Post-COVID ME/CFSNCT06118138
Hyperbaric High Pressure Oxygen Therapy in Post-COVID Syndrome and ME/CFS
An observational study of Post-COVID ME/CFS, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The objective of this observational study is to document symptom progression in 60 patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) who undergo Hyperbaric Oxygen Therapy (HBOT) following COVID or other infections. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-COVID ME/CFS
- What is being tested?
- Hyperbaric oxygen therapy (HBOT)
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sixty male or female patients, aged between 18 and 65 years, will be included in the study. ME/CFS patients currently participating in the CFS_CARE study through the Bavaria Clinic in Kreischa will have the opportunity to receive HBOT treatment as an additional option provided by the clinic upon completion of the CFS_CARE study. Additionally, these patients will be invited to participate in this observational study during the final CFS_CARE presentation at the 12-month mark.
Who may be able to join
- Participants between the ages of 18 and 65 years who have previously participated in the CFS_CARE study and have been diagnosed with ME/CFS
- ME/CFS diagnosis based on the Canadian Consensus Criteria (CCC), characterized by exercise intolerance and symptom worsening lasting for a minimum of 14 hours
- Disease severity determined by a Bell Score ranging from 30 to 70
- Plan to undergo 20 or 40 days of HBOT
- Consent provided by the patient
Who cannot join
- Unwillingness to consent to the storage of pseudonymized clinical data as a part of the study
- Pregnancy
- Presence of medical conditions that could potentially pose a risk during HBOT (e.g., heart failure, pulmonary disease, major depression, panic attacks)
- Acute infection (e.g., COVID, HIV, or hepatitis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Observational Study of Hyperbaric High Pressure Oxygen Therapy (HBOT) in Patients With Post-COVID Syndrome (PCS) and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
The objective of this observational study is to document symptom progression in 60 patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) who undergo Hyperbaric Oxygen Therapy (HBOT) following COVID or other infections. Participants will receive HBOT treatment as an additional option after completing the Chronic Fatigue Syndrome CARE (CFS_CARE) study and will be invited to take part in this observational study. Patients will complete health evaluations in the form of questionnaires, including the 36-Item Short Form Health Survey (SF-36), to assess changes in ME/CFS-related symptoms after HBOT. Rather than evaluating the efficacy of HBOT itself, the study will focus on observing and documenting these changes. Its goal is to offer valuable insights into symptom progression in ME/CFS patients receiving HBOT, which can serve as a foundation for future interventional randomized controlled trials.
Read the detailed description
Following mild to moderate COVID infection, around 10% of individuals develop post-COVID syndrome (PCS) characterized by symptoms like fatigue, exercise intolerance, cognitive impairment, headaches, and muscle pain (Kedor et al., 2022). Some PCS patients may later be diagnosed with ME/CFS, a severe and chronic disease triggered by infections (Renz-Polster \& Scheibenbogen, 2022). ME/CFS presents symptoms such as debilitating fatigue, exercise intolerance, post-exertional malaise (PEM), headaches, muscle pain, cognitive impairment ("brain fog"), orthostatic intolerance, autonomic dysfunction, sleep disturbances, and a general feeling of illness. Currently, no curative therapy for ME/CFS exists. Therapeutic procedures for ME/CFS mainly focus on symptom management, but evidence-based and standardized treatments are urgently needed due to the high number of patients and the impact on healthcare (Renz-Polster \& Scheibenbogen, 2022). Off-label drug and non-drug approaches are used, but their effectiveness lacks sufficient evidence from controlled trials.
ME/CFS and PCS may have different underlying pathomechanisms, with some patients showing endothelial dysfunction and reduced blood flow (Haffke et al., 2022). Enhancing blood flow and promoting the formation of new capillaries is a potential therapeutic approach due to the presumed role of reduced blood flow. In this regard, HBOT is under investigation as a treatment for ME/CFS and PCS, showing promising results in trials (e.g., Zilberman-Itskovich et al., 2022; Robbins et al., 2021; Kjiellberg et al., 2022; Akarsu et al., 2013). This non-interventional observational study aims to document symptom progression in 60 patients with ME/CFS who underwent HBOT following COVID or other infections. The study does not focus on evaluating the efficacy of HBOT itself.
