Breathing Treatment + Carbon Dioxide for Vocal Cord Dysfunction

(EILO Trial)

Overseen By Rita R Patel

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Indiana University

Must not be taking: Beta blockers

Disqualifiers: Asthma, Cardiac disease, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Rita Patel

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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

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?

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 1 Intervention

Participants will breathe Hypercapnic Gas (10% CO2 (carbon dioxide) and 21%O2 (oxygen), balance N210% (nitrogen)).

Group II: Breathing exercise Experimental Treatment 1 Intervention

Random Assignment to breathing conditions (rest breathing, rapid breathing, quick nasal sniff, pursed lip breathing), in a single blinded randomized design

Group III: Control Arm Active Control 1 Intervention

Participants will breathe room air

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+