MoblO2 to Maintain Oxygenation

NCT07704567 | Recruiting DMC FDA Device

• 2 other identifiers: 4311R44HL160356
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients with chronic lung disease (e.g., chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD)) require supplemental oxygen (O2) at some point during their disease course. Practitioners prescribe O2 to patients with chronic lung disease in hopes of the following: 1) that it will limit desaturation events and combat breathlessness, thus preventing the frustratingly slow pace and numerous rest breaks patients are forced to adopt while doing even simple tasks; 2) that it will allow patients to be more active physically (perhaps increase their ability to exercise) and socially (perhaps leave the home more often); 3) that it will stave off putative complications of hypoxemia (e.g., cognitive dysfunction, pulmonary hypertension) and 4) that it will improve health-related quality of life (HRQL). However, despite the rationale for O2, and prescribers' good intentions, patients generally view O2 with frustration and fear - it threatens their HRQL, which is already impaired by having a condition that imposes itself on every aspect of their lives. Nasal cannulas and delivery devices call unwanted attention to patients when they are out in public. O2 users feel stigmatized and are often viewed as "smokers who get what they deserve, even if they never smoked a day in their lives" - or as disabled, sick or even infectious. O2 steals patients' independence, forcing them to plan their lives around it. The anxiety that patients and their caregivers experience around running out of oxygen, or not getting enough, immobilizes them and restricts participation in activities outside of the home. O2 disrupts the home environment, adding stress, and creating a burden for patients' caregiver-loved-ones who are often saddled with the responsibility of ensuring adequate equipment and supply of O2, and O2 is a constant reminder to patients they are living with a condition that could shorten their lives. O2 delivery equipment is typically heavy, unwieldy and intimidating. Different recommendations (e.g., insurance companies use 88% as a cut-off for SpO2, while many practitioners focus on 90%) make it confusing for patients, which almost certainly affects adherence. O2-requiringpatients are starving for things that can make their lives easier. An auto-adjusting O2 delivery device - one that automatically delivers the correct amount of O2 to maintain blood oxygen at desired, pre-set levels - would alleviate the need for patients to constantly (incessantly for many) monitor their peripheral oxygen saturation (SpO2) and adjust O2flow to meet the demands as exertion levels vary . The MoblO2 device is a battery-operated, light-weight, closed-loop O2 delivery device that houses a regulator (which attaches to compressed gas O2 tanks) and adjusts O2 flow to meet a pre-set blood oxygen level. A pulse oximeter is worn on the ear and transmits via Bluetooth to the device, which adjusts an internal valve to control flow on a second-to-second basis. The user sets the dial to the highest flow of O2 needed to meet the demands of activities they might perform (up to 15 liters per minute), and the device adjusts flow, up to the pre-set level to maintain SpO2 at a preset level (e.g., \> 90%). To conserve O2 supply in the tank - and to avoid over-oxygenation (which could be problematic for a small percentage of patients with the most severe COPD) - the MoblO2 begins to limit O2 flow at a SpO2 of 93%. The device can be manually over-ridden by the user, and should the battery run out - or the device fail for some unforeseen reason - the default position is valve open, so the users receive whatever flow of oxygen has been set on the dial. Given the substantial burdens of O2 on patients and their families, the hassles patients describe with having to monitor their SpO2 and repeatedly adjust the flow of O2 to meet their needs, patients and experts around the world have called for improvements in O2 delivery equipment. The MoblO2 is just such a remarkable improvement and a giant step forward in helping to ease the burdens of O2 on patients who require it. The purpose of this study is to investigate the effects of the MoblO2 O2 delivery device on a range of outcomes, including physical activity, amount (liters) O2 use; maintenance of adequate SpO2 levels; patient reported outcomes including symptoms, HRQL and satisfaction with the MoblO2 O2 device.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Intersitital Lung Disease

Keywords

COPD; ILD; supplemental oxygen; symptoms; oxygen delivery

Outcome Measures

Primary Outcomes (1)

• Moderately vigorous physical activity (MVPA)

  Time spent in moderately vigorous physical activity as assessed by actigraphy

  1 week with the MoblO2 controlling O2 flow and 1 week with MoblO2 not controlling O2 flow]

Secondary Outcomes (2)

• Symptoms in COPD

  1 week change from baseline for each arm

• Symptoms in Pulmonary Fibrosis

  1 week change from baseline for each arm

Other Outcomes (6)

• Oxygen Use

  1 week change from baseline for each arm

• Saturation outcomes

  1 week change from baseline for each arm

• Physical Activity

  1 week

Study Arms (2)

First week: MoblO2 controls flow

ACTIVE COMPARATOR

MoblO2 controls flow first week and not second week

Other: MoblO2 controls O2 flow

First week: MoblO2 DOES NOT control flow

ACTIVE COMPARATOR

MoblO2 controls flow second wee and not first week

Other: MoblO2 does not control flow

Interventions

MoblO2 controls O2 flow OTHER

MoblO2 O2 flow regulator controls O2 flow to the patient via an algorithm that integrates data input from sources such as peripheral oxygen saturation

First week: MoblO2 controls flow

MoblO2 does not control flow OTHER

This is the week that the MoblO2 does not control O2 flow

First week: MoblO2 DOES NOT control flow

Eligibility Criteria

• Age: 25 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously-diagnosed COPD or chronic interstitial lung disease Prescribed O2 for use with exertion at least 1 month prior to enrollment Age 25 years old or greater Self-reported stable symptoms and stable oxygen needs for at least 2 weeks Consent to using compressed gas tanks to deliver O2 during the 2-week study period

You may not qualify if:

• Active angina Musculoskeletal disease that precludes physical activity Need for O2 at rest Patient needing more than 10 L/min continuous flow with exertion on O2 screen Patient prescribed 10L/min continuous flow (or more) by their prescribing practitioner

Sponsors & Collaborators

• Minnesota HealthSolutions: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Related Publications (3)

• Lindell KO, Collins EG, Catanzarite L, Garvey CM, Hernandez C, Mclaughlin S, Schneidman AM, Meek PM, Jacobs SS. Equipment, access and worry about running short of oxygen: Key concerns in the ATS patient supplemental oxygen survey. Heart Lung. 2019 May-Jun;48(3):245-249. doi: 10.1016/j.hrtlng.2018.12.006. Epub 2018 Dec 28. No abstract available.

  PMID: 30598231 BACKGROUND

• Cardenosa SC, Palomo M, Francesqui J, Alsina X, Hernandez C, Albacar N, Blanco I, Embid C, Barbera JA, Hernandez-Gonzalez F, Sellares J. Home Oxygen Monitoring in Patients with Interstitial Lung Disease. Ann Am Thorac Soc. 2022 Mar;19(3):493-497. doi: 10.1513/AnnalsATS.202103-319RL. No abstract available.

  PMID: 34793688 BACKGROUND

• Swigris JJ. Transitions and touchpoints in idiopathic pulmonary fibrosis. BMJ Open Respir Res. 2018 Jun 29;5(1):e000317. doi: 10.1136/bmjresp-2018-000317. eCollection 2018.

  PMID: 30018766 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jeff Swigris, DO, MS

CONTACT

303-398-1790; swigrisj@njhealth.org

Kaitlin Fier, MPH

CONTACT

303-398-1790; fierk@njhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 15, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)