Chronic Fatigue Syndrome, ME/CFS
Conditions
Keywords
Hyperbaric oxygen therapy, Myalgic Encephalomyelitis, HBOT, ME/CFS, Chronic Fatigue Syndrome
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHyperbaric oxygen therapy
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.
DEVICESHAM treatment
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.
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A Prospective, Randomized, Double-Blind, Sham-Controlled Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject willing and able to read, understand and sign an informed consent * Diagnosis of mild to moderate severity of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome * Patients diagnosed with CFS for more than 1 years * Stable psychological and pharmacological treatment for more than three months prior to inclusion
Exclusion criteria
1. Inability to attend scheduled clinic visits and/or comply with the study protocol 2. Severe and very severe cases of ME/CFS 3. History or diagnosis of, brain tumors, brain surgery, epilepsy, neurodegenerative diseases 4. Active malignancy 5. Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture 6. Active smokers 7. Chronic heart failure with ejection fraction of 30 or less 8. Chest pathology incompatible with pressure changes (including active asthma or COPD) 9. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year) 10. Pregnancy 11. An inability to perform an awake brain MRI 12. An inability to perform Neurotrax 13. Participation in another medical study 14. HBOT for any reason prior to study enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary exercise test (CPET) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DePaul Post-Exertional Malaise Questionnaire (DPEMQ) | 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 | 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. |
| Short Form-36 Health Survey (SF-36) | 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 | 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. |
| Pittsburgh Sleep Quality Index (PSQI) | 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 | 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. |
| Brief Symptom Inventory-18 (BSI-18) | 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 | 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. |
| NeuroTrax | 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 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 |
| Brain MRI | 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 | 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. |
| Brain EEG | 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 | 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. |
| Sleep EEG | 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) | 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. |
| Orthostatic Intolerance - 10-min NASA Lean Test (NLT) | 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). | 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 |
| Body Composition | 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 | 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. |
| Hand Grip test | 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 | 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 |
| Peripheral blood biomarkers | 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 | Whole blood and plasma will be collected and stored for future biomarker analysis |
| Muscle biopsy | Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session. | 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. |
| FUNCAP55 - a 55-item functional capacity questionnaire | The day after each CPET. and once a month during the study | Reliable for assessing functional capacity. May assist in diagnosis and follow-up. |
| Urine Test | 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 | Taken and stored for future analysis. |
Countries
Israel
Contacts
CONTACTEli Kravchik, MD
CONTACTShai Efrati, Prof
PRINCIPAL_INVESTIGATOREli Kravchik, MD
principle investigator
Outcome results
None listed