AzTrials
AzTrials

COPD (Chronic Obstructive Pulmonary Disease)SSeifertNCT07704567

MoblO2 to Maintain Oxygenation

A study of COPD (Chronic Obstructive Pulmonary Disease) and Intersitital Lung Disease, run by Minnesota HealthSolutions at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 95 years
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
9 Jul 2026to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jeff Swigris, DO, MS contact

303-398-1790

swigrisj@njhealth.org

Kaitlin Fier, MPH contact

303-398-1790

fierk@njhealth.org

United States1 site, 1 recruiting
  • National Jewish Health

    Denver, Colorado, 80206

    Recruiting

Other trials in United States

About this study

Official title: MOBoxy: MoblO2 to Maintain Oxygenation

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.

Read more

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.

Read the detailed description

This is a single-center (National Jewish Health), three-week, unblinded (to O2 delivery), cross-over trial of the MoblO2 device in patients with COPD or ILD who do not require O2 at rest but have been prescribed O2 for use with activity.

Once enrolled, each subject will be given an activity monitor and wear it for one week while using their own O2 device as they normally would. After week one, they will continue to wear the activity monitor and be provided a home-fill, stationary O2 concentrator and two D tanks (cylinders) that they will fill from the concentrator. The MoblO2 device will be attached to one D tank, and the other will be in reserve for if/when the first tank runs out, in which case, the MoblO2 device will be removed from the empty tank, attached to the reserve tank for use, and the first tank will be filled from the concentrator and left in reserve.

For the next two weeks, whenever patients exert, they will be asked to use the D tanks with the MoblO2 system supplied by the study. 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 B), the MoblO2 device will be in place atop the D cylinder and will collect data and control O2 flow.

III.B.1. Screening to establish O2 flow: Consented patients will be screened for O2 needs via an O2 titration protocol as follows: patients will be instructed to walk as fast as possible (without running or jogging) back and forth on a 30-meter course in quiet, low-traffic hallway while their SpO2 is monitored. The walk continues until 3 minutes are completed or SpO2 falls to ≤ 88%. If SpO2 does not fall to ≤ 88% by 3 minutes, the patient does not qualify for the study. If SpO2 falls to ≤ 88% before 3 minutes, the walk is halted, and the patient rests for 5 minutes. O2 is then added in 2L/min increments - continuous flow O2, delivered via an E tank on a trolley that the patient pulls while walking - until the patient is able to complete 3 minutes without the SpO2 falling to ≤ 88% for 15 seconds or more. Five-minute rest periods will be ensured between all walks.

Patients who need > 15 L/min O2 will be excluded. Because patients may exert to degrees greater than they did during the screening walks, for the week of the study that the MoblO2 device is in control mode the flow set on the device will be the higher of the following: 1) the flow determined by the screening protocol or 2) the highest flow that a patient has used in the last week.

III.B.2. Randomization: Which of the two weeks (A or B) the MoblO2 device will control O2 flow will be randomly assigned via a random number generator; thus, subjects could be randomized to either order: AB or BA. Each of the two sites will randomly assign the order.

Patient subjects will have previously-diagnosed COPD or chronic ILD and will have been prescribed by their treating practitioner O2 for use with exertion (but not at rest) for at least one month prior to enrollment. In total, 48 subjects will be recruited: 24 from National Jewish Health and 24 from Stanford University. At each site, 12 subjects will have COPD, and 12 subjects will have ILD.

The study will include a number of assessment tools, including actigraphy and patient-reported outcome measures. The Actigraph used is the GT3X + Tri-Axis Actigraphy Monitor (Actigraph LLC; Pensacola, FL) worn on the waist using the provided manufacturer's bands. Subjects will be asked to wear the Actigraph during waking hours, except when bathing or showering. Subjects will receive a charger, and they will be asked to charge the device overnight. Actigraph proprietary software will be used to generate values for sedentary time and time spent in moderately vigorous physical activity.

All questionnaires will be administered in electronic format via REDcap and in the same order at each visit. For subjects with COPD, the order will be: CAT, O2 satisfaction survey, FSS, IPAQ, Proactive, PGI-Dyspnea, PGI-Cough, PGI-Energy, and PGI-QOL. For subjects with ILD, the order will be: L-PF, O2 satisfaction survey, FSS, IPAQ, Proactive, PGI-Dyspnea, PGI-Cough, PGI-Energy, and PGI-QOL.

Outcome analyses. The initial analyses will compare the MoblO2 controlling O2 flow vs. not. In other analyses, the investigators will compare the MoblO2 controlling O2 flow vs. baseline. The following outcomes will be analyzed using a generalized linear model, with the difference in outcome of interest as the dependent variable:

Activity outcomes (time spent in moderately vigorous physical activity or sedentary time) Oxygen outcomes (total liters used, MoblO2 over-rides (per hour) Saturation outcomes (% time with SpO2 < 90%, % time with SpO2 < 88%, number of desaturation events < 88% per hour) Questionnaire outcomes (CAT score, L-PF scores (Symptoms Module, Dyspnea domain, Cough domain, Energy domain, Impacts Module, L-PF total), IPAQ, Proactive, FSS and PGI) Oxygen satisfaction survey

Being tested
MoblO2 controls O2 flow, MoblO2 does not control flow
Keywords
COPD, ILD, supplemental oxygen, symptoms, oxygen delivery
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoblO2 controls O2 flowOther

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

  • MoblO2 does not control flowOther

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

Study groups in NCT07704567
Study groupRoleWhat they receive
First week: MoblO2 controls flowActive comparatorMoblO2 controls flow first week and not second week
Receives: Other: MoblO2 controls O2 flow
First week: MoblO2 DOES NOT control flowActive comparatorMoblO2 controls flow second wee and not first week
Receives: Other: MoblO2 does not control flow

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Moderately vigorous physical activity (MVPA)

    Time spent in moderately vigorous physical activity as assessed by actigraphy

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

Secondary outcomes (2)
  1. Symptoms in COPD

    Symptom assessment for patients with COPD. The total score ranges from 0 to 40, with higher scores suggesting a greater impact of COPD on a patient's health.

    Measured: 1 week change from baseline for each arm

  2. Symptoms in Pulmonary Fibrosis

    Disease specific questionnaire for patients with ILD. The L-PF is a 44-item questionnaire that yields six scores (Symptoms Module, Dyspnea domain, Cough domain, Energy domain, Impacts Module, and Total), each ranging from 0 to 100, with higher scores indicating worse symptoms or greater negative impact of disease.

    Measured: 1 week change from baseline for each arm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start9 Jul 2026
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07704567
Sponsor's protocol ID
4311
Other IDs
R44HL160356
Acronym
SSeifert
Status last verified
Jul 2026
First submitted
30 Jun 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: This is a pilot study designed to begin the assessment process for the MoblO2 device.

Publications

  • 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.

    PubMed 30598231
  • 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.

    PubMed 34793688
  • 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.

    PubMed 30018766

Questions about this trial

What is this clinical trial studying?

A study of COPD (Chronic Obstructive Pulmonary Disease) and Intersitital Lung Disease, run by Minnesota HealthSolutions at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeff Swigris, DO, MS (303-398-1790, swigrisj@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Moderately vigorous physical activity (MVPA) (time frame: 1 week with the MoblO2 controlling O2 flow and 1 week with MoblO2 not controlling O2 flow]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07704567, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in