Disorder of Vocal Cord Clinical Trial
Official title:
Exercise-induced Paradoxical Vocal Fold Motion Disorder: Clinical Feature Characteristics and Potential Mechanisms
Verified date | October 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | July 3, 2017 |
Est. primary completion date | July 3, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mass Eye and Ear Infirmary | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Massachusetts Eye and Ear Infirmary |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Estimates of autonomic balance, determined with systolic blood pressure at maximum exertion | 1 year | ||
Other | Estimates of autonomic balance, determined with heart rate recovery | Heart rate recovery determined by the difference between heart rate at maximum exertion and heart rate at the 2-minutes post-recovery time point. | 1 year | |
Other | Assessment of temperament, based on the Early-Adolescent Temperament Questionnaire - revised - short form (EATQ-R-SF) | 1 year | ||
Primary | Estimates of vocal fold angle at anterior commissure, determined on laryngoscopic digital images taken at height of inspiration prior to start of exhalation | 1 year | ||
Primary | Self-report of dyspnea severity, determined on 100mm visual analog scale | 1 year | ||
Secondary | Amount arytenoid prolapse, rated on a 0-3 scale based on videoendoscopic images | 1 year | ||
Secondary | Amount of epiglottic collapse, rated on a 0-3 scale based on videoendoscopic images | 1 year | ||
Secondary | Amount of ventricular compression, rated on a 0-3 scale based on videoendoscopic images | 1 year | ||
Secondary | Self-report of cough severity, determined based on 100mm visual analog scale | 1 year | ||
Secondary | Self-report of neck tightness severity, determined based on 100mm visual analog scale | self-reported ratings of symptoms of cough, globus sensation, neck tightness, dysphonia, and stridor | 1 year | |
Secondary | Self-report of stridor severity, determined based on 100mm visual analog scale | 1 year |