COPD (Chronic Obstructive Pulmonary Disease)DaiLiHOT_1NCT05553847
Automated Oxygen Titration in Daily Life in Patients With COPD on Home Oxygen
A study testing Automated oxygen titration based on the oxygen saturation during activity in people with COPD (Chronic Obstructive Pulmonary Disease), run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the effect of automated oxygen titration compared to the usual fixed dose oxygen on the patient's ability to perform activities of daily living. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Automated oxygen titration based on the oxygen saturation during activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Oct 2022to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified history of COPD with FEV1/FVC < 0.70 and FEV1 < 50 %
- Hypoxemic at rest (SpO2≤ 90 %) and fulfilment of general national criteria for LTOT
- Partial pressure of Oxygen (PaO2) (without oxygen supplement) ≤7.3 kPa in clinically stable and optimally treated condition
- Increase in PaO2 after oxygen supplementation (to 8.0-9.0 kPa) without decrease in arterial pH (> 0.03 kPa)
- The oxygen is used at least 15 hours daily (optimally 24 hours daily)
- The treatment is handled by hospital departments with lung medical expertise.
- Able to walk at least 30 meters
- Age >18, Cognitively able to participate in the study and willing to give informed consent
Who cannot join
- Pulmonary or cardiac condition other than COPD limiting physical performance
- Unstable heart condition or stenotic aortic valve disease
- A physical condition including paralysis, lower extremity pain, or back problem limiting physical performance
- Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated Oxygen Titration to Improve Activities of Daily Living in Patients With Chronic Obstructive Pulmonary Disease on Home Oxygen
The purpose of this study is to examine the effect of automated oxygen titration compared to the usual fixed dose oxygen on the patient's ability to perform activities of daily living.
Read the detailed description
The patient's ability to perform ADL assessed by the Glittre-ADL test with automatic oxygen titration compared to usual fixed dose will be examined.
The patients will be invited to a visit at one of the participating hospitals. The Glittre-ADL will be performed according to the protocol validated by Skumlien et al. The first test is performed for familiarization in order to avoid a learning effect in the primary tests. The patients will use the fixed-dose oxygen, established after titration to a SpO2 of 90-94 % at rest.
After the familiarization test and gathering of demographics, further two Glittre-ADL tests will be performed on the same day or at another day pending on patient preference. In random order the patients will use A) automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min and B) their usual fixed dose of oxygen. In both arms O2matic will monitor pulse rate and saturation continuously during the test, but only in the automated oxygen therapy arm O2matic adjusts the oxygen flow. The patients will all use a rollator as walking aid. The oxygen equipment will be placed in the rollator and the tests will be conducted without the steps (due to the use of rollator). The minimum interval between tests will be 20 minutes or until the vital values and symptoms are returned to baseline. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale.
Study Analysis Plan
- Paired sample t-test: time used in the Glittre test using AutOx vs Time used using Fixed oxygen (in seconds)
- Paired sample t-test: Borg score after Glittre using Autox vs Borg score after Glittre when using Fixed oxygen (on a scale from 0-10) A test for carryover effect will be performed by comparing the first and the second tests before being divided into the Autox and fixed oxygen groups.
Variables will be examined for normality and analyzed with either a paired t-test (in case of normality) or Wilcoxon-signed-rank test (in case of non-normality). The median of the differences between tests will be used for a value. The number of patients who reach a Minimal Clinically Important Difference (MCID) in either the Dyspnea score or in time used in the Glittre test will be reported.
Difference in time spent within saturation intervals will be extracted from the CSV files and combined using Excel.
IBM SPSS Statistics for Windows, ver. 29.0.1.0 will be used for all statistical analyses.
- Being tested
- Automated oxygen titration based on the oxygen saturation during activity
- Keywords
- Activity, Automated oxygen titration, ADL, long term oxygen treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated oxygen titration based on the oxygen saturation during activityOther
A device will be used, which automatically adjusts the oxygen flow to the dosage necessary for keeping the saturation at the recommended level (90-94%). If the saturation falls below 90%, oxygen flow will increase, and if the saturation increases above 94%, oxygen flow decreases in order to stay on target.
| Study group | Role | What they receive |
|---|---|---|
| Usual oxygen dose | No intervention | A Glittre-ADL tests will be performed and the patients will use their usual fixed dose of oxygen. Pulse rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale |
| Automated oxygen dose | Experimental | A Glittre-ADL tests will be performed and the patients will use automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min. Pulse rate, oxygen flow rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale Receives: Other: Automated oxygen titration based on the oxygen saturation during activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time used for the Glittre-ADL test
Change in time used to complete the Glittre-ADL test with automated titration compared to fixed-dose treatment
Measured: Immediately after intervention (control arm test and automated oxygen titration arm) on the same day
Secondary outcomes (3)
Dyspnea
Change in Dyspnea Borg (in units from 0-10) scores after performing Glittre ADL test between arms
Measured: Immediately after the intervention
Saturation
Change in time spent within acceptable SpO2-interval (SpO2 90 - 94 %) and time spent with moderate hypoxemia (SpO2 < 88 %) and severe hypoxemia (SpO2 < 85 %) in the two Glittre-ADL tests
Measured: Immediately after the intervention
Oxygen consumption
Change in average oxygen consumption between the two tests
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start30 Oct 2022
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- multicentre double blinded randomized crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Linette Marie Kofod, Copenhagen University Hospital, Hvidovre
- Investigators
- Linette M Kofod, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553847
- Sponsor's protocol ID
- Fys1977
- Acronym
- DaiLiHOT_1
- Status last verified
- Nov 2023
- First submitted
- 15 Sep 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data could be available on reasonable request, but needs to follow the rules set by the danish Data Protection Agency.
