Breathing and vocal cord behavior during exercise

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

This will test a tiny wearable neck sensor plus breathing and carbon-dioxide measurements to see if they can detect and explain exercise-induced vocal cord problems in active 18–26-year-olds.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 26 Years
• Sex: All
• Sponsor: Indiana University (other)
• Locations: 1 site (Bloomington, Indiana)
• Trial ID: NCT07420530 on ClinicalTrials.gov

What this trial studies

This early-phase study uses a miniature, soft skin-mounted sensor together with pulmonary and CO2 measurements to capture mechano-acoustic signatures during symptomatic and asymptomatic breathing in people with exercise-induced laryngeal obstruction (EILO). Participants complete three in-person visits: a free run with the device on the neck, an exercise treadmill session, and an MRI visit. The study quantifies the relationship between pulmonary mechanics, PCO2 maintenance, and vocal fold aperture before and during exercise-induced symptoms. Results aim to identify biophysiological factors and mechanisms that underlie paradoxical vocal fold motion during exercise.

Who should consider this trial

Good fit: Physically active 18–26-year-olds diagnosed with EILO who report exercise-exacerbated breathing difficulty, score ≥7 on the Dyspnea Index, and meet low-risk health criteria are the ideal candidates.

Not a fit: People outside the 18–26 age range or those with asthma, other significant lung or heart disease, uncontrolled hypertension, claustrophobia, metal implants, current smoking, or other exclusionary conditions are unlikely to benefit from joining.

Why it matters

Potential benefit: If successful, this could enable earlier, noninvasive detection of exercise-induced vocal cord dysfunction and support more targeted breathing treatments.

How similar studies have performed: Exercise laryngoscopy and CO2-related breathing interventions have prior use, but applying a soft wearable mechano-acoustic sensor to identify EILO signatures is novel with limited clinical precedent.

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 magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.

Inclusion Criteria for Controls

* Physically active \>2.5 hours per week
* Age range of 18-26 years
* Classified as low risk, based on the modified 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 magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.

Exclusion Criteria for EILO:

* Individuals older than 26 years and younger than 18 years of age.
* Women who are pregnant or could possibly be pregnant.
* BMI \> 25 kg/m2
* A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire
* Current smoker
* Positive 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.
* Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
* Do not report the following: Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise

Exclusion Criteria for Controls

* Individuals older than 26 years and younger than 18 years of age.
* Women who are pregnant or could possibly be pregnant.
* BMI \> 25 kg/m2
* A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire
* Current smoker
* Positive 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.
* Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
* Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Where this trial is running

Bloomington, Indiana

• Indiana University — Bloomington, Indiana, United States (RECRUITING)

Study contacts

• Principal investigator: Rita Patel — Indiana University
• Study coordinator: Rita R Patel

Conditions: Exercise-Induced Vocal Cord Dysfunction, Paradoxical Vocal Fold Motion, Vocal Cord Dysfunction