Motor Neuron Disease / Amyotrophic Lateral Sclerosis3TLANCT05136222
Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease
A study testing Intervention polysomnography in people with Motor Neuron Disease / Amyotrophic Lateral Sclerosis, run by University of Melbourne at 13 sites in Australia.
Trial summary
A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Neuron Disease / Amyotrophic Lateral Sclerosis
- What is being tested?
- Intervention polysomnography
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 13 sitesAustralia
- Study dates
- 15 Dec 2021to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Clinical indication to commence long term NIV
- Confirmed clinical diagnosis of underlying condition
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Australia13 sites, 13 recruiting
- Not yet recruiting
Flinders Medical Centre
Adelaide
Dr Vinod Aiyappan
- Not yet recruiting
The Prince Charles Hospital
Brisbane
Dr Deanne Curtin
- Not yet recruiting
Motor Neurone Disease Australia
Canberra
Dr Gethin Thomas
- Recruiting
Austin Health
Melbourne
Associate Professor Mark Howard
- Not yet recruiting
Australian MND Registry
Melbourne
A/Professor Paul Talman
- Not yet recruiting
FightMND
Melbourne
Dr Bec Sheean
- Not yet recruiting
Institute for Breathing and Sleep
Melbourne
Associate Professor Mark Howard
- Not yet recruiting
Monash University
Melbourne
Professor Natasha Lannin
- Not yet recruiting
University of Melbourne
Melbourne
Professor David Berlowitz
- Not yet recruiting
Sir Charles Gairdner Hospital
Perth
Dr Bhajan Singh
- Not yet recruiting
Macquarie University
Sydney
Professor Dominic Rowe
- Not yet recruiting
Royal Prince Alfred Hospital
Sydney
Dr Amanda Piper
- Not yet recruiting
Westmead Hospital
Sydney
Dr John Wheatley
About this study
Official title: A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease (PSG4NIVinMND; 3, Three Letter Acronyms [3TLA])
A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.
Read the detailed 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.
- Being tested
- Intervention polysomnography, Sham polysomnography
- Keywords
- Non-invasive ventilation, Polysomnography, Sleep study, Amyotrophic lateral sclerosis, Chronic respiratory failure
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention polysomnographyOther
Please refer to 'Arms: Intervention' section.
Sham polysomnographyOther
Please refer to 'Arms: Control' section.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Intervention polysomnography |
| Control | Placebo comparator | 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. Receives: Other: Sham polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence with NIV
Defined as using NIV > 4 hours/day during the NIV treatment period.
Measured: Change during the acclimatization period (~3 weeks) and during the NIV treatment period (~7-8 weeks) (approx. 10 weeks total per participant).
Secondary outcomes (25)
Intolerance of NIV
Defined as cessation of NIV during the NIV treatment period and/or < 4 hours.
Measured: Change during the acclimatization period (~ 3 weeks) and during the NIV treatment period (~7-8 weeks) (approx. 10 weeks total per participant).
Respiratory function
Forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC]
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.
Maximal inspiratory/expiratory pressure
'MIPs/MEPs'.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.
Sniff nasal pressure
'SNIP'.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.
Arousal index (during polysomnography)
Defined as the number of electroencephalogram (EEG) arousals observed per hour of total sleep time (TST).
Measured: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Asynchrony index (during polysomnography)
Defined as the number of asynchrony events per hour of sleep.
Measured: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Oxygen indices (during polysomnography)
Multiple measures to summarise oxygenation as one single outcome including oxygen desaturation index (defined as the total number of oxygen desaturation episodes [= 4%] per hour of total), sleep time, nadir SpO2, and time with SpO2 < 90%, area under the curve and others.
Measured: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Total sleep time (during polysomnography)
Total amount of time asleep in minutes.
Measured: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
% rapid eye movement (REM) sleep (during polysomnography)
Percentage of sleep characterised by eye movement, relaxation of the body, faster. respiration, and increased brain activity
Measured: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
% slow wave sleep (SWS) (during polysomnography)
Percentage of 'deep sleep'.
Measured: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Asynchrony sub-indices (during polysomnography)
Ineffective efforts, double-trigger etc.
