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。儿童睡眠呼吸障碍是通过多导睡眠图诊断的，这是昂贵的，并且不容易为绝大多数患者所用，其中80%的患者仍未确诊。这项试点临床研究旨在比较创新诊断设备SomnaPatchTM与多导睡眠图。本研究将招募有睡眠呼吸障碍风险的儿童。具体目的是验证SomnaPatchTM器械的设计是否适合儿童面部;并评估SomnaPatchTM器械与多导睡眠图之间的一致性。如果这项研究表明这两种技术之间存在良好的一致性，那么类似创可贴的SomnaPatchTM设备可能会被整合到睡眠专家和儿科医生的临床实践中，作为一种易于使用且廉价的工具，用于诊断睡眠呼吸障碍。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，从而降低医疗成本，提高儿科患者及其家人的生活质量。

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.