Understanding Exercise-Induced Vocal Cord Dysfunction

This study is looking into Exercise-Induced Laryngeal Obstruction (EILO), also known as Exercise-Induced Vocal Cord Dysfunction, which causes breathing difficulties during exercise. Researchers want to understand how breathing patterns and carbon dioxide levels affect the vocal cords in people with EILO. You might breathe a special gas mixture containing Carbon Dioxide (10% CO2, 21% O2, balance N2) and perform different breathing exercises like rapid breathing or pursed lip breathing. The goal is to evaluate a new wearable device for diagnosing EILO and to identify what causes this condition. To join, you should be 18-26 years old, physically active, and have a diagnosis of EILO. The study aims to enroll 120 participants.

Study design
This is an interventional study with 120 planned participants. You will be randomly assigned to different breathing conditions in a single-blinded design, meaning you won't know which breathing condition you're doing.
What's involved
The study involves measurements from a wearable device during real-time running at baseline and during procedures.
Compensation
Not stated in the trial record.
Follow-up
Device measurements are taken at Baseline and Periprocedural time points.

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NCT07420530

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

Recruiting
PHASE2Ages 18–26Interventional
Indiana University
~130 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Carbon DioxideMechano-acoustic device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device measurements from real time running
Measured over Baseline and Periprocedural
+10 more outcomes measured
Exercise-Induced Vocal Cord Dysfunction
Paradoxical Vocal Fold Motion
Vocal Cord Dysfunction
1 sites across 1 states
Indiana1
  • Rita Patel · PRINCIPAL_INVESTIGATOR · Indiana University

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Eligibility criteria

Inclusion

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.
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

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
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
  • Device measurements from real time runningBaseline and Periprocedural

    Muscle activation of cricothyroid/sternohyoid muscle measured via customized surface electromyography amplifier

  • Device measurements from real time runningBaseline and Periprocedural

    Normalized amplitude (100% of maximum voluntary contraction) Burst duration (milliseconds) prior to and during Exercise-Induced Laryngeal Obstruction event of laryngeal closure.

  • Device measurements from real time runningBaseline and Perioprocedural

    Exercise-Induced Laryngeal Obstruction signature detected via ultra-low noise micro-electromechanical (MEMS) microphone amplitude (dB) prior to and during EILO. EILO signature detected via accelerometer (g, where g represents the gravitational acceleration of 9.8 m/s2) prior to and during EILO

  • Treadmill testingBaseline and Perioprocedural

    Breathing frequency (breaths per minute)

  • Treadmill testingBase-line

    Tidal volume (Liters)

  • Treadmill testingBreath-by-breath baseline and Perioprocedural

    Ventilation (Liters/minute)

  • Treadmill testingBaseline and Periprocedural

    Partial pressure of arterial carbon dioxide estimated from end-tidal partial pressure of carbon dioxide; PetCO2) (mmHg)

  • MRI Upper Airway SizeBaseline

    Length (mm), width (mm), and cross-sectional area (mm2) of oropharynx, supraglottis, glottis, immediate subglottis.

  • Upper Airway AerodynamicsBaseline and Periprocedural

    pressure (Pa) across oropharynx, supraglottis, and subglottis

  • Upper Airway AerodynamicsBaseline and Periprocedural

    volume flow rate (l/s) across oropharynx, supraglottis, and subglottis

  • Upper Airway AerodynamicsBaseline and Periprocedural

    flow velocities (m/s) across oropharynx, supraglottis, and subglottis