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
基本信息
- 批准号:8239265
- 负责人:
- 金额:$ 62.86万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:12 year oldAddressAdherenceAdultAdvocateAffectAftercareAttentionBehaviorBehavioralBody mass indexChildChildhoodClinicalClinical ResearchCognitionContinuous Positive Airway PressureControl GroupsDataEnrollmentEpidemicEvaluationFamilyFundingGoalsHealthHome environmentHyperactive behaviorInvestigationLaboratoriesLinkMeasuresMonitorMorbidity - disease rateNeuropsychological TestsObesityOperative Surgical ProceduresOutcomeParentsParticipantPatientsPlayPolysomnographyPostoperative PeriodProtocols documentationPublishingQuestionnairesRandomizedRandomized Clinical TrialsResearchResearch PersonnelResidual stateResourcesRisk FactorsRoleSamplingSleepSleep Apnea SyndromesSpecialistSymptomsTestingTimeTitrationsUnited States National Institutes of Healthbasecandidate identificationclinical carefollow-upimprovedinattentioninnovationinstrumentneurobehavioralneurobehavioral testnovelnovel strategies
项目摘要
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.
PUBLIC HEALTH RELEVANCE: Obstructive sleep-disordered breathing is common in children and most often treated by adenotonsillectomy, but after surgery the condition may persist, in which case it could still promote serious consequences, such as inattention, hyperactivity, and daytime sleepiness. This research will help to determine for the first time how children should be assessed for residual sleep-disordered breathing after adenotonsillectomy, and whether continuous positive airway pressure, the mainstay of treatment for adult sleep apnea, can be helpful for some children post-operatively to further improve cognition and behavior.
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,是腺样体扁桃体切除术的常见原因,腺样体扁桃体切除术是儿童时期第二常见的外科手术。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,并且与SDB的水平有关,否则会被认为是轻度的。虽然腺样体切除术曾经被认为是非常有效的,但最近在流行性肥胖中的研究表明,超过一半的手术患者在手术后仍然有残留的SDB,尽管通常在轻度水平。许多睡眠专家现在提倡在SDB通过腺样体扁桃体切除术治疗后,通过多导睡眠图或其他方式进行常规评估。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价结果仍然不明确,并且持续气道正压通气(CPAP)的潜在临床益处(成人SDB的主要治疗方法)在接受腺样体扁桃体切除术的儿童中尚未得到充分证明。因此,现在提出的研究的主要目标是检查SDB的腺样体扁桃体切除术后CPAP的神经行为益处,并确定经充分验证的基于EEG的问卷和多导睡眠图在术后确定哪些患者可能受益于CPAP中可以发挥什么作用。腺样体切除术后4个月,将对120名儿童进行基于睡眠实验室的多导睡眠图、睡眠问卷、日间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学测试。结果将表明,在扁桃体腺样体切除术后,SDB问卷可以帮助确定儿童谁应该有多导睡眠图,以评估残留的SDB,残留的SDB与持续的神经行为发病率。然后,研究人员将随机分配80名受试者接受CPAP治疗,40名受试者不接受CPAP治疗,治疗第一组并监测依从性,6个月后通过父母睡眠问卷,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重新评估所有120名参与者。结果将记录多导睡眠描记术识别受益于SDB进一步治疗的儿童;涉及腺样体扁桃体切除术后残留SDB作为持续性神经行为问题的原因;并表明残留SDB的成功治疗可以提供切实的临床益处。研究人员对儿童SDB的临床研究有着长期而成功的记录;主观和客观评估的新方法;以及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重大影响:它们将有助于为常见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。
公共卫生相关性:阻塞性睡眠呼吸障碍在儿童中很常见,最常见的治疗方法是腺样体切除术,但手术后病情可能会持续存在,在这种情况下,它仍然可能导致严重的后果,如注意力不集中,多动和白天嗜睡。这项研究将有助于首次确定如何评估腺样体切除术后儿童的残余睡眠呼吸障碍,以及持续气道正压通气(成人睡眠呼吸暂停的主要治疗方法)是否有助于一些儿童术后进一步改善认知和行为。
项目成果
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RONALD D CHERVIN其他文献
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{{ truncateString('RONALD D CHERVIN', 18)}}的其他基金
Multi-Institutional Training in Genetic/Genomic Approaches to Sleep Disorders
睡眠障碍遗传/基因组方法的多机构培训
- 批准号:
8550477 - 财政年份:2013
- 资助金额:
$ 62.86万 - 项目类别:
Mechanical Airway Support Device to Treat Obstructive Sleep Disordered Breathing
机械气道支持装置治疗阻塞性睡眠呼吸障碍
- 批准号:
8589130 - 财政年份:2013
- 资助金额:
$ 62.86万 - 项目类别:
Multi-Institutional Training in Genetic/Genomic Approaches to Sleep Disorders
睡眠障碍遗传/基因组方法的多机构培训
- 批准号:
8700488 - 财政年份:2013
- 资助金额:
$ 62.86万 - 项目类别:
Multi-Institutional Training in Genetic/Genomic Approaches to Sleep Disorders
睡眠障碍遗传/基因组方法的多机构培训
- 批准号:
8845597 - 财政年份:2013
- 资助金额:
$ 62.86万 - 项目类别:
Multi-Institutional Training in Genetic/Genomic Approaches to Sleep Disorders
睡眠障碍遗传/基因组方法的多机构培训
- 批准号:
10201708 - 财政年份:2013
- 资助金额:
$ 62.86万 - 项目类别:
Multi-Institutional Training in Genetic/Genomic Approaches to Sleep Disorders
睡眠障碍遗传/基因组方法的多机构培训
- 批准号:
10449264 - 财政年份:2013
- 资助金额:
$ 62.86万 - 项目类别:
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:
8389610 - 财政年份:2011
- 资助金额:
$ 62.86万 - 项目类别:
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:
8792236 - 财政年份:2011
- 资助金额:
$ 62.86万 - 项目类别:
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 - 财政年份:2011
- 资助金额:
$ 62.86万 - 项目类别:
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