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 - often 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 minimum 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 optimisation of NIV leads to better outcomes in people with MND. The previous trial determined that the use of a sleep study (also called 'polysomnography' or 'PSG') can improve the way people are initially set up with NIV. This study will replicate and extend the initial study in a larger randomised controlled trial (RCT) across multiple sites. This will also include a 12-month follow-up period to evaluate longer-term outcomes.
Trial sites and are eligibility criteria are listed below. In order to take part in a clinical trial, you should first speak to your neurologist or MND Clinic.
After an initial NIV set-up and an acclimatisation period (3 weeks), participants will undergo single night in-laboratory sleep study. This will be performed and supervised by a sleep scientist and the results will be used to adjust NIV settings to optimize ventilation for the specific patient. Participants will be asked to continue to use NIV as prescribed for the 7 weeks.
The participants allocated to the control group will also be asked to attend a single night in-laboratory sleep study. 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.
Eligibility criteria
| VIC | Austin Hospital | Kayla Bruzzese kayla.bruzzese@austin.org.au 03 9496 3688 |
| NSW | Royal Prince Alfred Hospital | Dr. Collette Menadue collette.menadue@health.nsw.gov.au 02 9515 8708 A/Prof Amanda Piper amanda.piper@health.nsw.gov.au 02 9515 8708 |
| Westmead Hospital | Dr Peter Wu peter.wu@health.nsw.gov.au 02 8890 7286 Trial Coordinator/Physiotherapist Lesley Howard Lesley.Howard@health.nsw.gov.au 02 8890 6042 | |
| Macquarie University Hospital | Richard Gan richard.gan@mq.edu.au 02 9812 3739 | |
| SA | Flinders Medical Centre | MND Nurse Practitioner Leanne Davis leanne.davis2@sa.gov.au Trial Coordinator Asha Kepatas asha.kapetas@sa.gov.au 08 8404 2203 |
| WA | Sir Charles Gairdner Hospital | Cam Harvey cameron.harvey@health.wa.gov.au 08 6457 2822 |
| QLD | The Prince Charles Hospital | Dr. Irene Szollosi TPCH.sleepresearch@health.qld.gov.au Trent Segal trent.segal@health.qld.gov.au 07 3139 6175 |
Principal Investigator for 3TLA Trial:
Professor David Berlowitz
david.berlowitz@austin.org.au
03 9496 3871
Trial Manager for 3TLA Trial:
Dr. Yasmin Ahamed
ahamedy@unimelb.edu.au
For more information visit ClinicalTrials.gov
