Non-invasive ventilation (NIV) is a treatment that uses positive pressure delivered via a face mask or mouthpiece to assist a person to breathe. It can be used as a long-term treatment for people whose breathing is failing - usually due to chronic conditions that produce weakness of the respiratory muscles such as in MND/ALS. Most people with MND/ALS use NIV at night initially. Even though NIV may improve survival and function, many are unable to use it for more than 4 hours per day (which is considered a threshold amount of use in order to gain a benefit) and many others are unable to tolerate it at all. This research team has recently provided evidence that specific and individualised titration of NIV leads to better outcomes in people with MND. A previous trial determined that the use of a sleep study (also called 'polysomnography') can improve the way people are initially set up with NIV. This study will replicate and extend the single site study in a large, multi-centre randomised controlled trial (RCT) across multiple sites This multi-centre RCT will also include a 12-month follow-up period to evaluate longer-term outcomes.
This trial of PSG-assisted commencement of non-invasive ventilation (NIV) in motor neurone disease (MND) follows the methodology of a previous single-site study (Hannan et al, 2019), with the addition of an open label cohort that extends until (the earlier of) 12 months or death.
After empirical NIV set-up and an acclimatisation period (3 weeks), participants will undergo single night in-laboratory polysomnography (PSG). The PSG will be performed and supervised by a sleep scientist. In the intervention group, the "intervention" PSG results will be used to adjust/titrate NIV settings to optimize ventilation and improve synchrony between the patient and the NIV device. Participants will be asked to continue to use NIV as prescribed for the subsequent 7 week intervention period.
The participants allocated to the control group will also be asked to attend a single night in-laboratory PSG. The NIV settings will not be adjusted throughout the PSG ("sham" PSG). Participants in the control group will retain their original settings after the sham PSG, and will be asked to continue to use NIV in this manner for the subsequent 7-week intervention period.
Flinders Medical Centre, Adelaide - Dr Vinod Aiyappan
The Prince Charles Hospital, Brisbane - Dr Deanne Curtin
Austin Health, Melbourne - Associate Professor Mark Howard
Institute for Breathing and Sleep, Melbourne - Associate Professor Mark Howard
Monash University, Melbourne - Professor Natasha Lannin
Sir Charles Gairdner Hospital, Perth - Dr Bhajan Singh
Macquarie University, Sydney - Professor Dominic Rowe
Royal Prince Alfred Hospital, Sydney - Dr Amanda Piper
Westmead Hospital, Sydney - Dr John Wheatley