Hyperbaric Oxygen Therapy for Chronic Fatigue Syndrome (CFS)

NCT07621068 | Not Yet Recruiting

• 1 other identifier: 0015-26-ASF
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Keywords

Hyperbaric oxygen therapy; Myalgic Encephalomyelitis

Outcome Measures

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).

  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 Outcomes (14)

• 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

• 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

• 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

• 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

• Montreal Cognitive Assessment (MoCA)

  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

Study Arms (2)

Hyperbaric oxygen therapy

ACTIVE COMPARATOR

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 Hyperbaric oxygen therapy

SHAM COMPARATOR

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

Interventions

Hyperbaric oxygen therapy DEVICE

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.

Hyperbaric oxygen therapy

SHAM treatment DEVICE

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.

Sham Hyperbaric oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Eli Kravchik, MD

  principle investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli Kravchik, MD

CONTACT

089779241; elikr@shamir.gov.il

Shai Efrati, Prof

CONTACT

efratishai@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: A Prospective, Randomized, Double-Blind, Sham-Controlled Study

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

IL (1)