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，影响着大约 50-100% 的儿童 儿童患有唐氏综合症 (DS) 的比例为 1-5%。这增加了 DS 儿童的患病率可能是由于解剖学危险因素以及肌张力低下和肌张力减退的风险增加所致。 肥胖导致 OSA 的病理生理学。 NIH 资助的家长资助“随机对照试验 患有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疗” 旨在测试睡眠期间补充氧气对于患有 DS 的儿童治疗 OSA 的作用 来自七个学术机构的 5-17 岁 DS 儿童的其他治疗失败的研究 我们。这项资助的动机是越来越多的证据表明 OSA 的诊断和严重程度存在种族差异。 造成这些差异的原因有多种；然而，最近的报告表明与技术相关的 深色皮肤儿童的偏差可能会导致低氧血症的低估。具体来说， OSA 的诊断是通过多导睡眠图 (PSG) 进行的，这需要使用氧饱和度测量 手指上的无创脉搏血氧仪 (SpO2) 作为动脉血氧测量的替代指标 饱和度（SaO2；金标准）。血氧测定法使用颜色传感技术，深色皮肤有 已被证明会影响血氧计的准确性。鉴于黑色素具有吸光特性， 假设皮肤色素沉着可能会影响传感器吸收光的方式，从而导致技术 - 氧气测量中的相关偏差。因此，该多样性补充提案旨在 调查 DS 儿童因种族/民族和皮肤色素沉着而产生的潜在血氧饱和度测量偏差 谁是补充氧气的潜在候选人。主要结果将是平均偏差 SpO2-SaO2 测量对之间、OSA 相关低氧血症事件的严重程度以及饱和度降低 使用两种常用的儿童脉搏血氧仪的灵敏度。我们首先检查差异 儿童同时进行 SpO2 和 SaO2（金标准）配对测量。接下来要了解的是 血氧计偏差对识别 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，以研究接受 DS 治疗的儿童的血氧饱和度相关偏差 PSG筛选。这项研究将填补评估睡眠相关程度的关键知识空白 患有 DS 和深色皮肤的儿童的呼吸障碍和低氧血症被低估了 量化 DS 儿童常见的合并症（例如肥胖、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 有效性和特殊人群的研究。