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New treatment option for Exercise-Induced Vocal Cord Dysfunction
Official title Respiratory and Real-time Dynamics in Exercise-Induced Paradoxical Vocal Fold Motion
ClinicalTrials.gov ID: NCT07420530
What this study is testing
What is Carbon Dioxide?
Carbon Dioxide is an investigational medicine, being studied as a potential treatment for exercise-induced vocal cord dysfunction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 26. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc. 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...
- No metallic, mechanical or magnetic implants such as cardiac devices, cochlear, or other non-removable ear implants, any prosthesis, stents, deep brain stimulator, etc.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bloomington, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 26 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bloomington, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.