Added high-flow oxygen therapy
DeviceAdded high-flow oxygen therapy using the device Lumis HFT during nighttime and at the patient's discretion daytime, with the usual care (low-flow oxygen therapy) the rest of the time.
Recruiting
NCT Number: NCT06247397
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Research Unit, Blekinge University of Technology, Karlskrona, Blekinge County, Sweden
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About this study
This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year.
The purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Standard care
OtherStandard care with low-flow oxygen therapy in accordance with clinical routine.
Primary outcomes
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Time to first hospitalization or death from all causes
Time frame: 1 year
Time to first hospitalization or death from all causes during 1 year after randomization in people with COPD (assessed using nationwide registry data)
Secondary outcomes
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Time to first all-cause hospitalization or all-cause death
Time frame: 1 year
Time to first all-cause hospitalization or all-cause death in people with ILD (assessed using nationwide registry data)
-
Rate of hospitalizations or death from all causes
Time frame: 1 year
Rate of hospitalizations or death from all causes assessed using nationwide registry data
-
Hospitalization rate from all causes
Time frame: 1 year
Hospitalization rate from all causes assessed using nationwide registry data
-
Hospitalization rate from respiratory disease
Time frame: 1 year
Hospitalization rate from respiratory disease assessed using nationwide registry data
-
Number of hospitalized days
Time frame: 1 year
Number of hospitalized days from all-causes, respiratory and cardiovascular disease using nationwide registry data
-
Hospitalization rate from cardiovascular disease
Time frame: 1 year
Hospitalization rate from cardiovascular disease assessed using nationwide registry data
-
Number of admissions to intensive care unit (ICU)
Time frame: 1 year
Number of admissions to ICU assessed using nationwide registry data
-
Number of days in ICU
Time frame: 1 year
Number of days in ICU assessed using nationwide registry data
-
Mortality rate from all causes
Time frame: 1 year
The mortality rate from all causes assessed using nationwide registry data
-
Mortality rate from respiratory disease
Time frame: 1 year
The mortality rate from respiratory disease assessed using nationwide registry data
-
Mortality rate from cardiovascular disease
Time frame: 1 year
The mortality rate from cardiovascular disease assessed using nationwide registry data
-
Time to first exacerbation
Time frame: 1 year
Time to first exacerbation after randomisation, defined as time to first dispensed antibiotics and/or oral corticosteroids, ED-visit or hospitalization for exacerbation assessed using self-reported and registry data
-
Number of exacerbations
Time frame: 1 year
Number of exacerbations of all severity assessed using self-reported and registry data
-
Incidence of cardiovascular disease
Time frame: 1 year
Incidence of cardiovascular disease assessed using nationwide registry data
-
Need for home mechanical ventilation
Time frame: 1 year
Need for starting home mechanical ventilation assessed using nationwide registry data
-
Rate of withdrawal of long-term oxygen therapy
Time frame: 1 year
Rate of withdrawal of long-term oxygen therapy assessed using nationwide registry data
-
Adverse events
Time frame: 3 and 12 months
Self-reported adverse events since study start assessed using a postal questionnaire.
-
Primary care utilization
Time frame: 1 year
Self-reported number of primary care contacts since the start of the study assessed using a postal questionnaire.
-
Health-related quality of life
Time frame: 3 and 12 months
Self-reported health-related quality of life assessed using the EuroQol Five Dimensions - Five Levels (EQ5D-5L) questionnaire.
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Health status
Time frame: 3 and 12 months
Self-reported health status assessed using the and the COPD Assessment Test (CAT) questionnaire.
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Breathlessness at exertion
Time frame: 3 and 12 months
Self-reported exertional breathlessness assessed using the Dyspnoea Exertion Scale (DES) questionnaire.
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Breathlessness
Time frame: 3 and 12 months
Self-reported breathlessness assessed using the Dyspnea-12 questionnaire.
-
Sleep quality
Time frame: 3 and 12 months
Self-reported sleep quality assessed using the modified Basic Nordic Sleep Questionnaire.
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Physical activity
Time frame: 3 and 12 months
Self-reported level of physical activity assessed using the modified Grimby-Frändin questionnaire.
-
Change in health status
Time frame: 3 and 12 months
Self-reported change in perceived health status assessed using the Global Impression of Change (GIC) scale.
-
Nasal symptoms
Time frame: 3 and 12 months
Self-reported nasal symptoms assessed using the modified Björklund questionnaire.
Other outcomes
-
Patient preference for continuing the treatment
Time frame: 3 and 12 months
Patients' self-reported patient preference for continuing the treatment assessed using postal questionnaire.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Skane University Hospital
Other
Collaborators
- Blekinge County Council Hospital
- Blekinge Institute of Technology
- Landstinget i Värmland
- Lund University
- Region Stockholm
- Region Västerbotten
- Region Örebro County
- Region Östergötland
- ResMed
- Swedish Heart Lung Foundation
- The Swedish Research Council
- Uppsala University Hospital
- Vastra Gotaland Region
Registry information
Official study title
Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial
Acronym: HILOT
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Feb 7, 2024
- Registry last updated
- May 21, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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