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

Study acronym: EILO
StatusRecruiting
PhasePhase 2
Started2026-08-12
View on ClinicalTrials.gov ↗

Amendment history

2026-08-12
Study Status, Oversight, Study Description, Study Design, Arms and Interventions v2
Phase changed: Early Phase 1 → Phase 2
Trial arms changed: 3 → 2
Start dateestimated 2026-04-20→confirmed 2026-08-12
Enrollment target120→130
InterventionsBreathing treatment (Behavioral), Carbon Dioxide (Drug)→Carbon Dioxide (Drug), Mechano-acoustic device (Device)
Study description+1,689 characters
Main Study At the first study visit, participants will sign informed consent, complete study questionnaires, have their height, weight, and body composition measured, and perform resting pulmonary function tests. Participants will then warm up on the treadmill for 10 minutes. An endoscope will be pl [...]
2026-02-26
Study Identification, Study Status, Sponsor/Collaborators v1
Start date2026-01-20→2026-04-20
Collaborators2 to 3 entries
National Institute on Deafness and Other Communication Disorders (NIDCD)
2026-02-11
Original filing
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.
Trial Details
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