COPDDaiLiHOT_2NCT05556187
Automated Oxygen Titration at Home in Patients With COPD on Home Oxygen
A study testing Individualized automated oxygen titration in people with COPD and Hypoxemia, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Twelwe patients with COPD and long term oxygen treatment (LTOT) will be included in the study. An automated home oxygen titrations (HOT) device will be attached to the patient´s home oxygen equipment. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Individualized automated oxygen titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 2023to 29 Dec 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
- The patients will also be excluded if they have a drop in pH to < 7,31 (venous blood gas) on 8 litres per minute of oxygen flow OR an increase in PvCO2 on > 1 kPa compared to usual fixed oxygen dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated Oxygen Titration in Daily Life of Patients With Chronic Obstructive Pulmonary Disease on Home Oxygen Treatment
Twelwe patients with COPD and long term oxygen treatment (LTOT) will be included in the study. An automated home oxygen titrations (HOT) device will be attached to the patient´s home oxygen equipment. For 2x4 consequent days, the patients will be monitored and saturations, oxygen flow and physical activity level will be registered. In randomized order, the patients will use their usual fixed oxygen dose or automated oxygen titration during the first four days and then crossover. The monitoring consists of a wrist pulse oximeter (register pulse and saturation which is send to the HOT device) and a physical activity sensor attached to the patient's knee. At study start and after both of the four days the patients´dyspnea and QoL will be assessed.
After the study period the patients will in an explorative design based on qualitative methodology be interviewed in order to explore the patients experiences with automated oxygen titration during daily activity and on dyspnea.
Read the detailed description
Twelve patients with COPD and long term oxygen treatment (LTOT) will be included in the study. The purpose is to evaluate the feasibility of automated oxygen titration during daily living incl. activities. The pilot feasibility design has been chosen as this will be
- the first study testing automated oxygen titration in the patients' home,
- the first study testing automated oxygen titration adjusted not only at rest but during the entire day with the possibility to deliver up to 8 l/min.
Demographic data, will be registered. Oxygen consumption and oxygen saturation (SpO2) will be registered. O2matic Home Oxygen Treatment (HOT) is a device, which based on continuous, non-invasive measurement of SpO2 adjusts oxygen flow to the patient within a defined target interval. SpO2-target can be set individually, but in this study will be fixed at 90 to 94 % with a flow from 0.5-8 l/min. If SpO2 falls below 90 % oxygen flow will increase, and if SpO2 increases above 94 % oxygen flow will decrease. The adjustments are done every second based on average SpO2 for the last 15 seconds.
Blood gas analysis (ABG): Two venous blood sample will be taken, the first with the usual oxygen dose and the second after 20 minutes with an oxygen flow of 8 l/min. The analysis will look at pH-value and the PvCO2.
Clinical COPD Questionnaire (CCQ): 24-hour CCQ measures health status and can be used to assess health-related quality of life (HRQL). It measures symptoms within the last 24 hours as well as functional and mental state, and it is a predictor of mortality in patients with COPD. It is a short questionnaire with 10 items rated on a scale with 6 grades. The items are dyspnea at rest and on exercise, fear of worsening in the condition, depression, cough and sputum, limitations with strenuous and moderate physical activity, limitations with daily activities and social activities. Besides the total score ranging from 0 to 6 there are 3 subscores representing symptoms, mental state and functional state. An improvement of 0.4 is considered clinically significant. CCQ is validated in several languages including danish, and has proven to have good reliability and validity and to be responsive to changes and interventions, such as exacerbations, pulmonary rehabilitation and smoking cessation.
Physical Activity Level: The physical activity will be monitored using A SENS motion® sensor. With a patch above the knee, SENS registers time at rest, standing, walking, steps taken and motion intensity. 600 steps per day has been suggested to be a clinically relevant difference for patients with COPD.
Intervention An O2matic HOT device will be attached to the patient´s home oxygen equipment. For 2x4 consequent days, the patients will be monitored and saturations, oxygen flow and physical activity level will be registered. In randomized order, the patients will use their usual fixed oxygen dose or automated oxygen titration during the first four days and then crossover. The monitoring consists of a wrist pulse oximeter (register pulse and saturation) and a physical activity sensor attached to the patient's knee. At study start and after both of the four days the patients will be assessed using the CCQ.
