Home sleep apnea testing compared to in-lab polysomnography for the evaluation of obstructive sleep apnea in children

家庭睡眠呼吸暂停测试与实验室多导睡眠图比较，用于评估儿童阻塞性睡眠呼吸暂停

• 批准号: 10425808
• 负责人: Christopher Michael Cielo
• 金额: $ 36.01万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10425808
• 关键词: 12 year old; Address; Adult; Affect; Age; Agreement; Apnea; Arousal; Cardiovascular system; Caregivers; Characteristics; Child; Childhood; Classification; Clinical; Clinical Data; Clinical Research; Clinical Treatment; Clinical Trials; Data; Decision Making; Devices; Diagnosis; Diagnostic; Down Syndrome; Electroencephalogram; Evaluation; Family; Gold; Home; Home environment; Hour; Institutional Review Boards; Knowledge; Laboratories; Left; Logistic Regressions; Masks; Medicine; Metabolic; Methods; Modality; Morbidity - disease rate; Obstructive Sleep Apnea; Outcome; Parents; Participant; Patients; Performance; Phase; Physicians; Polysomnography; Population; Procedures; Protocols documentation; Questionnaires; Receiver Operating Characteristics; Recommendation; Reporting; Research Personnel; Resources; Sample Size; Sensitivity and Specificity; Severities; Site; Sleep; Sleep Apnea Syndromes; Test Result; Testing; Therapeutic; Time; Treatment outcome; Youth; accurate diagnostics; active method; base; clinical center; clinical practice; comparative effectiveness trial; cost; diagnostic accuracy; diagnostic tool; functional outcomes; indexing; laboratory facility; neurobehavioral; patient oriented; preference; primary outcome; randomized trial; trial comparing

1 PROJECT SUMMARY/ABSTRACT 2 Obstructive sleep apnea (OSA) affects as much as 5% of children, and results in significant cardiovascular and 3 neurobehavioral morbidity if left untreated. The gold standard for evaluation of OSA in children is in-laboratory 4 polysomnography (PSG). However, PSG is resource-intensive, requiring caregivers to spend a night away 5 from home, and facilities are limited. Consequently, 90% of children who undergo adenotonsillectomy to treat 6 OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an alternative to PSG 7 where a patient has an unattended OSA assessment in their home. Clinical trials in adults showed no 8 difference in functional or treatment outcomes in those evaluated by HSAT compared to PSG, but similar 9 studies have not been conducted in children. The performance of HSAT compared to PSG in children is 10 unknown, and this has been a critical barrier to its clinical use as a diagnostic tool in the pediatric population. 11 HSAT has been shown to be feasible in children and our preliminary data have shown that HSAT may be 12 accurate compared to PSG and preferable to families. This milestone-driven comparative effectiveness trial will 13 compare HSAT to PSG for the evaluation of OSA in children through the following Aims: 14 1) Compare the diagnostic accuracy of HSAT with PSG for determining OSA status 15 2) Determine the agreement between HSAT and PSG results for therapeutic decision-making 16 3) Determine child/parent-reported acceptability of HSAT and preference of HSAT vs PSG. 17 To accomplish these aims, 317 children age 5-12 years old clinically referred for evaluation of OSA will 18 undergo HSAT and PSG within one week in random order and OSA classification between the two modalities 19 will be compared within subjects using receiver operating characteristics. Off-site investigators who are 20 pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and HSAT or 21 PSG result and agreement between therapeutic decision between the two tests will be assessed. Parent- and 22 child-reported questionnaires assessing preference and acceptability will be compared between HSAT and 23 PSG, and parent-reported feasibility of HSAT will be assessed. 24 The results of this comparative effectiveness trial will provide critical data directly comparing HSAT to the gold 25 standard in-lab PSG to determine its clinical utility. If shown to be diagnostically accurate and result in the 26 equivalent therapeutic decision as PSG, HSAT could provide a more patient-centered diagnostic alternative 27 that dramatically increase the capacity for OSA evaluation in children, reducing morbidity related to delayed 28 diagnosis and increasing objective testing prior to adenotonsillectomy.

1项目概要/摘要 2阻塞性睡眠呼吸暂停（OSA）影响多达5%的儿童，并导致显著的心血管和 3神经行为发病率，如果不治疗。儿童OSA评估的金标准是实验室检查 4多导睡眠图（PSG）。然而，PSG是资源密集型的，需要护理人员在外面过夜 5、设施有限。因此，90%的儿童接受腺样体切除术治疗， 6例阻塞性睡眠呼吸暂停（OSA）多导睡眠图（PSG）未确诊。家庭睡眠呼吸暂停测试（HSAT）是PSG的替代品 7.患者在家中进行无人值守的OSA评估。成人临床试验显示， HSAT评估的功能或治疗结局与PSG相比存在8处差异，但相似 9项研究未在儿童中进行。HSAT与PSG在儿童中的性能相比， 10未知，这一直是其作为儿科人群诊断工具临床使用的关键障碍。 11 HSAT已被证明是可行的儿童和我们的初步数据表明，HSAT可能是 12与PSG相比准确，更适合家庭。这项里程碑式的比较有效性试验将 13通过以下目的比较HSAT与PSG在儿童OSA评估中的作用： 1）比较HSAT与PSG用于确定OSA状态的诊断准确性 15 2）确定HSAT和PSG结果之间的一致性，用于治疗决策 16 3）确定儿童/父母报告的HSAT的可接受性和HSAT相对于PSG的偏好。 17为了实现这些目标，317名年龄在5-12岁之间的儿童临床转诊进行OSA评估， 18例在一周内随机接受HSAT和PSG检查，OSA分级在两种模式之间 将使用受试者操作特征在受试者中比较19项。非现场调查员， 20名儿科睡眠医学医生将根据临床数据和HSAT提供治疗决定， 将评估21 PSG结果和两种测试之间的治疗决策之间的一致性。父-和 22个儿童报告的问卷评估偏好和可接受性将比较HSAT和 23 PSG和父母报告的HSAT可行性将被评估。 24这项比较有效性试验的结果将提供直接比较HSAT和黄金的关键数据。 25个标准实验室内PSG，以确定其临床效用。如果显示诊断准确并导致 26项与PSG等效的治疗决策，HSAT可提供一种更以患者为中心的诊断替代方案 27，大大提高了儿童OSA评估的能力，降低了与延迟相关的发病率。 28诊断和增加客观测试前腺样体切除术。