ME/CFS patients currently participating in the Chronic Fatigue Syndrome CARE (CFS_CARE) study at Klinik Bavaria in Kreischa will have the opportunity to receive HBOT treatment as a supplementary offer from the clinic upon completion of the CFS_CARE study. Additionally, these patients will be invited to participate in this observational study during the final CFS_CARE presentation at the 12-month mark. HBOT is performed as part of the Conformité Européenne (CE) certificate, as an outpatient procedure within standard clinical practice, and independent of the study focus. Throughout the HBOT treatment, patients will undergo health assessments and symptom evaluations four weeks after treatment initiation and four weeks after completing the HBOT sessions. To facilitate this, patients will receive a link to a RedCap file containing questionnaires, including those previously utilized in the CFS_CARE study (36-Item Short Form Health Survey (SF-36), Munich Berlin Symptom Questionnaire (MBSQ), Chalder Fatigue Questionnaire, Bell Score). Completing the questionnaires typically requires approximately 45 minutes. The questionnaires will be collected every two months over 12 months, resulting in a total follow-up period of 10 months. A follow-up visit at the outpatient clinic is scheduled for four weeks after HBOT is completed.
The study's primary endpoint is to identify improvements in physical function following HBOT. This will be achieved by utilizing the SF-36 Physical Function (PF) questionnaire, which commonly serves as the primary endpoint in clinical trials focused on ME/CFS. It has been shown that an increase of at least 10 points in the SF-36 PF (range 0 - 100 = healthy) defines clinically relevant improvement ("a little better"), and an increase of 20 points defines greater clinical improvement ("much better") (Brigden 2018). Therefore, an increase of at least 10 points 4 weeks after HBOT is defined as a response and assessed as the primary endpoint.
The study-related measures do not pose significant risks or additional burdens to participants aside from the time required to complete the questionnaires. However, it has the potential to generate valuable knowledge regarding HBOT as a potential treatment for ME/CFS. To date, there has been no documentation of the efficacy of HBOT in ME/CFS through a clinical trial employing objective methods. The results of this observational study are expected to serve as the foundation for a potential interventional randomized controlled trial (RCT).
- Conditions
- Post-COVID ME/CFS
- Being tested
- Hyperbaric oxygen therapy (HBOT)
- Keywords
- Post-COVID Syndrome, Long COVID, Chronic Fatigue Syndrome
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapy (HBOT)Combination product
HBOT is a medical treatment employed for various conditions. It entails breathing 100% oxygen within a pressurized chamber known as a hyperbaric chamber. This oxygen-rich environment promotes healing and aids in combating specific infections.
In this study, the investigators will administer HBOT using a hyperbaric chamber set to 2 times the normal atmospheric pressure, indicated as 2 atmosphere absolute (ATA). This pressure surge enhances oxygen dissolution into the bloodstream, surpassing levels achievable at sea level. The pressure will be raised incrementally, followed by HBOT sessions lasting for a total of 90 minutes. The 90-minute sessions include brief 5-minute intervals for ambient air every 20 minutes to ensure safety and comfort. Treatment will be conducted five days a week over eight weeks.
Supervised by competent healthcare professionals, HBOT is considered safe, with potential side effects primarily stemming from heightened pressure and, in rare cases, oxygen toxicity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36).
The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change of 10 points in SF-36-PF from baseline to week four is considered clinically meaningful.
Measured: 4 weeks after completion of HBOT therapy
Secondary outcomes (8)
Duration of improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)
Duration of the effect of HBOT therapy as assessed by SF-36 PF. Intra-patient change in physical and mental fatigue from baseline to follow-up points will be documented as indexed by the SF-36 PF.
