Long COVIDQoL COVID HBOTNCT06159309
Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients
An observational study of Long COVID and Long COVID-19 Syndrome, run by Rutger Lalieu at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Long COVID-19 Syndrome, Long Covid19
- What is being tested?
- Hyperbaric oxygen therapy
- How many people
- 200 participants
- Where
- 6 sitesNetherlands
- Study dates
- 6 Feb 2023to Aug 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will consist of post-Covid patients from the Netherlands, who are treated with hyperbaric oxygen therapy at several different treatment centers. All patients are adults and will receive standard clinical hyperbaric oxygen therapy at these clinics.
Who may be able to join
- Long COVID patients who are reffered for treatment with hyperbaric oxygen therapy
- Patients are suffering from cognitive symptoms for \>3 months after Covid infection
Who cannot join
- Patients who are not able to fill in questionnaires and informed consent.
- Patients who can't read or do not understand the Dutch language
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
DVK Amersfoort
Amersfoort, Utrecht, 3813 TZ
DVK Geldrop
Geldrop, North Brabant, 5664 HB
DVK Hogeveen
Hoogeveen, Drenthe, 7909 AK
HGC Rijswijk
Rijswijk, South Holland, 2288EG
DVK Rotterdam
Rotterdam, South Holland, 3081 AA
DVK Waalwijk
Waalwijk, North Brabant, 5141 BM
About this study
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.
Read the detailed 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.
- Conditions
- Long COVID, Long COVID-19 Syndrome, Long Covid19, Long Covid 19
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- registry, covid, long-covid, post-covid
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyOther
HBOT per local protocol, i.e. 40 sessions 2.4 ATA, at the discretion of the hyperbaric physician
| Study group | Role | What they receive |
|---|---|---|
| Long Covid patients | All post-COVID patients that are referred for hyperbaric oxygen (and that are eligible for treatment) Receives: Other: Hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life 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
Measured: 3 and 12 months
Secondary outcomes (5)
Long Covid symptoms
What symptoms do Long COVID patients who were referred for HBOT suffer from?
Measured: 3 and 12 months
Cognitive complaints
Is there any improvement of symptoms in Long COVID patients with cognitive symptoms during HBOT and after HBOT?
Measured: 3 and 12 months
Work
Do changes in absence at work occur after treatment with HBOT in Long COVID patients with cognitive symptoms?
Measured: 3 and 12 months
Risk factors quality of life
What are risk factors for low health related quality of life in Long COVID patients with cognitive symptoms who are treated with HBOT?
Measured: 3 and 12 months
Profile of non-responders versus responders
What are the differences in baseline characteristics of patients that are non-responders and responders after HBOT?
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start6 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Rutger Lalieu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rutger Lalieu, Hyperbaar Geneeskundig Centrum Rijswijk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159309
- Sponsor's protocol ID
- MEC-2023-0433
- Acronym
- QoL COVID HBOT
- Status last verified
- May 2025
- First submitted
- 4 Dec 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is retrieved from patient files (after informed consent). Even though the data is pseudonymised, there is too much risk of confidentialty breach.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients
- ClinicalTrials.gov ID
- NCT06159309
- Acronym / sponsor ID
- QoL COVID HBOT / MEC-2023-0433
- Conditions
- Long COVID, Long COVID-19 Syndrome, Long Covid19, Long Covid 19
- Keywords
- registry, covid, long-covid, post-covid
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rutger LalieuUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long Covid patients | – | Other: Hyperbaric oxygen therapyAll post-COVID patients that are referred for hyperbaric oxygen (and that are eligible for treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will consist of post-Covid patients from the Netherlands, who are treated with hyperbaric oxygen therapy at several different treatment centers. All patients are adults and will receive standard clinical hyperbaric oxygen therapy at these clinics.
Key inclusion criteria (2 listed)
- Long COVID patients who are reffered for treatment with hyperbaric oxygen therapy
- Patients are suffering from cognitive symptoms for \>3 months after Covid infection
Key exclusion criteria (2 listed)
- Patients who are not able to fill in questionnaires and informed consent.
- Patients who can't read or do not understand the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyHBOT per local protocol, i.e. 40 sessions 2.4 ATA, at the discretion of the hyperbaric physician | Other | Long Covid patients |
Primary outcome
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
5 secondary outcomes
Long Covid symptoms
Time frame: 3 and 12 months
Cognitive complaints
Time frame: 3 and 12 months
Work
Time frame: 3 and 12 months
Risk factors quality of life
Time frame: 3 and 12 months
Profile of non-responders versus responders
Time frame: 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No. The data is retrieved from patient files (after informed consent). Even though the data is pseudonymised, there is too much risk of confidentialty breach.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and Long COVID-19 Syndrome, run by Rutger Lalieu at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life 3 and 12 months (time frame: 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.