MyCardio LLC, SleepImage®, 3513 Brighton Blvd, Denver, CO, 80216, USA.
Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, 80045, USA.
Sleep Breath. 2020 Dec;24(4):1739-1749. doi: 10.1007/s11325-020-02049-6. Epub 2020 Mar 28.
Sleep quality is vital for healthy development in children. Sleep disorders are prevalent and negatively affect sleep quality. Early identification and appropriate intervention can improve children's health and quality of life. The current reference standard, polysomnography (PSG) has limitations regarding availability, cost, and access and may not replicate normal sleep patterns in the home. Simple, accurate sleep tests, available for repeated testing should be beneficial in management of sleep disorders.
Secondary analysis of PSG data from the prospective multicenter Childhood Adenotonsillectomy Trial (CHAT) to evaluate FDA-cleared cloud-based software (Software-as-a-Medical-Device), which is based on analysis of photoplethysmogram data (PPG; plethysmogram-signal (PLETH) and oxygen saturation data (SpO)), to automatically generate a novel apnea-hypopnea index (sAHI). sAHI is compared to manually scored AHI from PSG.
Significant correlation is observed comparing the software-generated sAHI and manually derived AHI from the in-laboratory PSG-studies (Pearson correlation = 0.954, p < 0.0001) and receiver operating characteristics (ROC) demonstrate strong agreement in all OSA categories (mild, moderate, severe) 91.4%[CI89.5, 93.4]; 96.7%[CI95.4, 97.9]; 98.6%[CI97.8, 99.4], sensitivities 95.4%[CI93.2, 97.0]; 86.5%[CI80.3, 91.3]; 88.4%[CI78.4, 94.9] and specificities 84.4%[CI79.7, 88.4]; 99.2%[CI98.2, 99.7]; 99.6%[CI98.8, 99.9], respectively.
sAHI is comparable to manual scoring of AHI from in-laboratory PSG studies and effective to rule-in and rule-out obstructive sleep apnea (OSA) in all disease categories, providing safe and convenient approach for diagnosis and management of OSA in children. The data is recorded with a single-sensor, making the method suitable for multi-night testing in the child's home at considerably lower cost. This technology provides a simple tool to adhere to guidelines for diagnosis and management of OSA in children.
Childhood Adenotonsillectomy Study for Children with OSA (CHAT) https://clinicaltrials.gov/ct2/show/NCT00560859.
睡眠质量对儿童健康发育至关重要。睡眠障碍普遍存在，会降低睡眠质量。早期识别和适当干预可以改善儿童的健康和生活质量。目前的参考标准多导睡眠图（PSG）在可用性、成本和可及性方面存在局限性，并且可能无法在家中复制正常的睡眠模式。简单、准确的睡眠测试，可重复测试，应有助于睡眠障碍的管理。
对前瞻性多中心儿童腺样体扁桃体切除术试验（CHAT）的 PSG 数据进行二次分析，以评估经美国食品和药物管理局（FDA）批准的基于光电容积描记图（PPG；容积脉搏信号（PLETH）和血氧饱和度数据（SpO ））分析的云基软件（软件即医疗设备），该软件可自动生成新型呼吸暂停低通气指数（sAHI）。sAHI 与 PSG 手动评分的 AHI 进行比较。
从实验室 PSG 研究中，软件生成的 sAHI 与手动得出的 AHI 之间存在显著相关性（皮尔逊相关系数=0.954，p<0.0001），接收者操作特征（ROC）在所有 OSA 类别（轻度、中度、重度）中均显示出强烈的一致性 91.4%[CI89.5, 93.4]；96.7%[CI95.4, 97.9]；98.6%[CI97.8, 99.4]，灵敏度 95.4%[CI93.2, 97.0]；86.5%[CI80.3, 91.3]；88.4%[CI78.4, 94.9]和特异性 84.4%[CI79.7, 88.4]；99.2%[CI98.2, 99.7]；99.6%[CI98.8, 99.9]。
sAHI 与实验室 PSG 研究中手动评分的 AHI 相当，可有效用于所有疾病类别的阻塞性睡眠呼吸暂停（OSA）的确诊和排除，为儿童 OSA 的诊断和管理提供了安全便捷的方法。该数据是通过单个传感器记录的，因此该方法适用于在家中进行多晚测试，成本大大降低。该技术为遵循儿童 OSA 诊断和管理指南提供了一种简单的工具。
儿童阻塞性睡眠呼吸暂停腺样体扁桃体切除术研究（CHAT）https://clinicaltrials.gov/ct2/show/NCT00560859。
