Portable Device to Diagnose/Monitor Pediatric Exercise-Induced Vocal Fold Motion

描述（由申请人提供）：运动引起的矛盾声带运动（EI-PVFM）是一种症状包括运动时呼吸困难和喘鸣的疾病，特别是在青少年运动员中。因为它的症状类似于运动引起的哮喘，所以通常用哮喘药物治疗。EI-PVFM对这些药物的不良反应导致剂量增加和长期使用的并发症。EI-PVFM的最佳治疗方法是由语言病理学家提供行为治疗。准确的诊断导致有效的治疗结果，将帮助这些年轻的运动员回到练习，避免滥用医疗资源。因此，需要明确的诊断工具来识别声带功能障碍患者并评估其治疗结果。目前诊断EI-PVFM的“金标准”是昂贵的侵入性喉镜检查。其他选择都有各自的缺点。例如，肺活量计灵敏度低（23%），并且依赖于儿童的努力来获得准确的测量；甲胆碱激发试验特异性较低（30%）；身体体积描记仪既麻烦又昂贵。研究人员先前开发了一种便携式气流扰动装置（APD），可以在自然呼吸条件下测量吸气和呼气呼吸阻力，要求考生的配合最少，包括不超过正常呼吸少于一分钟。正如先前报道和我们最近在初步研究中发现的那样，当患有i - pvfm的患者有症状时，吸气阻力增加，而在休息或经过有效的呼吸训练后，吸气阻力降低。APD的主要优点包括非侵入性，易用性（需要不到1分钟的自然呼吸），儿童友好（即使是2岁的儿童），便携性（在各种地点应用），以及相对较小的影响气流泄漏口。第一阶段的资金将使我们能够研究使用APD作为EI-PVFM诊断工具的可行性，并在更大范围内测试其与喉镜检查相比的敏感性和特异性，适用于EI-PVFM。在第二阶段，我们计划提高流量传感器的准确性和灵敏度，并增加在运动期间使用的配置，包括流量-体积显示，并在包括少数民族和少数民族在内的大量儿科人群中测试该设备/方法。为了将APD投入商业生产（我们的长期目标），进一步的开发和改进是必要的。在此之后，必须获得临床数据，并寻求监管部门的批准。APD的应用市场非常广泛，包括诊所、医生办公室、运动训练场所、学校，以及为大量儿科人群参与各种体育活动。由于其便携尺寸，低成本和易于操作，APD是运动训练场地监测的理想设备。在第二阶段，我们计划在不同诊所的至少400个人身上测试该设备。

DESCRIPTION (provided by applicant): Exercise induced paradoxical vocal fold motion (EI-PVFM) is a condition which symptoms include breathing difficulty and stridor during exercise, particular in adolescent athletes. Because its symptoms mimic exercise induced asthma, it is often treated with asthmatic medications. Poor response of EI-PVFM to these medications results in increased dosage and complications from long-term use. The optimal treatment for EI-PVFM is behavioral therapy provided by speech-language pathologist. Accurate diagnosis leads to effective treatment outcome that will help these young athletes to return to practice and avoid misuse of medical resources. Thus, definitive diagnostic tools are needed to identify patients with vocal cord dysfunction and evaluate their treatment outcome. The current "gold standard" for diagnosing EI-PVFM is the expensive and invasive laryngoscopy. Other alternatives have their respective disadvantages. For instance, the spirometry has low sensitivity (23%) and dependent on the child's effort to obtain accurate measurement; the methacholine challenge test has low specificity (30%); the body plethysmography is cumbersome and expensive. The investigators have previously developed a portable airflow perturbation device (APD) that can measure inspiratory and expiratory respiratory resistance under natural breathing condition that requests minimal cooperation from the examinee that includes no more than normal breathing for less than a minute. As previously reported and recently discovered in our preliminary study, the inspiratory resistance increased when the patient with EI-PVFM was symptomatic, whereas it decreased at rest or after effective breathing training. Major advantages of the APD include non-invasiveness, ease of use (requiring natural breathing for less than 1 minute), child-friendly (even for 2-year-old children), portability (applications at various sites), and relatively less effect by airflow leak at the mouthpiece. Phase I funding will enable us to investigate the feasibility of using the APD as a diagnostic tool for EI-PVFM and test its sensitivity and specificity comparing to laryngoscopic exams in wider range applicable to EI-PVFM. In Phase II we plan to improve the flow sensor's accuracy and sensitivity, and add configurations to be used during exercise with additional measurements including flow-volume display, and test the device/method using large pediatric population including minorities and ethnic groups. To bring APD into commercial production (our long term objective) for this new application, further development and refinements are necessary. After that, clinical data must be obtained, and regulatory approval must be sought. The market for this application of the APD is very wide, including clinics, physician's offices, sport training sites, schools, and for a large number of pediatric population involved in a variety of sport activities. Because of its portable size, low cost, and ease of operation, the APD is an ideal device for monitoring at sport training sites. In Phase II we plan to test the device on at least 400 individuals at different clinics. PUBLIC HEALTH RELEVANCE: Exercise-Induced respiratory disorder is very common among your athletes (mostly girls) and is usually undetected or misdiagnosed/mistreated. We are proposing a simple diagnostic/management device that is non-invasive, effortless, simple, and at low cost compared to the invasive and expensive laryngoscope.