An interventional study of Monoplace Hyperbaric Chamber (Class III medical device). in Post COVID-19 Condition, Post-COVID-19 Syndrome and Post-COVID Syndrome, sponsored by Sunnybrook Health Sciences Centre. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
Over 500 million individuals worldwide have contracted COVID-19. Among those that have 'recovered' from the acute infection, many suffer from post-COVID-19 condition (experiencing 1 or more symptoms 3 months from the onset of acute COVID-19 infection, with symptoms lasting at least 2 months). Many of these common symptoms, including fatigue, myalgia, and difficulty focusing ('brain fog'), can seriously compromise one's quality of life.
Existing treatments predominantly focus on supportive management and specific symptom control, and most approaches have mixed or limited effectiveness. Recently, hyperbaric oxygen therapy (HBOT), acknowledged for its anti-inflammatory effects, has emerged as a potential treatment for post-COVID-19 condition symptoms. However, HBOT is time and resource-intensive, requiring between 20-40 daily treatments. Therefore, the feasibility of assessing HBOT efficacy via a large-scale randomized controlled trial is still being determined. Hence, this study aims to evaluate adherence to the protocol and the feasibility of proceeding with the full trial. The goal of the full trial will be to evaluate the impact of HBOT treatment on post-COVID-19 condition symptoms.
This prospective, crossover, randomized pilot trial enrolls adult patients officially diagnosed with post-COVID-19 condition by a healthcare practitioner who continue to experience symptoms, particularly fatigue, at least 3 months following their initial COVID-19 infection. Participants will be assigned randomly (stratified by sex) to either begin HBOT treatments immediately or after a 60-day interval. All patients will be followed for 12 months from the start of treatment, with assessments 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. A subjective questionnaire regarding patient satisfaction will also be completed after the last HBOT treatment session and at 1 year after the start of treatment.
520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Symptoms that persist more than 12 weeks:
Exclusion Criteria:
HBOT treatments will be scheduled to start immediately after referral.
Device: Monoplace Hyperbaric Chamber (Class III medical device).
HBOT treatments will be scheduled to start 60 days after referral.
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.
Recruitment rate - referral
Quantify referral rate from healthcare providers
Time frame: 9 months
Recruitment rate - inclusion
Number of patients meeting inclusion criteria
Time frame: 9 months
Recruitment rate - consent
Patient consent rate
Time frame: 9 months
Adherence to HBOT protocol
Number of Participants received minimum 4 treatments per week with \>35 treatments
Time frame: 9 months recruitment + 8 weeks treatment
Adherence to HBOT protocol - satisfaction
Subjective patient satisfaction questionnaire inquiring about HBOT experience, barriers to and promoters of treatment
Time frame: After last HBOT treatment and at 12 month follow-up
Feasibility of Clinical Outcome Measures
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.
Time frame: Up to 1 year after start of treatment
The impact of HBOT on post COVID-19 condition - PDQ
The validated clinical deficit scale, Perceived Deficits Questionnaire (PDQ), will be used 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
Time frame: Up to 1 year after start of treatment
The impact of HBOT on post COVID-19 condition - FSS
The validated clinical deficit scale, Fatigue Severity Scale (FSS), will be used 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
Time frame: Up to 1 year after start of treatment
The impact of HBOT on post COVID-19 condition - SF-36
The validated clinical deficit scale, QoL Short Form Survey (SF-36), will be used 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.
Time frame: Up to 1 year after start of treatment
The impact of time to initiation of HBOT on outcomes following initial infection outcome - PDQ
Validated clinical deficit scales PDQ will be compared with FSS and SF-36 between immediate and delayed start groups
Time frame: Up to 1 year after start of treatment
The impact of time to initiation of HBOT on outcomes following initial infection outcome - FSS
Validated clinical deficit scale FSS will be compared with PDQ and SF-36 between immediate and delayed start groups
Time frame: Up to 1 year after start of treatment
The impact of time to initiation of HBOT on outcomes following initial infection outcome - SF-36
Validated clinical deficit scale SF-36 will be compared with PDQ and FSS between immediate and delayed start groups
Time frame: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - PDQ
Validated clinical deficit scale PDQ will be compared relative to baseline scores
Time frame: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - FSS
Validated clinical deficit scale FSS will be compared relative to baseline scores
Time frame: Up to 1 year after start of treatment
Initial infection severity as a mediator of HBOT impact - SF-36
Validated clinical deficit scale SF-36 will be compared relative to baseline scores
Time frame: Up to 1 year after start of treatment
Long-term symptomatic impact at 1 year - PDQ
Assessed using validated clinical deficit scale PDQ at 12 months after start of treatment
Time frame: 12 month follow-up
Long-term symptomatic impact at 1 year - FSS
Assessed using validated clinical deficit scale FSS at 12 months after start of treatment
Time frame: 12 month follow-up
Long-term symptomatic impact at 1 year - SF-36
Assessed using validated clinical deficit scales SF-36 at 12 months after start of treatment
Time frame: 12 month follow-up
Plan to share: Yes — De-identified data will be available upon request to study PIs following publication.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre