Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2028-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease

NCT07226284

PARKINSON DISEASE (Disorder) Parkinson's Disease (PD)

RECRUITING NA

Virtual Reality in Motor Neurone Disease

NCT06256107

Motor Neuron Disease

COMPLETED NA

Exercise to Improve Sleep in Parkinson's Disease

NCT05644327

Parkinson Disease

RECRUITING NA

Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease

NCT05524961

Parkinson Disease

RECRUITING NA

Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial

NCT02927691

Parkinson's Disease Dysphagia Dystussia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Motor Neuron Disease / Amyotrophic Lateral Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial with 12 month cohort follow-up

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The attending sleep scientist will refer to a database that reveals (statistician-generated) participant's treatment allocation. The sleep scientist will not reveal the treatment allocation to the Clinical team, Research team or the participant.

Centralised allocation concealment will be ensured through the Adept/REDCap trial database.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

This trial of PSG-assisted commencement of non-invasive ventilation (NIV) in motor neurone disease (MND) follows the methodology of our previous single-site study (Hannan et al 2019 ERJ), with the addition of an open label cohort that extends until (the earlier of) 12 months or death.

After empirical NIV set-up and an acclimatisation period (3 weeks), participants will undergo single night in-laboratory polysomnography (PSG). The PSG will be performed and supervised by a sleep scientist. In the intervention group, the "intervention" PSG results will be used to adjust/titrate NIV settings to optimize ventilation and improve synchrony between the patient and the NIV device. Participants will be asked to continue to use NIV as prescribed for the subsequent 7 week intervention period.

Group Type EXPERIMENTAL

Intervention polysomnography

Intervention Type OTHER

Please refer to 'Arms: Intervention' section.

Control

The participants allocated to the control group will also be asked to attend a single night in-laboratory PSG. The NIV settings will not be adjusted throughout the PSG ("sham" PSG). Participants in the control group will retain their original settings after the sham PSG, and will be asked to continue to use NIV in this manner for the subsequent 7 week intervention period.

Group Type PLACEBO_COMPARATOR

Sham polysomnography

Intervention Type OTHER

Please refer to 'Arms: Control' section.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention polysomnography

Please refer to 'Arms: Intervention' section.

Intervention Type OTHER

Sham polysomnography

Please refer to 'Arms: Control' section.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abbey Sawyer, PhD

Role: STUDY_CHAIR

University of Melbourne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.