P020 Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): Study protocol for a randomised controlled trial

Abstract

Abstract Introduction The benefits of using non-invasive ventilation (NIV) on survival in motor neurone disease (MND) are well-established. Recent MND cohort studies have extended this finding to suggest that adherence with NIV of >4 hours/day improves survival more than <4 hours/day, and that any use increases survival more than no use at all. Despite these data, only approximately 19% of Australians with MND start NIV. Our team has recently demonstrated that specific and individualised NIV titration using polysomnography (PSG) leads to better NIV usage in MND. However, for this clinical practice model to result in sustained benefits, evidence of effectiveness across multiple sites, as well as culture and practice change must occur. The primary aim of this randomised controlled trial (RCT) is to determine if the proportion of participants using NIV for >4 hours/day during the 7-week post-randomisation period is higher in the PSG (Intervention) than the Control group. Methods A two-arm, individual participant, assessor-blinded RCT in 7 MND care centres across Australia. Eligible participants will be randomised (1:1) to either the Intervention (PSG assisted optimization of NIV) or a Control group (sham PSG). Respiratory, sleep and patient-reported outcome measures will be collected at baseline and follow-up 7 weeks after the PSG. An implementation science program, health economic evaluation and 12-month cohort follow-up will be undertaken. Data collection is underway. Trial Registration ClinicalTrials.gov (#CT05136222).