Status:
COMPLETED
Portable Oxygen Concentrator (POC) Versus Standard of Care in Long-COVID: Randomized Crossover Exploratory Pilot Study.
Lead Sponsor:
Inogen Inc.
Collaborating Sponsors:
The Montreal Health Innovations Coordinating Center (MHICC)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, open label, randomized, crossover, pilot, exploratory study to describe the effect of the Inogen One® G4 POC on brain hypoxia, peripheral oxygen saturation and cognitive function in adu...
Detailed Description
After a 2-week screening/baseline evaluation, participants will be randomized in a 1:1 allocation ratio to one of the following 2 sequences: 1) portable oxygen concentrator (POC) for a first 2-week pe...
Eligibility Criteria
Inclusion
- Ability and willingness to give written informed consent prior to any study-specific screening procedures and to comply with the requirements of the study
- Male or female, aged ≥ 18 years of age
- Diagnosed with Long-COVID
- Patient self-reported concerns regarding cognitive functioning or recent diagnosis of COVID-19 related cognitive impairment
- MoCA test scores ranging from 13 to 25/30 at screening
- Oxygen saturation SpO2 ≤ 93 % on fingertip pulse oximetry and/or \< 60% on brain NIRS, at rest or during effort and/ or 10% relative decrease in brain saturation during exercise as compared to baseline value at screening
- Ability to perform exercise treadmill test at screening
- Tolerability of pulsed oxygen (O2) therapy delivered by POC at screening
- Willingness and ability to wear POC.
Exclusion
- Contraindication to the use of POC including allergy to cannula material
- Pregnancy or planning to become pregnant during the study
- Non-COVID-related cause for cognitive impairment (such as Parkinson's disease, multiple sclerosis, Alzheimer's disease, stroke, brain tumor, or dementia)
- Subjects with respiratory infection at screening or randomization and/or acute bronchitis requiring antibiotics at the time of randomization or expected during the treatment
- Participation in other interventional clinical trial within 30 days of randomization or expect to participate in any other investigational clinical trial during the conduct of this trial
- Subjects who should be excluded in the opinion of the investigator
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05212831
Start Date
June 8 2022
End Date
March 2 2023
Last Update
July 14 2023
Active Locations (2)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8
2
Centre ÉPIC de l'Institut de cardiologie de Montréal
Montreal, Quebec, Canada, H1T1N6