Measured: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Dyspnoea Amyotrophic Lateral Sclerosis (DALS-15)
A measure of breathlessness in people with ALS/MND.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Health-related quality of life - Severe Respiratory Insufficient Questionnaire (SRI)
A measure of health-related quality of life.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Health-related quality of life - Assessment of Quality of Life (8-Dimension-AQoL)
A measure of health-related quality of life.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Health-related quality of life - Calgary Sleep Apnoea Quality of Life Index (SAQLI)
A measure of health-related quality of life.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Functional rating - Amyotrophic Lateral Sclerosis Functional Rating Scale (Revised) (ALSFRS)
A clinical measure of functional rating in people with ALS/MND. Minimum score: 0, maximum score: 40. The higher the score the more function is retained.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Sleep quality - Pittsburgh Sleep Quality Index (PSQI)
A measure of sleep quality.
Measured: RCT: During the baseline and during the follow-up assessment. Cohort: At 3, 6 and 12 months following RCT commencement.
Daytime somnolence - Epworth Sleepiness Scale (ESS)
A measure of daytime sleepiness.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Daytime somnolence - Karolinska Sleepiness Scales (KSS)
The KSS is rating of the current daytime sleepiness state using a 9-point scale (1 = very alert to 9 = very sleepy, fighting sleep).
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Carer burden - Caregiver Burden Scale (CBS)
A measure of caregiver burden. Rated ona scale from 0 (never) to 4 (nearly always), with higher scores indicating greater carer burden.
Measured: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Cost effectiveness of the intervention
Economic evaluation using MBS/PBS data.
Measured: Throughout the trial period (approx. 5 years) (retrospective analysis).
Usual clinical care practices
Multidisciplinary clinician surveys at each recruitment site.
Measured: At trial commencement and trial end.
Usual care and the barriers and enablers to undertaking the intervention
Multidisciplinary clinician focus groups at each recruitment site.
Measured: At trial commencement (start of RCT) and trial end (end of RCT; approx. 4 to 5 years).
Experience of receiving the intervention and the barriers and enablers to the PSG and NIV usage
Participant semi-structured interviews.
Measured: At trial end (end of RCT; approx. 4 to 5 years)
Experience of the person they are caring for receiving the intervention and the barriers and enablers to the PSG and NIV usage
Caregiver semi-structured interviews.
Measured: At trial end (end of RCT; approx. 4 to 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start15 Dec 2021
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Motor Neuron Disease / Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial with 12 month cohort follow-up
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Austin Hospital, Melbourne Australia, Institute for Breathing and Sleep, Australia, Royal Prince Alfred Hospital, Sydney, Australia, Macquarie University, Australia, Macquarie Health, Western Sydney Local Health District, Flinders Medical Centre, Sir Charles Gairdner Hospital, The Prince Charles Hospital, Monash University, Motor Neurone Disease Australia, FightMND, Australian Motor Neurone Disease Registry, Calvary Bethlehem, Perron Institute for Neurological and Translational Science
- Responsible party
- Sponsor
- Investigators
- Abbey Sawyer, PhD, Study chair, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136222
- Sponsor's protocol ID
- CT20020
- Acronym
- 3TLA
- Status last verified
- Jun 2022
- First submitted
- 21 Oct 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset in de-identified form will be shared on request to corresponding author.
Publications
Graco M, Berlowitz DJ, Sawyer A, Holland AE, Carey KA, Ahamed Y, Ridgers A, Lannin NA; 3TLA trial Group. Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): protocol for a process evaluation of a clinical trial. Trials. 2025 Mar 6;26(1):79. doi: 10.1186/s13063-025-08784-z.
PubMed 40050976Berlowitz DJ, Rowe D, Howard ME, Piper A, Graco M, Braat S, Singh B, Souza TV, Lannin N, McLean A, Sawyer A, Carey KA, Ahamed Y; 3TLA Trial Group. Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): study protocol for a randomised controlled trial. Trials. 2025 Jan 6;26(1):10. doi: 10.1186/s13063-024-08464-4.
PubMed 39762986
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease (PSG4NIVinMND; 3, Three Letter Acronyms [3TLA])
- ClinicalTrials.gov ID
- NCT05136222
- Acronym / sponsor ID
- 3TLA / CT20020
- Keywords
- Non-invasive ventilation, Polysomnography, Sleep study, Amyotrophic lateral sclerosis, Chronic respiratory failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Austin Hospital, Melbourne Australia, Institute for Breathing and Sleep, Australia, Royal Prince Alfred Hospital, Sydney, Australia, Macquarie University, Australia, Macquarie Health, Western Sydney Local Health District, Flinders Medical Centre, Sir Charles Gairdner Hospital, The Prince Charles Hospital, Monash University, Motor Neurone Disease Australia, FightMND, Australian Motor Neurone Disease Registry, Calvary Bethlehem, Perron Institute for Neurological and Translational Science
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 29 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial with 12 month cohort follow-up
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intervention polysomnographyThis 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. |
| Control | Placebo comparator | Other: Sham polysomnographyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Clinical indication to commence long term NIV
- Confirmed clinical diagnosis of underlying condition
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention polysomnographyPlease refer to 'Arms: Intervention' section. | Other | Intervention |
| Sham polysomnographyPlease refer to 'Arms: Control' section. | Other | Control |
Primary outcome
Adherence with NIV
Time frame: 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.
