Hyperbaric Oxygen Therapy for Chronic Fatigue Syndrome (CFS)

Shamir Medical Center (Assaf-Harofeh)

Status: Not yet enrolling

Conditions: Chronic Fatigue Syndrome

Treatments: Device: Hyperbaric oxygen therapy; Device: SHAM treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07621068

0015-26-ASF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups

Hyperbaric oxygen therapy

Active Comparator group

Description:

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.

Treatment:

Device: Hyperbaric oxygen therapy

Sham Hyperbaric oxygen therapy

Sham Comparator group

Description:

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.

Treatment:

Device: SHAM treatment