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
Inclusion Criteria3
- Age \>18 years
- Clinical indication to commence long term NIV
- Confirmed clinical diagnosis of underlying condition
Exclusion Criteria5
- 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
Interventions
OTHERIntervention polysomnography
Please refer to 'Arms: Intervention' section.
OTHERSham polysomnography
Please refer to 'Arms: Control' section.
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT05136222