Automated oxygen adjustment for patients with lung fibrosis during walking
OXYWILD - Automated Oxygen Titration With O2matic During Walking in Patients With Fibrotic Interstitial Lung Diseases (F-ILD): A Randomized Study
This study is testing a new system that automatically adjusts oxygen levels for people with lung fibrosis while they walk, to see if it helps them breathe easier and enjoy daily activities without worrying about their oxygen levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06465654 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a new automated oxygen titration system, known as Closed Loop Oxygen Titration (CLOT), for patients suffering from fibrotic lung disease. Participants will undergo a six-minute walking test to assess their oxygen saturation levels, and the system will automatically adjust the oxygen flow to meet their needs during physical activity. The goal is to reduce the burden of managing oxygen levels manually, allowing patients to engage more freely in daily activities without the constant worry of oxygen saturation. The study will be conducted at Aarhus University Hospital with oversight from pulmonary specialists.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a verified diagnosis of fibrotic interstitial lung disease who experience oxygen desaturation during exertion.
Not a fit: Patients currently on long-term oxygen treatment or with other significant pulmonary or cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with lung fibrosis by providing more effective and user-friendly oxygen therapy.
How similar studies have performed: Previous studies have shown success with automated oxygen titration in other lung diseases, but this specific application in fibrotic lung disease is novel.
Eligibility criteria
Show full 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)
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Janne H Jensen, MSc — Aarhus University Hospital, Department of Physiotherapy and Occopational therapy
- Study coordinator: Janne H Jensen, MSc
- Email: jannhast@rm.dk
- Phone: 78456730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.