← Back to Search

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

RESTORE Trial Summary

This trial is looking at the effects of a portable oxygen concentrator on brain hypoxia, peripheral oxygen saturation, and cognitive function in adults with long-term COVID-19.

Eligible Conditions

Coronavirus

RESTORE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14+/-3 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

COVID-19 related brain hypoxia and peripheral oxygen saturation

MoCA test

Other neuropsychological tests

+1 more

Secondary outcome measures

Anxiety, mood, and subjective cognitive impairment

Functional status

Pulmonary function

+1 more

RESTORE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Inogen Inc.Lead Sponsor

3 Previous Clinical Trials

148 Total Patients Enrolled

The Montreal Health Innovations Coordinating Center (MHICC)OTHER

13 Previous Clinical Trials

10,865 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are participating in this investigation?

"Affirmative. As evidenced by the information posted on clinicaltrials.gov, this medical experiment is presently seeking patients to enroll in it; with 20 participants sought from two different locations since its initial posting of June 8th 2022 and last update dated August 4th 2022."

Answered by AI

What is the primary goal of this research endeavor?

"This clinical trial will last approximately 14 +/- 3 days and aims to measure performance using the MoCA test. Additionally, its secondary objectives are assessing safety outcomes of Inogen One® G4 POC, determining how it affects post-COVID functional status, and observing any impacts on anxiety levels, moods, and subjective cognitive impairment."

Answered by AI

Is this experiment currently looking for participants?

"Affirmative. According to the clinicaltrials.gov portal, this medical trial commenced on June 8th 2022 and was most recently updated on August 4th 2022. The study requires 20 participants recruited from two healthcare facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Portable Oxygen Concentrator (POC) Versus Standard of Care in Long-COVID: Randomized Crossover Exploratory Pilot Study.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05212831.