Measured: Collected every 2 months over a total of 12 months after completion of HBOT therapy
Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale
The Chalder Fatigue Scale measures the extent and severity of tiredness and has been used in multiple randomized trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is answered on a 4-point scale with an overall score ranging from 0 (asymptomatic) to 33 (maximum symptomology). Intra-patient change in physical and mental fatigue from baseline to follow-up points will be documented as indexed by the Chalder Fatigue Scale.
Measured: Collected every 2 months over a total of 12 months after completion of HBOT therapy
Improvement in functional disability as measured by the Bell disability scale
The Bell disability scale is a standard assessment in ME/CFS that evaluates functional ability in adult ME/CFS patients. Eleven statements describe patient status such as level of symptoms at rest, level of symptoms with exercise, activity level, and ability to perform work, travel and self care. Its score ranges from 0 (bedridden) to 100 (no symptoms). Intra-patient change from baseline to follow-up points will be documented as indexed by the Bell score.
Measured: Collected every 2 months over a total of 12 months after completion of HBOT therapy
Improvement in disease severity based on self- reported symptoms as measured by the Munich Berlin Symptom Questionnaire (MBSQ)
The Munich Berlin Symptom Questionnaire (MBSQ) is a questionnaire for ME/CFS that captures the Institute of Medicine (IOM) and Canadian Consensus Criteria (CCC) as well as a total of 44 symptoms from 8 domains on a scale of 0 - 4 for frequency and severity. From this, a score for total symptom severity ranging from 0 (not present) to 352 (very severe) is calculated. Intra-patient change from baseline to follow-up points will be documented as indexed by the MBSQ.
Measured: Collected every 2 months over a total of 12 months after completion of HBOT therapy
Improvement in muscle strength as measured by the hand grip strength (HGS) test
The Hand Grip Strength (HGS) test is a simple yet effective measurement of muscular strength. It involves gripping a dynamometer (or other grip strength measurement device) with maximal force using the dominant hand. The device measures exerted force in kilograms or pounds. Hand grip strength reflects overall muscle strength providing insights into a person's physical health, functional capacity, and potential muscular deficiencies. Intra-patient change in hand grip strength (HGS) from baseline to week four.
Measured: 4 weeks after completion of HBOT therapy
Assessment and documentation of tolerability
Assessment and documentation of tolerability with a questionnaire that is collected at the end of the HBOT therapy
Measured: On the day of completion of HBOT therapy
Improvement in orthostatic tolerance as measured by the National Aeronautics and Space Administration (NASA) 10 Minute Lean Test
The NASA 10-Minute Lean Test evaluates a person's susceptibility to gravitational effects. In post-COVID ME/CFS research, it probes cardiovascular and autonomic nervous system issues stemming from a SARS-CoV-2 infection. During the test, an person lies flat on their back with a slightly elevated head, while blood pressure and heart rate are monitored during a controlled tilt to a head-down position. In about 10 minutes, this provides valuable insights into cardiovascular adaptability and potential dysregulation, aiding understanding of symptoms like dizziness, fatigue, and palpitations in long-COVID patients. Intra-patient change in the NASA 10 Minute Lean Test from baseline to week four.
Measured: 4 weeks after completion of HBOT therapy
Improvement in exercise capacity measured by the 1-Minute Sit-to-Stand Test
The 1-Minute Sit-to-Stand Test is a validated and reliable test for quantifying exercise capacity. In this test, the person starts in a seated position and is instructed to stand up and sit down as many times as possible within a one-minute period. The test provides valuable insights into a person's muscle strength, endurance, and overall physical fitness. Intra-patient change in the 1-minute Sit-to-Stand Test from baseline to week four.
Measured: 4 weeks after completion of HBOT therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start15 Jul 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post-COVID ME/CFSStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- KLINIK BAVARIA Kreischa, Vivantes Klinikum im Friedrichshain
- Responsible party
- Principal investigator, Carmen Scheibenbogen, Charite University, Berlin, Germany
- Investigators
- Carmen Scheibenbogen, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118138
- Sponsor's protocol ID
- HBOT
- Other IDs
- 01EP2201
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kedor C, Freitag H, Meyer-Arndt L, Wittke K, Hanitsch LG, Zoller T, Steinbeis F, Haffke M, Rudolf G, Heidecker B, Bobbert T, Spranger J, Volk HD, Skurk C, Konietschke F, Paul F, Behrends U, Bellmann-Strobl J, Scheibenbogen C. A prospective observational study of post-COVID-19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity. Nat Commun. 2022 Aug 30;13(1):5104. doi: 10.1038/s41467-022-32507-6.
