RecruitingPhase 2NCT07420530

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


Sponsor

Indiana University

Enrollment

130 participants

Start Date

Aug 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Breathing treatment and a drug called Carbon Dioxide for people with exercise-induced vocal cord dysfunction, paradoxical vocal fold motion, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarbon Dioxide

Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen))

DEVICEMechano-acoustic device

A custom developed mechanoacoustic sensor will be worn on the neck using a Velcro strap. The device will collect audio recordings of breathing and breath sounds and will collect muscle activity from the neck muscles.


Locations(1)

Indiana University

Bloomington, Indiana, United States

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NCT07420530


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