NCT06379620

Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction

Pilot Open Label Use of the Hi-OXSR to Increase PaCO2 for the Treatment of Post COVID-19 Cognitive Dysfunction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation. Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction.

Conditions

• Post COVID-19 Condition

Interventions

Type	Name	Description
DEVICE	Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)	Subjects will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days

Timeline

• Start date: 2022-11-29
• Primary completion: 2024-03-04
• Completion: 2024-03-04
• First posted: 2024-04-23
• Last updated: 2024-04-25

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study