Publications
Kofod LM, Hansen EF, Brocki BC, Kristensen MT, Roberts NB, Westerdahl E. Optimised oxygenation improves functional capacity during daily activities in patients with COPD on long-term oxygen therapy: a randomised crossover trial. Thorax. 2025 Oct 15;80(11):803-809. doi: 10.1136/thorax-2024-221883.
PubMed 40473413
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Oxygen Titration to Improve Activities of Daily Living in Patients With Chronic Obstructive Pulmonary Disease on Home Oxygen
- ClinicalTrials.gov ID
- NCT05553847
- Acronym / sponsor ID
- DaiLiHOT_1 / Fys1977
- Keywords
- Activity, Automated oxygen titration, ADL, long term oxygen treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Örebro University, Sweden, University Hospital Bispebjerg and Frederiksberg
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of automated oxygen titration compared to the usual fixed dose oxygen on the patient's ability to perform activities of daily living.
Detailed description
The patient's ability to perform ADL assessed by the Glittre-ADL test with automatic oxygen titration compared to usual fixed dose will be examined.
The patients will be invited to a visit at one of the participating hospitals. The Glittre-ADL will be performed according to the protocol validated by Skumlien et al. The first test is performed for familiarization in order to avoid a learning effect in the primary tests. The patients will use the fixed-dose oxygen, established after titration to a SpO2 of 90-94 % at rest.
After the familiarization test and gathering of demographics, further two Glittre-ADL tests will be performed on the same day or at another day pending on patient preference. In random order the patients will use A) automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min and B) their usual fixed dose of oxygen. In both arms O2matic will monitor pulse rate and saturation continuously during the test, but only in the automated oxygen therapy arm O2matic adjusts the oxygen flow. The patients will all use a rollator as walking aid. The oxygen equipment will be placed in the rollator and the tests will be conducted without the steps (due to the use of rollator). The minimum interval between tests will be 20 minutes or until the vital values and symptoms are returned to baseline. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale.
Study Analysis Plan
- Paired sample t-test: time used in the Glittre test using AutOx vs Time used using Fixed oxygen (in seconds)
- Paired sample t-test: Borg score after Glittre using Autox vs Borg score after Glittre when using Fixed oxygen (on a scale from 0-10) A test for carryover effect will be performed by comparing the first and the second tests before being divided into the Autox and fixed oxygen groups.
Variables will be examined for normality and analyzed with either a paired t-test (in case of normality) or Wilcoxon-signed-rank test (in case of non-normality). The median of the differences between tests will be used for a value. The number of patients who reach a Minimal Clinically Important Difference (MCID) in either the Dyspnea score or in time used in the Glittre test will be reported.
Difference in time spent within saturation intervals will be extracted from the CSV files and combined using Excel.
IBM SPSS Statistics for Windows, ver. 29.0.1.0 will be used for all statistical analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- multicentre double blinded randomized crossover trial
| Arm | Type | Receives |
|---|---|---|
| Usual oxygen dose | No intervention | –A Glittre-ADL tests will be performed and the patients will use their usual fixed dose of oxygen. Pulse rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale |
| Automated oxygen dose | Experimental | Other: Automated oxygen titration based on the oxygen saturation during activityA Glittre-ADL tests will be performed and the patients will use automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min. Pulse rate, oxygen flow rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Verified history of COPD with FEV1/FVC < 0.70 and FEV1 < 50 %
- Hypoxemic at rest (SpO2≤ 90 %) and fulfilment of general national criteria for LTOT
- Able to walk at least 30 meters
- Age >18, Cognitively able to participate in the study and willing to give informed consent
Key exclusion criteria (4 listed)
- Pulmonary or cardiac condition other than COPD limiting physical performance
- Unstable heart condition or stenotic aortic valve disease
- A physical condition including paralysis, lower extremity pain, or back problem limiting physical performance
- Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated oxygen titration based on the oxygen saturation during activityA device will be used, which automatically adjusts the oxygen flow to the dosage necessary for keeping the saturation at the recommended level (90-94%). If the saturation falls below 90%, oxygen flow will increase, and if the saturation increases above 94%, oxygen flow decreases in order to stay on target. | Other | Automated oxygen dose |
Primary outcome
Time used for the Glittre-ADL test
Time frame: Immediately after intervention (control arm test and automated oxygen titration arm) on the same day
Change in time used to complete the Glittre-ADL test with automated titration compared to fixed-dose treatment
3 secondary outcomes
Dyspnea
Time frame: Immediately after the intervention
Saturation
Time frame: Immediately after the intervention
Oxygen consumption
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 40473413Kofod LM, Hansen EF, Brocki BC, Kristensen MT, Roberts NB, Westerdahl E. Optimised oxygenation improves functional capacity during daily activities in patients with COPD on long-term oxygen therapy: a randomised crossover trial. Thorax. 2025 Oct 15;80(11):803-809. doi: 10.1136/thorax-2024-221883.
- Individual participant dataSharing planned: Yes. Data could be available on reasonable request, but needs to follow the rules set by the danish Data Protection Agency.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linette M Kofod principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated oxygen titration based on the oxygen saturation during activity in people with COPD (Chronic Obstructive Pulmonary Disease), run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time used for the Glittre-ADL test (time frame: Immediately after intervention (control arm test and automated oxygen titration arm) on the same day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.