Randomized Control Trial of oxygen therapy in Children and Adolescents with Down Syndrome and Obstructive Sleep Apnea

唐氏综合症和阻塞性睡眠呼吸暂停儿童和青少年氧疗的随机对照试验

• 批准号: 10838939
• 负责人: Raouf S. Amin
• 金额: $ 24.5万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10838939
• 关键词: Adolescent; Affect; Anatomy; Blood; Breathing; Child; Childhood; Clinical Trials; Clinical effectiveness; Color; Darkness; Data; Devices; Diagnosis; Disparity; Disparity in diagnosis; Down Syndrome; Ensure; Equity; Ethnic Origin; Event; Fingers; Functional disorder; Funding; General Population; Grant; Health; Heart Diseases; Hypoxemia; Infrastructure; Knowledge; Light; Measurement; Melanins; Morbidity - disease rate; Muscle hypotonia; Obesity; Obstructive Sleep Apnea; Oxygen; Oxygen Therapy Care; Oxygen saturation measurement; Polysomnography; Population Heterogeneity; Prevalence; Property; Proxy; Pulse Oximetry; Randomized, Controlled Trials; Reporting; Research; Risk; Risk Factors; Role; Severities; Site; Skin Pigmentation; Sleep; Special Population; Supplementation; Technology; Testing; United States National Institutes of Health; absorption; aged; comorbidity; design; high risk; parent grant; primary outcome; racial bias; racial disparity; recruit; screening; sensor; sensor technology; skills; supplemental oxygen

Project Abstract Pediatric obstructive sleep apnea (OSA) is a significant health problem affecting approximately 50-100% of children with Down syndrome (DS) compared to 1-5% of children in the general population. This increased prevalence in children with DS is likely due to anatomic risk factors and increased risk for hypotonia and obesity that contribute to the pathophysiology of OSA. The NIH-funded parent grant “Randomized Control Trial of Oxygen Therapy in Children and Adolescents with Down Syndrome and Obstructive Sleep Apnea (DOSA)” aims to test the role of supplemental oxygen during sleep as a treatment for OSA in children with DS who have failed other treatments in children aged 5-17 years with DS, recruited from seven academic sites across the US. This grant is motivated by growing evidence for racial disparities in the diagnosis and severity of OSA. There are multiple reasons for these disparities; however, recent reports have suggested technology-related biases in children with darkly pigmented skin that may result in under-estimated of hypoxemia. Specifically, diagnosis of OSA is by polysomnogram (PSG), which requires measurement of oxygen saturation using a noninvasive pulse oximetry device (SpO2) on the finger as a proxy for blood measurement of arterial oxygen saturation (SaO2; the gold standard). Oximetry uses color sensing technology, and darkly pigmented skin has been shown to influence the accuracy of oximeters. Given the light-absorbing properties of melanin, it is hypothesized that skin pigmentation could affect how light is absorbed by the sensor leading to technology- related biases in oxygen measurements. This diversity supplement proposal is therefore designed to investigate potential oximetry measurement biases by race/ethnicity and skin pigmentation in children with DS who are potential candidates for oxygen supplementation. The primary outcomes will be the mean bias between SpO2-SaO2 measurement pairs, the severity of OSA-related hypoxemic events, and desaturation sensitivity using two commonly used pulse oximetry devices in children. We will first examine the differences between simultaneous SpO2 and SaO2 (gold standard) paired measurements in children. Next, to understand the impact of oximeter biases on identifying OSA-related hypoxemia in children with DS, we will leverage the established infrastructure of the DOSA trial to study oximetry-related biases in children with DS undergoing PSG screening. This study will fill critical knowledge gaps in evaluating the extent to which sleep-related breathing disturbances and hypoxemia are under-estimated in children with DS and darkly pigmented skin and quantifying the influence of co-morbidities common in children with DS (e.g., obesity, heart disease) on SpO2 measurements. Through this research, I will gain critical skills in clinical trials, disparities research, clinical effectiveness, and studies of special populations.

项目摘要 小儿阻塞性睡眠呼吸暂停（OSA）是一个重大的健康问题，影响了约50-100％ 唐氏综合症（DS）的儿童比一般人群中有1-5％的儿童。这增加了 DS儿童的患病率可能是由于解剖危险因素以及降低和 有助于OSA的病理生理学的肥胖症。 NIH资助的父母赠款“随机控制试验 唐氏综合症和阻塞性睡眠呼吸暂停（DOSA）的儿童和青少年的氧气治疗” 旨在测试睡眠期间补充氧的作用，作为在患有DS儿童的OSA治疗 在5-17岁的DS儿童中，其他治疗措施失败，从七个学术地点招募 我们。这笔赠款是由OSA诊断和严重性中种族差异的越来越多的证据所激发的。 这些分布有多种原因；但是，最近的报告提出了与技术有关的 皮肤深色皮肤的儿童的偏见可能导致低氧血症低估。具体来说， OSA的诊断是通过多词函数图（PSG）的，它需要使用A测量氧饱和 手指上的无创脉搏血氧仪装置（SPO2）作为动脉氧的血液测量的代理 饱和度（SAO2；黄金标准）。血氧仪使用颜色传感技术，皮肤深色的皮肤具有 被证明会影响氧合的准确性。鉴于黑色素的吸收特性，它是 假设皮肤色素沉着可能会影响传感器吸收光的方式 - 氧测量中的相关偏见。因此，这种多样性补充提案旨在 研究DS儿童的种族/种族和皮肤色素沉着来研究潜在的血氧仪测量偏差 谁是补充氧气的潜在候选者。主要结果将是平均偏见 在SPO2-SAO2测量对，与OSA相关的低氧事件的严重程度和讨论之间 使用儿童中两个常用的脉搏血氧饱和装置的敏感性。我们将首先检查差异 在儿童的同时SPO2和SAO2（黄金标准）配对的测量之间。接下来，要理解 氧偏见对鉴定DS儿童中与OSA相关的低氧血症的影响，我们将利用 DOSA试验的建立基础设施研究了患有DS的儿童的氧合相关偏见 PSG筛选。这项研究将填补关键的知识差距，以评估与睡眠相关的程度 在患有DS和黑暗的皮肤的儿童中，呼吸障碍和低氧血症的估计不足 量化DS儿童（例如肥胖症，心脏病）对SPO2的儿童常见的合并症的影响 测量。通过这项研究，我将获得临床试验，差异研究，临床的关键技能 有效性和特殊人群的研究。