Actively Recruiting

Early Phase 1
Age: 18Years - 26Years
All Genders
Healthy Volunteers
ID07420530

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

Led by Indiana University ยท Updated on 2026-03-02

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

P

Purdue University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying Exercise-Induced Laryngeal Obstruction (EILO), also known as paradoxical vocal fold motion, to better understand the breathing difficulties experienced during exercise. This early-phase study aims to evaluate a new soft, wearable device that measures breathing patterns and vocal fold movements in real time. The goal is to identify unique breathing mechanics and biophysiological factors that contribute to EILO, which could help with early diagnosis and management of this condition. Participants will take part in three separate visits involving different activities. They will wear the device while running freely and during treadmill exercise tests. Additionally, some participants will breathe room air or a gas mixture containing carbon dioxide and oxygen in a randomized, single-blinded design. Vocal tract MRI scans will also be performed to observe upper airway structure. Different breathing exercises such as rest breathing, rapid breathing, nasal sniff, and pursed lip breathing will be assigned randomly. During the study, participants will be monitored through device measurements capturing real-time breathing and treadmill testing data. MRI scans will assess the size and aerodynamics of the upper airway. Participants will also self-rate their breathlessness. The study includes assessment of symptoms both during exercise and at rest. Safety and physical activity readiness will be checked, and the study is expected to run until 2032 with participants aged 18 to 26 years. The research will enhance understanding of breathing control mechanisms in EILO.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 26Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Physically active more than 2.5 hours per week
  • Diagnosed with Exercise-Induced Laryngeal Obstruction (EILO) by a physician or speech language pathologist (for patient group)
  • Age between 18 and 26 years
  • Greater difficulty breathing indoors compared to outdoors, worsened at peak exercise and stopping 1-5 minutes after exercise (for patient group)
  • Score of 7 or higher on the Dyspnea Index for upper airway symptoms (for patient group)
  • Classified as low risk based on Physical Activity Readiness Questionnaire, body mass index, and non-smoking status
  • No history of voice disorders, cognitive difficulties, asthma or lung disease, cardiac disease, serious orthopedic injuries, uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, or use of beta blockers
  • No metallic, mechanical, or magnetic implants such as cardiac devices, cochlear implants, prostheses, stents, or deep brain stimulators
  • For control group: same criteria except no EILO diagnosis or symptoms
Not Eligible

You will not qualify if you...

  • Younger than 18 or older than 26 years
  • Women who are pregnant or may be pregnant
  • Body mass index over 25 kg/m2
  • Any positive answer on the Physical Activity Readiness Questionnaire
  • Current smokers
  • History of voice disorders, cognitive difficulties, asthma or lung disease, cardiac disease, serious orthopedic injuries, uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, or use of beta blockers
  • Presence of metallic, mechanical, or magnetic implants such as cardiac devices, cochlear implants, prostheses, stents, or deep brain stimulators
  • Significant acute or chronic medical, neurological, or other illness that may affect safety or study completion
  • For patient group: not reporting greater breathing difficulty indoors or symptoms worsened at peak exercise and stopping 1-5 minutes after exercise

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single session on study day

Participants undergo assigned breathing interventions including breathing room air, hypercapnic gas, or randomized breathing exercises in a single blinded design.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Indiana University

Bloomington, Indiana, United States, 47401

Actively Recruiting

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Research Team

R

Rita R Patel

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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