Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA) - A Multi-centre Randomised Controlled Tr

This dataset will contain de identified participant level data from the 3TLA multicentre randomised controlled trial, which evaluates whether incorporating overnight polysomnography (PSG) improves commencement and early adherence to non invasive ventilation (NIV) in people with motor neurone disease (MND).
The 3TLA trial randomises participants (1:1) to either:
•PSG assisted NIV titration (intervention), or
•Sham PSG with usual care (control).
The trial is conducted across seven MND specialist centres in Australia, with a 7 week intervention period followed by extended follow up (up to 12 months).

The dataset includes demographic variables, clinical eligibility characteristics, respiratory assessments, polysomnography metrics, NIV device download data (usage hours, pressures, leak, respiratory events), patient reported outcomes, quality of life measures, and follow up assessments. Process evaluation data (interview summaries, site implementation metrics) will also be available, consistent with the accompanying process evaluation protocol.

This dataset enables evaluation of the clinical effectiveness of PSG assisted NIV initiation, patient adherence patterns, sleep respiratory physiology in MND, and implementation processes across multiple centres.

Protocol papers have been published (SLEEP Advances 2022; Trials 2025).
DOI: 10.1186/s13063-024-08464-4
DOI: 10.1186/s13063-025-08784-z

No results are yet published, as the trial is ongoing

Primary completion expected 28 February 2026
Full study completion expected 28 February 2028