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Recruiting Not applicable NCT05136222

Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease

No applicable phase (e.g. observational)
Conditions: Motor Neuron Disease / Amyotrophic Lateral Sclerosis

Sponsor: University of Melbourne

trial.available_in: БГ
Overview
A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.
Description
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.
Who can participate
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
Locations 1
Australia (1)
Flinders Medical Centre
Adelaide
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.12.2021
Completion date
28.02.2028
Registry ID
NCT05136222
Source
anzctr
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