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）是一个严重的健康问题，影响大约50-100%的儿童， 唐氏综合症（DS）儿童占总人口的1-5%。这种增加的 DS儿童的患病率可能是由于解剖学风险因素和张力减退风险增加， 导致OSA病理生理学的肥胖症。美国国立卫生研究院资助的父母补助“随机对照试验 氧气治疗唐氏综合征和阻塞性睡眠呼吸暂停（DOSA）的儿童和青少年” 目的是测试在睡眠期间补充氧气作为治疗患有DS的儿童OSA的作用， 其他治疗失败的5-17岁DS儿童，从7个学术中心招募， 我们这项拨款的动机是越来越多的证据表明，在OSA的诊断和严重程度方面存在种族差异。 造成这些差异的原因有多种;然而，最近的报告表明， 对深色皮肤儿童的偏见可能导致对低氧血症的低估。具体地说， 阻塞性睡眠呼吸暂停综合症的诊断是通过多导睡眠图（PSG）进行的，该图需要使用血氧饱和度测量仪测量血氧饱和度。 手指上的无创脉搏血氧仪（SpO 2）作为动脉血氧血液测量的替代 饱和度（SaO 2;黄金标准）。血氧测定使用颜色传感技术，深色皮肤具有 已被证明会影响血氧计的准确性。鉴于黑色素的吸光特性， 假设皮肤色素沉着会影响传感器吸收光线的方式，从而导致技术- 氧气测量中的相关偏差。因此，这一多样性补充提案旨在 通过种族/民族和皮肤色素沉着调查DS儿童的潜在血氧测定偏倚 他们是氧气补充的潜在候选人。主要结果是平均偏倚 SpO 2-SaO 2测量值对之间、OSA相关低氧血症事件的严重程度和去饱和度 使用两种常用的脉搏血氧仪设备在儿童中的灵敏度。我们先来看看 儿童SpO 2和SaO 2（金标准）配对测量值之间的差异。接下来，为了理解 血氧计偏差对确定DS儿童OSA相关低氧血症的影响，我们将利用 建立DOSA试验的基础设施，以研究接受DS治疗的儿童中的血氧测定相关偏倚 PSG筛查。这项研究将填补关键的知识空白，在评估睡眠相关的程度， 呼吸紊乱和低氧血症在DS和深色皮肤的儿童中被低估， 量化DS儿童中常见的合并症的影响（例如，肥胖、心脏病）对SpO 2的影响 测量.通过这项研究，我将获得在临床试验，差异研究，临床 有效性和特殊人群的研究。