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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.
Enrollment
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Inclusion criteria
Exclusion criteria
History of cognitive dysfunction prior to COVID infection
Hospitalization for the treatment of COVID
Participating in another investigational trial or the use of an investigational drug within 30 days of screening
For individuals of childbearing potential:
positive pregnancy test at screening or lactating or unwilling to practice a medically acceptable form of contraception from screening to Day 14 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
History of pulmonary hypertension
History of narcolepsy
Moderate to severe COPD
Interstitial Pulmonary Fibrosis
End-tidal PCO2 >55 mmHg during training treatment
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
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37 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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