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)

University of Aarhus

Status: Enrolling

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

Treatments: Device: Placebo; Other: Intermittent hypoxia-hyperoxia treatment (IHHT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07317401

Sagsnr.: 2500959

10.46540/3165-00221B (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups, including a placebo group

Intermittent hypoxia-hyperoxia treatment (IHHT)

Active Comparator group

Description:

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.

Treatment:

Other: Intermittent hypoxia-hyperoxia treatment (IHHT)

Sham treatment

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo