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 adults with longterm- COVID.
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 period followed by standard of care (SOC) for a second 2-week period or 2) SOC for a first 2-week period followed by POC for a second 2-week period. There will be a washout period of one week between the two treatment periods. A total of 10 subjects will be enrolled per sequence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Inogen One® G4 will be used for a minimum of 3h per day at Setting 3 during the intervention period.
Montreal Heart Institute
Montreal, Quebec, Canada
Centre ÉPIC de l'Institut de cardiologie de Montréal
Montreal, Quebec, Canada
COVID-19 related brain hypoxia and peripheral oxygen saturation
To describe the effect of the Inogen One® G4 POC on COVID-19 related brain hypoxia and peripheral oxygen saturation
Time frame: 14+/-3 days
VO2max during cardiopulmonary exercise test
To describe the effect of the Inogen One® G4 POC on VO2max during cardiopulmonary exercise test
Time frame: 14+/-3 days
MoCA test
To describe the effect of the Inogen One® G4 POC on Cognitive performance using the MoCA test
Time frame: 14+/-3 days
Other neuropsychological tests
To describe the effect of the Inogen One® G4 POC on Cognitive health assessments using other neuropsychological tests
Time frame: 14+/-3 days
Functional status
To describe the effect of the Inogen One® G4 POC on post-COVID functional status
Time frame: 14+/-3 days
Anxiety, mood, and subjective cognitive impairment
To describe the effect of the Inogen One® G4 POC on anxiety, mood, and subjective cognitive impairment
Time frame: 14+/-3 days
Pulmonary function
To describe the effect of the Inogen One® G4 POC on the post COVID-19 pulmonary function
Time frame: 14+/-3 days
Safety outcomes
To determine the safety outcomes of the Inogen One® G4 POC in this subject population
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Time frame: 14+/-3 days