Using sleep studies to improve breathing support in motor neurone disease
Official title: A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease (PSG4NIVinMND; 3, Three Letter Acronyms [3TLA])
Run by University of Melbourne · NCT05136222 · Data updated 2026-11-12
This study is testing if using sleep studies can help people with motor neurone disease get better breathing support from non-invasive ventilation to improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 244 (estimated) |
| Sponsor | University of Melbourne Academic / other |
| Locations | 13 sites (Adelaide and 12 other locations) |
| Status | Recruiting |
| Started | December 15, 2021 |
| Main results expected | February 28, 2026 |
| Study ends | February 28, 2028 |
| Registry record updated | June 23, 2022 |
| Trial ID | NCT05136222 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years with a confirmed diagnosis of MND/ALS who require long-term NIV support.
✕Probably not a fit
Patients who are medically unstable or have previously shown intolerance to NIV may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of personalized non-invasive ventilation (NIV) titration using polysomnography in patients with motor neurone disease (MND) or amyotrophic lateral sclerosis (ALS). Conducted across seven care centers in Australia, the study randomly assigns participants to receive either intervention or sham polysomnography to optimize their NIV settings. The aim is to enhance the duration and tolerance of NIV use, which is crucial for improving respiratory function and overall quality of life. Participants will be followed for 12 months to assess long-term outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly improve the ability of patients with MND/ALS to use NIV effectively, leading to better respiratory function and quality of life.
How similar studies have gone: Previous studies have shown promising results with individualized NIV titration, making this approach a potentially effective extension of earlier findings.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Austin Health
Melbourne, Australia Recruiting -
Flinders Medical Centre
Adelaide, Australia Not yet recruiting -
The Prince Charles Hospital
Brisbane, Australia Not yet recruiting -
Motor Neurone Disease Australia
Canberra, Australia Not yet recruiting -
Australian MND Registry
Melbourne, Australia Not yet recruiting -
FightMND
Melbourne, Australia Not yet recruiting
Show 7 more locations
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Institute for Breathing and Sleep
Melbourne, Australia Not yet recruiting -
Monash University
Melbourne, Australia Not yet recruiting -
University of Melbourne
Melbourne, Australia Not yet recruiting -
Sir Charles Gairdner Hospital
Perth, Australia Not yet recruiting -
Macquarie University
Sydney, Australia Not yet recruiting -
Royal Prince Alfred Hospital
Sydney, Australia Not yet recruiting -
Westmead Hospital
Sydney, Australia Not yet recruiting
Study contacts
- Study coordinator: David Berlowitz, PhD
- Email: david.berlowitz@austin.org.au
- Phone: +613 9496 3871
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Electrical stimulation to reduce facial pain and improve jaw movement and chewing in people with motor neuron disease
This trial will try one 30-minute session of non-invasive facial electrical stimulation to see if it reduces jaw and facial pain and improves chewing and jaw movement for people with ALS or PLS.
-
Observational study on amyotrophic lateral sclerosis
This study is collecting health information from people with ALS, those with related genetic mutations, and healthy volunteers to help improve treatments and understand the disease better.
-
Testing drugs to slow down motor neurone disease progression
This study is testing if the drug amantadine can help slow down motor neurone disease and improve survival for people living with it.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.