PubMed 36042189Renz-Polster H, Scheibenbogen C. [Post-COVID syndrome with fatigue and exercise intolerance: myalgic encephalomyelitis/chronic fatigue syndrome]. Inn Med (Heidelb). 2022 Aug;63(8):830-839. doi: 10.1007/s00108-022-01369-x. Epub 2022 Jul 13. German.
PubMed 35925074Haffke M, Freitag H, Rudolf G, Seifert M, Doehner W, Scherbakov N, Hanitsch L, Wittke K, Bauer S, Konietschke F, Paul F, Bellmann-Strobl J, Kedor C, Scheibenbogen C, Sotzny F. Endothelial dysfunction and altered endothelial biomarkers in patients with post-COVID-19 syndrome and chronic fatigue syndrome (ME/CFS). J Transl Med. 2022 Mar 22;20(1):138. doi: 10.1186/s12967-022-03346-2.
PubMed 35317812Zilberman-Itskovich S, Catalogna M, Sasson E, Elman-Shina K, Hadanny A, Lang E, Finci S, Polak N, Fishlev G, Korin C, Shorer R, Parag Y, Sova M, Efrati S. Hyperbaric oxygen therapy improves neurocognitive functions and symptoms of post-COVID condition: randomized controlled trial. Sci Rep. 2022 Jul 12;12(1):11252. doi: 10.1038/s41598-022-15565-0.
PubMed 35821512Robbins T, Gonevski M, Clark C, Baitule S, Sharma K, Magar A, Patel K, Sankar S, Kyrou I, Ali A, Randeva HS. Hyperbaric oxygen therapy for the treatment of long COVID: early evaluation of a highly promising intervention. Clin Med (Lond). 2021 Nov;21(6):e629-e632. doi: 10.7861/clinmed.2021-0462.
PubMed 34862223Kjellberg A, Abdel-Halim L, Hassler A, El Gharbi S, Al-Ezerjawi S, Bostrom E, Sundberg CJ, Pernow J, Medson K, Kowalski JH, Rodriguez-Wallberg KA, Zheng X, Catrina S, Runold M, Stahlberg M, Bruchfeld J, Nygren-Bonnier M, Lindholm P. Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial. BMJ Open. 2022 Nov 2;12(11):e061870. doi: 10.1136/bmjopen-2022-061870.
PubMed 36323462Akarsu S, Tekin L, Ay H, Carli AB, Tok F, Simsek K, Kiralp MZ. The efficacy of hyperbaric oxygen therapy in the management of chronic fatigue syndrome. Undersea Hyperb Med. 2013 Mar-Apr;40(2):197-200.
PubMed 23682549Kim L, Camma G, Peters CK, Mantwill M, Muller O, Lepretre N, Heindrich C, Rust R, Krill M, Hartung TJ, Reess LG, Krohn S, Heymann CV, Wittke K, Finke C, Scheibenbogen C. Hyperbaric oxygen therapy improves clinical symptoms and functional capacity and modulates thalamic connectivity in ME/CFS: a prospective cohort study. J Transl Med. 2026 Jun 5;24(1):744. doi: 10.1186/s12967-026-08324-6.
PubMed 42249466
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Hyperbaric High Pressure Oxygen Therapy (HBOT) in Patients With Post-COVID Syndrome (PCS) and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- ClinicalTrials.gov ID
- NCT06118138
- Acronym / sponsor ID
- HBOT
- Conditions
- Post-COVID ME/CFS
- Keywords
- Post-COVID Syndrome, Long COVID, Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- KLINIK BAVARIA Kreischa, Vivantes Klinikum im Friedrichshain
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Nov 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.
