RecruitingNot ApplicableNCT06082518

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments (PCS-HBOT Study)


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

40 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • Age ≥ 18 years old
  • Officially diagnosed with post COVID-19 condition by a healthcare practitioner
  • At least three months since SARS-CoV-2 infection
  • 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 Criteria5

  • Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)
  • Patients with cognitive difficulties and/or mental retardation before COVID diagnosis
  • History of traumatic brain injury
  • Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)
  • Known pregnancy or planning a pregnancy in women of childbearing age

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Interventions

DEVICEMonoplace 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.


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT06082518


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