Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

High-flow oxygen therapy for patients on long-term oxygen therapy

Official title: Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial

Run by Skane University Hospital · NCT06247397 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment310 (estimated)
SponsorSkane University Hospital
Academic / other
Locations2 sites (Karlskrona, Blekinge County and 1 other locations)
StatusRecruiting
StartedJune 10, 2024
Main results expectedDecember 2027
Study endsDecember 2028
Registry record updatedMay 21, 2025
Trial IDNCT06247397 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who are currently using home mechanical ventilation or have conditions like obstructive sleep apnea may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this approach is being evaluated in this trial, similar studies have shown promise in improving outcomes for patients with chronic respiratory conditions.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.