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Oxygen Therapy Device

Inogen One® G4 for Coronavirus (RESTORE Trial)

N/A
Waitlist Available
Research Sponsored by Inogen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14+/-3 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a portable oxygen device to help adults with long-term COVID. The device aims to improve oxygen levels in the blood, which may enhance brain function and overall health. Participants will use the device for a short period and then switch to usual treatment to compare results.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14+/-3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14+/-3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
COVID-19 related brain hypoxia and peripheral oxygen saturation
MoCA test
Other neuropsychological tests
+1 more
Secondary study objectives
Anxiety, mood, and subjective cognitive impairment
Functional status
Pulmonary function
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Portable Oxygen ConcentratorExperimental Treatment1 Intervention
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.
Group II: Standard of Care (SOC)Active Control1 Intervention
SOC is defined as the patient symptoms or complications based treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inogen One® G4
2022
N/A
~30

Find a Location

Who is running the clinical trial?

Inogen Inc.Lead Sponsor
4 Previous Clinical Trials
188 Total Patients Enrolled
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
10,865 Total Patients Enrolled
~6 spots leftby Nov 2025
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