Post-Covid syndrome, also known as long Covid, is a clinical condition in which patientsexperience long term symptoms after Covid-19 infection. Treatment options for post-Covidare not effective. Therefore, there is an urgent need for a novel therapy. The firststudy results of HBOT in post-Covid patients are promising. Previous research from Israelhas shown improvements in quality of life after HBOT. However, long term results areunknown. Therefore, this study aims to evaluate quality of life at one year afterhyperbaric oxygen therapy in post-Covid patients with cognitive symptoms. It ishypothesized that quality of life at one year after HBOT is improved. Furthermore, thisstudy aims to evaluate return to work after HBOT. To our knowledge this was not donebefore. An observational prospective cohort study will be conducted to answer theresearch questions. All post-Covid patients who are treated with hyperbaric oxygentherapy in participating centers, will be eligible for inclusion. Questionnaires andmedical doctor consultations will be used in order to collect all data.There are no risks for participants, since only 7 questionnaires are not part of standardclinical care. The burden is approximately 40 minutes extra in total for participants,compared to standard clinical care.
The study design is a prospective observational cohort study. Questionnaires and medical
doctor consultations will be used in order to collect all data. All patients treated with
HBOT have medical doctor consultations at baseline and every 10th session of HBOT
(standard clinical care).
At baseline, the following characteristics will be collected: gender, age, BMI, medical
history, Covid infection information, vaccination status, work status before Covid
infection, previous Covid treatments, hospital and/or intensive care unit admission
during Covid infection and smoking status. Furthermore, all patients treated are asked to
fill out the SF-36 and EQ-5D questionnaires, a proprietary post-Covid symptoms
questionnaire, and a questionnaire regaring work status. These questionnaires are
repeated after 20, 40 (50) sessions of HBOT and after 3 and 12 months after the last
treatment session.
During the following medical doctor consultations, side effects, changes in medication
and interruptions of HBOT will be recorded as well to monitor compliance.
An interim analysis will be performed after 6 months to continue or stop treatments,
based on the clinical results (as measured with the Physical Component Score of the SF-36
questionnaire). The minimal clinically important difference (MCID) to warrant early
termination of therapy is if <5% of patients improves 3 points. The upper limit (and
reason to continue) is if >50% achieve an MCID of 7 points.
Other: Hyperbaric oxygen therapy
HBOT per local protocol, i.e. 40 sessions 2.4 ATA, at the discretion of the hyperbaric
physician
Inclusion Criteria:
- Long COVID patients who are reffered for treatment with hyperbaric oxygen therapy
- Patients are suffering from cognitive symptoms for >3 months after Covid
infection
Exclusion Criteria:
- Patients who are not able to fill in questionnaires and informed consent.
- Patients who can't read or do not understand the Dutch language
DVK Hogeveen
Hoogeveen, Drenthe, Netherlands
DVK Geldrop
Geldrop, Noord-Brabant, Netherlands
DVK Waalwijk
Waalwijk, Noord-Brabant, Netherlands
HGC Rijswijk
Rijswijk, South-Holland, Netherlands
DVK Rotterdam
Rotterdam, South-Holland, Netherlands
DVK Amersfoort
Amersfoort, Utrecht, Netherlands
Not Provided