Portable Oxygen Concentrator (POC) Versus Standard of Care in Long-COVID: Randomized Crossover Exploratory Pilot Study. (RESTORE)

July 13, 2023 updated by: Inogen Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T1C8
        • Montreal Heart Institute
      • Montréal, Quebec, Canada, H1T1N6
        • Centre ÉPIC de l'Institut de cardiologie de Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ability and willingness to give written informed consent prior to any study-specific screening procedures and to comply with the requirements of the study
  2. Male or female, aged ≥ 18 years of age
  3. Diagnosed with Long-COVID
  4. Patient self-reported concerns regarding cognitive functioning or recent diagnosis of COVID-19 related cognitive impairment
  5. MoCA test scores ranging from 13 to 25/30 at screening
  6. 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
  7. Ability to perform exercise treadmill test at screening
  8. Tolerability of pulsed oxygen (O2) therapy delivered by POC at screening
  9. Willingness and ability to wear POC.

Exclusion Criteria:

  1. Contraindication to the use of POC including allergy to cannula material
  2. Pregnancy or planning to become pregnant during the study
  3. Non-COVID-related cause for cognitive impairment (such as Parkinson's disease, multiple sclerosis, Alzheimer's disease, stroke, brain tumor, or dementia)
  4. Subjects with respiratory infection at screening or randomization and/or acute bronchitis requiring antibiotics at the time of randomization or expected during the treatment
  5. 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
  6. Subjects who should be excluded in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care (SOC)
SOC is defined as the patient symptoms or complications based treatment.
Experimental: Portable Oxygen Concentrator

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
14+/-3 days
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
14+/-3 days
MoCA test
Time Frame: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on Cognitive performance using the MoCA test
14+/-3 days
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
14+/-3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional status
Time Frame: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on post-COVID functional status
14+/-3 days
Anxiety, mood, and subjective cognitive impairment
Time Frame: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on anxiety, mood, and subjective cognitive impairment
14+/-3 days
Pulmonary function
Time Frame: 14+/-3 days
To describe the effect of the Inogen One® G4 POC on the post COVID-19 pulmonary function
14+/-3 days
Safety outcomes
Time Frame: 14+/-3 days
To determine the safety outcomes of the Inogen One® G4 POC in this subject population
14+/-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inogen Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Montreal Health Innovations Coordinating Center (MHICC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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