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

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.

The main study will enroll 60 participants with EILO and 60 without EILO to complete three separate visits:

1. Exercise treadmill study
2. Free running with the device on the neck
3. Undergoing MRI (Magnetic Resonance Imaging) of the vocal tract.

An additional substudy limited to the mechanoacoustic device will enroll 10 additional participants (5 healthy and 5 with EILO). These participants will complete a single study visit during which the mechano-acoustic device will be worn during four sequential conditions.

Conditions

• Exercise-Induced Vocal Cord Dysfunction
• Paradoxical Vocal Fold Motion
• Vocal Cord Dysfunction

Interventions

DRUG

Carbon Dioxide

Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen))

DEVICE

Mechano-acoustic device

A custom developed mechanoacoustic sensor will be worn on the neck using a Velcro strap. The device will collect audio recordings of breathing and breath sounds and will collect muscle activity from the neck muscles.

Sponsors & Collaborators

• Purdue University

  collaborator OTHER

• National Jewish Health

  collaborator OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Indiana University

  lead OTHER

Principal Investigators

• Rita Patel · Indiana University

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

26 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-12

Primary Completion

2032-01-20

Completion

2032-01-20

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations