COPDO2matic-HOT1NCT04606290
Automated Oxygen Titration with O2matic Home Oxygen Therapy (O2matic HOT) Phase 1
A study testing O2matic HOT and Oxygen concentrator in people with COPD and Chronic Hypoxemic Respiratory Failure, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial summary
O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Chronic Hypoxemic Respiratory Failure
- What is being tested?
- O2matic HOT and Oxygen concentrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- 28 Oct 2020to 1 Jul 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified COPD with FEV1/FVC < 0.70
- Need of LTOT (PaO2 <= 7.3 kPa or SpO2 < 88 % on ambient air)
- Cognitively able to participate
- Willing to provide informed consent
Who cannot join
- Moderate or severe exacerbation in COPD within 4 weeks from study start
- Major comorbidities (cancer, uncontrolled chronic disease)
- Asthma or other disease with need of higher SpO2
- Pregnancy
- Fall in pH below 7.35 or increase in PaCO2 > 1 kPa on 5 liters of oxygen
- Active smoking
- LTOT use less than 1 hours/day
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre University Hospital
Hvidovre, 2650
Næstved University Hospital
Næstved
About this study
Official title: Automated Oxygen Titration to Patients with COPD and Domiciliary Long-term Oxygen Treatment
O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. In this crossover trial patients are admitted for 24 hours twice. Once with usual fixed dose oxygen and once with oxygen titration by O2matic HOT.
Read the detailed description
The purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (LTOT) is better than manually controlled oxygen treatment in keeping SpO2 within intended target interval. In manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.
- Conditions
- COPD, Chronic Hypoxemic Respiratory Failure
- Being tested
- O2matic HOT, Oxygen concentrator
- Keywords
- O2matic, Closed-loop, Pulse oximetry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2matic HOTDevice
Automated oxygen titration with O2matic HOT
Oxygen concentratorDevice
Fixed dose oxygen flow from concentrator
| Study group | Role | What they receive |
|---|---|---|
| Manual | Active comparator | Fixed dose oxygen Receives: Device: Oxygen concentrator |
| O2matic | Experimental | Automated oxygen titration Receives: Device: O2matic HOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in intended SpO2-interval
Percentage of time with SpO2 in intended interval
Measured: 24 hours
Secondary outcomes (7)
Percentage of time with SpO2 below 85 %
Percentage of time with SpO2 below 85 %
Measured: 24 hours
Percentage of time with SpO2 below target but not below 85 %
Percentage of time with SpO2 below target but not below 85 %
Measured: 24 hours
Percentage of time with SpO2 above target
Percentage of time with SpO2 above target
Measured: 24 hours
Change in PaCO2 from baseline
Change in PaCO2 from baseline to 8 hours
Measured: 8 hours
Change in PaCO2 from baseline
Change in PaCO2 from baseline to 24 hours
Measured: 24 hours
Accumulated oxygen usage
Accumulated oxygen usage in 24 hours
Measured: 24 hours
Adverse and serious adverse events
Adverse and serious adverse events, such as respiratory acidosis
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start28 Oct 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark, Naestved Hospital
- Responsible party
- Principal investigator, Ejvind Frausing Hansen, Hvidovre University Hospital
- Investigators
- Thomas Ringbaek, PhD, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606290
- Sponsor's protocol ID
- O2matic-HOT1
- Acronym
- O2matic-HOT1
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Oxygen Titration to Patients with COPD and Domiciliary Long-term Oxygen Treatment
- ClinicalTrials.gov ID
- NCT04606290
- Acronym / sponsor ID
- O2matic-HOT1 / O2matic-HOT1
- Conditions
- COPD, Chronic Hypoxemic Respiratory Failure
- Keywords
- O2matic, Closed-loop, Pulse oximetry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark, Naestved Hospital
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 28 Oct 2020 (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.
O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. In this crossover trial patients are admitted for 24 hours twice. Once with usual fixed dose oxygen and once with oxygen titration by O2matic HOT.
Detailed description
The purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (LTOT) is better than manually controlled oxygen treatment in keeping SpO2 within intended target interval. In manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual | Active comparator | Device: Oxygen concentratorFixed dose oxygen |
| O2matic | Experimental | Device: O2matic HOTAutomated oxygen titration |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Verified COPD with FEV1/FVC < 0.70
- Need of LTOT (PaO2 <= 7.3 kPa or SpO2 < 88 % on ambient air)
- Cognitively able to participate
- Willing to provide informed consent
Key exclusion criteria (7 listed)
- Moderate or severe exacerbation in COPD within 4 weeks from study start
- Major comorbidities (cancer, uncontrolled chronic disease)
- Asthma or other disease with need of higher SpO2
- Pregnancy
- Fall in pH below 7.35 or increase in PaCO2 > 1 kPa on 5 liters of oxygen
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 |
|---|---|---|
| O2matic HOTAutomated oxygen titration with O2matic HOT | Device | O2matic |
| Oxygen concentratorFixed dose oxygen flow from concentrator | Device | Manual |
Primary outcome
Percentage of time in intended SpO2-interval
Time frame: 24 hours
Percentage of time with SpO2 in intended interval
7 secondary outcomes
Percentage of time with SpO2 below 85 %
Time frame: 24 hours
Percentage of time with SpO2 below target but not below 85 %
Time frame: 24 hours
Percentage of time with SpO2 above target
Time frame: 24 hours
Change in PaCO2 from baseline
Time frame: 8 hours
Change in PaCO2 from baseline
Time frame: 24 hours
Accumulated oxygen usage
Time frame: 24 hours
Adverse and serious adverse events
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Thomas Ringbaek, PhD study chair
Hvidovre University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O2matic HOT and Oxygen concentrator in people with COPD and Chronic Hypoxemic Respiratory Failure, run by Hvidovre University Hospital at 2 sites 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Percentage of time in intended SpO2-interval (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.