NCT07512687

Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia

Recruiting
NAAges 18–85InterventionalTreatment
State University of New York at Buffalo
~24 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Portable Oxygen ConcentratorPortable compressed oxygen D-tanksNo ambulatory oxygen therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Steps Per Day
Measured over Daily steps during each 2-week intervention (POC, D-Tank, no oxygen therapy).
Interstitial Lung Disease
Chronic Obstructive Pulmonary Disease
Hypoxemia
1 sites across 1 states
New York1
  • Kristopher Clark, MD · PRINCIPAL_INVESTIGATOR · State University of Buffalo Jacobs School of Medicine and Biomedical Sciences

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Eligibility criteria

Inclusion

Adults \>= 18 years old and \<= 85 years old with fibrotic ILD or COPD able to provide informed consent
Fibrotic ILD includes idiopathic pulmonary fibrosis, sarcoidosis, or other ILD with fibrotic changes on lung imaging (reticulations, honeycombing, traction bronchiectasis)
COPD participants will have fixed airway obstruction on spirometry less than 70%-predicted as per Global Initiative for Obstructive Lung Disease (GOLD) diagnostic criteria
Participants will self-report as being ambulatory outside of home without use of assistance device such as a cane or walker
Stable lung disease on stable medical therapy for preceding 3 months
Isolated exertional hypoxemia (SpO2 less than 89% for \>=10 seconds) on a 6MWT conducted while breathing room air
Able to maintain SpO2 \>=89% for the full duration of a 6MWT while using the the POC and portable oxygen D-tank at POC setting of no higher than 6 and D-tank flow rate no higher than 6 liters per minute

Exclusion

People \<18 years old or \>85 years old
Participants with mixed ILD and COPD diagnoses
Resting hypoxemia less than 89% while breathing room air
Emergency room visit or hospital admission in 3 months prior to recruitment
Change in medical therapy in 3 months prior to recruitment
Need for ambulatory assistive device such as cane or walker
Pregnant
Currently smoking or residing with a current smoker
Currently engaged in a pulmonary rehabilitation program
Participants without a smartphone compatible with the Oxiwear app (necessary to collect Oxiwear oxygen saturation data) or those with a compatible smartphone but without home wifi or cellular service plan allowing for Oxiwear data uploading
  • Steps Per DayDaily steps during each 2-week intervention (POC, D-Tank, no oxygen therapy).

    The primary outcome is a change in number of steps per day between each AOT device (POC and D-tanks) and compared to no oxygen therapy. Steps per day will be measured by ActiGraph LEAP, a wrist-worn device FDA-cleared for measuring activity. Participants will be instructed to wear this device during all waking hours.