Exercise-induced Paradoxical Vocal Fold Motion Disorder: Clinical Feature Characteristics and Potential Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Self-report of dyspnea severity, determined on 100mm visual analog scale
研究概览
简要总结
Exercise-induced paradoxical vocal fold motion disorder (E-PVFMD) - which severely impacts the lives of up to 1 million adolescents in the U.S. annually - is under- or mis-diagnosed in as many as 80% of cases, leading to ineffective, protracted periods of management. Additionally, what makes those with the condition different from those at risk for the condition (e.g., playing sports/engaging in athletic activity within a competitive athletic environment) is unclear. The goals of this proposed study are to address this diagnostic challenge by (1) pursuing a previously published preliminary taxonomic algorithm for the clinical identification and classification of EPVFMD, and by (2) elucidating potential underlying mechanisms driving this clinical presentation. Study outcomes will improve sensitivity and specificity of diagnosis protocols for PVFMD, thereby reducing prevalence of misdiagnosis and improving clinical management in individuals with this disorder in the future. Outcomes will also be used to create preventative care measures for adolescents at risk for the condition.
详细描述
The experimental protocol consists of five stages in total (Stages IV): (1) Screening, (2) Pre-Baseline, (3) Baseline Laryngoscopy Condition, (4) Exercise Laryngoscopy Condition, and (5) Recovery. The following sections describe procedures conducted within each of the five stages
Stage I: Screening
To determine eligibility, all consenting participants will (1) undergo spirometric screening to rule out any indication of pulmonary pathology, (2) report they partake in athletic activity within a competitive environment (self-perceived/reported), and (3) complete the Dyspnea Index (DI). Participants with less than 80% predicted FEV1 on spirometry will be excluded from the study and referred to the pediatric pulmonary clinic at Massachusetts General Hospital (MGH). Anyone who reports they feel their sports-related activities are not competitive will be excluded. Participants in the E-PVFMD group who score less than 10 out of 40 on the DI will be excluded from the study, whereas participants in the at-risk group who score more than 6 out of 40 on the DI will be excluded from the study.
Stage II: PreBaseline
All participants who have passed the screening will rate the worst severity of perceived shortness of breath experienced during the screening period, as well as other symptoms relating to PVFMD (i.e., cough, globus, dysphonia, laryngeal pain/tension), on a 0100mm visual analog scale (VAS). These values will later serve as anchors for subsequent symptom ratings. Rating severity of symptoms prior to laryngoscopy will also prime participants for symptom severity ratings in subsequent conditions, described shortly in detail. Next, blood pressure (SBP) and heart rate (HR) readings will be obtained three times (x3) at 30-second intervals or greater over a 5minute period, using a blood and heart rate monitor. The three readings will then be averaged and used as anchors for SBP and HR readings taken during subsequent study phases. Two self-reported questionnaires will then be administered to all enrolled participants: the Early Adolescent Temperament Questionnaire - Revised-short form (EATQ-R-SF) and the Paffenbarger Physical Activity Questionnaire (PPAQ). Participants will read and complete the two questionnaires on their own, although the PI or parent/guardian may clarify questions or help participants read instructions, especially with younger participants. Last, a respiratory transducer band will be placed on ribs 5-8 to measure respiratory rate (RR) and tidal volumes (TV). These parameters may be used to stratify/bin data, posthoc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents (ages 12-18yo)
- •Exercise regularly (at least 40min 3x/week) in competitive athletic environment
- •Inclusion criteria specific to E-PVFMD group: report of atypical dyspnea during exertion and associated decrements in athletic performance for more than 2 weeks prior to presentation; Score of > 10/40 on the Dyspnea Index
排除标准
- •Developmental or cognitive disorder precluding ability to follow directions or read instructions
- •Behavioral disorder that would disrupt study protocol or potentially affect outcome parameters (e.g., attention-deficit/hyperactivity disorder [ADHD], oppositional defiant disorder [ODD]).
- •Neuromuscular disorders affecting the respiratory or phonatory system (e.g., ALS, Myasthenia Gravis)
- •Supralaryngeal anatomical defects impeding airflow
- •Cardiovascular conditions/disorders (e.g., hypertension)
- •Poorly controlled obstructive pulmonary disorders (e.g., asthma)
- •Use of the following medications: (a) antihypertensive, (b) cardiovascular, (c) psychotropic
- •Identifiable (organic) vocal fold pathology occluding more than a 1/3 of the airway (e.g., lesions, nodules), found on laryngeal examination
- •Intolerance to flexible nasoendoscopy
- •E-PVFMD group only: absence of signs or symptoms of acute E-PVFMD attack with exercise provocation challenge at maximum exertion at or before the 3minute mark.
- •At-Risk group only: Positive signs or symptoms of an acute E-PVFMD attack with exercise provocation challenge at maximum exertion.
结局指标
主要结局
Self-report of dyspnea severity, determined on 100mm visual analog scale
时间窗: 1 year
Estimates of vocal fold angle at anterior commissure, determined on laryngoscopic digital images taken at height of inspiration prior to start of exhalation
时间窗: 1 year
次要结局
- Amount arytenoid prolapse, rated on a 0-3 scale based on videoendoscopic images(1 year)
- Amount of epiglottic collapse, rated on a 0-3 scale based on videoendoscopic images(1 year)
- Self-report of cough severity, determined based on 100mm visual analog scale(1 year)
- Amount of ventricular compression, rated on a 0-3 scale based on videoendoscopic images(1 year)
- Self-report of neck tightness severity, determined based on 100mm visual analog scale(1 year)
- Self-report of stridor severity, determined based on 100mm visual analog scale(1 year)
研究者
Adrianna Shembel
Principal Investigator
University of Pittsburgh
