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

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))
• 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.

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. 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.

Key Dates

First listed

Feb 19, 2026

Start date

Aug 12, 2026

Status verified

Aug 2026

Primary completion

Jan 20, 2032

Completion

Jan 20, 2032

Study Design

Enrollment

130 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Active Comparator: Control Participants
  Participants without Exercise-induced laryngeal obstruction (EILO).
• Active Comparator: EILO Participants

Primary Outcome Measure

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

Central Contacts

• Rita R Patel
  812-855-3886
  [email protected]

Locations (1)

Find similar trials in Bloomington, IN

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