This study is testing a new treatment for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and long-term symptoms after COVID-19. Both conditions cause extreme fatigue, muscle pain, "brain fog," and trouble concentrating, which often get worse after physical or mental activity. Currently, no effective treatments are available.
The treatment being studied is called Intermittent Hypoxia-Hyperoxia Treatment (IHHT). It uses a machine called HypoxBreath 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, 104 patients with ME/CFS will be randomly assigned to receive either IHHT or a placebo treatment with normal oxygen levels over eight weeks. The placebo group will follow a similar procedure without oxygen changes. An additional 20 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.
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
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
Parallel
Intermittent hypoxia-hyperoxia treatment (IHHT)
Other interventionThe apparatus used to deliver the IHHT is the HypoxBreath machine (TUR GmbH, Rostock, Germany, CE Medical device class IIa). The HypoxBreath 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
DeviceThe 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.
Change in SF-36 Vitality Domain score from baseline to post-treatment
Change in the vitality domain of the 36-Item Short Form Health Survey (SF-36), assessing fatigue and energy-related quality of life.
Change in health-related quality of life (SF-36 domains)
Assessment of additional SF-36 quality-of-life domains.
Change in fatigue severity (Fatigue Severity Scale, FSS)
Assessment of fatigue severity and functional impact using the Fatigue Severity Scale (FSS).
Change in functional capacity (FUNCAP-27)
Assessment of functional capacity using the FUNCAP-27 questionnaire.
Change in autonomic symptoms (COMPASS-31)
Assessment of autonomic symptom burden using the Composite Autonomic Symptom Score-31 (COMPASS-31).
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University of Aarhus
Lead sponsor
Independent Research Fund Denmark
Collaborator
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