REVEALS Registry of Validated Endpoints in ALS
Research type
Research Study
Full title
TRICALS RESEARCH INTO THE COURSE OF ALS: A MULTI-CENTRE STUDY OF RESPIRATORY DECLINE AND ASSOCIATED SYMPTOMS IN PEOPLE WITH ALS/MND
IRAS ID
242722
Contact name
Christopher McDermott
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 9 months, 13 days
Research summary
Motor neurone disease is a life shortening disorder, in which the nerves that connect the muscles to the nervous system die. This leads to a progressive weakness of the muscles needed for movement of the arms and legs, chewing and swallowing, and breathing. Usually individuals affected by MND succumb to the illness and die within 2-3 years. There is no cure and treatment is aimed at easing symptoms.
Therapies that improve breathing have the potential to improve both quality of life, and possibly survival. This is evidenced by the beneficial effect of NIV (airway support) on survival (up to 9 months). Drugs that enhance breathing muscle strength therefore have the potential to significantly enhance quality of life and survival, both by delaying the time to introduction of NIV, and by enhancing cough and secretion management. However, definitive measures that evaluate the impact of changes in lung efficiency and the ability to cough are lacking. This is a barrier to the development and identification of effective new treatments improving breathing muscle strength.
The overall aim of this study is to identify the most appropriate outcome measures to detect meaningful clinical differences in breathing and cough muscle strength which can be used in future studies to evaluate the effectiveness of new treatments.
We aim to recruit 300 patients from six MND clinics around Europe. We will carry out four respiratory assessments: sniff nasal inspiratory press (SNIP); slow vital capacity (SVC); forced vital capacity (FVC); and peak cough flow (PCF). We will administer questionnaires to assess respiratory symptoms, quality of life, sleep, fatigue, secretion management, and caregiver burden. Patients will be followed up for 18 months at 3 monthly intervals. We will also contact patients remotely every 2 weeks to record the details of any chest infections.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0174
Date of REC Opinion
29 Mar 2018
REC opinion
Further Information Favourable Opinion