Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Post-Viral Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to Improve Fatigue, Pain, and Quality of Life by Targeting Mitochondrial Dysfunction and Autonomic Nervous System Impairment
NCT ID: NCT07317401
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2025-12-01
2029-01-01
Brief Summary
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The treatment being studied is called Intermittent Hypoxia-Hyperoxia Treatment (IHHT). It uses a machine called CellOxy to deliver short cycles of low oxygen (hypoxia) and high oxygen (hyperoxia) through a mask. Each session lasts 22-40 minutes and is carefully monitored to track oxygen levels, heart rate, and breathing. The therapy is customized for each patient to ensure comfort and effectiveness. IHHT is believed to help the body adapt to oxygen-related stress, improving energy production and reducing inflammation.
In this trial, 87 patients with ME/CFS will be randomly assigned to receive either IHHT or a placebo treatment with normal oxygen levels over six weeks. The placebo group will follow a similar procedure without oxygen changes. An additional 17 healthy individuals will be recruited as a comparison group, but they will not undergo the treatment.
Participants will have medical check-ups before and after treatment to evaluate changes in fatigue, mental sharpness, pain, autonomic nervous system function, and overall quality of life. Blood samples and small skin biopsies will also be taken to study the biological processes behind ME/CFS and how the treatment works.
This research aims to find out if IHHT can improve the lives of people with ME/CFS or long-term COVID symptoms. The results could also provide new insights into the causes of these challenging conditions and guide future treatments.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intermittent hypoxia-hyperoxia treatment (IHHT)
An individualized treatment is administered to patients in 4-7 intervals, within 22-40 minutes. Blood oxygen saturation (O2-Sat) rises and falls cyclically, due to fluctuating fractions of inspired oxygen (FiO2): 9-13% in the hypoxic phase and 36% in the hyperoxic restitution phase.
Intermittent hypoxia-hyperoxia treatment (IHHT)
The apparatus used to deliver the IHHT is the CellOxy machine (TUR GmbH, Rostock, Germany, CE Medical device class IIa). The CellOxy machine is constructed with a built-in compressor, an air reservoir, and a set of membranes, making it possible for the machine to either add or remove oxygen from the atmospheric air, thus delivering a dynamic FiO2 (fraction of inspired oxygen). The individualized therapy settings are regulated via the attached user interface. It is connected to a desk monitor and a data-collecting server.
Sham treatment
The placebo group will undergo 'sham treatment' with air breathing at 21% FiO2. To equate the sensation of IHHT, airbrakes will be simulated similar to the IHHT intervals in the treatment protocol.
Placebo
The placebo group will undergo 'sham treatment' with air breathing at 21% FiO2. To equate the sensation of oxygen therapy, airbrakes will be simulated similar to the oxygen therapy intervals in the treatment protocol.
Interventions
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Intermittent hypoxia-hyperoxia treatment (IHHT)
The apparatus used to deliver the IHHT is the CellOxy machine (TUR GmbH, Rostock, Germany, CE Medical device class IIa). The CellOxy machine is constructed with a built-in compressor, an air reservoir, and a set of membranes, making it possible for the machine to either add or remove oxygen from the atmospheric air, thus delivering a dynamic FiO2 (fraction of inspired oxygen). The individualized therapy settings are regulated via the attached user interface. It is connected to a desk monitor and a data-collecting server.
Placebo
The placebo group will undergo 'sham treatment' with air breathing at 21% FiO2. To equate the sensation of oxygen therapy, airbrakes will be simulated similar to the oxygen therapy intervals in the treatment protocol.
Eligibility Criteria
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Inclusion Criteria
* Presence of post-exertional malaise (PEM)
* Disease duration \> 6 months
* Mild or moderate disease severity according to NICE guidelines
* Ability to attend clinic visits for inclusion and IHHT intervention
* Female sex
* Age 20-59 years
* Ability to attend clinic visits
* Female sex
* Age 20-59 years
* BMI matched to ME/CFS participants
* Activity level matched to ME/CFS participants
Exclusion Criteria
* Disease severity classified as severe according to NICE guidelines
* Inability to attend clinic visits
* Male sex
* Age \< 20 or \> 59 years
Healthy Controls
* History or current diagnosis of ME/CFS
* Inability to attend clinic visits
* Male sex
* Age \< 20 or \> 59 years
20 Years
59 Years
FEMALE
Yes
Sponsors
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Independent Research Fund Denmark
INDUSTRY
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University
Aarhus, Region Midt, Denmark
Countries
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Central Contacts
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Facility Contacts
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English
Role: backup
Other Identifiers
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10.46540/3165-00221B
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Sagsnr.: 2500959
Identifier Type: -
Identifier Source: org_study_id
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