FLEXIBLE ADHESIVE PATCH FOR DIAGNOSING SLEEP DISORDERED BREATHING IN CHILDREN

描述（由申请人提供）：本研究的目的是测试一种创新的柔性皮肤粘附装置用于诊断儿童睡眠呼吸暂停的可行性。睡眠呼吸暂停影响了6%的普通儿科人群和50%的肥胖儿童。儿童睡眠呼吸暂停会导致严重的健康、发育和生活质量问题，如学习缺陷、认知、行为异常、嗜睡和心血管疾病。小儿睡眠呼吸障碍是用多导睡眠图诊断出来的，这是昂贵的，而且对绝大多数患者来说并不容易获得，其中80%的患者仍未被诊断出来。这项试点临床研究旨在比较创新的诊断设备SomnaPatchTM和多导睡眠图。本研究将招募有睡眠呼吸障碍风险的儿童。具体目标是使SomnaPatchTM设备的设计小型化，以适应儿童的面部；并评估SomnaPatchTM设备与多导睡眠仪之间的一致性。如果这项研究显示两种技术之间有良好的一致性，那么这种类似创可贴的SomnaPatchTM设备可能会作为一种易于使用且价格低廉的诊断睡眠呼吸障碍的工具，被睡眠专家和儿科医生纳入临床实践。SomnaPatchTM可以帮助目前未确诊的患者，并帮助预防未经治疗的睡眠呼吸暂停的破坏性长期后果，因此，降低医疗保健成本，提高儿科患者及其家属的生活质量。

DESCRIPTION (provided by applicant): The objective of this study is to test the feasibility of an innovative flexible skin-adhesive device for diagnosis of sleep apnea in children. Sleep apnea affects up to 6% of the general pediatric population and up to 50% of obese children. Childhood sleep apnea causes significant health, developmental and quality of life problems, such as learning deficits, cognitive, behavioral abnormalities, sleepiness, and cardiovascular morbidities. Pediatric sleep disordered breathing is diagnosed with polysomnography, which is expensive and is not readily available to the vast majority of patients, eighty percent of whom remain undiagnosed. This pilot clinical research study is designed to compare the innovative diagnostic device SomnaPatchTM with polysomnography. Children at risk of sleep disordered breathing will be recruited for this study. The specific aims are to miniaturize the design of the SomnaPatchTM device to fit child's face; and to assess the agreement between the SomnaPatchTM device and polysomnography. If this research study shows good agreement between the two techniques, the BandAid-like SomnaPatchTM device can potentially be integrated into clinical practice of sleep specialists and pediatricians as an easy-to-use and inexpensive tool for the diagnosis of sleep disordered breathing. SomnaPatchTM can reach currently undiagnosed patients and help prevent the devastating long-term consequences of untreated sleep apnea, therefore, reducing the healthcare costs and improving quality of life of pediatric patients and their families.