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Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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

NCT07420530•Indiana University

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

Age

18 - 26 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
+3 more criteria

Exclusion Criteria

•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.
+6 more criteria

Locations (1)

Indiana University

Bloomington, Indiana, United States

Key Dates

Start Date

April 20, 2026

Primary Completion Date

January 20, 2032

Completion Date

January 20, 2032

Last Updated

March 2, 2026

Enrollment

120

ESTIMATED participants

Conditions

Exercise-Induced Vocal Cord DysfunctionParadoxical Vocal Fold MotionVocal Cord Dysfunction

Interventions

Carbon Dioxide

DRUG

Breathing treatment

BEHAVIORAL

Contacts

Rita R Patel

CONTACT

812-855-3886 patelrir@iu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Use of a Device Called Impulse Oscillometry in Participants With Vocal Cord Disorders or Asthma

Is Laryngeal Ultrasound Useful in the Assessment for ILO? A Protocol for a Two-stage Exploratory Pilot Study

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