Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion

The overall objectives of the proposed research are to: 1. Evaluate the diagnostic validity of a novel mechano-acoustic signatures of task-characteristic activity during symptomatic and asymptomatic breathing in Exercise-Induced Laryngeal Obstruction (EILO) patients with the use of a novel miniature, soft wearable skin-mounted device, 2. Identify the mechanism/s of paradoxical respiratory control in EILO by quantifying the relationship between pulmonary mechanics, partial pressure of carbon dioxide (PCO2) maintenance, and vocal fold aperture prior to and during symptomatic and asymptomatic exercise ventilation, and 3. Identify unique biophysiological factors contributing to EILO among exercisers with and without EILO. Findings will be highly novel and clinically significant for early identification and management of EILO. The main study will enroll 60 participants with EILO and 60 without EILO to complete three separate visits: 1. Exercise treadmill study 2. Free running with the device on the neck 3. Undergoing MRI (Magnetic Resonance Imaging) of the vocal tract. An additional substudy limited to the mechanoacoustic device will enroll 10 additional participants (5 healthy and 5 with EILO). These participants will complete a single study visit during which the mechano-acoustic device will be worn during four sequential conditions.

NCT Number	NCT07420530
Lead Sponsor	Indiana University Collaborators: Purdue University, National Jewish Health, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions	Exercise-Induced Vocal Cord Dysfunction, Paradoxical Vocal Fold Motion, Vocal Cord Dysfunction
Enrollment	130 participants
Start Date	2026-08-12
Primary Completion	2032-01-20 (estimated)
Study Completion	2032-01-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-14