15 Participants NeededMy employer runs this trial

Heliox for Work of Breathing

TD
Overseen ByTimothy D Mickleborough, PhD
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 explores whether breathing a special gas mixture called heliox, which is lighter than normal air, can reduce breathlessness and improve mental clarity in challenging breathing situations. This is particularly crucial for individuals who must make quick decisions and perform precise actions in demanding work environments. Participants will breathe both regular air and heliox to determine any differences. The trial seeks individuals who exercise intensely for at least two hours a week and have no lung issues, such as asthma. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications. The trial excludes participants who take selective serotonin reuptake inhibitors, stimulant medication, antibiotics, and those who chronically consume pain medication like Aleve or Tylenol.

What is the safety track record for this treatment?

Research shows that Heliox, a mix of helium and oxygen, is generally safe and well-tolerated by the body. Studies have found no harmful effects or organ damage associated with its use. This gas mixture has been used for many years to assist people with breathing problems, as it can ease the breathing process. For example, it has helped patients with airway issues breathe with less effort. Heliox is also known for not being toxic or carcinogenic. Although specific safety data from this trial is not yet available, its study in Phase 4 trials indicates that previous research has already deemed it safe for humans.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Heliox for managing the work of breathing because it offers a unique approach compared to standard treatments like bronchodilators and corticosteroids. Heliox is a gas mixture of helium and oxygen that reduces airway resistance, making it easier for patients to breathe. Unlike typical treatments that target inflammation or airway constriction, Heliox works by physically altering the gas properties, allowing for smoother airflow and quicker relief. This novel mechanism can be particularly beneficial in acute respiratory situations, potentially providing rapid improvement in breathing without the side effects associated with traditional medications.

What evidence suggests that heliox could be effective for reducing work of breathing?

Research has shown that heliox, a mix of helium and oxygen, can ease breathing by reducing airway resistance. Studies have found that heliox quickly lowers the breathing rate and improves airflow for individuals with breathing difficulties. For those with lung diseases that obstruct airflow, heliox eases breathing with less effort. In severe asthma cases, heliox improved airflow and reduced the effort needed to breathe. In this trial, participants will experience both room air and heliox conditions to assess its effectiveness. These findings suggest it could also benefit individuals facing increased breathing challenges, such as those in military settings.23678

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-40 who speak English, have normal lung and cognitive function, exercise intensely at least 2 hours per week, and have a BMI of 35 or less. People with certain health conditions, medication use, allergies to latex, irregular periods (for women), high blood pressure or pulse, smokers, or those who are pregnant cannot join.

Inclusion Criteria

English speaking and reading
I am between 18 and 40 years old.
Normal pulmonary function assessed by a resting forced expiratory volume in 1 second over forced vital capacity (FEV1/FVC) > 75% of predicted
See 4 more

Exclusion Criteria

Taking birth control for the sole purpose of period cessation (eg., Mirena IUD)
Known allergy or hypersensitivity to latex
Are color blind
See 5 more

Timeline for a Trial Participant

Screening/Familiarization

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Experimental Visit

Participants complete two full-length breathing tasks under randomized conditions (room air or heliox) with biometric monitoring and cognitive assessments.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Heliox

Trial Overview

The study tests if breathing a special gas mixture called heliox (helium and oxygen) instead of regular air can make breathing feel easier and improve thinking skills when it's harder to breathe. Participants will try both gases in different sessions.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Room Air, then Heliox InspirateActive Control1 Intervention
Group II: Heliox Inspirate, then Room AirActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

The effectiveness of heliox in acute respiratory distress ... - PMC

[9,10] Heliox has the following benefits: Reduces resistance to flow within the airways and consequently decreases the work of breath during spontaneous and non ...

Effects of heliox and non-invasive neurally adjusted ...

Heliox administration was associated with a rapid decrease in respiratory rate. After 15, 60 and 180 min of heliox ventilation RR was ...

The use of heliox in critical care - PMC - NIH

Heliox breathing reduces air flow resistance within the bronchial tree in patients with obstructive lung disease, and has beneficial effects in severe asthma ...

Heliox on the Work of Breathing in Adult Patients With ...

The aim of this study was to analyze the effect of Heliox versus conventional oxygen therapy in patients with lower airway stenosis on muscular effort measured ...

Heliox - an overview

Breathing heliox (the concentration in clinical use ranges from 80:20 to 60:40) results in more laminar flow, reduced airway resistance, and reduced work of ...

Heliox, dyspnoea and exercise in COPD - PMC - NIH

Heliox gas mixtures are known to be nontoxic, noncarcinogenic and have no lasting effects on any human organ systems [7]. Historically, Heliox was used by ...

Low-Pressure Heliox-Based Rebreather System to Reduce ...

The aim of this study was to test the ability of a low-pressure, low-flow, heliox-based rebreathing system to reduce work of breathing and conserve gas ...