A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease (PSG4NIVinMND; 3, Three Letter Acronyms [3TLA])

Study Purpose:

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

Study Status:

Recruiting

Disease:

Motor Neuron Disease / Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

N/A

Intervention Name:

Intervention polysomnography, Sham polysomnography

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Abbey Sawyer, PhD, University of Melbourne

Clinicaltrials.gov ID:

NCT05136222

Neals Affiliated?

No

Coordinating Center Contact Information

David Berlowitz, PhD / email hidden; JavaScript is required / +613 9496 3871

Full Study Summary:

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.

Study Sponsor:

University of Melbourne

Estimated Enrollment:

244

Estimated Study Start Date:

12 / 15 / 2021

Estimated Study Completion Date:

02 / 28 / 2028

Posting Last Modified Date:

06 / 23 / 2022

Date Study Added to neals.org:

11 / 29 / 2021

Minimum Age:

18 Years

Maximum Age:

N/A

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

Flinders Medical Centre | Not yet recruiting

Dr Vinod Aiyappan

Adelaide
Australia

The Prince Charles Hospital | Not yet recruiting

Dr Deanne Curtin

Brisbane
Australia

Motor Neurone Disease Australia | Not yet recruiting

Dr Gethin Thomas

Canberra
Australia

Austin Health | Recruiting

Associate Professor Mark Howard

Melbourne
Australia

Australian MND Registry | Not yet recruiting

A/Professor Paul Talman

Melbourne
Australia

FightMND | Not yet recruiting

Dr Bec Sheean

Melbourne
Australia

Institute for Breathing and Sleep | Not yet recruiting

Associate Professor Mark Howard

Melbourne
Australia

Monash University | Not yet recruiting

Professor Natasha Lannin

Melbourne
Australia

University of Melbourne | Not yet recruiting

Professor David Berlowitz

Melbourne
Australia

Sir Charles Gairdner Hospital | Not yet recruiting

Dr Bhajan Singh

Perth
Australia

Macquarie University | Not yet recruiting

Professor Dominic Rowe

Sydney
Australia

Royal Prince Alfred Hospital | Not yet recruiting

Dr Amanda Piper

Sydney
Australia

Westmead Hospital | Not yet recruiting

Dr John Wheatley

Sydney
Australia