CompletedNot Applicable

Exercise-induced Paradoxical Vocal Fold Motion Disorder: Clinical Features and Potential Mechanisms

United States27 participantsStarted 2016-11

Plain-language summary

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.

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 cha…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Estimates of vocal fold angle at anterior commissure, determined on laryngoscopic digital images taken at height of inspiration prior to start of exhalation

Timeframe: 1 year

Self-report of dyspnea severity, determined on 100mm visual analog scale

Timeframe: 1 year

Trial details

NCT IDNCT02947009

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07-03

View on ClinicalTrials.gov More Disorder of Vocal Cord trials