RecruitingNot ApplicableNCT05136222

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])


Sponsor

University of Melbourne

Enrollment

244 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether conducting a special overnight sleep study (polysomnography) can help doctors better fine-tune the breathing machine settings (non-invasive ventilation/NIV) for people with motor neurone disease (MND), a condition that progressively weakens muscles including breathing muscles. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of motor neurone disease or a similar condition - Your doctor has recommended starting long-term breathing support (non-invasive ventilation) **You may NOT be eligible if...** - Your condition is medically unstable - Your breathing problems are caused by sedating medications - You have been using a breathing machine for more than 1 month in the past 3 months - You cannot consent or have previously been intolerant of non-invasive ventilation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIntervention polysomnography

Please refer to 'Arms: Intervention' section.

OTHERSham polysomnography

Please refer to 'Arms: Control' section.


Locations(13)

Flinders Medical Centre

Adelaide, Australia

The Prince Charles Hospital

Brisbane, Australia

Motor Neurone Disease Australia

Canberra, Australia

Austin Health

Melbourne, Australia

Australian MND Registry

Melbourne, Australia

FightMND

Melbourne, Australia

Institute for Breathing and Sleep

Melbourne, Australia

Monash University

Melbourne, Australia

University of Melbourne

Melbourne, Australia

Sir Charles Gairdner Hospital

Perth, Australia

Macquarie University

Sydney, Australia

Royal Prince Alfred Hospital

Sydney, Australia

Westmead Hospital

Sydney, Australia

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NCT05136222


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