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

用于诊断/监测儿童运动引起的声带运动的便携式设备

基本信息

批准号：
7803804
负责人：
JAFAR VOSSOUGHI
金额：
$ 14.21万
依托单位：
ENGINEERING AND SCIENTIFIC RESEARCH ASSO
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-01 至 2012-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7803804
关键词：
2 year old Adolescent Airway Resistance Asthma Behavior Therapy Breathing Child Childhood Chronic Obstructive Airway Disease Clinic Clinical Data Code Computer software Data Data Analyses Development Devices Diagnosis Diagnostic Disadvantaged Dyspnea Ethnic group Exercise Exercise-Induced Asthma Exhalation Feasibility Studies Functional disorder Funding Gold Grant Image Indium Individual Language Laryngoscopes Laryngoscopy Lead Legal patent Lung Manuscripts Marketing Measurement Measures Medical Methods Minority Modification Monitor Motion Pathologist Patients Pharmaceutical Preparations Phase Physicians&apos Offices Plethysmography Population Preparation Production Publications Pulmonary function tests Reading Recruitment Activity Refractory Reporting Research Personnel Resistance Resources Respiration Respiration Disorders Rest Schools Self-Help Devices Sensitivity and Specificity Site Slide Small Business Innovation Research Grant Specificity Speech Spirometry Sports Staging Stridor Symptoms Techniques Testing Training Treatment outcome Video Recording Work asthmatic patient cost diagnosis standard dosage effective therapy exhaustion experience follow-up girls improved methacholine monitoring device noninvasive diagnosis novel diagnostics operation portability public health relevance respiratory response sensor tool trend vocal cord

项目摘要

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.

描述（由申请人提供）：运动引起的反常声带运动（EI-PVFM）是一种症状包括运动期间呼吸困难和喘鸣的病症，特别是在青少年运动员中。由于其症状与运动诱发的哮喘相似，因此通常用哮喘药物治疗。 EI-PVFM 对这些药物的反应不佳会导致长期使用剂量增加和并发症。 EI-PVFM 的最佳治疗方法是由言语病理学家提供的行为疗法。准确的诊断可以带来有效的治疗结果，帮助这些年轻运动员重返训练并避免医疗资源的滥用。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他们的治疗结果。目前诊断 EI-PVFM 的“黄金标准”是昂贵的侵入性喉镜检查。其他替代方案也有各自的缺点。例如，肺活量测定法的灵敏度较低（23%），并且依赖于儿童的努力来获得准确的测量结果；乙酰甲胆碱激发试验特异性较低（30%）；身体体积描记法既麻烦又昂贵。研究人员此前开发了一种便携式气流扰动装置（APD），可以测量自然呼吸条件下的吸气和呼气呼吸阻力，该呼吸条件要求受检者进行最少的合作，包括不超过正常呼吸时间不超过一分钟。正如之前报道和我们最近在初步研究中发现的那样，当 EI-PVFM 患者出现症状时，吸气阻力增加，而在休息或有效呼吸训练后吸气阻力下降。 APD的主要优点包括无创性、使用方便（需要自然呼吸时间小于1分钟）、儿童友好（即使是2岁儿童）、便携（在不同部位应用）、影响相对较小由于吹口处的气流泄漏。第一阶段的资金将使我们能够调查使用 APD 作为 EI-PVFM 诊断工具的可行性，并测试其与适用于 EI-PVFM 的更广泛范围内的喉镜检查相比的敏感性和特异性。在第二阶段，我们计划提高流量传感器的准确性和灵敏度，并添加运动期间使用的配置以及包括流量显示在内的附加测量，并使用包括少数民族和族裔群体在内的大量儿科人群测试设备/方法。为了将 APD 投入商业化生产（我们的长期目标），这一新应用需要进一步的开发和完善。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、低成本且易于操作，APD 是运动训练现场监测的理想设备。在第二阶段，我们计划在不同诊所的至少 400 人身上测试该设备。公共卫生相关性：运动引起的呼吸系统疾病在运动员（主要是女孩）中非常常见，并且通常未被发现或被误诊/误治。我们提出了一种简单的诊断/管理设备，与侵入性且昂贵的喉镜相比，该设备是非侵入性、轻松、简单且成本低廉的。