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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