Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients

Last updated: May 31, 2025
Sponsor: Rutger Lalieu
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Covid-19

Treatment

Hyperbaric oxygen therapy

Clinical Study ID

NCT06159309
MEC-2023-0433
  • Ages > 18
  • All Genders

Study Summary

Post-Covid syndrome, also known as long Covid, is a clinical condition in which patients experience long term symptoms after Covid-19 infection. Treatment options for post-Covid are not effective. Therefore, there is an urgent need for a novel therapy. The first study results of HBOT in post-Covid patients are promising. Previous research from Israel has shown improvements in quality of life after HBOT. However, long term results are unknown. Therefore, this study aims to evaluate quality of life at one year after hyperbaric oxygen therapy in post-Covid patients with cognitive symptoms. It is hypothesized that quality of life at one year after HBOT is improved. Furthermore, this study aims to evaluate return to work after HBOT. To our knowledge this was not done before. An observational prospective cohort study will be conducted to answer the research questions. All post-Covid patients who are treated with hyperbaric oxygen therapy in participating centers, will be eligible for inclusion. Questionnaires and medical 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 standard clinical care. The burden is approximately 40 minutes extra in total for participants, compared to standard clinical care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Long COVID patients who are reffered for treatment with hyperbaric oxygen therapy

  • Patients are suffering from cognitive symptoms for >3 months after Covidinfection

Exclusion

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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Hyperbaric oxygen therapy
Phase:
Study Start date:
February 06, 2023
Estimated Completion Date:
August 31, 2025

Study Description

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.

Connect with a study center

  • DVK Hogeveen

    Hoogeveen, Drenthe 7909 AK
    Netherlands

    Site Not Available

  • DVK Geldrop

    Geldrop, Noord-Brabant 5664 HB
    Netherlands

    Site Not Available

  • DVK Waalwijk

    Waalwijk, Noord-Brabant 5141 BM
    Netherlands

    Site Not Available

  • HGC Rijswijk

    Rijswijk, South-Holland 2288EG
    Netherlands

    Site Not Available

  • DVK Rotterdam

    Rotterdam, South-Holland 3081 AA
    Netherlands

    Site Not Available

  • DVK Amersfoort

    Amersfoort, Utrecht 3813 TZ
    Netherlands

    Site Not Available

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