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:
Neals Affiliated?
No
Coordinating Center Contact Information
David Berlowitz, PhD / email hidden; JavaScript is required / +613 9496 3871
Full Study Summary:
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