The objective of this observational study is to document symptom progression in 60 patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) who undergo Hyperbaric Oxygen Therapy (HBOT) following COVID or other infections. Participants will receive HBOT treatment as an additional option after completing the Chronic Fatigue Syndrome CARE (CFS_CARE) study and will be invited to take part in this observational study. Patients will complete health evaluations in the form of questionnaires, including the 36-Item Short Form Health Survey (SF-36), to assess changes in ME/CFS-related symptoms after HBOT. Rather than evaluating the efficacy of HBOT itself, the study will focus on observing and documenting these changes. Its goal is to offer valuable insights into symptom progression in ME/CFS patients receiving HBOT, which can serve as a foundation for future interventional randomized controlled trials.
Detailed description
Following mild to moderate COVID infection, around 10% of individuals develop post-COVID syndrome (PCS) characterized by symptoms like fatigue, exercise intolerance, cognitive impairment, headaches, and muscle pain (Kedor et al., 2022). Some PCS patients may later be diagnosed with ME/CFS, a severe and chronic disease triggered by infections (Renz-Polster \& Scheibenbogen, 2022). ME/CFS presents symptoms such as debilitating fatigue, exercise intolerance, post-exertional malaise (PEM), headaches, muscle pain, cognitive impairment ("brain fog"), orthostatic intolerance, autonomic dysfunction, sleep disturbances, and a general feeling of illness. Currently, no curative therapy for ME/CFS exists. Therapeutic procedures for ME/CFS mainly focus on symptom management, but evidence-based and standardized treatments are urgently needed due to the high number of patients and the impact on healthcare (Renz-Polster \& Scheibenbogen, 2022). Off-label drug and non-drug approaches are used, but their effectiveness lacks sufficient evidence from controlled trials.
ME/CFS and PCS may have different underlying pathomechanisms, with some patients showing endothelial dysfunction and reduced blood flow (Haffke et al., 2022). Enhancing blood flow and promoting the formation of new capillaries is a potential therapeutic approach due to the presumed role of reduced blood flow. In this regard, HBOT is under investigation as a treatment for ME/CFS and PCS, showing promising results in trials (e.g., Zilberman-Itskovich et al., 2022; Robbins et al., 2021; Kjiellberg et al., 2022; Akarsu et al., 2013). This non-interventional observational study aims to document symptom progression in 60 patients with ME/CFS who underwent HBOT following COVID or other infections. The study does not focus on evaluating the efficacy of HBOT itself.
ME/CFS patients currently participating in the Chronic Fatigue Syndrome CARE (CFS_CARE) study at Klinik Bavaria in Kreischa will have the opportunity to receive HBOT treatment as a supplementary offer from the clinic upon completion of the CFS_CARE study. Additionally, these patients will be invited to participate in this observational study during the final CFS_CARE presentation at the 12-month mark. HBOT is performed as part of the Conformité Européenne (CE) certificate, as an outpatient procedure within standard clinical practice, and independent of the study focus. Throughout the HBOT treatment, patients will undergo health assessments and symptom evaluations four weeks after treatment initiation and four weeks after completing the HBOT sessions. To facilitate this, patients will receive a link to a RedCap file containing questionnaires, including those previously utilized in the CFS_CARE study (36-Item Short Form Health Survey (SF-36), Munich Berlin Symptom Questionnaire (MBSQ), Chalder Fatigue Questionnaire, Bell Score). Completing the questionnaires typically requires approximately 45 minutes. The questionnaires will be collected every two months over 12 months, resulting in a total follow-up period of 10 months. A follow-up visit at the outpatient clinic is scheduled for four weeks after HBOT is completed.
The study's primary endpoint is to identify improvements in physical function following HBOT. This will be achieved by utilizing the SF-36 Physical Function (PF) questionnaire, which commonly serves as the primary endpoint in clinical trials focused on ME/CFS. It has been shown that an increase of at least 10 points in the SF-36 PF (range 0 - 100 = healthy) defines clinically relevant improvement ("a little better"), and an increase of 20 points defines greater clinical improvement ("much better") (Brigden 2018). Therefore, an increase of at least 10 points 4 weeks after HBOT is defined as a response and assessed as the primary endpoint.
