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

描述（由申请人提供）：运动诱发的声带反常运动（EI-PVFM）是一种症状包括运动期间呼吸困难和喘鸣的疾病，尤其是青少年运动员。由于其症状类似运动诱发的哮喘，因此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言语语言病理学家提供的行为治疗。准确的诊断导致有效的治疗结果，这将有助于这些年轻的运动员返回实践，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”是昂贵且有创的喉镜检查。其他替代方案有其各自的缺点。例如，肺功能测定法的灵敏度低（23%），依赖于儿童的努力，以获得准确的测量;乙酰甲胆碱激发试验的特异性低（30%）;身体体积描记法是繁琐和昂贵的。研究人员之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，要求受试者最小限度的合作，包括不超过正常呼吸不到一分钟。正如以前报道的和最近在我们的初步研究中发现的，当EI-PVFM患者有症状时，吸气阻力增加，而在休息时或有效的呼吸训练后，吸气阻力降低。APD的主要优点包括无创性、易用性（需要自然呼吸不到1分钟）、儿童友好型（甚至适用于2岁儿童）、便携性（适用于各种部位）以及吸嘴处气流泄漏的影响相对较小。I期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，并在更广泛的EI-PVFM适用范围内测试其与喉镜检查相比的灵敏度和特异性。在第二阶段，我们计划提高流量传感器的准确度和灵敏度，并增加在运动期间使用的配置，包括流量显示，并使用大量儿科人群（包括少数民族和种族群体）测试器械/方法。为了使APD进入商业化生产（我们的长期目标），这种新的应用，进一步的开发和完善是必要的。之后，必须获得临床数据，并寻求监管部门的批准。APD的这种应用的市场非常广泛，包括诊所、医生办公室、运动训练场所、学校以及参与各种体育活动的大量儿科人群。由于其便携式尺寸，低成本和易于操作，APD是一个理想的设备，监测在体育训练场所。在第二阶段，我们计划在不同诊所的至少400名患者身上测试该设备。 公共卫生相关性：运动诱发的呼吸系统疾病在运动员中非常常见（大多数是女孩），通常未被发现或被误诊/虐待。我们提出了一种简单的诊断/管理设备，与侵入性和昂贵的喉镜相比，该设备是非侵入性的、不费力的、简单的并且成本低。

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.