Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With 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
- Registry status
- Not yet recruiting
- Study type
- Not specified in the registry data
- Phase
- Not applicable
- Sponsor
- University of Aarhus
Overview
ClinicalTrials.gov lists this study as Not yet recruiting.
Enrollment: 104 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- Yes
ClinicalTrials.gov lists the following eligibility criteria.
ME/CFS Patients
Inclusion Criteria:
* 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
* Presence of post-exertional malaise (PEM)
* Mild or moderate disease severity according to NICE guidelines
* Body mass index (BMI) \>18 and \<30 kg/m²
* Ability and willingness to attend study visits and complete the intervention protocol
* Provision of written informed consent
* Willingness to comply with all study procedures and restrictions throughout the study period
* Use of highly effective contraception during study participation for women of childbearing potential
Exclusion Criteria:
* 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
* Presence of clinically significant neurological disease, peripheral nerve disorder, or other neurological dysfunction not considered part of ME/CFS
* Active internal disease or clinically significant cardiovascular, pulmonary, metabolic, renal, hepatic, endocrine, or systemic disease that may interfere with study participation or interpretation of outcomes
* Obstructive lung disease
* Claustrophobia
* History of spontaneous pneumothorax
* Presence of implanted medical devices, prostheses, or other conditions considered incompatible with IHHT
* Chronic pain conditions not considered part of ME/CFS and likely to interfere with assessments
* Current structured graded exercise therapy (GET) or structured exercise programme
* Significant alcohol, tobacco, or cannabis use considered likely to interfere with study participation or interpretation of outcomes
* Inability to comply with study procedures or communicate meaningfully with study personnel
* Any condition which, in the opinion of the investigator, may compromise participant safety or study integrity
Healthy Controls
Inclusion Criteria:
* Female sex
* Age 20-59 years
* Body mass index (BMI) \>18 and \<30 kg/m²
* Ability and willingness to attend study visits
* Provision of written informed consent
* Good general health without clinically significant chronic medical, neurological, psychiatric, or pain conditions
* Activity level and BMI broadly matched to ME/CFS participants
* Willingness to comply with all study procedures and restrictions throughout the study period
* Use of highly effective contraception during study participation for women of childbearing potential
Exclusion Criteria:
* Current or previous diagnosis of ME/CFS
* Participation in another clinical trial that may interfere with the present study
* Pregnancy, planned pregnancy, or breastfeeding
* Presence of clinically significant psychiatric, neurological, cardiovascular, pulmonary, metabolic, renal, hepatic, endocrine, or systemic disease
* Chronic pain conditions, migraine disorder, or recurrent headache/back pain likely to interfere with study assessments
* Obstructive lung disease
* Claustrophobia
* History of spontaneous pneumothorax
* Presence of implanted medical devices, prostheses, or other conditions considered incompatible with study procedures
* Current structured exercise programme or recent major change in exercise habits
* Significant alcohol, tobacco, or cannabis use considered likely to interfere with study participation or interpretation of outcomes
* Inability to comply with study procedures or communicate meaningfully with study personnel
* Any condition which, in the opinion of the investigator, may compromise participant safety or study integrity
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: Denmark
- Region Midt, Denmark: 1
Sample of listed locations
- Aarhus University — Aarhus, Region Midt, 8200, Denmark — Site recruitment status not specified in the registry data
Study details
- Start date
- June 1, 2026
- Primary completion date
- June 1, 2027
- First posted
- January 5, 2026
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07317401
- Registry last updated
- May 22, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07317401 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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