Baseline visit
- The patients will be asked to meet for a baseline testing at the hospital. Besides gathering information, two venous blood gases will be taken. The first with the usual oxygen dose and the next after 20 minutes of 8 l/min. The blood sample will be analyzed in order to avoid respiratory acidosis at home (the patients will be excluded if the develop hypercapnia according the exclusion criteria).
- The randomization will be performed, and the SENS monitor will be attached above the knee.
- An appointment will be made for a home visit depending on the order of the randomization. The home visits will be made by the primary investigator
- The patients will be followed for 2x4 days. Four days with usual fixed oxygen dose and four days with automated oxygen titration.
In a "non- pilot" design CCQ could be a primary outcome, which would require 42 patients to show a MCID of 0.4 with a standard deviation = 0.9. A convenience sample of 12 patients is chosen in the present study, as we consider 12 patients to give a clear impression on the use of HOT at home and also a high enough number of patients to gather data on differences on SpO2 interval, CCQ and the activities performed by the patients, well knowing that we cannot expect to detect a difference with high probability.
Continuous variables are examined for normality and analyzed with either paired t-test (in case of normality) or Wilcoxon-signed-rank test (in case of non-normality). IBM SPSS Statistics for Windows, ver. 25.0 will be used for all statistical analyses.
- Being tested
- Individualized automated oxygen titration
- Keywords
- long term oxygen treatment, Automated oxygen titration, Physiotherapy, Activities of daily living
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized automated oxygen titrationOther
Automated oxygen titration based on the oxygen saturation during the entire day.
| Study group | Role | What they receive |
|---|---|---|
| Usual fixed oxygen dose | No intervention | * The oxygen dose will be as usual. * The patient's activity level will be monitored using SENS. * The patient will be asked to wear a wrist pulse oximeter to monitor pulse rate and saturation. |
| Automated oxygen titration | Experimental | * The O2matic equipment will be installed in the home of the patients. The SpO2-target will be set at 90-94%
* The patient's activity level will be monitored using SENS.
* The patient will be asked to wear a wrist pulse oximeter to monitor pulse rate and saturation and send the information to O2matic. O2matic will adjust the oxygen flow between 0.5-8 l/min according to the algorithm in the devise aiming at the SpO2-target interval.
* The patients will use their usual portable oxygen devises for use when being active outdoor. They are allowed a higher oxygenflow if needed. Receives: Other: Individualized automated oxygen titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using automated oxygen titration at home
Automated oxygen titration during daily living will be considered feasible if
- Data is successfully transmitted from the wrist pulse oximeter to O2matic HOT and further to the cloud solution (<10 % data loss).
- The patients are wearing the wrist pulse oximeter for more than 50 % of the daytime (08:00 - 20:00)
- The time spent within acceptable SpO2-interval is statistically different between arms and in favor of automated oxygen titration with a difference of at least 10 percentage difference in time.
- The patients are at least as active with O2matic HOT as with conventional oxygen therapy, measured by SENS activity monitor.
- The patients are safe with no serious adverse events, including hypercapnia leading to unscheduled healthcare contacts.
Measured: Immediately after the 2x4 days intervention
Secondary outcomes (2)
Change in CCQ-score
The difference in CCQ-score after four days using automated oxygen titration compared to usual fixed dose.
Measured: Immediately after the intervention
Physical activity
Difference in physical activity level (time spend walking and standing vs sitting or lying). Steps taken.
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 posted27 Sep 2022
- Study start10 Jan 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 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 COPDStudies 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
- The study will be conducted as a multicentre pilot randomized crossover feasibility trial.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Linette Marie Kofod, Hvidovre University Hospital
- Investigators
- Linette M Kofod, PT, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556187
- Sponsor's protocol ID
- DaiLiHOT_2
- Acronym
- DaiLiHOT_2
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data access in Denmark are under very strict juristic data protection law. Any possible access or sharing demands a part application to; (1) Danish Data Protection Agency, (2) Ethics Committee of the Capital Region, (3) National Health Data Authorities. Only if the applications are approved data will be considered available for sharing. The authors will not be able to support this process.
Publications
Kofod LM, Hansen EF, Kristensen MT, Brocki BC, Westerdahl E. Automated Oxygen Delivery in Home Setting for Patients with COPD on Long-Term Oxygen Therapy - A Randomized Crossover Feasibility Trial. Int J Chron Obstruct Pulmon Dis. 2025 Nov 14;20:3697-3712. doi: 10.2147/COPD.S546748. eCollection 2025.
