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What is the autonomic dysfunction feasibility study you're funding about?

Led by: Prof Julia Newton

Aims: People with M.E. frequently have symptoms of light-headedness and dizziness which has been shown in studies to be related to drops in blood pressure when they stand up. These drops in blood pressure are called autonomic dysfunction.

This study seeks to find out if a standardised treatment approach to autonomic dysfunction is possible, by checking if people with M.E. are willing and able to participate in a six-week non-pharmacological intervention programme, and the effect this has on their symptoms.

Prof Newton says: “In those with autonomic dysfunction it is recognised that increasing fluid intake orally and doing things to reduced drops in blood pressure in a structured way will lead to improvements in autonomic dysfunction and reduce symptoms.

“This study sets out to see whether people with M.E. are able to perform the same manoeuvres as people with autonomic dysfunction and whether they are able to increase their oral fluid intake. The study will also consider whether people with M.E. are able to take part in a clinical trial of this type and whether there are lessons that we can learn from them taking part that might help us do better trials in the future. We believe this study will provide important pilot data, enabling us to submit an application to the National Institutes of Health Research’s Efficacy and Mechanism Evaluation programme for a large randomised control trial.”

Cost: £30,000, made possible by donations to our Clare Francis Research Fund and match-funding with Newcastle University

Length of study: 18 months

Study begins: 2016

Background information: People with M.E. frequently have symptoms of light-headedness and dizziness which has been shown in studies to be related to drops in blood pressure when they stand up. These drops in blood pressure can happen in people without M.E. and are called autonomic dysfunction.

This feasibility study is proposed to assess patient recruitment response and willingness to participate and comply with standardised non-pharmacological interventions of the type used routinely for autonomic dysfunction in syncope units. The study will provide outcome data to inform study design including sample size in a subsequent definitive trial. It will include qualitative interviews with patients to assess their reasons for agreeing or not to participate in the study and the experiences of the intervention.