The ME Association is delighted to announce that a grant has been awarded from the Ramsay Research Fund to Professor Sivan and a team based in Leeds. They will conduct a pilot study to develop and test a new protocol for managing Dysautonomia (Postural Orthostatic Tachycardia Syndrome (PoTS) and Orthostatic Intolerance (OI)) in people with ME/CFS and Long Covid.
We hope that the outcomes from this research will be used in a larger application to the National Institute for Health and Care Research (NIHR) in 2025/26 and that the protocol when implemented will bring relief to the hundreds of thousands of people who suffer from these very debilitating symptoms.
Professor Sivan says:
“Dysautonomia is an underdiagnosed clinical syndrome highly prevalent in ME/CFS and other related conditions (Long Covid and other post-viral syndromes). The evidence for strategies used in managing dysautonomia is patchy; hence, in this study, we will closely evaluate the currently used strategies which will help advance the management of not only dysautonomia but also ME/CFS and related conditions.”
Professor Manoj Sivan, Professor in Rehabilitation Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; and NHS Consultant, Leeds Teaching Hospitals NHS Trust and Leeds NHS Long Covid service.
Developing and testing a personalised Dysautonomia Management Protocol (DMP) in ME/CFS and Long Covid.
A proof-of-concept study.
Study Abstract
Background:
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Persistent Long Covid (LC) for more than 1 year are complex multisystem conditions with significant functional disability and reduced quality of life.
There are currently over 1 million individuals with ME/CFS and persistent LC in the UK. Dysautonomia is a clinical syndrome often seen in more than half of these individuals (the reported prevalence ranges from 30% to 100%). The efficacy of several simple management strategies is unknown.
Aim:
To develop and test the effectiveness of an 8-week clinical supervised personalised Dysautonomia Management Protocol (DMP) in a cohort of ME/CFS and persistent LC patients with objective evidence of dysautonomia. This first step is necessary before approaching the NIHR for larger-scale controlled studies.
Design:
Exploratory prospective study to develop and test a DMP comprising of a) increased fluid intake b) increased salt intake c) regulate food amount and type and d) optimise physical/ cognitive/ emotional exertion to avoid crashes, e) calf muscle function and e) pharmacological agents in select cases of Postural Tachycardia Syndrome (PoTS) and Orthostatic Hypotension (OH).
The interventions will be tested in a sequential manner for each patient to estimate which intervention has the best effect (accepting the fact that there will be a summative effect of interventions).
Patients: Individuals with ME/CFS or persistent LC with subjective symptoms of dysautonomia on questionnaires and objective evidence of dysautonomia [either on the NASA LEAN test or active stand test]. Sample size: N=50 (25 ME/CFS and 25 LC).
Intervention: An 8-week DMP involving weekly telephone follow-up to review the different elements of the protocol.
Outcomes: Follow-up weekly using subjective testing of dysautonomia with the Yorkshire Rehabilitation Scale (YRS), Composite Autonomic Symptom Score (COMPASS-31) and objective test the Adapted Autonomic Profile (aAP).
Analysis: Pre-post comparison of outcomes within-participants using standard statistical tests such as Wicoxon signed rank test.
Conclusion:
This study will provide an estimation of the efficacy of management strategies used in managing subjective and objective dysautonomia in ME/CFS and persistent LC and lead to the development of an evidence-based DMP for these disabling conditions.
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