ME/CFSNCT07874217
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
A study testing Cryotherapy in people with ME/CFS and Fibromyalgia (FM), run by Oxford Brookes University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- ME/CFS, Fibromyalgia (FM), Long-COVID
- What is being tested?
- Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2026to 8 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Brookes University - Centre for Movement, Occupation and Rehabilitation Sciences (MOReS)
Oxford, Oxon, OX3 0BP
Patrick Esser, +44 (0) 1865 534881, pesser@brookes.ac.uk
Richard Baskerville, +44 (0) 1865 534881, rbaskerville@brookes.ac.uk
About this study
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.
Read more
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.
Read the detailed description
Chronic fatiguing illnesses such as ME/CFS, Fibromyalgia, and Long COVID share strikingly similar symptom profiles: persistent fatigue, post-exertional malaise, cognitive impairment, unrefreshing sleep, autonomic dysfunction, and widespread pain. Increasingly, research demonstrates that these symptoms arise from overlapping biological disturbances involving systemic inflammation, autonomic dysregulation, endothelial impairment, and disrupted cellular energy production. These processes are thought to reinforce one another, creating a self-sustaining cycle of physiological stress that maintains chronic illness.
Whole-Body Cryotherapy (WBCT) offers a biologically plausible intervention that can interrupt these pathological loops. Brief exposure to extreme cold triggers a rapid multisystem response across neurovascular, immune, and metabolic pathways. Evidence suggests that WBCT enhances autonomic balance, improves microvascular function through vasoconstriction-vasodilation cycling, reduces oxidative stress, and stimulates anti-inflammatory signalling. Preliminary clinical work, including studies in ME/CFS, shows reductions in fatigue, improved cognitive clarity, and better autonomic regulation following multi-session cryotherapy. Early mechanistic findings, such as changes in blood-brain barrier proteins like claudin-5, further support WBCT's potential to modulate barrier integrity and downstream neuroimmune activity.
The present study is therefore designed as a pilot feasibility investigation to determine whether a fully powered mechanistic trial is achievable. The protocol includes four groups: healthy controls, ME/CFS, Fibromyalgia, and Long COVID each completing ten WBCT sessions over two weeks, with comprehensive pre- and post-intervention assessments.
Central to this study is establishing whether recruitment, retention, and completion of intensive multidimensional outcome measures are practical within this population. Alongside feasibility assessment, the study will explore changes in symptom burden using validated clinical surveys, and will collect objective data on sleep, physical activity, and mitochondrial and immunometabolic function through biospecimens. These exploratory measures will provide essential estimates of variability, acceptability, and sensitivity to change, all of which are required to refine the design of a future randomised controlled trial.
The multi- \& trans-disciplinary integration of patient-reported outcomes, wearable-derived physiological data, and advanced cellular and molecular assays provides a coherent mechanistic framework for understanding WBCT's multisystem effects. If participants can be successfully recruited, retained, and assessed, the findings will offer both practical and scientific justification for progression to a larger, definitive study capable of evaluating therapeutic efficacy.
- Conditions
- ME/CFS, Fibromyalgia (FM), Long-COVID, Control Group
- Being tested
- Cryotherapy
- Keywords
- Cryotherapy, Fatigue, ME/CFS, Long-Covid, Fibromyalgia
- Medical subject headings
- Fatigue Syndrome, Chronic, Fibromyalgia, Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
Intervention: Whole-body cryotherapy intervention consists of 10 sessions administered over 2 consecutive weeks. Sessions will be conducted in an indirect liquid nitrogen-cooled cryochamber with a prechamber set at -60∘°C and a main chamber at -120∘°C. To maximise safety and tolerability in this sensitive patient population, the protocol features a gradual increase in exposure time. Following a 30-second familiarisation session (sessions 1 \& 2), exposure time in the main chamber will increase incrementally from 1 minute on day 1 to a maximum of 3.5 minutes on day 10. Participants will wear standardised protective clothing (gloves, socks, headband, and mask) during all sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy Intervention (all) | Experimental | 10 sessions administered over 2 consecutive weeks. Sessions will be conducted in an indirect liquid nitrogen-cooled cryochamber with a prechamber set at -60∘°C and a main chamber at -120∘°C.
To maximise safety and tolerability in this sensitive patient population, the protocol features a gradual increase in exposure time. Following a 30-second familiarisation step (pre-chamber) followed by a 2-minute exposure in the main chamber will increase incrementally from 2 minute on day 1 to a maximum of 3.5 minutes on day 10 Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome measurements
recruitment and retention, whereby targets for each are set at 20% and 80%, respectively
Measured: Change pre to post intervention (2-weeks)
Secondary outcomes (11)
Short-form 36
The SF-36 assesses health-related quality of life across eight domains. Scores range from 0 to 100 for each domain, with higher scores indicating better health and quality of life.
