Could breathing different oxygen levels ease chronic fatigue?
NCT ID NCT07317401
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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20 to 59 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Aarhus University
Aarhus, Region Midt, 8200, Denmark
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