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Recruiting EARLY_Phase 1 NCT07420530

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

Trial Parameters

Condition Exercise-Induced Vocal Cord Dysfunction
Sponsor Indiana University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age 26 Years
Start Date 2026-04-20
Completion 2032-01-20
Interventions
Carbon DioxideBreathing treatment

Brief 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.

Eligibility Criteria

Inclusion Criteria for Exercise-Induced Laryngeal Obstruction (EILO): * Physically active \>2.5 hours per week * Patients with EILO, as diagnosed by routine clinical examination by physician and/or speech language pathologist * Age range of 18-26 years * Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise * Score of 7 or higher on the Dyspnea Index, which is a validated instrument to capture participant self-report of upper airway dyspnea symptoms. * Classified as low risk, based on the modified Physical Activity Readiness Questionnaire (PAR-Q) questionnaire, body mass index, and non-smoking status * Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers. * No metallic, mechanical or ma

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