Volume mode NIV in ALS
Research type
Research Study
Full title
Volume targeted versus pressure targeted non-invasive ventilation in amyotrophic lateral sclerosis: a randomised control trial.
IRAS ID
293304
Contact name
David Parr
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Amyotrophic lateral sclerosis (ALS) is one of five motor neurone diseases (MNDs). It is a rare, incurable disease characterised by progressive destruction of nerve cells called motor neurones that instruct a patient's muscles to contract, to enable all movements, including walking, talking, speaking and swallowing. At any one time in England there are between 4-5 people per 100, 000 living with ALS. The average life expectancy is between 3-5 years.
Over time as more motor neurone cells are damaged, the muscles used to breathe will weaken and patients will develop breathlessness and sleep disturbances. This can be very distressing and reduce a patient's health- related quality of life (HRQOL). Eventually the condition may progress to the extent that the patient will develop respiratory failure, which is the leading cause of death in ALS.
Standard care to treat breathlessness and sleep disturbances in ALS is non-invasive ventilation (NIV). This treatment requires a patient to wear a mask connected to a tube and ventilator; this helps the patient to breathe in and out. NIV has been shown to improve symptoms, HRQOL and prolong life in ALS.
Commencing NIV at the earliest opportunity is important as it allows a patient to receive maximum benefit. Regular monitoring of symptoms is recommended, and this includes tests of breathing, sleep and blood every 3 months.
NIV is provided by either using volume or pressure to support breathing. This study will follow a standard care pathway and aim to recruit 40 ALS patients randomised to receive either pressure NIV or volume NIV. Each patient will enrol onto the study for 90 days and attend 5 hospital visits. The study will assess if volume NIV improves a patient's symptoms sooner and allows a patient to use the NIV for longer periods thereby improving HRQOL.
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0326
Date of REC Opinion
19 Jan 2022
REC opinion
Further Information Favourable Opinion