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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
120
Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen))
Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design
Indiana University
Bloomington, Indiana, United States
RECRUITINGDevice measurements from real time running
Muscle activation of cricothyroid/sternohyoid muscle measured via customized surface electromyography amplifier
Time frame: Baseline and Periprocedural
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
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
Treadmill testing
Breathing frequency (breaths per minute)
Time frame: Baseline and Perioprocedural
Treadmill testing
Tidal volume (Liters)
Time frame: Base-line
Treadmill testing
Ventilation (Liters/minute)
Time frame: Breath-by-breath baseline and Perioprocedural
Treadmill testing
Partial pressure of arterial carbon dioxide estimated from end-tidal partial pressure of carbon dioxide; PetCO2) (mmHg)
Time frame: Baseline and Periprocedural
MRI Upper Airway Size
Length (mm), width (mm), and cross-sectional area (mm2) of oropharynx, supraglottis, glottis, immediate subglottis.
Time frame: Baseline
Upper Airway Aerodynamics
pressure (Pa) across oropharynx, supraglottis, and subglottis
Time frame: Baseline and Periprocedural
Upper Airway Aerodynamics
volume flow rate (l/s) across oropharynx, supraglottis, and subglottis
Time frame: Baseline and Periprocedural
Upper Airway Aerodynamics
flow velocities (m/s) across oropharynx, supraglottis, and subglottis
Time frame: Baseline and Periprocedural
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.