PubMed 41268438
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Oxygen Titration in Daily Life of Patients With Chronic Obstructive Pulmonary Disease on Home Oxygen Treatment
- ClinicalTrials.gov ID
- NCT05556187
- Acronym / sponsor ID
- DaiLiHOT_2 / DaiLiHOT_2
- Keywords
- long term oxygen treatment, Automated oxygen titration, Physiotherapy, Activities of daily living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 27 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.
Twelwe patients with COPD and long term oxygen treatment (LTOT) will be included in the study. An automated home oxygen titrations (HOT) device will be attached to the patient´s home oxygen equipment. For 2x4 consequent days, the patients will be monitored and saturations, oxygen flow and physical activity level will be registered. In randomized order, the patients will use their usual fixed oxygen dose or automated oxygen titration during the first four days and then crossover. The monitoring consists of a wrist pulse oximeter (register pulse and saturation which is send to the HOT device) and a physical activity sensor attached to the patient's knee. At study start and after both of the four days the patients´dyspnea and QoL will be assessed.
After the study period the patients will in an explorative design based on qualitative methodology be interviewed in order to explore the patients experiences with automated oxygen titration during daily activity and on dyspnea.
Detailed description
Twelve patients with COPD and long term oxygen treatment (LTOT) will be included in the study. The purpose is to evaluate the feasibility of automated oxygen titration during daily living incl. activities. The pilot feasibility design has been chosen as this will be
- the first study testing automated oxygen titration in the patients' home,
- the first study testing automated oxygen titration adjusted not only at rest but during the entire day with the possibility to deliver up to 8 l/min.
Demographic data, will be registered. Oxygen consumption and oxygen saturation (SpO2) will be registered. O2matic Home Oxygen Treatment (HOT) is a device, which based on continuous, non-invasive measurement of SpO2 adjusts oxygen flow to the patient within a defined target interval. SpO2-target can be set individually, but in this study will be fixed at 90 to 94 % with a flow from 0.5-8 l/min. If SpO2 falls below 90 % oxygen flow will increase, and if SpO2 increases above 94 % oxygen flow will decrease. The adjustments are done every second based on average SpO2 for the last 15 seconds.
Blood gas analysis (ABG): Two venous blood sample will be taken, the first with the usual oxygen dose and the second after 20 minutes with an oxygen flow of 8 l/min. The analysis will look at pH-value and the PvCO2.
Clinical COPD Questionnaire (CCQ): 24-hour CCQ measures health status and can be used to assess health-related quality of life (HRQL). It measures symptoms within the last 24 hours as well as functional and mental state, and it is a predictor of mortality in patients with COPD. It is a short questionnaire with 10 items rated on a scale with 6 grades. The items are dyspnea at rest and on exercise, fear of worsening in the condition, depression, cough and sputum, limitations with strenuous and moderate physical activity, limitations with daily activities and social activities. Besides the total score ranging from 0 to 6 there are 3 subscores representing symptoms, mental state and functional state. An improvement of 0.4 is considered clinically significant. CCQ is validated in several languages including danish, and has proven to have good reliability and validity and to be responsive to changes and interventions, such as exacerbations, pulmonary rehabilitation and smoking cessation.
Physical Activity Level: The physical activity will be monitored using A SENS motion® sensor. With a patch above the knee, SENS registers time at rest, standing, walking, steps taken and motion intensity. 600 steps per day has been suggested to be a clinically relevant difference for patients with COPD.
Intervention An O2matic HOT device will be attached to the patient´s home oxygen equipment. For 2x4 consequent days, the patients will be monitored and saturations, oxygen flow and physical activity level will be registered. In randomized order, the patients will use their usual fixed oxygen dose or automated oxygen titration during the first four days and then crossover. The monitoring consists of a wrist pulse oximeter (register pulse and saturation) and a physical activity sensor attached to the patient's knee. At study start and after both of the four days the patients will be assessed using the CCQ.
Baseline visit
- The patients will be asked to meet for a baseline testing at the hospital. Besides gathering information, two venous blood gases will be taken. The first with the usual oxygen dose and the next after 20 minutes of 8 l/min. The blood sample will be analyzed in order to avoid respiratory acidosis at home (the patients will be excluded if the develop hypercapnia according the exclusion criteria).
