NCT05212831

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Inogen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2022-06-08
• Primary completion: 2023-03-02
• Completion: 2023-03-02
• First posted: 2022-01-28
• Last updated: 2023-07-14

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated device study