High-flow oxygen therapy for patients on long-term oxygen therapy
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial
This study is testing if adding high-flow oxygen therapy at night can help people with COPD or interstitial lung disease who are already using long-term oxygen therapy feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Skane University Hospital Academic / other |
| Locations | 2 sites (Karlskrona, Blekinge County and 1 other locations) |
| Trial ID | NCT06247397 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of adding high-flow oxygen therapy to standard low-flow oxygen therapy in patients with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) who are already on long-term oxygen therapy. Conducted in Sweden, the study recruits participants through the Swedish National Registry for Respiratory Failure and compares the outcomes of those receiving high-flow therapy at night against those receiving only standard therapy over a one-year period. The goal is to enhance treatment protocols and improve patient outcomes in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older who are on long-term oxygen therapy for COPD or ILD and meet specific health criteria.
Not a fit: Patients who are currently using home mechanical ventilation or have conditions like obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and reduce adverse events for patients with chronic respiratory failure.
How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in improving outcomes for patients with chronic respiratory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Karlskrona, Blekinge County and 1 other locations
- Research Unit, Blekinge University of Technology — Karlskrona, Blekinge County, Sweden (Recruiting)
- Department of Heart, Lung and Clinical Physiology, Örebro University Hospital — Örebro, Sweden (Recruiting)
Study contacts
- Principal investigator: Magnus Ekström, MD, PhD — Skane University Hospital
- Study coordinator: Magnus Ekström, MD, PhD
- Email: magnus.ekstrom@med.lu.se
- Phone: 0455731000
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.