- The randomization will be performed, and the SENS monitor will be attached above the knee.
- An appointment will be made for a home visit depending on the order of the randomization. The home visits will be made by the primary investigator
- The patients will be followed for 2x4 days. Four days with usual fixed oxygen dose and four days with automated oxygen titration.
In a "non- pilot" design CCQ could be a primary outcome, which would require 42 patients to show a MCID of 0.4 with a standard deviation = 0.9. A convenience sample of 12 patients is chosen in the present study, as we consider 12 patients to give a clear impression on the use of HOT at home and also a high enough number of patients to gather data on differences on SpO2 interval, CCQ and the activities performed by the patients, well knowing that we cannot expect to detect a difference with high probability.
Continuous variables are examined for normality and analyzed with either paired t-test (in case of normality) or Wilcoxon-signed-rank test (in case of non-normality). IBM SPSS Statistics for Windows, ver. 25.0 will be used for all statistical analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted as a multicentre pilot randomized crossover feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| Usual fixed oxygen dose | No intervention | –* The oxygen dose will be as usual. * The patient's activity level will be monitored using SENS. * The patient will be asked to wear a wrist pulse oximeter to monitor pulse rate and saturation. |
| Automated oxygen titration | Experimental | Other: Individualized automated oxygen titration* The O2matic equipment will be installed in the home of the patients. The SpO2-target will be set at 90-94% * The patient's activity level will be monitored using SENS. * The patient will be asked to wear a wrist pulse oximeter to monitor pulse rate and saturation and send the information to O2matic. O2matic will adjust the oxygen flow between 0.5-8 l/min according to the algorithm in the devise aiming at the SpO2-target interval. * The patients will use their usual portable oxygen devises for use when being active outdoor. They are allowed a higher oxygenflow if needed. |
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 (5 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
- The patients will also be excluded if they have a drop in pH to < 7,31 (venous blood gas) on 8 litres per minute of oxygen flow OR an increase in PvCO2 on > 1 kPa compared to usual fixed oxygen dose.
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 |
|---|---|---|
| Individualized automated oxygen titrationAutomated oxygen titration based on the oxygen saturation during the entire day. | Other | Automated oxygen titration |
Primary outcome
Feasibility of using automated oxygen titration at home
Time frame: Immediately after the 2x4 days intervention
Automated oxygen titration during daily living will be considered feasible if 1. Data is successfully transmitted from the wrist pulse oximeter to O2matic HOT and further to the cloud solution (<10 % data loss). 2. The patients are wearing the wrist pulse oximeter for more than 50 % of the daytime (08:00 - 20:00) 3. The time spent within acceptable SpO2-interval is statistically different between arms and in favor of automated oxygen titration with a difference of at least 10 percentage difference in time. 4. The patients are at least as active with O2matic HOT as with conventional oxygen therapy, measured by SENS activity monitor. 5. The patients are safe with no serious adverse events, including hypercapnia leading to unscheduled healthcare contacts.
2 secondary outcomes
Change in CCQ-score
Time frame: Immediately after the intervention
Physical activity
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 31 Jan 2024.
- Derived from this study: PubMed 41268438Kofod LM, Hansen EF, Kristensen MT, Brocki BC, Westerdahl E. Automated Oxygen Delivery in Home Setting for Patients with COPD on Long-Term Oxygen Therapy - A Randomized Crossover Feasibility Trial. Int J Chron Obstruct Pulmon Dis. 2025 Nov 14;20:3697-3712. doi: 10.2147/COPD.S546748. eCollection 2025.
- Individual participant dataSharing planned: No. Data access in Denmark are under very strict juristic data protection law. Any possible access or sharing demands a part application to; (1) Danish Data Protection Agency, (2) Ethics Committee of the Capital Region, (3) National Health Data Authorities. Only if the applications are approved data will be considered available for sharing. The authors will not be able to support this process.
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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, PT 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 Individualized automated oxygen titration in people with COPD and Hypoxemia, 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 5 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 31 Jan 2024. 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?
Feasibility of using automated oxygen titration at home (time frame: Immediately after the 2x4 days intervention). 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 NCT05556187, 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 31 Jan 2024.