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 儿童阻塞性睡眠呼吸暂停(OSA)是一个严重的健康问题，大约50%-100%的儿童受到影响 患有唐氏综合症(DS)的儿童占总人口的1-5%。这增加了 DS儿童的患病率可能是由于解剖危险因素和低眼压和高眼压风险增加所致 肥胖是导致阻塞性睡眠呼吸暂停综合征的病理生理因素。美国国立卫生研究院资助的父母资助的“随机对照试验” 氧疗在唐氏综合征和阻塞性睡眠呼吸暂停(DOSA)儿童和青少年中的应用 旨在测试睡眠中补充氧气对患有阻塞性睡眠呼吸暂停综合征的儿童的治疗作用 从7个学术站点招募的5-17岁DS儿童的其他治疗失败 我们。这笔赠款的动机是越来越多的证据表明，阻塞性睡眠呼吸暂停综合征的诊断和严重程度存在种族差异。 造成这些差异的原因是多方面的；然而，最近的报告表明，与技术有关 有深色皮肤的儿童存在偏见，这可能会导致低估低氧血症。具体来说， 阻塞性睡眠呼吸暂停的诊断是通过多导睡眠图(PSG)，这需要测量血氧饱和度使用 手指上的无创脉搏血氧仪(SpO2)替代动脉血氧饱和度测量 饱和度(SaO2；黄金标准)。血氧仪使用颜色传感技术，深色皮肤 已被证明会影响血氧计的准确性。鉴于黑色素的光吸收特性，它是 假设皮肤色素沉着会影响传感器吸收光线的方式，从而产生了这项技术-- 氧气测量中的相关偏差。因此，这项多样性补充建议旨在 根据种族/民族和皮肤色素沉着调查DS儿童潜在的血氧测量偏差 他们是氧气补充的潜在候选者。主要结果将是平均值偏差 在SpO2-SaO2测量对之间，OSA相关低氧事件的严重性和减饱和度 两种常用的脉搏血氧仪在儿童中的灵敏度。我们将首先考察它们之间的差异 在儿童同时测量SpO2和SaO2(黄金标准)之间的配对测量。接下来，要了解 血氧仪偏差对识别DS儿童OSA相关低氧血症的影响，我们将利用 建立了DOSA试验的基础设施，以研究DS儿童在接受治疗时的血氧量相关偏差 PSG筛查。这项研究将填补在评估睡眠相关程度方面的关键知识空白 患有DS和深色皮肤的儿童呼吸障碍和低氧血症被低估 量化DS儿童常见的共病(如肥胖、心脏病)对SpO2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 有效性和对特殊人群的研究。