Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition

Sponsor
University Health Network, Toronto
Study ID
NCT06452095
Status
Recruiting
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Conditions

  • Long COVID
  • Post Acute Sequelae of COVID-19
  • Post-COVID-19 Condition

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperbaric Oxygen therapy — DEVICE
    The SECHRIST INDUSTRIES mono-place Hyperbaric Chambers OR Sigma Series mono-place Hyperbaric Chambers

Study Details

The RECLAIM study platform will be used to explore whether the use of Hyperbaric Oxygen therapy (HBOT) improves the symptoms of post covid cognitive dysfunction. Hyperbaric oxygen therapy is a well-established medical treatment. HBOT promotes healing by delivering a high concentration of oxygen into the body. This high level of oxygen has a number of known benefits, such as growth of new blood vessels, as well as regulating immune and inflammation responses. It helps protect the brain and other nervous tissue from inflammation. HBOT may also have antiviral effects. Collectively, it has the potential to target the underlying mechanisms believed to play a critical role in the development of Long COVID. Many individuals with Long COVID complain of fatigue, brain fog, muscle aches and other symptoms. There is evidence to suggest that these symptoms may be a problem with the blood vessels, resulting in abnormal delivery of oxygen to tissues. Thus, our group is investigating whether HBOT improves post-COVID cognitive dysfunction.

Key Dates

First listed
Jun 11, 2024
Start date
Jan 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hyperbaric oxygen therapy
    HBOT GROUP will have HBOT with 100% oxygen for 90 min, once daily, five times a week for 8 consecutive weeks. This will be given at a slightly higher pressure than normal air pressure (2 times regular air pressure)
  • Sham Comparator: Hyperbaric oxygen sham
    CONTROL GROUP will have sham treatment, which will look and feel like HBOT, but will not have high enough oxygen concentration for any therapeutic or health benefit. Sham treatment with 21% oxygen (the amount of oxygen normally present in the air) for 90 min, once daily, five times a week for 8 consecutive weeks. This will be given at standard atmospheric pressure (1.03 ATA). The air pressure will vary slightly to mimic the feeling of HBOT.

Primary Outcome Measure

Simple reaction time [SRT] task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit [ Time Frame: Baseline/Start of intervention to two months ]

Central Contacts

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