The study-related measures do not pose significant risks or additional burdens to participants aside from the time required to complete the questionnaires. However, it has the potential to generate valuable knowledge regarding HBOT as a potential treatment for ME/CFS. To date, there has been no documentation of the efficacy of HBOT in ME/CFS through a clinical trial employing objective methods. The results of this observational study are expected to serve as the foundation for a potential interventional randomized controlled trial (RCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty male or female patients, aged between 18 and 65 years, will be included in the study. ME/CFS patients currently participating in the CFS_CARE study through the Bavaria Clinic in Kreischa will have the opportunity to receive HBOT treatment as an additional option provided by the clinic upon completion of the CFS_CARE study. Additionally, these patients will be invited to participate in this observational study during the final CFS_CARE presentation at the 12-month mark.
Key inclusion criteria (5 listed)
- Participants between the ages of 18 and 65 years who have previously participated in the CFS_CARE study and have been diagnosed with ME/CFS
- ME/CFS diagnosis based on the Canadian Consensus Criteria (CCC), characterized by exercise intolerance and symptom worsening lasting for a minimum of 14 hours
- Disease severity determined by a Bell Score ranging from 30 to 70
- Plan to undergo 20 or 40 days of HBOT
- Consent provided by the patient
Key exclusion criteria (4 listed)
- Unwillingness to consent to the storage of pseudonymized clinical data as a part of the study
- Pregnancy
- Presence of medical conditions that could potentially pose a risk during HBOT (e.g., heart failure, pulmonary disease, major depression, panic attacks)
- Acute infection (e.g., COVID, HIV, or hepatitis)
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 therapy (HBOT)HBOT is a medical treatment employed for various conditions. It entails breathing 100% oxygen within a pressurized chamber known as a hyperbaric chamber. This oxygen-rich environment promotes healing and aids in combating specific infections. In this study, the investigators will administer HBOT using a hyperbaric chamber set to 2 times the normal atmospheric pressure, indicated as 2 atmosphere absolute (ATA). This pressure surge enhances oxygen dissolution into the bloodstream, surpassing levels achievable at sea level. The pressure will be raised incrementally, followed by HBOT sessions lasting for a total of 90 minutes. The 90-minute sessions include brief 5-minute intervals for ambient air every 20 minutes to ensure safety and comfort. Treatment will be conducted five days a week over eight weeks. Supervised by competent healthcare professionals, HBOT is considered safe, with potential side effects primarily stemming from heightened pressure and, in rare cases, oxygen toxicity. | Combination product | – |
Primary outcome
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36).
Time frame: 4 weeks after completion of HBOT therapy
The Short Form 36 Health Survey (SF-36) is an established and widely used health-related quality of life measure. The Physical Function (PF) domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change of 10 points in SF-36-PF from baseline to week four is considered clinically meaningful.
8 secondary outcomes
Duration of improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: Collected every 2 months over a total of 12 months after completion of HBOT therapy
Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale
Time frame: Collected every 2 months over a total of 12 months after completion of HBOT therapy
Improvement in functional disability as measured by the Bell disability scale
Time frame: Collected every 2 months over a total of 12 months after completion of HBOT therapy
Improvement in disease severity based on self- reported symptoms as measured by the Munich Berlin Symptom Questionnaire (MBSQ)
Time frame: Collected every 2 months over a total of 12 months after completion of HBOT therapy
Improvement in muscle strength as measured by the hand grip strength (HGS) test
Time frame: 4 weeks after completion of HBOT therapy
Assessment and documentation of tolerability
Time frame: On the day of completion of HBOT therapy
Improvement in orthostatic tolerance as measured by the National Aeronautics and Space Administration (NASA) 10 Minute Lean Test
Time frame: 4 weeks after completion of HBOT therapy
Improvement in exercise capacity measured by the 1-Minute Sit-to-Stand Test
Time frame: 4 weeks after completion of HBOT therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 36042189Kedor C, Freitag H, Meyer-Arndt L, Wittke K, Hanitsch LG, Zoller T, Steinbeis F, Haffke M, Rudolf G, Heidecker B, Bobbert T, Spranger J, Volk HD, Skurk C, Konietschke F, Paul F, Behrends U, Bellmann-Strobl J, Scheibenbogen C. A prospective observational study of post-COVID-19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity. Nat Commun. 2022 Aug 30;13(1):5104. doi: 10.1038/s41467-022-32507-6.
