The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action. The main questions it aims to answer are: * What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID? * What are the changes in absence from work after treatment with HBOT? * What is the cost-effectiveness of treatment with HBOT? * What are possible mechanisms of action of HBOT? Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)
Da Vinci Clinic
Amersfoort, Netherlands
Da Vinci Clinic
Geldrop, Netherlands
Da Vinci Clinic
Hoogeveen, Netherlands
HGC Rijswijk
Rijswijk, Netherlands
Da Vinci Clinic
Rotterdam, Netherlands
Erasmus MC
Rotterdam, Netherlands
Da Vinci Clinic
Waalwijk, Netherlands
Physical and mental component scores of the 36-item Short Form Survey (SF-36)
Range 0-100, with higher scores indicating higher quality of life
Time frame: Week 20 (i.e. 3-months after end of HBOT)
Euroqol-5D (EQ-5D)
Descriptive for 5 dimensions + visual analogue score (VAS, range 0-100 with higher scores indicating higher quality of life)
Time frame: Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment).
Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns
Time frame: Worn continuously until week 34
Biochemical parameters
Time frame: Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)
Absence from work
Time frame: Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment).
Cost-effectiveness
Time frame: Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).
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