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Could pressurized oxygen ease chronic fatigue? new trial aims to find out

NCT ID NCT07621068

Symptom relief Sponsor: Assaf-Harofeh Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) can help people with mild to moderate chronic fatigue syndrome. 74 participants will receive either real treatment or a sham (placebo) for 60 sessions over 3 months. Researchers will measure physical performance, fatigue, and other symptoms to see if the therapy provides real relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber)
What this could lead to
If it works, this could offer a new way to reduce fatigue and improve daily function for people with chronic fatigue syndrome.
What could go wrong
This is an early-stage trial with only 74 participants, and the sham control may reveal no benefit. The treatment is time-intensive (60 sessions) and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

myalgic encephalomeyelitis/chronic fatigue syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic fatigue syndrome Me/CFS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Zrifin, 70300, Israel

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