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

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.

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Key information

Conditions

Post COVID-19 Condition COVID-19 Chronic Disease Cognition Disorders Cognitive Dysfunction Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Mental Disorders Neurocognitive Disorders Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ability to provide written informed consent.
Previously diagnosed with cognitive dysfunction following recovery from COVID.
Not pregnant at time of study.
Oxygen saturation on room air ≥92% at screening.
Willing and able to comply with the treatment schedule and procedures.

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

Treatment and study plan

Hi-OxSR Sequential Rebreathing mask (oxygen concentrator)

Device

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

Primary outcomes

Safety of use of Hi-OX sequential rebreathing device

Time frame: 45 days

Any unanticipated adverse events reporting

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: Hi-OXSR

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Apr 23, 2024
Registry last updated: Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed