MoblO2 for Chronic Lung Diseases

(MOBoxy Trial)

Overseen By Clinical Research Unit, National Jewish Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Jewish Health

Disqualifiers: Active angina, Musculoskeletal disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the MoblO2 device, which automatically adjusts oxygen flow to help individuals with chronic lung diseases like COPD and ILD manage their oxygen needs more effectively. The goal is to determine if this device can improve physical activity, oxygen use, and overall quality of life for patients. Participants must have used oxygen during physical activity for at least a month and have stable symptoms. The trial will also assess patient satisfaction with the device. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance their daily lives.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on the use of the MoblO2 device for oxygen delivery, so you may not need to change your medications, but it's best to confirm with the trial coordinators.

What prior data suggests that the MoblO2 device is safe for patients with chronic lung diseases?

Research shows that the MoblO2 device is designed to help people with chronic lung diseases, such as COPD, by improving oxygen delivery. The goal is to make oxygen therapy easier and safer for patients. Although specific safety data is limited, several important features can be highlighted.

First, the MoblO2 is user-friendly and automatically adjusts oxygen flow, helping to prevent issues like over- or under-delivery of oxygen. If the device malfunctions, a safety feature maintains oxygen delivery at the set level, preventing sudden oxygen loss.

Second, the device includes a pulse oximeter, which measures blood oxygen levels. It adjusts oxygen delivery based on these readings to maintain safe blood oxygen levels.

As this is an early-stage trial, extensive safety data may not yet be available. However, the design of the MoblO2 suggests a focus on patient safety and ease of use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MoblO2 because it offers a new approach to managing chronic lung diseases. Unlike conventional treatments like inhaled corticosteroids or bronchodilators, which primarily focus on reducing inflammation or relaxing airway muscles, MoblO2 aims to enhance oxygen delivery directly to the lungs. This could potentially lead to faster symptom relief and improved lung function. By targeting oxygen transport, MoblO2 has the potential to improve quality of life for patients in ways current options might not fully achieve.

What evidence suggests that the MoblO2 device is effective for chronic lung diseases?

Research shows that devices like MoblO2, which automatically adjust oxygen levels, can help control symptoms and reduce flare-ups in people with chronic lung disease. Early results suggest these devices keep blood oxygen levels stable without constant manual adjustments, which can be challenging for patients. This automatic control may reduce breathlessness and enable more physical and social activities. By addressing the anxiety and stigma linked to traditional oxygen therapy, MoblO2 aims to improve users' overall quality of life. Although specific data on MoblO2 is limited, the concept of automated oxygen delivery appears promising for enhancing patient satisfaction and outcomes. Participants in this trial will join either the MoblO2 control group or the MoblO2 no control group to evaluate its effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Jeff Swigris, DO, MS

Principal Investigator

National Jewish Health

Are You a Good Fit for This Trial?

This trial is for patients with chronic lung diseases like COPD or ILD who need supplemental oxygen. It aims to help them maintain their blood oxygen levels without the constant hassle of adjusting their O2 flow.

Inclusion Criteria

I have been diagnosed with COPD or chronic lung disease.

I have been using prescribed oxygen for at least a month when I exert myself.

I am 25 years old or older.

Exclusion Criteria

I need more than 10 liters per minute of oxygen when I move around.

Hemoglobin less than 10mg/dL

I currently experience chest pain due to heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Monitoring

Participants wear an activity monitor while using their own O2 device as they normally would

1 week

No additional visits required

Treatment

Participants use the MoblO2 device with D tanks; one week with MoblO2 controlling O2 flow and one week without

2 weeks

2 visits (in-person) for device setup and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MoblO2

Trial Overview The MoblO2 device, a lightweight, auto-adjusting oxygen delivery system that uses Bluetooth and a pulse oximeter to keep blood oxygen at preset levels, is being tested for its impact on patient activity, quality of life, and satisfaction.

How Is the Trial Designed?

Group I: MoblO2 control Experimental Treatment 1 Intervention

MoblO2 control

Group II: MoblO2 no control Active Control 1 Intervention

Who Is Running the Clinical Trial?

National Jewish Health

Lead Sponsor

Trials

145

Recruited

318,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Minnesota Health Solutions

Industry Sponsor

Trials

1

Recruited

30+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9537656/

Long-Term Outcome of Chronic Obstructive Pulmonary ... However, among 1,679 patients with COPD followed up for three years, 16% of exacerbation-naïve patients experienced new exacerbations, and even 5% experienced ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10066569/

Global Initiative for Chronic Obstructive Lung Disease 2023 ... Factors independently associated with poor outcome include older age, lower body mass index, comorbidities (e.g. cardiovascular disease or lung cancer), ...

3. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-022-02297-y

Recognising the importance of chronic lung disease Chronic respiratory disease is one of five non-communicable disease (NCD) areas that contribute to the highest mortality and morbidity globally.

4. mdpi.com mdpi.com/2077-0383/14/9/3118

Advances in Therapeutics for Chronic Lung Diseases Early clinical trials have shown promising results with improved symptom control and a reduction in the frequency of exacerbations [37]. Like bronchial ...

5. lung.org lung.org/lung-health-diseases/lung-disease-lookup/chronic-lung-disease

Chronic Lung Disease 35.2 million people in America were living with chronic lung disease in 2023. 586,000 people died due to lung disease, making it the 3rd leading cause of death ...

6. medicaldevicenavigator.com medicaldevicenavigator.com/moblo2_device_trial_announced_to_address_oxygenation/

MoblO2 Device Trial Announced to Address Oxygenation ... MoblO2 is a medical device designed to enhance oxygenation in patients with chronic respiratory conditions. Chronic Obstructive Pulmonary Disease (COPD) and ...

7. withpower.com withpower.com/t/brovana

Brovana: Everything you need to know | Power Approved as Treatment by the FDA. Arformoterol, otherwise called Brovana, is approved by the FDA for 1 uses such as Chronic Obstructive Pulmonary Disease .

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK83163/

Chronic Lung Disease - NCBI - NIH Chronic lung disease includes the conditions of chronic obstructive pulmonary disease (COPD), sleep-disordered breathing, and interstitial lung disease.

9. who.int who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)

Chronic obstructive pulmonary disease (COPD) COPD is a common lung disease causing restricted airflow and breathing problems. It is sometimes called emphysema or chronic bronchitis.