An interventional study of Inogen One® G4 in COVID-19, sponsored by Inogen Inc.. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Inogen Inc. · Not applicable, Interventional, and Treatment
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 21 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Inogen Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SOC is defined as the patient symptoms or complications based treatment.
Inogen One® G4 Portable Oxygen Concentrator (POC) is used on a prescriptive basis by subjects requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula which channels oxygen from the concentrator to the subject. Inogen One® G4 is designed to provide a flow of high purity oxygen. Inogen One® G4 may be used in home, institution, vehicle and various mobile environments.
Device: Inogen One® G4
Inogen One® G4 will be used for a minimum of 3h per day at Setting 3 during the intervention period.
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
Time frame: 14+/-3 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Mar 2023, 8 months.
Of 138 industry-sponsored interventional studies with no phase under COVID-19, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 8 months is above that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Inogen Inc.