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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intervention polysomnography
Other interventionPlease refer to 'Arms: Intervention' section.
Sham polysomnography
Other interventionPlease refer to 'Arms: Control' section.
Treatment groups
244 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adherence with NIV
Defined as using NIV \> 4 hours/day during the NIV treatment period.
Time frame
Change during the acclimatization period (~3 weeks) and during the NIV treatment period (~7-8 weeks) (approx. 10 weeks total per participant).Secondary outcomes
1
Intolerance of NIV
Defined as cessation of NIV during the NIV treatment period and/or \< 4 hours.
Time frame
Change during the acclimatization period (~ 3 weeks) and during the NIV treatment period (~7-8 weeks) (approx. 10 weeks total per participant).2
Respiratory function
Forced expiratory volume in 1 second \[FEV1\], forced vital capacity \[FVC\]
Time frame
During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.3
Maximal inspiratory/expiratory pressure
'MIPs/MEPs'.
Time frame
During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.4
Sniff nasal pressure
'SNIP'.
Time frame
During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.Other outcomes
1
Arterial Blood Gas (ABG) (during polysomnography)
Arterial Blood Gas
Time frame
RCT: During the baseline (following the acclimatisation period) and during the follow-up assessment. Cohort: Not Collected.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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