A nationwide, randomised controlled trial that will determine if the use of an overnight, in-laboratory sleep study can increase NIV usage in people with MND.
Polysomnography (PSG) for non-invasive ventilation (NIV) in motor neurone disease (MND) - 3-three letter accronyns, or '3TLA'.
The PSG4NIVinMND (3TLA) Trial is a randomised controlled trial funded by the Medical Research Future Fund (MRFF).
The trial will compare two different types of usual care for the use of non-invasive ventilation in people with motor neurone disease (MND).
Who is participating?
Adults who are given a diagnosis of MND by neurologists at participating centres will be considered for the trial if:
Medically stable at the time of screening
Suitable for outpatient implementation of NIV
Clinical indication to commence long term NIV according to local protocols, published guidelines and/or specialist opinion
Confirmed clinical diagnosis of MND
Age >18 years
The main reasons why somebody may not fit the study criteria are:
Medically unstable
Hypoventilation attributable to medications with sedative/respiratory depressant side-effects
Previous use of NIV for more than 1 month in the previous 3 months
Inability to provide informed consent
Previous intolerance of NIV
Pregnancy
Can I sign up to the trial?
Unfortunately this is not the type of research that enthusiastic volunteers can just sign up to. This is because the research is embedded into clinical MND care. Therefore all participants need to go through the normal clinical processes for commencing NIV. This means potential participants must be referred by their neurologist or MND team at one of the participating centres. What is involved? 1. Signing up to the study: At a usual MND clinic appointment, the team will discuss the trial and provide a person with written information if the person is interested in taking part. If eligible and willing to take part, and if clinically indicated, a person will be set up on NIV as per the usual processes at each clinical site. The participant will then be asked to take the NIV device home to use for ~ 3 weeks. A number of questionnaires will also be completed at the first study visit.
2. Randomisation: After the 3 week acclimatization period of NIV, the participant will be allocated randomly (by chance using a computer programme) to one of two sleep study types: 1. Sham sleep study (usual care) 2. Sleep study titration of NIV settings (intervention group)
3. Treatment: Participants will complete their NIV treatment for the next 7 weeks before returning to their clinical site for review.
4. Follow Up: A number of questionnaires will also be completed at the follow-up study visit.
All participants will be asked to complete questionnaires again at 3, 6 and 12 months in line with their usual clinical reviews. After this, the participant has completed the trial.
More details
Participant data will be de-identified when collected with the use of a unique participant identification number (trial identifier).
All participants will have access to their usual Clinical team throughout the trial period as they would under normal circumstances.
The trial is registered at ClinicalTrials.gov. Ethical approval for all sites has been granted by Austin Health (HREC/68088/Austin-2021)
You can find out more about the trial by using the menu on the left hand side.
Previous research
A single-site version of this trial has previously been conducted by members of our team.
