Breathing Treatment + Carbon Dioxide for Vocal Cord Dysfunction
(EILO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how breathing treatments and carbon dioxide affect individuals with vocal cord dysfunction during exercise. It seeks to discover new methods for diagnosing and managing exercise-induced breathing problems. Participants will breathe either regular air or a special gas mix, try various breathing exercises, and undergo tests such as running, treadmill exercises, and an MRI scan of the vocal tract. The trial seeks physically active individuals diagnosed with exercise-induced breathing issues, experiencing difficulty breathing that worsens during exercise but improves shortly afterward. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants a chance to contribute to groundbreaking discoveries in managing exercise-induced breathing issues.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are using beta blockers or have uncontrolled hypertension, you may not be eligible to participate.
What prior data suggests that this device is safe for evaluating vocal cord dysfunction?
Previous studies have shown that breathing exercises improve breathing and voice quality. Some studies report that participants experience up to a 72.5% improvement in breathing, suggesting these exercises are generally well-tolerated and beneficial for those with vocal cord issues.
Research on carbon dioxide has primarily focused on its use in laser treatments, which differs from inhalation. Some reports mention risks like CO2 narcosis—confusion or unconsciousness due to CO2 build-up—when breathing fails. However, these effects are rare and usually linked to specific medical conditions.
As this trial is in its earliest phase, the main goal is to assess the treatment's safety. This helps researchers understand both potential benefits and any risks.12345Why are researchers excited about this trial?
Researchers are excited about this trial for vocal cord dysfunction because it explores innovative techniques that diverge from typical treatments like speech therapy and medications. This trial investigates the use of hypercapnic gas (10% carbon dioxide) which could offer a new way to manage the condition by adjusting breathing responses. Additionally, the study incorporates specific breathing exercises, which might provide a non-invasive and drug-free option to alleviate symptoms. These approaches could lead to quicker, more effective symptom relief compared to traditional methods.
What evidence suggests that this trial's treatments could be effective for vocal cord dysfunction?
Studies have shown that breathing exercises can help treat vocal cord dysfunction, with about 72.5% of patients reporting improved breathing after using these techniques. This trial will assign participants to different breathing conditions, including rest breathing, rapid breathing, quick nasal sniff, and pursed lip breathing, to evaluate their effectiveness.
While researchers have more commonly studied carbon dioxide in laser treatments for vocal cords, its use in breathing treatments is newer. In this trial, participants in the experimental arm will breathe a hypercapnic gas mixture containing carbon dioxide. Controlling carbon dioxide levels might help manage breathing and vocal cord function during exercise. Early signs suggest this approach could be promising, but more research is needed to confirm its effectiveness.12367Who Is on the Research Team?
Rita Patel
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
This trial is for physically active adults aged 18-26 who either have exercise-induced vocal cord dysfunction (EILO) or are healthy controls. Participants must not have asthma, heart disease, serious injuries, metal implants, or other major health issues. Non-smokers only.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Participants undergo free running with the device on the neck to evaluate mechano-acoustic signatures
Exercise Testing
Participants perform an exercise treadmill study to assess pulmonary mechanics and PCO2 maintenance
Imaging
Participants undergo MRI of the vocal tract to measure upper airway size and aerodynamics
Follow-up
Participants are monitored for safety and effectiveness after the initial assessments and testing
What Are the Treatments Tested in This Trial?
Interventions
- Breathing treatment
- Carbon Dioxide
Trial Overview
The study uses a wearable device to monitor breathing and throat activity during exercise in people with and without EILO. It also tests the effects of controlled breathing treatments and carbon dioxide exposure across three visits: running, treadmill exercise, and MRI scans.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants without Exercise-induced laryngeal obstruction (EILO).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Purdue University
Collaborator
National Jewish Health
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Citations
The Impact of Respiratory Exercises on Voice Outcomes
Respiratory improvements were reported in 12 articles. Nine of 12 articles also reported some voice improvements, although these were limited to subsets of ...
Predictors of voice therapy efficacy in vocal cord ...
Of the 107 (58.2 %) patients with documented perceived breathing improvement percentages recorded, the mean maximal percent improvement was 72.5 ± 21.5 %. Mean ...
Effect of Vocal Exercise on Respiratory Function and Voice ...
A previous study reported that vocal intonation therapy was effective in improving respiratory dysfunction and vocal quality in patients with cervical SCI.
Vocal Cord Dysfunction: Rapid Evidence Review
Therapeutic breathing maneuvers and vocal cord relaxation techniques are effective first-line treatments for dyspnea that occurs with vocal cord dysfunction.
Perspectives on Dysfunctional Breathing in Voice and ...
Asthma: Vocal cord dysfunction ... Treatment Outcomes Following a Holistic Breathing Approach for Exercise-Induced Laryngeal Obstruction.
Vocal Cord Dysfunction Breathing Exercises
Use these breathing techniques at any sign of tightness or stridor/noisy breathing. If this occurs during activity, stop activity, do exercise until it stops.
7.
nationaljewish.org
nationaljewish.org/about-us/news/press-releases/2016/novel-therapy-helps-athletes-overcome-vocal-cord-dysfunctionNovel Therapy Helps Athletes Overcome Vocal Cord ...
Olin teaches breathing techniques to keep the throat open during exercise and teaches patients certain psychological tools to conquer symptoms.
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