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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06465654
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Janne Hastrup Jensen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Janne H Jensen, MSc
Principal Investigator Affiliation Aarhus University Hospital, Department of Physiotherapy and Occopational therapy
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Fibrosis Lung, Respiratory Therapy
Additional Details

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.

Arms & Interventions

Arms

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.

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 0 - 15 liters/minute.

Interventions

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: - 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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Janne H Jensen, MSc

[email protected]

78456730

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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