Not yet recruiting NCT07621068
Hyperbaric Oxygen Therapy for Chronic Fatigue Syndrome (CFS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric oxygen therapy, SHAM treatment.
- Who it may be relevant to
- Registry conditions: Chronic Fatigue Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hyperbaric Oxygen Therapy for Chronic Fatigue Syndrome (CFS) - A Prospective, Randomized, Double-Blind, Sham-Controlled Study
Overview
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
- Device Hyperbaric 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. - Device SHAM 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.
Primary outcome measures
- Cardiopulmonary exercise test (CPET) [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]
Secondary outcome measures (12)
- DePaul Post-Exertional Malaise Questionnaire (DPEMQ) [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) [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) [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) [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]
- Montreal Cognitive Assessment (MoCA) [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 [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 [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 [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 [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) [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 [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 [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]
Eligibility criteria
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
- 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
- Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
- Active smokers
- Chronic heart failure with ejection fraction of 30 or less
- Chest pathology incompatible with pressure changes (including active asthma or COPD)
- Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
- Pregnancy
- An inability to perform an awake brain MRI
- An inability to perform Neurotrax
- Participation in another medical study
- HBOT for any reason prior to study enrolment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh — Zrifin
Identifiers
NCT: NCT07621068 · 0015-26-ASF