Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT)

May 15, 2025 updated by: Magnus Ekström, Skane University Hospital

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Örebro, Sweden, 70185
        • Recruiting
        • Department of Heart, Lung and Clinical Physiology, Örebro University Hospital
        • Contact:
          • Josefin Sundh, MD, PhD
    • Blekinge
      • Karlskrona, Blekinge, Sweden, 37185
        • Recruiting
        • Research Unit, Blekinge University of Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-flow oxygen therapy
Intervention arm
Device: Added high-flow oxygen therapy
Added 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.
Active Comparator: Low-flow oxygen therapy
Comparison arm
Other: Standard care
Standard care with low-flow oxygen therapy in accordance with clinical routine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
1 year
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
1 year
Hospitalization rate from all causes
Time Frame: 1 year
Hospitalization rate from all causes assessed using nationwide registry data
1 year
Hospitalization rate from respiratory disease
Time Frame: 1 year
Hospitalization rate from respiratory disease assessed using nationwide registry data
1 year
Number of hospitalized days
Time Frame: 1 year
Number of hospitalized days from all-causes, respiratory and cardiovascular disease using nationwide registry data
1 year
Hospitalization rate from cardiovascular disease
Time Frame: 1 year
Hospitalization rate from cardiovascular disease assessed using nationwide registry data
1 year
Number of admissions to intensive care unit (ICU)
Time Frame: 1 year
Number of admissions to ICU assessed using nationwide registry data
1 year
Number of days in ICU
Time Frame: 1 year
Number of days in ICU assessed using nationwide registry data
1 year
Mortality rate from all causes
Time Frame: 1 year
The mortality rate from all causes assessed using nationwide registry data
1 year
Mortality rate from respiratory disease
Time Frame: 1 year
The mortality rate from respiratory disease assessed using nationwide registry data
1 year
Mortality rate from cardiovascular disease
Time Frame: 1 year
The mortality rate from cardiovascular disease assessed using nationwide registry data
1 year
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
1 year
Number of exacerbations
Time Frame: 1 year
Number of exacerbations of all severity assessed using self-reported and registry data
1 year
Incidence of cardiovascular disease
Time Frame: 1 year
Incidence of cardiovascular disease assessed using nationwide registry data
1 year
Need for home mechanical ventilation
Time Frame: 1 year
Need for starting home mechanical ventilation assessed using nationwide registry data
1 year
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
1 year
Adverse events
Time Frame: 3 and 12 months
Self-reported adverse events since study start assessed using a postal questionnaire.
3 and 12 months
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.
1 year
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.
3 and 12 months
Health status
Time Frame: 3 and 12 months
Self-reported health status assessed using the and the COPD Assessment Test (CAT) questionnaire.
3 and 12 months
Breathlessness at exertion
Time Frame: 3 and 12 months
Self-reported exertional breathlessness assessed using the Dyspnoea Exertion Scale (DES) questionnaire.
3 and 12 months
Breathlessness
Time Frame: 3 and 12 months
Self-reported breathlessness assessed using the Dyspnea-12 questionnaire.
3 and 12 months
Sleep quality
Time Frame: 3 and 12 months
Self-reported sleep quality assessed using the modified Basic Nordic Sleep Questionnaire.
3 and 12 months
Physical activity
Time Frame: 3 and 12 months
Self-reported level of physical activity assessed using the modified Grimby-Frändin questionnaire.
3 and 12 months
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.
3 and 12 months
Nasal symptoms
Time Frame: 3 and 12 months
Self-reported nasal symptoms assessed using the modified Björklund questionnaire.
3 and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Skane University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University
The Swedish Research Council
ResMed
Vastra Gotaland Region
Region Östergötland
Region Stockholm
Region Örebro County
Region Västerbotten
Swedish Heart Lung Foundation
Uppsala University Hospital
Blekinge County Council Hospital
Blekinge Institute of Technology
Landstinget i Värmland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Magnus Ekström, MD, PhD, Skåne University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HILOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD cannot be shared due to restrictions in the current ethical approval. Pseudonymized IPD can be shared upon reasonable request and separate ethical approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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