Recruiting
Phase 2

EILO Evaluation

Sponsor:

Indiana University

Code:

NCT07420530

Conditions

Exercise-Induced Vocal Cord Dysfunction

Paradoxical Vocal Fold Motion

Vocal Cord Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Accepted

Interventions

Carbon Dioxide

Mechano-acoustic device

Study Details

Brief summary:

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.

Conditions

Exercise-Induced Vocal Cord Dysfunction

Paradoxical Vocal Fold Motion

Vocal Cord Dysfunction

Study ID

NCT07420530

Start date

Aug 12, 2026

Status verified date

Aug, 2026

Completion date

Jan 20, 2032

Anticipated

Primary completion date

Jan 20, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Accepted

Inclusion Criteria for Exercise-Induced Laryngeal Obstruction (EILO):

  • 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
  • Score of 7 or higher on the Dyspnea Index, which is a validated instrument to capture participant self-report of upper airway dyspnea symptoms.
  • Classified as low risk, based on the modified Physical Activity Readiness Questionnaire (PAR-Q) questionnaire, body mass index, and non-smoking status
  • Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
  • No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.

Inclusion Criteria for Controls

  • Physically active >2.5 hours per week
  • Age range of 18-26 years
  • Classified as low risk, based on the modified PAR-Q questionnaire, body mass index, and non-smoking status
  • Negative history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
  • No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.

Exclusion Criteria for EILO:

  • 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
  • Current smoker
  • Positive history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
  • Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
  • Do not report the following: Greater difficulty breathing inside compared to out and difficulty breathing which is exacerbated at peak exercise and stops 1-5 minutes after exercise

Exclusion Criteria for Controls

  • 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
  • Current smoker
  • Positive history of voice disorders, self-report of cognitive difficulties, asthma or other lung disease, cardiac disease, serious orthopedic injuries, current uncontrolled hypertension, illicit drug use, seizure/epilepsy, claustrophobia, use of beta blockers.
  • Presence of metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
  • Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Control Participants

Participants without Exercise-induced laryngeal obstruction (EILO).

active comparator: EILO Participants

Interventions

Carbon Dioxide

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

Mechano-acoustic 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.

Primary outcome measure

  • Device measurements from real time running [ Time Frame: Baseline and Periprocedural ]
  • Device measurements from real time running [ Time Frame: Baseline and Periprocedural ]
  • Device measurements from real time running [ Time Frame: Baseline and Perioprocedural ]
  • Treadmill testing [ Time Frame: Baseline and Perioprocedural ]
  • Treadmill testing [ Time Frame: Base-line ]
  • Treadmill testing [ Time Frame: Breath-by-breath baseline and Perioprocedural ]
  • Treadmill testing [ Time Frame: Baseline and Periprocedural ]
  • MRI Upper Airway Size [ Time Frame: Baseline ]
  • Upper Airway Aerodynamics [ Time Frame: Baseline and Periprocedural ]
  • Upper Airway Aerodynamics [ Time Frame: Baseline and Periprocedural ]
  • Upper Airway Aerodynamics [ Time Frame: Baseline and Periprocedural ]

Central Contacts and Locations

Central contacts

Locations

Indiana University

Recruiting

Bloomington, Indiana, United States, 47401

Contacts

More Information

Sponsor

Indiana University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-14.