Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease

Last updated: June 19, 2022
Sponsor: University of Melbourne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT05136222
CT20020
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years
  • Clinical indication to commence long term NIV
  • Confirmed clinical diagnosis of underlying condition

Exclusion

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

Study Design

Total Participants: 244
Study Start date:
December 15, 2021
Estimated Completion Date:
February 28, 2028

Study 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.

Connect with a study center

  • Flinders Medical Centre

    Adelaide,
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Brisbane,
    Australia

    Site Not Available

  • Motor Neurone Disease Australia

    Canberra,
    Australia

    Site Not Available

  • Austin Health

    Melbourne,
    Australia

    Active - Recruiting

  • Australian MND Registry

    Melbourne,
    Australia

    Site Not Available

  • FightMND

    Melbourne,
    Australia

    Site Not Available

  • Institute for Breathing and Sleep

    Melbourne,
    Australia

    Site Not Available

  • Monash University

    Melbourne,
    Australia

    Site Not Available

  • University of Melbourne

    Melbourne,
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Perth,
    Australia

    Site Not Available

  • Macquarie University

    Sydney,
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Sydney,
    Australia

    Site Not Available

  • Westmead Hospital

    Sydney,
    Australia

    Site Not Available

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