Hyperbaric Oxygen Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssaf-Harofeh Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to attend scheduled clinic visits and/or comply with the study protocol
Severe and very severe cases of ME/CFS
History or diagnosis of, brain tumors, brain surgery, epilepsy, neurodegenerative diseases
Active malignancy
Trial design
Design model
Parallel
Treatments tested in this trial
Hyperbaric oxygen therapy
Device60 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.
SHAM treatment
Device60 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.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Hyperbaric oxygen therapyActive comparator 1 intervention
Group B: Sham Hyperbaric oxygen therapySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 periodSecondary outcomes
1
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 period2
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 period3
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 period4
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 periodLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)Recruiting70300, Zrifin
Israel
IsraelSponsors and contacts
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Source ClinicalTrials.gov