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Recruiting NCT07420530

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

Early Phase I Interventional Exercise-Induced Vocal Cord Dysfunction Paradoxical Vocal Fold Motion Vocal Cord Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carbon Dioxide, Breathing treatment.
Who it may be relevant to
Registry conditions: Exercise-Induced Vocal Cord Dysfunction, Paradoxical Vocal Fold Motion, Vocal Cord Dysfunction. Basic parameters: 18 years — 26 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Self-rating of dyspnea [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Indiana University — Bloomington

Identifiers

NCT: NCT07420530 · 29009 · R01DC023381

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