NCT06247397Recruiting
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- First submitted
- 17 Jan 2024
- Start date
- 10 Jun 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Skane University Hospital
- Diseases
- COPD
- NCT number
- NCT06247397
What you commit to
- Study type: Interventional
- Planned participants: 310
- From 10 Jun 2024 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous treatment with home HFOT
- Current treatment with home mechanical ventilation
- Current treatment with home CPAP
Other illness
- Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)
Other
- 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
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Unit, Blekinge University of Technology Coordinator of this site? Confirm its status | Karlskrona | Sweden | Recruiting |
| Department of Heart, Lung and Clinical Physiology, Örebro University Hospital Coordinator of this site? Confirm its status | Örebro | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.