Study title	A multi-centre evaluation of excessive saliva management in patients with motor neurone disease (ProSec 3)
UK Chief Investigator	Professor Chris McDermott
Research summary	Motor neuron disease (MND) is a life-shortening disorder, in which the nerves needed to activate muscles die. This leads to progressive weakness of the muscles, including those needed for movement of the limbs, chewing, swallowing, and breathing. MND usually leads to death within 2-3 years. There is no cure and treatment is aimed at easing symptoms. Unfortunately, there is a lack of high quality evidence to guide doctors in the treatment of the distressing symptoms of MND. A particularly troublesome and common disease symptom is persistent drooling. Drooling causes breakdown of the skin around the mouth, speech disturbance, disruption of sleep, coughing and a higher risk of choking. Drooling of saliva can also affect a patient’s mental wellbeing, by causing distress, embarrassment and social withdrawal. Another problem is that uncontrolled drooling can prevent individuals from receiving machine-based breathing treatments, the use of which can prolong a good quality of life. We plan to recruit 500 MND patients from around the UK, recording details of the prevalence and daily impact of saliva problems, treatments received, any side effects experienced and changes in the symptom over time. These data will enable us to: Describe how common problems with saliva are in people with MND Describe how saliva problems are currently treated Identify which and how often drugs for saliva problems cause side effects Identify the effectiveness of each treatment for saliva problems Further develop an existing assessment tool for the severity of saliva problems in MND patients The findings of this research will help doctors to better manage problems with excessive saliva production in people with MND and improve the quality of life of those patients. It will also verify a system of assessing the severity and progression of saliva problems, enabling the evaluation of potential treatments in future studies.
Inclusion/exclusion criteria	Inclusion criteria: - Age 18 or older - Amyotrophic lateral sclerosis/ Primary lateral sclerosis/ Progressive muscular atrophy/ Progressive bulbar palsy as diagnosed by a consultant neurologist. Exclusion criteria: - Inability to give informed consent.
Current status	Closed to recruitment - data being analysed
Locations	England: Birmingham Bradford Bury St. Edmunds Cambridge Canterbury Coventry Farnham, Surrey Leeds Leicester Liverpool London (King's College Hospital) London (Royal London Hospital) London (St George's Hospital, Tooting) Luton Manchester Newcastle Oxford Plymouth Preston Rochester Salford Sheffield Solihull Somerset Partnership Community Care Stoke Sussex Community NHS Foundation-trust Scotland: Ayrshire Dundee Edinburgh Glasgow Wales: Llanelli
Contact details	Coordinating centre: Dr Sarah Boddy Email: s.l.boddy@sheffield.ac.uk Phone: 0114 222 2267.
Recruitment group(s)	Patients with MND.
Recruitment target(s)	500 patients nationally.
Key dates	Recruitment start date (actual): 20 February 2018 Recruitment end date (actual): 30 August 2020 Follow-up end date (target): 30 August 2020.
Funder(s)	Marie Curie and the Motor Neurone Disease Association
Sponsor	Sheffield Teaching Hospitals NHS Foundation Trust.
Study design	Longitudinal, Observational (questionnaire).
Intervention (if applicable)	Not applicable.
Phase (if applicable)	Not applicable.
Outcome measures	Primary outcome measure: Frequency of secretion problems as recorded from the saliva section of the ALSFRS-R. Secondary outcome measures: Descriptive; CSS-MND; Global change questionnaire; Modified Likert Scale.
Publications / Results reports	Links will be provided when papers from this study are published. Publications from the previous single-centre study (PDFs): Management of sialorrhoea in motor neuron disease A survey of current UK practice Management of oral secretions in neurological disease Developing an outcome measure for excessive saliva management in MND and an evaluation of saliva burden in Sheffield A multicentre evaluation of oropharyngeal secretion management practices in amyotrophic lateral sclerosis
Participant Information Sheet	Download here