CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Diagnostic Studybehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02947009
NCT02947009N/ACompleted

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

University of Pittsburgh·interventional·Posted Oct 27, 2016·Updated Aug 14, 2017

In Brief

A clinical study evaluating Diagnostic Study for Disorder of Vocal Cord. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 27, 2016
Enrollment StartNov 1, 2016
Primary CompletionJul 3, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.7 years ago

Interventions

Diagnostic Studybehavioral

Participants will undergo laryngoscopy at baseline and with exercise challenge and will rate severity of various symptoms related to the larynx (ex. shortness of breath, voice changes, cough).