PneumoCool Device for Shortness of Breath

(BREATHE-easy Trial)

Overseen By Sarah Karow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Delirium, Dementia, Brain injury, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to hospital discharge or 30 days, whichever happens earlier

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called PneumoCool to determine if it can reduce shortness of breath. The device is small, portable, and uses special air to provide relief, potentially benefiting hospital patients. Participants will either use the PneumoCool device or receive standard hospital care, such as a fan. Those who frequently experience shortness of breath and are staying in one of the participating hospitals for more than a day may be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative solutions for breathing difficulties.

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

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

What prior data suggests that the PneumoCool device is safe for alleviating shortness of breath?

Research has shown that better airflow can help reduce feelings of breathlessness. The PneumoCool device uses high-quality air to assist with shortness of breath. Although specific safety data on the PneumoCool device is not available, similar devices that improve airflow have been used safely in medical settings.

The trial phase is labeled "Not Applicable," indicating that the treatment is new and specific safety information might not yet be available. However, because it uses airflow, which is generally safe, it might be well-tolerated. Always consult a healthcare professional before joining a trial to understand any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for shortness of breath, which typically involves supportive measures like fans or other hospital-provided aids, the PneumoCool device offers a unique approach by directly channeling medical air to the patient’s face. This method specifically targets dyspnea (shortness of breath) with a focused airflow, potentially providing more effective and immediate relief. Researchers are excited about PneumoCool because it represents a novel delivery method that could enhance comfort and breathability for patients struggling with respiratory distress.

What evidence suggests that the PneumoCool device is effective for shortness of breath?

Research has shown that the PneumoCool device, which participants in this trial may receive, might help reduce shortness of breath by clearing airways. Studies have found that medical-grade air can ease breathlessness in patients. The device's portable, bladeless design makes it convenient for hospital use. Early findings suggest that directing air at the face can soothe and assist with breathing difficulties. Although more information is needed, initial evidence appears promising for those with breathing challenges. ^{1 2 5 6 7}

Who Is on the Research Team?

Sonal R Pannu, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are hospitalized with expected stays longer than a day and experiencing significant shortness of breath. It's not suitable for patients with delirium, dementia, brain injuries that prevent consent or device use, those on continuous mechanical ventilation, or prisoners.

Inclusion Criteria

I am admitted to the specified hospital and will stay for more than a day.

I often feel short of breath.

Exclusion Criteria

I rely on a machine to help me breathe all the time.

You have a condition that affects your ability to think clearly or remember things.

I cannot use the device due to my motor disability.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the PneumoCool device or usual therapy to alleviate dyspnea

Up to hospital discharge or 30 days, whichever happens earlier

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 days after enrollment

What Are the Treatments Tested in This Trial?

Interventions

• PneumoCool

Trial Overview The BREATHE-easy trial is testing the PneumoCool device against standard hospital care to see if it better relieves shortness of breath in patients. Participants will be randomly assigned to either receive this new bladeless air device or continue with usual supportive measures.

How Is the Trial Designed?

Group I: Device arm Active Control 1 Intervention

The patients in the device arm will get the Pneumocool device to channel medical air to their face to alleviate dyspnea

Group II: Standard of Care arm Placebo Group 1 Intervention

The patients in the standard of care arm can get a fan or any other supportive care that is currently available in the hospital for alleviating dyspnea

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. withpower.com withpower.com/trial/phase-dyspnea-5-2022-9fdf2

PneumoCool Device for Shortness of Breath ... This suggests that the PneumoCool treatment might also be effective in reducing shortness of breath by helping clear airways.

2. trialx.com trialx.com/clinical-trials/listings/239102/breathlessness-relieved-by-employing-medical-air-to-be-titrated-by-hospitalized-patients-to-improve-inpatient-experience/

Breathlessness Relieved by Employing Medical Air to be ... The BREATHE-easy is a randomized control trial assessing the efficacy of the novel PneumoCool device to alleviate subjective shortness of breath ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05416437?term=AREA%5BBasicSearch%5D(Air)&rank=5

Breathlessness Relieved by Employing Medical Air to be ... Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to ...

4. publications.ersnet.org publications.ersnet.org/content/erjor/early/2025/09/29/23120541.00388-2025.full.pdf

Airflow for reducing breathlessness in people with serious ... Conclusion: The results suggest a beneficial effect of a (handheld) fan for the relief of breathlessness in people with serious respiratory ...

5. clinconnect.io clinconnect.io/trials/NCT05416437

Breathlessness Relieved by Employing Medical Air to be The BREATHE-easy is a randomized control trial assessing the efficacy of the novel PneumoCool device to alleviate subjective shortness of breath.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06373939/performance-and-safety-of-the-pneumoscope-device-in-adults-and-children

Performance and Safety of the Pneumoscope Device in ... This study aims to assess the performance and safety of the Pneumoscope in recording respiratory sounds, body temperature, non-invasive blood ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8870831/

Breath Sensor Technology for the Use in Mechanical Lung ... We here propose the use of a novel breath volatile organic compound sensor technology to be used in a mechanical lung ventilation machine for this purpose.