部分原因是值得进一步治疗的评估结果仍然不明确，而且持续气道正压(CPAP)-成人SDB的主要治疗方法-的潜在临床益处在接受腺样体扁桃体切除术的儿童中尚未得到很好的证明。因此，现在提出的这项研究的主要目标是检查SDB腺体扁桃体切除术后CPAP对神经行为的益处，并确定有效的基于症状的问卷和多导睡眠图在术后确定哪些患者可能从CPAP中受益方面起到什么作用。扁桃体切除术四个月后，120名儿童将接受基于睡眠实验室的多导睡眠图、睡眠问卷、白天嗜睡的多重睡眠潜伏期测试、标准父母行为评级和神经心理测试的评估。结果将表明，扁桃体切除术后，SDB问卷可以帮助确定哪些儿童应该进行多导睡眠图以评估残留的SDB，并且残留的SDB与持续的神经行为障碍有关。然后，研究人员将随机选择80名接受CPAP的受试者和40名不接受CPAP的受试者，治疗第一组并监测依从性，并在6个月后重新评估所有120名参与者的父母睡眠问卷、多导睡眠图、多重睡眠潜伏期测试、父母行为评级和神经心理测试。结果将证明，多导睡眠图确定了哪些儿童受益于SDB的进一步治疗；暗示扁桃体切除术后残留的SDB是持续神经行为问题的原因；并表明成功治疗残留的SDB可以提供切实的临床好处。研究人员对儿童SDB的临床研究有着长期和成功的记录；对其主观和客观评估的新方法；以及其治疗的神经行为益处。现在提出的关键、及时和创新的方案的结果可能会产生实质性的影响：它们将有助于为常见的和相应的临床决策提供信息，指导昂贵资源的分配，证明随后的大型多中心随机临床试验的合理性，并改善许多儿童的健康、认知和行为。