Measured: Change between pre and post intervention (2-weeks)
EQ-5D-5L - Health-related quality of life
The EQ-5D-5L assesses health-related quality of life across five dimensions, each scored from 1 (no problems) to 5 (extreme problems). Higher scores indicate greater health problems. The EQ visual analogue scale ranges from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Change between pre and post intervention (2-weeks)
Fatigue Symptom Survey
The Fatigue Symptom Survey assesses the severity and characteristics of fatigue symptoms. Higher scores indicate greater fatigue severity.
Measured: Change between pre and post intervention (2-weeks)
Chalder Fatigue Scale
The Chalder Fatigue Scale assesses physical and mental fatigue. Scores range from 0 to 11 using the bimodal scoring method, with higher scores indicating greater fatigue.
Measured: Change between pre and post intervention (2-weeks)
Fatigue Impact Scale
The Fatigue Impact Scale assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. Scores range from 0 to 160, with higher scores indicating a greater impact of fatigue on daily functioning.
Measured: Change between pre and post intervention (2-weeks)
Epworth Sleepiness Scale
The Epworth Sleepiness Scale assesses daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. A score of 11 or above indicates excessive daytime sleepiness.
Measured: Change between pre and post intervention (2-weeks)
COMPASS-31
The COMPASS-31 assesses symptoms of autonomic dysfunction across multiple autonomic domains. Scores range from 0 to 100, with higher scores indicating greater autonomic symptom burden.
Measured: Change between pre and post intervention (2-weeks)
Barthel Index
The Barthel Index assesses independence in activities of daily living. Scores range from 0 to 100, with higher scores indicating greater independence and lower scores indicating greater dependence.
Measured: Change between pre and post intervention (2-weeks)
Near Infrared Spectroscopy (NIRS) - Mitochondrial functioning
NIRS will assess skeletal muscle oxygenation and haemodynamic responses as indicators of mitochondrial and muscle oxidative function. Outcomes will be reported as changes in NIRS-derived measures from baseline, with the direction of change interpreted according to the specific parameter assessed.
Measured: Change between pre and post intervention (2-weeks)
Physical Activity and Sleep - Wrist-worn tri-axial accelerometer
A wrist-worn tri-axial accelerometer (Axivity AX3) will objectively assess physical activity and sleep. Outcomes will include measures such as daily activity levels, sedentary time, sleep duration and sleep-related parameters. Higher physical activity values indicate greater activity, while higher sedentary time indicates greater sedentary behaviour.
Measured: Change between pre and post intervention (2-weeks)
Blood, urine, stool and saliva - Biomarker and multi-omic analyses
Blood, urine, stool and saliva samples will be collected for biomarker, multi-omic and cellular analyses. Outcomes will include measures of gut barrier integrity, immune function, bioenergetics, plasma and gut metabolomics, and gut microbiome composition. Individual biomarkers and molecular measures will be reported according to their validated assay-specific units and direction of change.
Measured: Change between pre and post intervention (2-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start5 Oct 2026
- Primary completion8 Jan 2027 (estimated)
- Study completion8 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ME/CFSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a Multi-Case-control, Feasibility Study with a single intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of Leicester, University College, London, Rosalind Franklin University of Medicine and Science
- Responsible party
- Principal investigator, Patrick Esser, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874217
- Sponsor's protocol ID
- 261994
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data supporting the published results may be made available to qualified researchers upon reasonable request, subject to review by the study team and appropriate ethical, governance and data protection requirements. Data will not be made publicly available as a complete dataset. Any data shared will be limited to that necessary to address the approved research question and will be consistent with participant consent and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07874217
- Acronym / sponsor ID
- 261994
- Conditions
- ME/CFS, Fibromyalgia (FM), Long-COVID, Control Group
- Keywords
- Cryotherapy, Fatigue, ME/CFS, Long-Covid, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- University of Oxford, University of Leicester, University College, London, Rosalind Franklin University of Medicine and Science
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 8 Jan 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic fatiguing illnesses such as ME/CFS, Fibromyalgia, and Long COVID share strikingly similar symptom profiles: persistent fatigue, post-exertional malaise, cognitive impairment, unrefreshing sleep, autonomic dysfunction, and widespread pain. Increasingly, research demonstrates that these symptoms arise from overlapping biological disturbances involving systemic inflammation, autonomic dysregulation, endothelial impairment, and disrupted cellular energy production. These processes are thought to reinforce one another, creating a self-sustaining cycle of physiological stress that maintains chronic illness.
