RespirAct Gas Challenge for Heart Disease Detection

(NIMO-Healthy Trial)

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Low blood pressure, Neurological, Pulmonary, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 days

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the RespirAct Gas Challenge safe for humans?

The safety of inhaled airway challenge agents, like methacholine, has been evaluated in various studies. These tests are generally considered safe, with protocols in place to minimize risks, such as using specific methods to reduce exposure to technical staff and ensuring the test is stopped if significant breathing changes occur. ^{1 2 3 4 5}

How does the RespirAct Gas Challenge treatment differ from other heart disease detection methods?

The RespirAct Gas Challenge is unique because it uses exhaled breath analysis, a non-invasive method, to detect heart disease, unlike traditional methods that often require more invasive procedures like blood tests or imaging. This approach leverages advanced sensor technology to analyze breath content, offering a simpler and potentially more accessible way to identify heart conditions. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a prospective pilot study to evaluate the safety, tolerability and efficacy of utilizing precise computer controlled gas challenge in healthy subjects for identification of coronary artery disease.

Eligibility Criteria

This clinical trial is open to adults aged 45 and older who have no known heart disease. Participants must be able to increase their breathing rate when asked, not be pregnant or nursing, don't have an IUD, can lie on their back for up to 40 minutes, and don't suffer from serious neurological, lung, kidney or liver diseases.

Inclusion Criteria

I do not have any heart diseases.

I am 45 years old or older.

Exclusion Criteria

My blood pressure is usually below 100/60.

You can't speed up your breathing when asked to do so.

I cannot lie on my back for 30-40 minutes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo computer-controlled gas challenges to evaluate safety, tolerability, and efficacy

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• RespirAct

Trial Overview The study is testing the safety and effectiveness of a needle-free method called RespirAct. It involves controlled breathing challenges using computer precision to detect coronary artery disease in healthy individuals.

Participant Groups

Group I: Hypoxia Group Experimental Treatment 1 Intervention

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Group II: Hypercapnia Group C Experimental Treatment 1 Intervention

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Group III: Hypercapnia Group B Experimental Treatment 1 Intervention

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Group IV: Hypercapnia Group A Experimental Treatment 1 Intervention

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Rohan Dharmakumar

Lead Sponsor

Trials

10

Recruited

120,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Realising the potential of various inhaled airway challenge agents through improved delivery to the lungs. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A screening test for airways reactivity. An abbreviated methacholine inhalation challenge. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A comparison of 2 methods of continuous aerosol administration during methacholine challenge testing. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Performance Evaluation of Wearable Respiratory Self-Training System Using Patch Type Magnetic Sensor. [2022]

5. England pubmed.ncbi.nlm.nih.gov

ERS technical standard on bronchial challenge testing: general considerations and performance of methacholine challenge tests. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Non-invasive assessment of exhaled breath pattern in patients with multiple chemical sensibility disorder. [2016]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Detecting Coronary Artery Disease Using Exhaled Breath Analysis. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Evolution of clinical and environmental health applications of exhaled breath research: Review of methods and instrumentation for gas-phase, condensate, and aerosols. [2023]

9. England pubmed.ncbi.nlm.nih.gov

News from the Breath Analysis Summit 2011. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[Evidence of waveform information in arterial blood gas by beat-by-beat sampling method in patients with heart failure]. [2018]