NCT05212831

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

January 21, 2022

Last Update Submit

July 13, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

  • 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

    14+/-3 days

  • VO2max during cardiopulmonary exercise test

    To describe the effect of the Inogen One® G4 POC on VO2max during cardiopulmonary exercise test

    14+/-3 days

  • MoCA test

    To describe the effect of the Inogen One® G4 POC on Cognitive performance using the MoCA test

    14+/-3 days

  • Other neuropsychological tests

    To describe the effect of the Inogen One® G4 POC on Cognitive health assessments using other neuropsychological tests

    14+/-3 days

Secondary Outcomes (4)

  • Functional status

    14+/-3 days

  • Anxiety, mood, and subjective cognitive impairment

    14+/-3 days

  • Pulmonary function

    14+/-3 days

  • Safety outcomes

    14+/-3 days

Study Arms (2)

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.

Device: Inogen One® G4

Interventions

Inogen One® G4DEVICE

Inogen One® G4 will be used for a minimum of 3h per day at Setting 3 during the intervention period.

Portable Oxygen Concentrator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

Centre ÉPIC de l'Institut de cardiologie de Montréal

Montreal, Quebec, H1T1N6, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

January 28, 2022

Study Start

June 8, 2022

Primary Completion

March 2, 2023

Study Completion

March 2, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)