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Clinical Trials in Australia / NCT05136222
Recruiting Not applicable

Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease

NCT05136222 · tracked via the Priya Life Science Australia tracker
Sponsor
University of Melbourne
Phase
Not applicable
Started
2021-12-15
Last updated
2022-06-23

Condition(s) studied

Motor Neuron Disease / Amyotrophic Lateral Sclerosis

Investigational drug(s) / intervention(s)

Intervention polysomnographySham polysomnography

Intervention polysomnography: Please refer to 'Arms: Intervention' section.

Sham polysomnography: Please refer to 'Arms: Control' section.

Study summary

A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Adherence with NIV — Change during the acclimatization period (~3 weeks) and during the NIV treatment period (~7-8 weeks) (approx. 10 weeks total per participant).
    Defined as using NIV \> 4 hours/day during the NIV treatment period.

Trial sites (13)

FacilityCityRegionStatus
Flinders Medical Centre Adelaide Australia Not Yet Recruiting
The Prince Charles Hospital Brisbane Australia Not Yet Recruiting
Motor Neurone Disease Australia Canberra Australia Not Yet Recruiting
Austin Health Melbourne Australia Recruiting
Australian MND Registry Melbourne Australia Not Yet Recruiting
FightMND Melbourne Australia Not Yet Recruiting
Institute for Breathing and Sleep Melbourne Australia Not Yet Recruiting
Monash University Melbourne Australia Not Yet Recruiting
University of Melbourne Melbourne Australia Not Yet Recruiting
Sir Charles Gairdner Hospital Perth Australia Not Yet Recruiting
Macquarie University Sydney Australia Not Yet Recruiting
Royal Prince Alfred Hospital Sydney Australia Not Yet Recruiting
Westmead Hospital Sydney Australia Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05136222 on ClinicalTrials.gov ↗ ← All trials in Australia