Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
Recruiting · NCT06247397 · Interventional (participants receive a specific treatment) · Lead sponsor: Skane University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Added high-flow oxygen therapyStandard care
What this trial is about
This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 40 years or older
- Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox
- COPD or ILD as main underlying reason for LTOT
- Oxygen concentrator as stationary oxygen source in the home including night-time
- Body mass index (BMI) \< 35 kg/m2
Exclusion criteria
- Current or previous treatment with home HFOT
- Current treatment with home mechanical ventilation
- Current treatment with home CPAP
- Hospitalized during the last 2 weeks
- Current smoking or contact with flames
- Self-reported average use of the LTOT \< 15h per day (24 hours)
- PaCO2 (breathing air at rest) \> 8 kPa
- Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)
- Inability to participate in the study procedures (as judged by the staff)
- Not eligible for continuing LTOT due to other reason (as judged by the staff)
- Expected survival less than 3 months (as judged by the staff)
Where it is running
2 locations listed.
- Department of Heart, Lung and Clinical Physiology, Örebro University Hospital - Örebro, Sweden
- Research Unit, Blekinge University of Technology - Karlskrona, Blekinge County, Sweden