130 Participants NeededMy employer runs this trial

Breathing Treatment + Carbon Dioxide for Vocal Cord Dysfunction

(EILO Trial)

RR
Overseen ByRita R Patel
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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.12367

Who Is on the Research Team?

RP

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

* 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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo free running with the device on the neck to evaluate mechano-acoustic signatures

1 day
1 visit (in-person)

Exercise Testing

Participants perform an exercise treadmill study to assess pulmonary mechanics and PCO2 maintenance

1 day
1 visit (in-person)

Imaging

Participants undergo MRI of the vocal tract to measure upper airway size and aerodynamics

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial assessments and testing

4 weeks

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

Group I: Control ParticipantsActive Control2 Interventions
Group II: EILO ParticipantsActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Purdue University

Collaborator

Trials
239
Recruited
72,200+

National Jewish Health

Collaborator

Trials
145
Recruited
318,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30819608/

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.

Novel 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.