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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Carbon Dioxide

    Drug

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

  • Mechano-acoustic device

    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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Control ParticipantsActive comparator 2 interventions
Group B: EILO ParticipantsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Device measurements from real time running

Muscle activation of cricothyroid/sternohyoid muscle measured via customized surface electromyography amplifier

Time frame
Baseline and Periprocedural
2

Device measurements from real time running

Normalized amplitude (100% of maximum voluntary contraction) Burst duration (milliseconds) prior to and during Exercise-Induced Laryngeal Obstruction event of laryngeal closure.

Time frame
Baseline and Periprocedural
3

Device measurements from real time running

Exercise-Induced Laryngeal Obstruction signature detected via ultra-low noise micro-electromechanical (MEMS) microphone amplitude (dB) prior to and during EILO. EILO signature detected via accelerometer (g, where g represents the gravitational acceleration of 9.8 m/s2) prior to and during EILO

Time frame
Baseline and Perioprocedural
4

Treadmill testing

Breathing frequency (breaths per minute)

Time frame
Baseline and Perioprocedural

Secondary outcomes

1

Self-rating of dyspnea

Dyspnea self-rating of breathing intensity and breathing unpleasantness rating on Visual Analog Scale of 0 to 100mm

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Purdue University

Collaborator

National Jewish Health

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator