NCT05136222

Polysomnographic Titration of Non-invasive Ventilation 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])

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.

Detailed description

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 - usually due to chronic conditions that produce weakness of the respiratory muscles such as motor neurone disease / amyotrophic lateral sclerosis \[MND/ALS\]chronic obstructive pulmonary disease). 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 threshold amount of use in order to gain a benefit) and many others are unable to tolerate it at all. Our team has recently provided evidence that specific and individualised titration of NIV leads to better outcomes in people with MND. This previous trial determined that the use of a sleep study (also called 'polysomnography') can improve the way people are initially set up with NIV. This study will replicate and extend the single site study in a large, multi-centre randomised controlled trial (RCT) across multiple sites This multi-centre RCT will also include a 12-month follow-up period to evaluate longer-term outcomes.

Conditions

• Motor Neuron Disease / Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
OTHER	Intervention polysomnography	Please refer to 'Arms: Intervention' section.
OTHER	Sham polysomnography	Please refer to 'Arms: Control' section.

Timeline

• Start date: 2021-12-15
• Primary completion: 2026-02-28
• Completion: 2028-02-28
• First posted: 2021-11-29
• Last updated: 2022-06-23

Locations

13 sites across 1 country: Australia