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

NCT02947009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-08-14

No results posted yet for this study

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.

Conditions

  • Disorder of Vocal Cord

Interventions

BEHAVIORAL

Diagnostic Study

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).

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    collaborator OTHER
  • University of Pittsburgh

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-07-03
Completion
2017-07-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02947009 on ClinicalTrials.gov