Not Yet RecruitingNot Applicable

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

Denmark104 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range20 Years – 59 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Eligibility Criteria ME/CFS Patients Inclusion Criteria: * Established diagnosis of ME/CFS according to the International Consensus Criteria (ICC) * 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 Exclusion Criteria: * Not meeting the International Consensus Criteria for ME/CFS * Disease severity classified as severe according to NICE guidelines * Inability to attend clinic visits * Male sex * Age \< 20 or \> 59 years Healthy Controls Inclusion Criteria: * 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: * History or current diagnosis of ME/CFS * Inability to attend clinic visits * Male sex * Age \< 20 or \> 59 years

What they're measuring

Change from baseline in quality of life vitality score (energy level and fatigue) using the self-reported SF-36 questionnaire.

Timeframe: Baseline and 6 weeks

Trial details

NCT IDNCT07317401

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Rikke KJ Olsen

+45 61262471 rikke.olsen@clin.au.dk