An interventional study of Hyperbaric oxygen therapy and SHAM treatment in Chronic Fatigue Syndrome and ME/CFS, sponsored by Assaf-Harofeh Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment
This study evaluates the effects of hyperbaric oxygen therapy (HBOT) in patients with mild to moderate CFS/ME. Participants will undergo 60 HBOT sessions over 3 months with a 3-month follow-up, including physical, cognitive, imaging, and laboratory assessments.
Hyperbaric oxygen therapy (HBOT) for Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) - The aim of the current study is to evaluate the effect of HBOT on patients suffering for mild to moderate CFS. Patients will undergo a series of 60 HBOT over a span of 3 months, with a 3 month follow-up period. Patient's evaluation point includes the following tests: physical performance, questionnaires, cognitive tests, brain MRI, EEG, blood tests \& muscle biopsy.
263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.
This study's planned enrollment of 74 is above the median of 60 across 177 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hyperbaric Oxygen Therapy: 60 consecutive sessions, 5 sessions per week within a three months' period. Each session includes breathing 100% oxygen by mask at 2 ATA for 90 minutes with 5-minute air breaks every 20 minutes.
Device: Hyperbaric oxygen therapy
SHAM therapy: 60 consecutive sessions, 5 sessions per week within a three months' period. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.02 ATA for 90 minutes with 5-minute air breaks, every 20 minutes.
Device: SHAM treatment
60 consecutive sessions of breathing 100% oxygen by mask at 2 ATA for 90 minutes with 5-minute air breaks every 20 minutes, 5 sessions per week within a three months' period.
60 consecutive sessions of breathing 21% oxygen by mask at 1 ATA for 90 minutes with 5-minute air breaks every 20 minutes, 5 sessions per week within a three months' period.
Cardiopulmonary exercise test (CPET)
Physical performance evaluated by cardiopulmonary exercise test (CPET) on a bicycle or a treadmill. CPET will be used to determine the peak oxygen consumption (Peak VO2), first ventilatory threshold (VT1) and if possible, the second ventilatory threshold (VT2). The day after each CPET an FUNCAP55 questionnaire will be filled to assess the functional capacity.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
A self-report instrument assessing the frequency and severity of post-exertional malaise symptoms in individuals with ME/CFS. Total scores typically range from the minimum value (no symptoms) to the maximum value (most severe and frequent symptoms), with higher scores indicating worse post-exertional malaise.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Short Form-36 Health Survey (SF-36)
A self-reported measure of health-related quality of life across eight domains. Each SF-36 scale is transformed to a 0 to 100 score, where 0 represents the worst health status and 100 represents the best health status. Higher scores indicate better health-related quality of life.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Pittsburgh Sleep Quality Index (PSQI)
a self-report questionnaire that assesses sleep quality and disturbances over the previous month. The measure consists of 19 individual items, creating 7 components that produce one global score. The score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Brief Symptom Inventory-18 (BSI-18)
The BSI-18 will be used to evaluate psychological distress. An 18 item self-report questionnaire which generates a global stress index (GSI), and three subscales: depression, anxiety, and somatization. Each item is rated on a 5-point scale, with distress ratings ranging from 0 (not at all) to 4 (extremely). Higher scores indicate greater psychological distress.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
NeuroTrax
NeuroTrax (NeuroTrax Corp., Houston, TX) is a computerized neurocognitive battery of tests used to assess brain wellness across multiple cognitive domains, including memory, executive function, visual spatial perception, verbal function, attention, information processing speed, and motor skills
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Brain MRI
Images will be acquired on MAGNETOM Vida 3T Scanner, T1-weighted images will be used for gray matter and hippocampal volumetric measurement. Statistical parametric mapping software SPM12, will be used for brain segmentation. Voxel-based morphometry (VBM) procedure to calculate the whole-brain volumes.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Brain EEG
Resting-state and task-related brain EEG measures. EEG will be recorded using a high-density dry-electrode system (115 channels, EEG-Sense, Israel). Recordings will include eyes-open rest (3 minutes), eyes-closed rest (3 minutes), and 20 minutes of cognitive tasks (N-Back, Stroop, Flanker, and multiple-object tracking). EEG data will undergo standard preprocessing (filtering, line-noise and artifact removal, and down-sampling). Primary EEG outcomes will include spectral measures (peak frequency and relative power; alpha, beta, theta, and delta band power), power spectral distribution, and functional connectivity indices. Event-related potentials will be extracted for the cognitive tasks, including event-related synchronization and desynchronization (ERS/ERD), with averages computed across artifact-free trials.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Sleep EEG
Physiological sleep EEG signals will be collected using a home wearable EEG headband (Muse S) paired with a mobile application. Multi-channel EEG will be recorded from frontal and temporal locations, together with inertial sensors to capture movement and head position. Primary sleep EEG outcomes will include validated sleep-wake classification and sleep staging metrics (percent time in light, deep, and REM sleep), sleep timing (bedtime, sleep onset, awakenings, final wake time), and sleep continuity indices (wake after sleep onset and sleep efficiency). Secondary analyses will include signal-level EEG features such as spectral power in conventional frequency bands and spindle-like activity. Higher sleep efficiency and higher proportions of deep (slow-wave) sleep will be interpreted as better sleep quality.
Time frame: Baseline (3 consecutive nights within 2 weeks before treatment), post-treatment (3 consecutive nights within 21±7 days after last HBOT/Sham session), and at the end of the 3-month follow-up period (3 consecutive nights)
Orthostatic Intolerance - 10-min NASA Lean Test (NLT)
The 10-min NASA Lean Test (NLT) will be performed by asking the subject to lay supine for 10 min and then leaning against a wall for 10 min, while blood pressure and heart rate are measured
Time frame: Baseline, monthly during treatment (3 months), at the post-treatment evaluation (within 21±7 days after last HBOT/Sham session), monthly during follow-up (3 months), at the end of the follow-up period (end of study evaluation).
Body Composition
Body composition will be assessed using the seca mBCA Ultra, a clinically validated segmental multi-frequency bioelectrical impedance analysis (SMF-BIA) system. The device estimates fat mass, fat-free mass, skeletal muscle mass, and total body water based on multi-frequency impedance measurements across body segments. Outcomes will include absolute values (kg or liters) and relative values (percentage of body weight) for each compartment. Higher fat mass and body fat percentage indicate greater adiposity, whereas higher fat-free mass and skeletal muscle mass indicate greater lean tissue.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Hand Grip test
Quick, non invasive assessment of the maximal force generated when squeezing a hand dynamometer. Reflecting strength of the hand and forearm muscles and serving as a proxy for overall muscle weakness, fatigability, and disease severity
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Peripheral blood biomarkers
Whole blood and plasma will be collected and stored for future biomarker analysis
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Muscle biopsy
A voluntary test. Participants will undergo a muscle biopsy using a 0.3mm Trucut needle in an aseptic technique. Muscle sample will be analysed using the Oxygraph (Oroboros Inc, Austria) for oxygen respiratory function, as well as staining for mitochondrial proteins and Mitochondrial DNA.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session.
FUNCAP55 - a 55-item functional capacity questionnaire
Reliable for assessing functional capacity. May assist in diagnosis and follow-up.
Time frame: The day after each CPET. and once a month during the study
Urine Test
Taken and stored for future analysis.
Time frame: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period
Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.
Of 73 non-industry interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 11 months is below that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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