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Active, Not Recruiting

NCT Number: NCT06159309

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Long COVID COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Long COVID-19 Syndrome Long Covid 19 Long Covid19 Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DVK Hogeveen, Hoogeveen, Drenthe, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Long COVID patients who are reffered for treatment with hyperbaric oxygen therapy
  • Patients are suffering from cognitive symptoms for &gt;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

Treatment and study plan

Hyperbaric Oxygen Therapy

Other

HBOT per local protocol, i.e. 40 sessions 2.4 ATA, at the discretion of the hyperbaric physician

Primary outcomes

  1. Quality of life 3 and 12 months

    Time frame: 3 and 12 months

    Is the expected improvement in quality of life in Long COVID patients after treatment with HBOT maintained at 12-months follow-up

Secondary outcomes

  1. Long Covid symptoms

    Time frame: 3 and 12 months

    What symptoms do Long COVID patients who were referred for HBOT suffer from?

  2. Cognitive complaints

    Time frame: 3 and 12 months

    Is there any improvement of symptoms in Long COVID patients with cognitive symptoms during HBOT and after HBOT?

  3. Work

    Time frame: 3 and 12 months

    Do changes in absence at work occur after treatment with HBOT in Long COVID patients with cognitive symptoms?

  4. Risk factors quality of life

    Time frame: 3 and 12 months

    What are risk factors for low health related quality of life in Long COVID patients with cognitive symptoms who are treated with HBOT?

  5. Profile of non-responders versus responders

    Time frame: 3 and 12 months

    What are the differences in baseline characteristics of patients that are non-responders and responders after HBOT?

Sponsors and collaborators

Lead sponsor

Rutger Lalieu

Other

Registry information

Acronym: QoL COVID HBOT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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