Extrait

Background and study aims Motor neurone disease (MND) is an incurable condition which affects the nervous system. It is often called amyotrophic lateral sclerosis (ALS) in some countries. When a person is suffering from MND, the nerve cells in the brain and spinal cord which control the movement of muscles (motor neurons) are gradually lost (neurodegeneration). MND is ultimately fatal, as it affects the muscles involved with breathing. The diaphragm is a large dome-shaped muscle which separates the lungs from the digestive organs in the abdomen. It is one of the most important muscles involved in ventilation (breathing in and out), helping to inflate and deflate the lungs by moving down and up. When the diaphragm is weakened, a person is not able to breath out the waste gas carbon dioxide from their lungs (respiratory failure) and coughing becomes difficult. This eventually leads to death. Non-invasive ventilation therapy (NIV) is the standard treatment given to respiratory failure patients with MND. In this type of treatment, patients wear a mask over their nose and/or mouth which provides extra assistance with breathing at night, and for some people, in the day. Although it has been shown to help improve the symptoms caused by breathing problems and, in some cases, help people live longer, it can be challenging to use and some patients struggle to follow the required regime meaning they fail to receive the benefits. Timely support is important to help patients to overcome the early hurdles and barriers in order to become regular NIV users. The Philips EncoreAnywhere is a system that allows continuous monitoring of the use and effectiveness of ventilation, allowing the treating clinician to instantly adjust the ventilator settings from a distance (telemonitoring). The aim of this study is to find out whether “real time” feedback and support, as well as being able to remotely change NIV settings using the EncoreAnywhere system could increase the number of MND patients successfully using NIV. Who can participate? Adults with MND and respiratory failure who are starting to use NIV which is provided by the MND clinic in Sheffield MND care and research centre at the Royal Hallamshire Hospital. What does the study involve? Participants are randomly allocated to one of two groups. Participants in both groups are given instructions to use NIV, which involves wearing a face mask connected to a ventilator (breathing machine) every night and in the daytime if needed. All patients have access to telephone advice from the respiratory therapist as well as online instructions using www.niv.mymnd.org.uk . All patients will have the EncoreAnywhere system installed on their breathing machine which will automatically collect information about their use of the machine. The staff caring for patients in the intervention group will be able to use the EncoreAnywhere system to see the data it collects every day. They will be able to see how it is used and can contact patients if they detect a problem with the machine or if the patient is not using it effectively. It also allows them to adjust the settings on the NIV device remotely. Those in the second group receive NIV but do not receive any additional monitoring than usual. After three months, participants in both groups are followed up to see how they are using NIV and what symptoms of breathing problems they are experiencing. Patients in the control group will have their data collected automatically by the EncoreAnywhere system but it will only be available to the staff looking after the patients after the study has finished. What are the possible benefits and risks of participating? Patients receiving extra monitoring may benefit from receive extra calls from the MND team, which may improve their use of NIV. There are no notable risks of taking part in the study. Where is the study run from? Motor Neurone Disorders Clinic, Royal Hallamshire Hospital (UK) When is the study starting and how long is it expected to run for? November 2015 to February 2017 Who is funding the study? 1. National Institute for Health Research (UK) 2. Philips Healthcare (UK) Who is the main contact? Dr Esther Hobson

Critère d'inclusion

• Topic: Dementias and neurodegeneration; Subtopic: All Diagnoses, Motor neurone disease; Disease: Motor neurone disease

Liens

• isrctn
• ictrp