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Could breathing different oxygen levels ease chronic fatigue?

NCT ID NCT07317401

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a treatment called Intermittent Hypoxia-Hyperoxia Treatment (IHHT) for people with ME/CFS or long COVID. The therapy uses a mask to deliver short cycles of low and high oxygen, aiming to improve energy and reduce inflammation. 104 patients will be randomly assigned to receive either the real treatment or a placebo over eight weeks. Researchers will measure changes in fatigue, mental clarity, pain, and quality of life.

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 104 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

20 to 59 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

ME/CFS Patients Inclusion Criteria: * Female sex * Age 20-59 years * Established diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to the International Consensus Criteria (ICC) * Disease duration \>6 months * Presence of post-exertional malaise (PEM) * Mild or moderate disease severity according to NICE guidelines * Body mass index (BMI) \>18 and \<30 kg/m² * Ability and willingness to attend study visits and complete the intervention protocol * Provision of written informed consent * Willingness to comply with all study procedures and restrictions throughout the study period * Use of highly effective contraception during study participation for women of childbearing potential Exclusion Criteria: * Severe ME/CFS according to NICE guidelines * Participation in another clinical trial that may interfere with the present study * Pregnancy, planned pregnancy, or breastfeeding * Presence of clinically significant psychiatric disease not considered part of ME/CFS and likely to interfere with study participation or interpretation of results * Presence of clinically significant neurological disease, peripheral nerve disorder, or other neurological dysfunction not considered part of ME/CFS * Active internal disease or clinically significant cardiovascular, pulmonary, metabolic, renal, hepatic, endocrine, or systemic disease that may interfere with study participation or interpretation of outcomes * Obstructive lung disease * Claustrophobia * History of spontaneous pneumothorax * Presence of implanted medical devices, prostheses, or other conditions considered incompatible with IHHT * Chronic pain conditions not considered part of ME/CFS and likely to interfere with assessments * Current structured graded exercise therapy (GET) or structured exercise programme * Significant alcohol, tobacco, or cannabis use considered likely to interfere with study participation or interpretation of outcomes * Inability to comply with study procedures or communicate meaningfully with study personnel * Any condition which, in the opinion of the investigator, may compromise participant safety or study integrity Healthy Controls Inclusion Criteria: * Female sex * Age 20-59 years * Body mass index (BMI) \>18 and \<30 kg/m² * Ability and willingness to attend study visits * Provision of written informed consent * Good general health without clinically significant chronic medical, neurological, psychiatric, or pain conditions * Activity level and BMI broadly matched to ME/CFS participants * Willingness to comply with all study procedures and restrictions throughout the study period * Use of highly effective contraception during study participation for women of childbearing potential Exclusion Criteria: * Current or previous diagnosis of ME/CFS * Participation in another clinical trial that may interfere with the present study * Pregnancy, planned pregnancy, or breastfeeding * Presence of clinically significant psychiatric, neurological, cardiovascular, pulmonary, metabolic, renal, hepatic, endocrine, or systemic disease * Chronic pain conditions, migraine disorder, or recurrent headache/back pain likely to interfere with study assessments * Obstructive lung disease * Claustrophobia * History of spontaneous pneumothorax * Presence of implanted medical devices, prostheses, or other conditions considered incompatible with study procedures * Current structured exercise programme or recent major change in exercise habits * Significant alcohol, tobacco, or cannabis use considered likely to interfere with study participation or interpretation of outcomes * Inability to comply with study procedures or communicate meaningfully with study personnel * Any condition which, in the opinion of the investigator, may compromise participant safety or study integrity

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Aarhus University

    Aarhus, Region Midt, 8200, Denmark

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