COVID-19RESTORENCT05212831
Portable Oxygen Concentrator (POC) Versus Standard of Care in Long-COVID: Randomized Crossover Exploratory Pilot Study.
A study testing Inogen One® G4 in people with COVID-19, run by Inogen Inc. at 2 sites in Canada.
Trial 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 adults with longterm- COVID. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Inogen One® G4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- 8 Jun 2022to 2 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal Heart Institute
Montreal, Quebec, H1T1C8
Centre ÉPIC de l'Institut de cardiologie de Montréal
Montreal, Quebec, H1T1N6
About this study
Official title: Portable Oxygen Concentrator (POC) Versus Standard of Care in Patients With Long-COVID Cognitive Impairment: a Randomized Crossover Exploratory Pilot Study.
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.
Read the 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 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.
- Conditions
- COVID-19
- Being tested
- Inogen One® G4
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inogen One® G4Device
Inogen One® G4 will be used for a minimum of 3h per day at Setting 3 during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | SOC is defined as the patient symptoms or complications based treatment. |
| Portable Oxygen Concentrator | Experimental | 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. Receives: Device: Inogen One® G4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14+/-3 days
VO2max during cardiopulmonary exercise test
To describe the effect of the Inogen One® G4 POC on VO2max during cardiopulmonary exercise test
Measured: 14+/-3 days
MoCA test
To describe the effect of the Inogen One® G4 POC on Cognitive performance using the MoCA test
Measured: 14+/-3 days
Other neuropsychological tests
To describe the effect of the Inogen One® G4 POC on Cognitive health assessments using other neuropsychological tests
Measured: 14+/-3 days
Secondary outcomes (4)
Functional status
To describe the effect of the Inogen One® G4 POC on post-COVID functional status
Measured: 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
Measured: 14+/-3 days
Pulmonary function
To describe the effect of the Inogen One® G4 POC on the post COVID-19 pulmonary function
Measured: 14+/-3 days
Safety outcomes
To determine the safety outcomes of the Inogen One® G4 POC in this subject population
Measured: 14+/-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start8 Jun 2022
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Montreal Health Innovations Coordinating Center (MHICC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212831
- Sponsor's protocol ID
- INO-01
- Acronym
- RESTORE
- Status last verified
- Jul 2023
- First submitted
- 21 Jan 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Oxygen Concentrator (POC) Versus Standard of Care in Patients With Long-COVID Cognitive Impairment: a Randomized Crossover Exploratory Pilot Study.
- ClinicalTrials.gov ID
- NCT05212831
- Acronym / sponsor ID
- RESTORE / INO-01
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Inogen Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Montreal Health Innovations Coordinating Center (MHICC)
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 28 Jan 2022 (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.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | No intervention | –SOC is defined as the patient symptoms or complications based treatment. |
| Portable Oxygen Concentrator | Experimental | Device: Inogen One® G4Inogen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Inogen One® G4Inogen One® G4 will be used for a minimum of 3h per day at Setting 3 during the intervention period. | Device | Portable Oxygen Concentrator |
Primary outcome
COVID-19 related brain hypoxia and peripheral oxygen saturation
Time frame: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on COVID-19 related brain hypoxia and peripheral oxygen saturation
VO2max during cardiopulmonary exercise test
Time frame: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on VO2max during cardiopulmonary exercise test
MoCA test
Time frame: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on Cognitive performance using the MoCA test
Other neuropsychological tests
Time frame: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on Cognitive health assessments using other neuropsychological tests
4 secondary outcomes
Functional status
Time frame: 14+/-3 days
Anxiety, mood, and subjective cognitive impairment
Time frame: 14+/-3 days
Pulmonary function
Time frame: 14+/-3 days
Safety outcomes
Time frame: 14+/-3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inogen One® G4 in people with COVID-19, run by Inogen Inc. at 2 sites in Canada.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jul 2023. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
COVID-19 related brain hypoxia and peripheral oxygen saturation (time frame: 14+/-3 days). The study lists 4 primary outcomes in all. 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 14 Jul 2023.