25 secondary outcomes
Intolerance of NIV
Time frame: Change during the acclimatization period (~ 3 weeks) and during the NIV treatment period (~7-8 weeks) (approx. 10 weeks total per participant).
Respiratory function
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.
Maximal inspiratory/expiratory pressure
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.
Sniff nasal pressure
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement as able.
Arousal index (during polysomnography)
Time frame: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Asynchrony index (during polysomnography)
Time frame: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Oxygen indices (during polysomnography)
Time frame: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Total sleep time (during polysomnography)
Time frame: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
% rapid eye movement (REM) sleep (during polysomnography)
Time frame: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
% slow wave sleep (SWS) (during polysomnography)
Time frame: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Asynchrony sub-indices (during polysomnography)
Time frame: During the baseline (following the ~3 week acclimatisation period) and during the follow-up assessment (~ week 3 + 7). Cohort: Not Collected.
Dyspnoea Amyotrophic Lateral Sclerosis (DALS-15)
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Health-related quality of life - Severe Respiratory Insufficient Questionnaire (SRI)
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Health-related quality of life - Assessment of Quality of Life (8-Dimension-AQoL)
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Health-related quality of life - Calgary Sleep Apnoea Quality of Life Index (SAQLI)
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Functional rating - Amyotrophic Lateral Sclerosis Functional Rating Scale (Revised) (ALSFRS)
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Sleep quality - Pittsburgh Sleep Quality Index (PSQI)
Time frame: RCT: During the baseline and during the follow-up assessment. Cohort: At 3, 6 and 12 months following RCT commencement.
Daytime somnolence - Epworth Sleepiness Scale (ESS)
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Daytime somnolence - Karolinska Sleepiness Scales (KSS)
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Carer burden - Caregiver Burden Scale (CBS)
Time frame: During the baseline (~week 0) and during the follow-up assessment (~ week 3 + 7). Cohort: At 3, 6 and 12 months following RCT commencement.
Cost effectiveness of the intervention
Time frame: Throughout the trial period (approx. 5 years) (retrospective analysis).
Usual clinical care practices
Time frame: At trial commencement and trial end.
Usual care and the barriers and enablers to undertaking the intervention
Time frame: At trial commencement (start of RCT) and trial end (end of RCT; approx. 4 to 5 years).
Experience of receiving the intervention and the barriers and enablers to the PSG and NIV usage
Time frame: At trial end (end of RCT; approx. 4 to 5 years)
Experience of the person they are caring for receiving the intervention and the barriers and enablers to the PSG and NIV usage
Time frame: At trial end (end of RCT; approx. 4 to 5 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Derived from this study: PubMed 40050976Graco M, Berlowitz DJ, Sawyer A, Holland AE, Carey KA, Ahamed Y, Ridgers A, Lannin NA; 3TLA trial Group. Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): protocol for a process evaluation of a clinical trial. Trials. 2025 Mar 6;26(1):79. doi: 10.1186/s13063-025-08784-z.
- Derived from this study: PubMed 39762986Berlowitz DJ, Rowe D, Howard ME, Piper A, Graco M, Braat S, Singh B, Souza TV, Lannin N, McLean A, Sawyer A, Carey KA, Ahamed Y; 3TLA Trial Group. Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): study protocol for a randomised controlled trial. Trials. 2025 Jan 6;26(1):10. doi: 10.1186/s13063-024-08464-4.
- Individual participant dataSharing planned: Yes. Dataset in de-identified form will be shared on request to corresponding author.
Related trials for Motor Neuron Disease / Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abbey Sawyer, PhD study chair
University of Melbourne
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention polysomnography in people with Motor Neuron Disease / Amyotrophic Lateral Sclerosis, run by University of Melbourne at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Berlowitz, PhD (+613 9496 3871, david.berlowitz@austin.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence with NIV (time frame: Change during the acclimatization period (~3 weeks) and during the NIV treatment period (~7-8 weeks) (approx. 10 weeks total per participant).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05136222, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.