Automated Oxygen Titration During Walking in Patients With Lung Fibrosis (OXYWILD) (OXYWILD)

September 26, 2025 updated by: Janne Hastrup Jensen

OXYWILD - Automated Oxygen Titration With O2matic During Walking in Patients With Fibrotic Interstitial Lung Diseases (F-ILD): A Randomized Study

Fibrotic lung disease is a group of severe scarring lung diseases with a dismal prognosis, often leading to respiratory failure and need for oxygen treatment. The symptom burden is often extremely high with dyspnea at rest and increasing dyspnea with exertion. Patients will often need more oxygen during activity thus repeatedly adjustments of oxygen flow rates are required to target an acceptable saturation at rest and during activities. This is impractical and can lead to an undesirable focus on oxygen levels as well as reduced use of the oxygen treatment in everyday life.

There is an urgent need for oxygen equipment that is easy to use to help patients live a life with fever symptom-related restrictions. Closed Loop Oxygen Titration (CLOT) is a new type of optimized oxygen treatment, which automatically adjusts the oxygen flow rate to the exact amount needed for the patient. The CLOT has already been tested and found useful in patients with other lung diseases, however it has not yet been tested in an isolated group of patients with fibrotic lung disease.

The goal of this clinical trial is therefore to study if automatically adjusted oxygen delivery can be useful for patients with fibrotic lung disease who needs oxygen treatment during activity.

The main questions aimed to be answered are: Will participants experience less breathlessness during walking, when the oxygen supply is individually adjusted to maintain an acceptable level of oxygen saturation?

Our hypotheses are that automatically adjusted oxygen dose during walking will results in less breathlessness compared to the usual fixed dose of oxygen. Furthermore, that participants will walk longer and maintain a better oxygen saturation during a walking test when offered automatically adjusted oxygen dose.

Participants will perform two walking tests with both automatically adjusted and fixed dose oxygen in random order, and the difference in sensation of breathlessness will be compared between the two tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recruitment of participants

Participants with fibrotic lung disease will be recruited by a pulmonary specialist from the Centre for Rare Lung Diseases, Department of Respiratory Diseases and Allergy, Aarhus University Hospital during a routine outpatient visit. If exertional oxygen desaturation is suspected or has been documented by a six-minute walking test the investigator, a pulmonary specialist will inform the patient about the study and ask for study participation.

The patient will be asked to sign the informed consent. The information given to the patient specifies that the informed consent gives access for study personnel to access the medical record for relevant information necessary to complete the study. The written informed consent form will be signed and personally dated by the subject and the person conducting the informed consent conversation.

Ethical considerations

No risk for the patients is considered to be related to participation in the study. The walking tests are conducted by an experienced physiotherapist with solid knowledge about patients with fibrotic lung disease and when to terminate walking tests due to clinical symptoms. Furthermore, patients are enquired to stop the test if they experience discomfort. Walking tests with or without oxygen supply is a part of standard clinical practice for patients with fibrotic lung disease at the Centre of Rare Lung Diseases and the O2matic has been approved for clinical use.

Patients can benefit individually by gaining knowledge about their oxygen need at exercise, and as a group contribute to increased knowledge about the effect of automated oxygen treatment on dyspnea during exercise and on exercise endurance. International guidelines have restricted recommendations for ambulatory oxygen therapy due to limited evidence. This study may contribute to stronger recommendations for the prescription of ambulatory oxygen therapy in the future.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Verified diagnosis of fibrotic interstitial lung disease
  • Desaturation during a recent (6 months) 6-minute walk test below 88% on atmospheric air or during an incremental shuttle walking test
  • Able to walk at least 50 meters
  • Self-reported stable respiratory symptoms in the previous 2 weeks
  • Age ≥ 18 years
  • Cognitively able to understand and participate in the study
  • Written informed consent

Exclusion Criteria:

  • Long term oxygen treatment
  • A pulmonary or cardiac condition other than fibrotic interstitial lung disease limiting exercise performance
  • Unstable heart condition or symptomatic stenotic valve disease
  • Any physical condition limiting exercise performance.
  • Smoking the previous 24 hours
  • Pregnancy
  • Anaemia, haemoglobin < 7.3 mmol/l (women) or < 8.3 mmol/l (men)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endurance shuttle walk test with fixed dose oxygen treatment
The participant will conduct an endurance shuttle walk test with a fixed oxygen dose of 4 liters/minute delivered by the O2matic.
Other: Fixed dose oxygen treatment
The participant will receive a fixed oxygen dose during a walking test. The participant will every minute during the walking test rate sensation of dyspnea on the BorgCR10 scale.
Experimental: Endurance shuttle walk test with automated variable dose oxygen treatment
The participant will conduct an endurance shuttle walk test with closed loop oxygen titration using O2matic to deliver a variable oxygen dosage set at an oxygen saturation target of 90 to 94 percent and an oxygen flow of 4 - 15 liters/minute.
Other: Automated variable dose oxygen treatment
The participant will receive closed loop oxygen titration during a walking test based on oxygen saturation measurements every second measured by a pulse oximeter connected to the O2matic. The participant will every minute during the walking test rate sensation of dyspnea on the BorgCR10 scale.
Other Names:
  • Closed loop oxygen titration with O2matic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Borg dyspnea score
Time Frame: At baseline and through completion (one day)
Primary outcome is the difference in Borg dyspnea score at isotime between the two endurance shuttle walk test (fixed dose oxygen compared to automated variable dose oxygen). The dyspnea score is rated every minute with the Borg Category-Ratio (CR)10 scale, where 0 is "no dyspnea at all" and 10 is "maximum dyspnea ever experienced".
At baseline and through completion (one day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking distance
Time Frame: At baseline and through completion (one day)
Difference in walking distance in meters between groups in Endurance shuttle walking test
At baseline and through completion (one day)
Walking time
Time Frame: At baseline and through completion (one day)
Difference in walking time in seconds between groups in Endurance shuttle walking test
At baseline and through completion (one day)
Oxygen flow rate
Time Frame: At baseline and through completion (one day)
Difference in average oxygen flow rate (liter/minute) between groups in Endurance shuttle walking test.
At baseline and through completion (one day)
Oxygen saturation levels
Time Frame: At baseline and through completion (one day)
Difference in time spent in seconds within acceptable oxygen saturation interval (oxygen saturation 90 - 94 percentage and time spent with moderate hypoxemia (oxygen saturation below 88 percentage) and severe hypoxemia (Oxygen saturation below 85 percentage) with moderate hypoxemia (oxygen saturation below 88 percentage) and severe hypoxemia (oxygen saturation below 85 percentage.
At baseline and through completion (one day)
Hypoxemia
Time Frame: At baseline and through completion (one day)
Time to first moderate hypoxemia and severe hypoxemia
At baseline and through completion (one day)
Difference in causes of walking limitations
Time Frame: At baseline and through completion (one day)
The participant is asked about factors limiting the walking distance.
At baseline and through completion (one day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janne Hastrup Jensen

Collaborators

Copenhagen University Hospital, Hvidovre

Investigators

  • Principal Investigator: Janne H Jensen, MSc, Aarhus University Hospital, Department of Physiotherapy and Occopational therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Actual)

September 10, 2025

Study Completion (Actual)

September 10, 2025

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAarhus_OXYWILD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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