Sleep-Disordered Breathing and CPAP after Adenotonsillectomy in Children

描述（由申请人提供）：阻塞性睡眠呼吸障碍（SDB）影响至少2-3%的儿童，是腺扁桃体切除术的常见原因，腺扁桃体切除术是儿童第二大最常见的外科手术。在SDB的后果中，神经行为问题，如注意力不集中，多动和白天嗜睡是最重要的一些，并且与SDB的水平有关，否则被认为是轻微的。虽然腺扁桃体切除术曾经被认为是非常有效的，但最近在肥胖症流行期间的研究表明，超过一半的手术患者术后仍有SDB残留，尽管通常是轻度的。许多睡眠专家现在提倡在SDB接受腺扁桃体切除术后，通过多导睡眠图或其他方式进行常规评估。然而，这远远不是通常的做法，部分原因是评估结果是否值得进一步治疗仍然不明确，持续气道正压通气（CPAP）（成人SDB的主要治疗方法）的潜在临床益处尚未在接受腺扁桃体切除术的儿童中得到很好的证明。因此，目前提出的研究的主要目标是检查SDB腺扁桃体切除术后CPAP的神经行为益处，并确定经过良好验证的基于症状的问卷调查和多导睡眠图在术后确定哪些患者可能受益于CPAP方面的作用。在腺扁桃体切除术后4个月，120名儿童将接受基于实验室的睡眠多导睡眠图、睡眠问卷、日间嗜睡的多次睡眠潜伏期测试、标准父母行为评分和神经心理测试。结果将表明，在腺扁桃体切除术后，SDB问卷可以帮助确定哪些儿童需要进行多导睡眠图来评估SDB残留，并且SDB残留与持续的神经行为发病率有关。研究人员将随机分配80名受试者接受CPAP， 40名受试者不接受CPAP，治疗第一组并监测依从性，6个月后用父母睡眠问卷、多导睡眠图、多次睡眠潜伏期测试、父母行为评分和神经心理测试重新评估所有120名参与者。结果将证明多导睡眠描记术识别出从SDB进一步治疗中受益的儿童；暗示腺扁桃体切除术后残留的SDB是持续性神经行为问题的原因；提示成功治疗残余SDB可带来切实的临床效益。研究者在儿童SDB的临床研究方面有着长期而成功的记录；主客观评价的新方法；以及治疗对神经行为的益处。现在提出的关键、及时和创新的方案的结果可能会产生重大影响：它们将有助于告知共同和相应的临床决策，指导昂贵资源的分配，证明后续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。

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.