48 Participants NeededMy employer runs this trial

MoblO2 for Chronic Obstructive Pulmonary Disease

(SSeifert Trial)

JS
KF
Overseen ByKaitlin Fier, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Minnesota HealthSolutions
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oxygen delivery device called MoblO2 for individuals with chronic lung diseases such as COPD or interstitial lung disease. The MoblO2 device automatically adjusts oxygen flow to maintain safe blood oxygen levels, potentially aiding in activity and improving quality of life. The trial examines whether this device facilitates physical activities and enhances patient satisfaction with oxygen therapy. Suitable participants include those with COPD or similar conditions who use oxygen during physical activity and have stable symptoms and oxygen needs. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve oxygen therapy for many.

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

Studies have shown that the MoblO2 device, designed for people with chronic lung diseases like COPD, is generally safe. Research indicates that the device adjusts oxygen flow based on individual needs, preventing both insufficient and excessive oxygen. This is crucial because too much oxygen can harm some patients with severe COPD.

The MoblO2 device uses a pulse oximeter, a small sensor, to monitor blood oxygen levels and adjusts the oxygen flow to maintain optimal levels. If the battery fails, the device continues to provide oxygen at the user's set level, reducing the risk of an unexpected oxygen shortage.

While specific data on negative effects from using MoblO2 is lacking, testing during its development suggests it is generally well-tolerated, indicating it is unlikely to cause harm when used as directed. However, as with any medical device, user experiences may vary, so discussing any concerns with a healthcare provider is advisable.12345

Why are researchers excited about this trial?

MoblO2 is unique because it focuses on controlling airflow in patients with Chronic Obstructive Pulmonary Disease (COPD) in a targeted way. Unlike standard treatments like bronchodilators and steroids that broadly open airways or reduce inflammation, MoblO2 aims to precisely regulate airflow, potentially offering a more tailored approach to managing symptoms. Researchers are excited about MoblO2 because it might provide quicker relief by directly managing the flow of air during specific periods, which could lead to better breathing efficiency and improved quality of life for COPD patients.

What evidence suggests that the MoblO2 device is effective for COPD?

Research has shown that long-term oxygen therapy might not always improve outcomes for COPD patients, particularly those with mild oxygen level drops. In this trial, participants will experience two different approaches with the MoblO2 device. In one arm, MoblO2 controls the oxygen flow during the first week, while in the other arm, it controls the flow during the second week. The MoblO2 device aims to change the current understanding by automatically adjusting oxygen flow to stabilize blood oxygen levels, potentially reducing the burden on patients. Early results suggest that this technology can help maintain steady oxygen levels, which might improve physical activity and quality of life. This new approach could offer more convenience and less stress for patients who need oxygen therapy.36789

Are You a Good Fit for This Trial?

This trial is for people with chronic lung diseases like COPD or interstitial lung disease who need supplemental oxygen. Participants should be adults who use oxygen at home and are able to operate the MoblO2 device.

Inclusion Criteria

I am 25 years old or older.
I have been prescribed oxygen for use during activity for at least 1 month.
Consent to using compressed gas tanks to deliver O2 during the 2-week study period
See 2 more

Exclusion Criteria

I need to use oxygen when I am resting.
I need more than 10 L/min of oxygen when active.
I currently have chest pain from angina.
See 2 more

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 use their own O2 device while wearing an activity monitor

1 week
1 visit (in-person)

Treatment

Participants use the MoblO2 device with and without control of O2 flow

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MoblO2

Trial Overview

The study compares two ways of using the MoblO2 device: one where it automatically adjusts oxygen flow based on blood levels, and another where it does not control the flow. The goal is to see if automatic adjustment improves activity, symptoms, and quality of life.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: First week: MoblO2 controls flowActive Control1 Intervention
Group II: First week: MoblO2 DOES NOT control flowActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Minnesota HealthSolutions

Lead Sponsor

Trials
16
Recruited
1,800+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

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During one of the weeks (Week A), the MoblO2 device will be in place atop the D cylinder and will collect data but not control O2 flow. For the other week (Week ...

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