NCT07317401

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

REenergizeME: Oxygen Therapy (OT) as a Novel Treatment for Post-Viral Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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 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.

Conditions

• Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)

Interventions

Type	Name	Description
OTHER	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.
DEVICE	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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2029-01-01
• First posted: 2026-01-05
• Last updated: 2026-03-18

Locations

1 site across 1 country: Denmark