Indiana University
Bloomington, Indiana, 47401, United States
Location status: Recruiting
NCT Number: NCT07420530
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.
Interested in participating?
Request Info18 year–26 year
All sexes
Interventional
Early Phase 1
Bloomington, Indiana, 47401, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Exercise-Induced Laryngeal Obstruction (EILO):
Inclusion criteria
for Controls
Exclusion criteria
for EILO:
Exclusion criteria
for Controls
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
Time frame: Baseline and Periprocedural
Muscle activation of cricothyroid/sternohyoid muscle measured via customized surface electromyography amplifier
Time frame: Baseline and Periprocedural
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 Perioprocedural
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
Breathing frequency (breaths per minute)
Time frame: Base-line
Tidal volume (Liters)
Time frame: Breath-by-breath baseline and Perioprocedural
Ventilation (Liters/minute)
Time frame: Baseline and Periprocedural
Partial pressure of arterial carbon dioxide estimated from end-tidal partial pressure of carbon dioxide; PetCO2) (mmHg)
Time frame: Baseline
Length (mm), width (mm), and cross-sectional area (mm2) of oropharynx, supraglottis, glottis, immediate subglottis.
Time frame: Baseline and Periprocedural
pressure (Pa) across oropharynx, supraglottis, and subglottis
Time frame: Baseline and Periprocedural
volume flow rate (l/s) across oropharynx, supraglottis, and subglottis
Time frame: Baseline and Periprocedural
flow velocities (m/s) across oropharynx, supraglottis, and subglottis
Time frame: Baseline
Dyspnea self-rating of breathing intensity and breathing unpleasantness rating on Visual Analog Scale of 0 to 100mm
Contact information is provided by the study sponsor or research team.
Indiana University
Other
Acronym: EILO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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