Portable, In-Home Assessment of Pediatric Sleep Apnea

小儿睡眠呼吸暂停的便携式家庭评估

• 批准号: 7110828
• 负责人: Daniel J Levendowski
• 金额: $ 19.76万
• 依托单位: ADVANCED BRAIN MONITORING, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-15 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7110828
• 关键词: adolescence (12-20); biomedical equipment development; brain electrical activity; clinical research; computer program /software; computer system design /evaluation; diagnosis quality /standard; disease /disorder proneness /risk; human subject; monitoring device; polysomnography; portable biomedical equipment; questionnaires; respiratory disorder diagnosis; sleep apnea

DESCRIPTION (provided by applicant): Obstructive Sleep Apnea (OSA), a highly prevalent, under-diagnosed condition is responsible for more mortality and morbidity than any other sleep disorder and has been identified as a major public health concern. Pediatric OSA is also widespread with an estimated prevalence of approximately 2% and is increasingly recognized as a significant cause of morbidity in children. There is a growing demand for validated, in-home assessment methods for pediatric OSA for diagnostic and treatment outcome evaluations and to facilitate large epidemiological studies. Accurate assessment of the severity of pediatric OSA is also required to identify children at risk for postoperative complications following tonsillectomy and adenoidectomy, the most common treatment for childhood OSA. The Apnea Risk Evaluation System (ARES) was designed by Advanced Brain Monitoring to incorporate existing knowledge on sleep-disordered breathing into an easy-to-administer in-home diagnostic system for SA that employs a multivariate approach, uniquely combining physiological data acquired during sleep with anthropomorphic and clinical information obtained from a standardized questionnaire. The ARES integrates an easily applied, single site (forehead) Unicorder to record physiological signals during sleep with automated identification of abnormal respiratory events to quantify severity of OSA. The goal of this proposal is to modify the ARES to meet the demand for accurate diagnosis of pediatric OSA. In Phase I, the investigators propose that the ARES be evaluated in a population of thirty patients between the ages of 13 and 18 referred to a sleep laboratory for OSA assessment. This age group was selected for the Phase I feasibility study because the head sizes of teens are sufficiently similar to adults to assess the limitations of the ARES Unicorder as currently designed. In addition, establishing feasibility for the use of the ARES in teens would be an important accomplishment given the dramatic rise in obesity and asthma (two important OSA risk factors) in this age group. The goals for Phase II will be to study a large population of children and to modify the ARES Unicorder to accommodate the developmental range of forehead shapes and sizes for children under the age of 13.

描述（由申请人提供）：阻塞性睡眠呼吸暂停 (OSA) 是一种高度流行、诊断不足的疾病，其死亡率和发病率高于任何其他睡眠障碍，并已被确定为主要的公共卫生问题。儿童 OSA 也很普遍，估计患病率约为 2%，并且越来越多地被认为是儿童发病的重要原因。人们对儿科 OSA 经验证的家庭评估方法的需求不断增长，以进行诊断和治疗结果评估，并促进大型流行病学研究。还需要准确评估儿童 OSA 的严重程度，以确定扁桃体切除术和腺样体切除术（儿童 OSA 最常见的治疗方法）术后并发症风险的儿童。呼吸暂停风险评估系统 (ARES) 由 Advanced Brain Monitoring 设计，旨在将有关睡眠呼吸障碍的现有知识纳入易于管理的 SA 家用诊断系统，该系统采用多变量方法，独特地结合了睡眠期间获取的生理数据具有从标准化问卷中获得的拟人化和临床信息。 ARES 集成了易于应用的单点（前额）Uniorder，用于记录睡眠期间的生理信号，并自动识别异常呼吸事件，以量化 OSA 的严重程度。该提案的目标是修改 ARES 以满足儿童 OSA 准确诊断的需求。在第一阶段，研究人员建议对 30 名年龄在 13 至 18 岁之间的患者进行 ARES 评估，这些患者被转至睡眠实验室进行 OSA 评估。该年龄组被选用于第一阶段可行性研究，因为青少年的头部尺寸与成年人足够相似，可以评估当前设计的 ARES Uniorder 的局限性。此外，考虑到青少年肥胖和哮喘（两个重要的 OSA 危险因素）的急剧增加，确定在青少年中使用 ARES 的可行性将是一项重要的成就。第二阶段的目标是研究大量儿童，并修改 ARES Uniorder 以适应 13 岁以下儿童额头形状和大小的发育范围。