NCT07874217 Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
| NCT ID | NCT07874217 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oxford Brookes University |
| Condition | ME/CFS |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-10-05 |
| Primary Completion | 2027-01-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-10-05 with a primary completion date of 2027-01-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic fatiguing illnesses such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Fibromyalgia, and Long COVID are becoming a major global health challenge. They cause severe personal and social strain and have no proven, widely effective treatments. Although these conditions have different names, they share many symptoms: long-lasting fatigue that doesn't improve with rest, worsening of symptoms after activity (post-exertional malaise), difficulties with thinking ("brain fog"), poor sleep, and widespread pain. Increasing evidence shows that these illnesses also share similar underlying biological problems. These include ongoing inflammation, problems with the autonomic nervous system (which controls automatic body functions), poor function of the blood vessels, and reduced energy production in cells. Whole-Body Cryotherapy (WBCT) is emerging as a promising non-drug treatment that may help break these cycles. WBCT involves very short, controlled exposure to extreme cold (around -110°C to -160°C). This triggers a rapid response across the nervous, immune, and metabolic systems. The cold acts as a powerful stimulus, encouraging the body to reset imbalanced systems. A session briefly narrows blood vessels and then causes them to widen again, improving blood flow and supporting healthy vessel function. WBCT also appears to reduce inflammation, lower oxidative stress, and improve parasympathetic ("rest-and-recover") nervous system activity. Early studies in ME/CFS and related conditions are encouraging. Small trials have reported reduced fatigue, clearer thinking, and better autonomic regulation after a course of WBCT sessions, with good safety. Research has also shown changes in blood-brain barrier proteins after WBCT, suggesting it may help repair "leaky" barriers that can drive symptoms in ME/CFS and Long COVID. By acting on inflammation, blood flow, and nervous system balance at the same time, WBCT could offers a scientifically grounded and potentially transformative approach in understanding the mechanism behind observed treatment effect.
Eligibility Criteria
Inclusion Criteria: * The study will recruit 40 adult participants (aged 18-65 years) divided across four groups: 10 healthy controls, 10 individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), 10 individuals with Fibromyalgia, and 10 individuals with Long COVID. The relatively small group size is appropriate for a pilot feasibility study, where the primary aim is to assess recruitment, retention, tolerability of the intervention, and the practicality of completing the proposed outcome measures. The sample size reflects the exploratory nature of the study, current resource availability and funding, and the intensive intervention schedule requiring ten visits over a two-week period. In addition, there is limited UK-based evidence regarding participant responses to whole-body cryotherapy within these clinical populations, further supporting a cautious, feasibility-focused sample size. Exclusion Criteria: * The primary physical risks relate to exposure to extreme cold during whole-body cryotherapy and minor discomfort associated with blood sampling. To mitigate these risks, all participants will undergo a structured medical screening using a standard WBCT medical questionnaire to identify contraindications (e.g. uncontrolled hypertension, cardiovascular disease, circulatory disorders such as Raynaud's disease, cryoglobulinaemia, severe respiratory disease, or claustrophobia). Individuals meeting exclusion criteria will not be enrolled.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07874217 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying ME/CFS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07874217 currently recruiting?
Yes, NCT07874217 is actively recruiting participants. Contact the research team at pesser@brookes.ac.uk for enrollment information.
Where is the NCT07874217 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT07874217 clinical trial?
NCT07874217 is sponsored by Oxford Brookes University. The trial plans to enroll 40 participants.