NCT07420530

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 26 Years
• Healthy volunteers: Accepted

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. For the study there are three separate visits: 1. Free running with the device on the neck 2. Exercise treadmill study 3. Undergoing MRI (Magnetic Resonance Imaging) of the vocal tract.

Conditions

• Exercise-Induced Vocal Cord Dysfunction
• Paradoxical Vocal Fold Motion
• Vocal Cord Dysfunction

Interventions

Type	Name	Description
DRUG	Carbon Dioxide	Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen))
BEHAVIORAL	Breathing treatment	Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design

Timeline

• Start date: 2026-04-20
• Primary completion: 2032-01-20
• Completion: 2032-01-20
• First posted: 2026-02-19
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study