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

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07420530
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 26 Years
Healthy Volunteers
Accepted

Interventions

  • Carbon Dioxide — DRUG
    Breathing Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen))
  • Breathing treatment — BEHAVIORAL
    Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design

Study Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
Feb 2026
Primary completion
Jan 20, 2032
Completion
Jan 20, 2032

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Control Arm
    Participants will breathe room air
  • Experimental: Experimental Arm
    Participants will breathe Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen)).
  • Other: Breathing exercise
    Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design

Primary Outcome Measure

Device measurements from real time running [ Time Frame: Baseline and Periprocedural ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityBloomingtonIndiana47401
Rita Patel
[email protected]
812-855-3886

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Indiana University· Bloomington, IN

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