Study Stopped
Slow recruitment
Automated Oxygen Titration with O2matic Home Oxygen Therapy (O2matic HOT) Phase 1
O2matic-HOT1
Automated Oxygen Titration to Patients with COPD and Domiciliary Long-term Oxygen Treatment
1 other identifier
interventional
10
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
October 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedOctober 15, 2024
October 1, 2024
2.7 years
October 24, 2020
October 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of time in intended SpO2-interval
Percentage of time with SpO2 in intended interval
24 hours
Secondary Outcomes (7)
Percentage of time with SpO2 below 85 %
24 hours
Percentage of time with SpO2 below target but not below 85 %
24 hours
Percentage of time with SpO2 above target
24 hours
Change in PaCO2 from baseline
8 hours
Change in PaCO2 from baseline
24 hours
- +2 more secondary outcomes
Study Arms (2)
Manual
ACTIVE COMPARATORFixed dose oxygen
O2matic
EXPERIMENTALAutomated oxygen titration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- Innovation Fund Denmarkcollaborator
- Naestved Hospitalcollaborator
Study Sites (2)
Hvidovre University Hospital
Hvidovre, 2650, Denmark
Næstved University Hospital
Næstved, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thomas Ringbaek, PhD
Hvidovre University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
October 24, 2020
First Posted
October 28, 2020
Study Start
October 28, 2020
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share