Actively Recruiting

Early Phase 1
Age: 18Years - 26Years
All Genders
Healthy Volunteers
NCT07420530

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

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

120

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

P

Purdue University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 EILO group)
  • Age between 18 and 26 years
  • Experience greater difficulty breathing indoors compared to outdoors, worsened at peak exercise and resolving within 1 to 5 minutes after exercise
  • Score of 7 or higher on the Dyspnea Index for upper airway breathing symptoms
  • Low risk based on modified Physical Activity Readiness Questionnaire (PAR-Q), body mass index, and non-smoking status
  • No history of voice disorders, cognitive difficulties, asthma, lung disease, cardiac disease, serious orthopedic injuries, uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, or beta blocker use
  • No metallic, mechanical, or magnetic implants such as cardiac devices, cochlear implants, prostheses, stents, or deep brain stimulators
  • For control group: Physically active more than 2.5 hours per week
  • Age between 18 and 26 years
  • Low risk based on modified PAR-Q questionnaire, body mass index, and non-smoking status
  • No history of voice disorders, cognitive difficulties, asthma, lung disease, cardiac disease, serious orthopedic injuries, uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, or beta blocker use
  • No metallic, mechanical, or magnetic implants such as cardiac devices, cochlear implants, prostheses, stents, or deep brain stimulators
Not Eligible

You will not qualify if you...

  • Age younger than 18 years or older than 26 years
  • Women who are pregnant or may be pregnant
  • Body mass index over 25 kg/m2
  • Any positive answer to the 14 questions on the PAR-Q pre-participation questionnaire
  • Current smoking
  • History of voice disorders, cognitive difficulties, asthma, lung disease, cardiac disease, serious orthopedic injuries, uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, or beta blocker use
  • Presence of metallic, mechanical, or magnetic implants such as cardiac devices, cochlear implants, prostheses, stents, or deep brain stimulators
  • Do not report greater difficulty breathing inside compared to outside that worsens at peak exercise and stops 1-5 minutes after exercise (for EILO group)
  • Significant acute or chronic medical, neurological, or other illnesses that could affect safety, study completion, or study goals

AI-Screening

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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

CONTACT

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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