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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-26
SponsorIndiana University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Carbon Dioxide
  • Mechano-acoustic device

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

Purdue University

Collaborator

National Jewish Health

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator