Post COVID-19 ConditionPost-COVID-19 SyndromePost-COVID SyndromeCOVID-19FatigueFatigue Syndrome, Chronic
Investigational drug(s) / intervention(s)
Monoplace Hyperbaric Chamber (Class III medical device).
Monoplace Hyperbaric Chamber (Class III medical device).: 40 hyperbaric oxygen therapy (HBOT) treatments (90 minute exposures at 2 atmospheres (ATM) per treatment), scheduled daily from Monday to Friday (i.e., 5 treatments per week) until treatments are completed (approximately 8 weeks). Treatments will be delivered in a medical grade, Health Canada-approved monoplace hyperbaric chamber and overseen by specialist hyperbaric physicians and a Certified Hyperbaric Technologist.
Device is being used in manner consistent with approved usage in Canada.
Study summary
Over 500 million people have been infected with COVID-19, and to date, more than 6 million people have died. Many individuals who have recovered from COVID-19 continue to experience symptoms even after they have been "cured" of the disease. This condition is known as post COVID-19 condition, which can have serious health consequences. A common symptom among these individuals is chronic fatigue, characterized by persistent tiredness or lack of energy. This study aims to explore a novel treatment for symptoms of post COVID-19 condition, known as hyperbaric oxygen therapy. This approach has shown promise in helping people with post COVID-19 conditions and treating some other causes of fatigue.
Hyperbaric oxygen therapy involves placing patients in a small chamber where they receive high oxygen gas levels. However, this treatment is expensive and time-consuming, and it is unclear if this treatment can be effectively assessed in a large-scale research study. This small study will help us decide if conducting a large research study is feasible. The investigators aim to assess if hyperbaric oxygen therapy can improve symptoms of post COVID-19 condition, such as fatigue.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years old
2. Officially diagnosed with post COVID-19 condition by a healthcare practitioner
3. At least three months since SARS-CoV-2 infection
4. Symptoms that persist more than 12 weeks:
* Chronic fatigue (must include) along with one of the following symptoms:
* Difficulty thinking or problem solving ('brain fog')
* Stress or anxiety
Exclusion Criteria:
1. Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)
2. Patients with cognitive difficulties and/or mental retardation before COVID diagnosis
3. History of traumatic brain injury
4. Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)
5. Known pregnancy or planning a pregnancy in women of childbearing age
Adherence to HBOT protocol — 9 months recruitment + 8 weeks treatment Number of Participants received minimum 4 treatments per week with \>35 treatments
Adherence to HBOT protocol - satisfaction — After last HBOT treatment and at 12 month follow-up Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment
Feasibility of Clinical Outcome Measures — Up to 1 year after start of treatment Feasibility of implementation of clinical outcome scales (PDQ, FSS, SF-36) to be completed at the time of enrollment (baseline), start of treatment (if starting 60 days after enrollment), 4 weeks after the start of treatment, and every 2 months from the first HBOT treatment for 1 year.
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Health Sciences Centre
Toronto
Ontario
More Sunnybrook Health Sciences Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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