Using sleep studies to improve breathing support in motor neurone disease
A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease (PSG4NIVinMND; 3, Three Letter Acronyms [3TLA])
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Melbourne Academic / other |
| Locations | 13 sites (Adelaide and 12 other locations) |
| Trial ID | NCT05136222 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with a confirmed diagnosis of MND/ALS who require long-term NIV support.
Not a fit: Patients who are medically unstable or have previously shown intolerance to NIV may not benefit from this study.
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 performed: Previous studies have shown promising results with individualized NIV titration, making this approach a potentially effective extension of earlier findings.
Eligibility criteria
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 this trial is running
Adelaide and 12 other locations
- 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)
- Austin Health — Melbourne, Australia (Recruiting)
- Australian MND Registry — Melbourne, Australia (Not_yet_recruiting)
- FightMND — Melbourne, Australia (Not_yet_recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.