Whole-Body Cryotherapy (WBCT) offers a biologically plausible intervention that can interrupt these pathological loops. Brief exposure to extreme cold triggers a rapid multisystem response across neurovascular, immune, and metabolic pathways. Evidence suggests that WBCT enhances autonomic balance, improves microvascular function through vasoconstriction-vasodilation cycling, reduces oxidative stress, and stimulates anti-inflammatory signalling. Preliminary clinical work, including studies in ME/CFS, shows reductions in fatigue, improved cognitive clarity, and better autonomic regulation following multi-session cryotherapy. Early mechanistic findings, such as changes in blood-brain barrier proteins like claudin-5, further support WBCT's potential to modulate barrier integrity and downstream neuroimmune activity.
The present study is therefore designed as a pilot feasibility investigation to determine whether a fully powered mechanistic trial is achievable. The protocol includes four groups: healthy controls, ME/CFS, Fibromyalgia, and Long COVID each completing ten WBCT sessions over two weeks, with comprehensive pre- and post-intervention assessments.
Central to this study is establishing whether recruitment, retention, and completion of intensive multidimensional outcome measures are practical within this population. Alongside feasibility assessment, the study will explore changes in symptom burden using validated clinical surveys, and will collect objective data on sleep, physical activity, and mitochondrial and immunometabolic function through biospecimens. These exploratory measures will provide essential estimates of variability, acceptability, and sensitivity to change, all of which are required to refine the design of a future randomised controlled trial.
The multi- \& trans-disciplinary integration of patient-reported outcomes, wearable-derived physiological data, and advanced cellular and molecular assays provides a coherent mechanistic framework for understanding WBCT's multisystem effects. If participants can be successfully recruited, retained, and assessed, the findings will offer both practical and scientific justification for progression to a larger, definitive study capable of evaluating therapeutic efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a Multi-Case-control, Feasibility Study with a single intervention
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy Intervention (all) | Experimental | Device: Cryotherapy10 sessions administered over 2 consecutive weeks. Sessions will be conducted in an indirect liquid nitrogen-cooled cryochamber with a prechamber set at -60∘°C and a main chamber at -120∘°C. To maximise safety and tolerability in this sensitive patient population, the protocol features a gradual increase in exposure time. Following a 30-second familiarisation step (pre-chamber) followed by a 2-minute exposure in the main chamber will increase incrementally from 2 minute on day 1 to a maximum of 3.5 minutes on day 10 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyIntervention: Whole-body cryotherapy intervention consists of 10 sessions administered over 2 consecutive weeks. Sessions will be conducted in an indirect liquid nitrogen-cooled cryochamber with a prechamber set at -60∘°C and a main chamber at -120∘°C. To maximise safety and tolerability in this sensitive patient population, the protocol features a gradual increase in exposure time. Following a 30-second familiarisation session (sessions 1 \& 2), exposure time in the main chamber will increase incrementally from 1 minute on day 1 to a maximum of 3.5 minutes on day 10. Participants will wear standardised protective clothing (gloves, socks, headband, and mask) during all sessions. | Device | Cryotherapy Intervention (all) |
Primary outcome
Feasibility outcome measurements
Time frame: Change pre to post intervention (2-weeks)
recruitment and retention, whereby targets for each are set at 20% and 80%, respectively
11 secondary outcomes
Short-form 36
Time frame: Change between pre and post intervention (2-weeks)
EQ-5D-5L - Health-related quality of life
Time frame: Change between pre and post intervention (2-weeks)
Fatigue Symptom Survey
Time frame: Change between pre and post intervention (2-weeks)
Chalder Fatigue Scale
Time frame: Change between pre and post intervention (2-weeks)
Fatigue Impact Scale
Time frame: Change between pre and post intervention (2-weeks)
Epworth Sleepiness Scale
Time frame: Change between pre and post intervention (2-weeks)
COMPASS-31
Time frame: Change between pre and post intervention (2-weeks)
Barthel Index
Time frame: Change between pre and post intervention (2-weeks)
Near Infrared Spectroscopy (NIRS) - Mitochondrial functioning
Time frame: Change between pre and post intervention (2-weeks)
Physical Activity and Sleep - Wrist-worn tri-axial accelerometer
Time frame: Change between pre and post intervention (2-weeks)
Blood, urine, stool and saliva - Biomarker and multi-omic analyses
Time frame: Change between pre and post intervention (2-weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data supporting the published results may be made available to qualified researchers upon reasonable request, subject to review by the study team and appropriate ethical, governance and data protection requirements. Data will not be made publicly available as a complete dataset. Any data shared will be limited to that necessary to address the approved research question and will be consistent with participant consent and applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with ME/CFS and Fibromyalgia (FM), run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Esser (+44 (0) 1865 534881, pesser@brookes.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome measurements (time frame: Change pre to post intervention (2-weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.