Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Melbourne
About this trial
A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.
Eligibility criteria
Qualifiers
Age >18 years
Clinical indication to commence long term NIV
Confirmed clinical diagnosis of underlying condition
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intervention polysomnography
- Sham polysomnography
Treatment groups
244 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Melbourne
Lead sponsor
Austin Hospital, Melbourne Australia
Collaborator
Institute for Breathing and Sleep, Australia
Collaborator
Royal Prince Alfred Hospital, Sydney, Australia
Collaborator
Macquarie University, Australia
Collaborator
Macquarie Health
Collaborator
Western Sydney Local Health District
Collaborator
Flinders Medical Centre
Collaborator
Sir Charles Gairdner Hospital
Collaborator
The Prince Charles Hospital
Collaborator
Monash University
Collaborator
Motor Neurone Disease Australia
Collaborator
FightMND
Collaborator
Australian Motor Neurone Disease Registry
Collaborator
Calvary Bethlehem
Collaborator
Perron Institute for Neurological and Translational Science
Collaborator
Source ClinicalTrials.gov