- Background: PubMed 35925074Renz-Polster H, Scheibenbogen C. [Post-COVID syndrome with fatigue and exercise intolerance: myalgic encephalomyelitis/chronic fatigue syndrome]. Inn Med (Heidelb). 2022 Aug;63(8):830-839. doi: 10.1007/s00108-022-01369-x. Epub 2022 Jul 13. German.
- Background: PubMed 35317812Haffke M, Freitag H, Rudolf G, Seifert M, Doehner W, Scherbakov N, Hanitsch L, Wittke K, Bauer S, Konietschke F, Paul F, Bellmann-Strobl J, Kedor C, Scheibenbogen C, Sotzny F. Endothelial dysfunction and altered endothelial biomarkers in patients with post-COVID-19 syndrome and chronic fatigue syndrome (ME/CFS). J Transl Med. 2022 Mar 22;20(1):138. doi: 10.1186/s12967-022-03346-2.
- Background: PubMed 35821512Zilberman-Itskovich S, Catalogna M, Sasson E, Elman-Shina K, Hadanny A, Lang E, Finci S, Polak N, Fishlev G, Korin C, Shorer R, Parag Y, Sova M, Efrati S. Hyperbaric oxygen therapy improves neurocognitive functions and symptoms of post-COVID condition: randomized controlled trial. Sci Rep. 2022 Jul 12;12(1):11252. doi: 10.1038/s41598-022-15565-0.
- Background: PubMed 34862223Robbins T, Gonevski M, Clark C, Baitule S, Sharma K, Magar A, Patel K, Sankar S, Kyrou I, Ali A, Randeva HS. Hyperbaric oxygen therapy for the treatment of long COVID: early evaluation of a highly promising intervention. Clin Med (Lond). 2021 Nov;21(6):e629-e632. doi: 10.7861/clinmed.2021-0462.
- Background: PubMed 36323462Kjellberg A, Abdel-Halim L, Hassler A, El Gharbi S, Al-Ezerjawi S, Bostrom E, Sundberg CJ, Pernow J, Medson K, Kowalski JH, Rodriguez-Wallberg KA, Zheng X, Catrina S, Runold M, Stahlberg M, Bruchfeld J, Nygren-Bonnier M, Lindholm P. Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial. BMJ Open. 2022 Nov 2;12(11):e061870. doi: 10.1136/bmjopen-2022-061870.
- Background: PubMed 23682549Akarsu S, Tekin L, Ay H, Carli AB, Tok F, Simsek K, Kiralp MZ. The efficacy of hyperbaric oxygen therapy in the management of chronic fatigue syndrome. Undersea Hyperb Med. 2013 Mar-Apr;40(2):197-200.
- Derived from this study: PubMed 42249466Kim L, Camma G, Peters CK, Mantwill M, Muller O, Lepretre N, Heindrich C, Rust R, Krill M, Hartung TJ, Reess LG, Krohn S, Heymann CV, Wittke K, Finke C, Scheibenbogen C. Hyperbaric oxygen therapy improves clinical symptoms and functional capacity and modulates thalamic connectivity in ME/CFS: a prospective cohort study. J Transl Med. 2026 Jun 5;24(1):744. doi: 10.1186/s12967-026-08324-6.
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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.
Carmen Scheibenbogen, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-COVID ME/CFS, run by Charite University, Berlin, Germany at 1 site in Germany.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36). (time frame: 4 weeks after completion of HBOT therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118138, which also lists 8 linked publications.
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 15 Apr 2026.