An interventional study of Automated variable dose oxygen treatment and Fixed dose oxygen treatment in Fibrosis Lung and Respiratory Therapy, sponsored by Janne Hastrup Jensen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Janne Hastrup Jensen · Not applicable, Interventional, and Treatment
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.
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.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 29 is below the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →This is the only study on the registry with Janne Hastrup Jensen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
Also known as: Closed loop oxygen titration with O2matic
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.
Borg dyspnea score
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".
Time frame: At baseline and through completion (one day)
Walking distance
Difference in walking distance in meters between groups in Endurance shuttle walking test
Time frame: At baseline and through completion (one day)
Walking time
Difference in walking time in seconds between groups in Endurance shuttle walking test
Time frame: At baseline and through completion (one day)
Oxygen flow rate
Difference in average oxygen flow rate (liter/minute) between groups in Endurance shuttle walking test.
Time frame: At baseline and through completion (one day)
Oxygen saturation levels
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.
Time frame: At baseline and through completion (one day)
Hypoxemia
Time to first moderate hypoxemia and severe hypoxemia
Time frame: At baseline and through completion (one day)
Difference in causes of walking limitations
The participant is asked about factors limiting the walking distance.
Time frame: At baseline and through completion (one day)
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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