Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA) - A Multi-centre Randomised Controlled Tr
The University of MelbourneDataset description
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 2028Date Information
Subjects
Health systems | Medical physiology not elsewhere classified | Neurology and neuromuscular diseasesIdentifiers
Source Study
Trial name (public)
Purpose:
Phase:
Trial acronym
Not available
Trial ID
NCT05136222
Funding
Not available
Scientific enquiries
Brief Summary
A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.
Key Inclusion Criteria
Inclusion Criteria: * Age >18 years * Clinical indication to commence long term NIV * Confirmed clinical diagnosis of underlying condition Exclusion Criteria: * Medically unstable * Hypoventilation attributable to medications with sedative/respiratory depressant side- effects * Use of NIV for more than 1 month in the previous 3 months * Inability to provide informed consent * Previous intolerance of NIV
Key Exclusion Criteria
Can healthy volunteers participate?
No
Population
Sample Size Not Available
Min. age 18 Years
Max. age N/A
Sex All
Condition category Non-invasive ventilation , Polysomnography , Sleep study , Amyotrophic lateral sclerosis , Chronic respiratory failure
Condition code Motor Neuron Disease / Amyotrophic Lateral Sclerosis
Intervention
Intervention code Other interventions - Intervention polysomnography , Other interventions - Sham polysomnography
Intervention Experimental This trial of PSG-assisted commencement of non-invasive ventilation (NIV) in motor neurone disease (MND) follows the methodology of our previous single-site study (Hannan et al 2019 ERJ), 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 .... Read more
Comparison
Control group Not available
Comparison not available.
Outcomes
Not Available
Will the study consider sharing individual participant data?
Yes
When can requests for individual participant data be made (start and end dates)?
5 years from study completion.
Who can request access to individual participant data?
Subject to optional consent, where participants give permission for data to be used for the purpose of: 1. The ethically approved research project only. 2. This ethically approved research project and any closely related future research projects. 3. This ethically approved research project and any future research projects that may or may not be related to this project.