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RECRUITING
NCT07420530
PHASE2

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

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 26 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-08-12

Completion Date

2032-01-20

Last Updated

2026-08-14

Healthy Volunteers

Yes

Interventions

DRUG

Carbon Dioxide

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

DEVICE

Mechano-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