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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000591459
Ethics application status
Approved
Date submitted
14/05/2025
Date registered
10/06/2025
Date last updated
10/06/2025
Date data sharing statement initially provided
10/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled trial comparing the effects of in-hospital and home-based methods of adjusting non-invasive ventilation settings in people with long-term breathing failure.
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Scientific title
A single-centre randomised controlled non-inferiority trial evaluating the effects of laboratory or home non-invasive ventilation (NIV) adjustment on NIV usage in people with chronic respiratory failure: Synchronise NIV@Home.
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Secondary ID [1]
314260
0
MRF2032193
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Universal Trial Number (UTN)
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Trial acronym
Synchronise NIV@Home RCT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuromuscular disease
337185
0
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Obesity hypoventilation syndrome
337189
0
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Chest wall disease
337187
0
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Chronic obstructive pulmonary disease
337186
0
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Chronic hypercapnic respiratory failure
337184
0
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Chronic obstructive pulmonary disease-obstructive sleep apnoea overlap syndrome
337188
0
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Condition category
Condition code
Respiratory
333600
333600
0
0
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Other respiratory disorders / diseases
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Respiratory
333599
333599
0
0
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Chronic obstructive pulmonary disease
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Public Health
333603
333603
0
0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All participants will undergo a standardised daytime titration of NIV (using Vivo 45LS ventilator [Breas Medical, Massachusetts, United States of America]), followed by a four-week acclimatisation period (Week 0 to Week 4). After this period, participants who are not successfully using NIV will be randomised to one of three study arms. These participants will complete a single overnight sleep study assessment and NIV adjustments corresponding to their study arm during the adjustment period (Week 5 to Week 8). Randomised participants may undergo additional overnight sleep studies if deemed necessary by the clinician reviewing the sleep study to improve NIV usage. Participants successfully using NIV after the acclimatisation period (Week 0 to Week 4) will not be randomised and therefore will not undergo a sleep study during the adjustment period (Week 5 to Week 8). All participants will be asked to continue using NIV as prescribed during the adjustment period (Week 5 to Week 8) and the follow up period (Week 9 to Week 16). All participants will complete a home-based review of summarised overnight NIV and respiratory data (approximately 10 hours) at end-intervention (Week 16). Participants who are not randomised at Week 4 (post-recruitment) will not be included in the primary analysis. All participants (randomised and non-randomised participants) will be included in an observational analysis (lower grade of evidence) comparing outcomes at end-intervention (Week 16).
Arm 2: Intervention
Participants randomised to Arm 2 will complete a home-based polygraphy sleep study (approximately 10 hours), with adjustments to NIV settings based on breath-by-breath analysis. On the day of the sleep study, participants will attend a telehealth assessment with a respiratory doctor, who will make any required adjustments to the NIV mask and/or settings as deemed necessary. An experienced sleep scientist will set up the polygraphy sleep study equipment in the participant's home for the participant to wear and sleep with overnight. Measurements will include thoracic and abdominal respibands, continuous oxygen saturation (SpO2) using a pulse oximeter with a finger probe, and transcutaneous carbon dioxide (PtcCO2) using transcutaneous capnography. Mask pressure, total flow, tidal volume and leak will be measured by the NIV device. The sleep study data will be analysed by experienced clinicians to determine optimal NIV settings based on breath-by-breath analysis within 72 hours of the sleep study. The optimal NIV settings will be applied and sleep study equipment will be collected during a home-visit session with a respiratory nurse.
Arm 3: Intervention
Participants randomised to Arm 3 will complete a home-based review of summarised overnight NIV and respiratory data (approximately 10 hours). On the day of the review, participants will attend a telehealth assessment with a respiratory doctor, who will make any required adjustments to the NIV mask and/or settings as deemed necessary. Participants will set up continuous SpO2 monitoring themselves using a pulse oximeter with a finger probe. Mask pressure, total flow, tidal volume and leak will be measured by the NIV device. Experienced clinicians will determine optimal NIV settings based on summarised, whole-night NIV data, analysed within 72 hours of NIV data collection. The optimal NIV settings will be applied through a second telehealth session with a respiratory nurse.
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Intervention code [1]
330871
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Treatment: Other
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Comparator / control treatment
Arm 1: Intervention
Participants randomised to Arm 1 will complete a polysomnography sleep study (approximately 10 hours) in an in-hospital sleep laboratory and adjustments to NIV settings will be based on breath-by-breath analysis. On the day of the sleep study, participants will be reviewed in person by a respiratory doctor, who will make any required adjustments to the NIV mask and/or settings as deemed necessary. An experienced sleep scientist will set up the polysomnography sleep study equipment in the in-hospital sleep laboratory for the participants to wear and sleep with overnight. Measurements will include electroencephalography (EEG) using seven electrodes, left and right electrooculography (EOG), submental and diaphragm electromyography (EMG), body position, thoracic and abdominal respibands, continuous SpO2 monitoring using a pulse oximeter with a finger probe, and PtcCO2 using transcutaneous capnography. Mask pressure, total flow, tidal volume and leak will be measured by the NIV device. The sleep study data will be analysed by experienced clinicians to determine optimal NIV settings based on a breath-by-breath analysis within 72 hours of the sleep study. The sleep study will be staged and scored as per published criteria (The American Academy of Sleep Medicine [AASM] Manual for the Scoring of Sleep and Associated Events: Version 3.0). The optimal NIV settings will be applied through a second telehealth session with a respiratory nurse.
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Control group
Active
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Outcomes
Primary outcome [1]
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NIV usage
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Assessment method [1]
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Group average daily NIV usage, averaged over four-week blocks, during the intervention period. Data will be collected directly from participant's NIV devices using cloud-based monitoring systems (BREAS EveryWare) and/or using data cards.
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Timepoint [1]
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Week 4, Week 8, Week 12 and Week 16 (primary end-point) post initial daytime titration of NIV.
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Secondary outcome [1]
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To understand the acceptability of the interventions and the implementation of the interventions from the perspective of patient participants
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Assessment method [1]
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A semi-structured interview and questionnaire with purposively recruited patient participants to explore the feasibility and acceptability of the models of care, including identification of barriers and facilitators to implementation, using the Theoretical Framework of Acceptability (TFA) and COM-B behaviour change framework.
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Timepoint [1]
447486
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Once only between week 16-20 post-initial daytime titration of NIV.
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Secondary outcome [2]
446672
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Sleep quality
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Assessment method [2]
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The Pittsburg Sleep Quality Index (PSQI)
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Timepoint [2]
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Week 0, Week 4 and Week 16 post-initial daytime titration of NIV.
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Secondary outcome [3]
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Control of Respiratory Failure on therapy
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Assessment method [3]
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Nocturnal SpO2 whilst on ventilation in the home using pulse oximeter with finger probe: Average SpO2 levels
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Timepoint [3]
446665
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Week 16 post-initial daytime titration of NIV.
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Secondary outcome [4]
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Resource requirements for analysis method
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Assessment method [4]
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Staff time required related to sleep study analysis method collected from medical and study records. Inpatient admission time for Arm 1 collected from medical and study records. Participant travel time and distance for Arm 1 self-reported by participant. Staff travel time and distance for Arm 2 and Arm 3 collected from medical and study records.
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Timepoint [4]
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [5]
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Adverse events
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Assessment method [5]
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Number of adverse events reported during study period, including safety concerns during the sleep study analysis method defined according to existing local clinical guidelines of the Victorian Respiratory Support Service (VRSS Sleep Laboratory Manual: Medical Emergency and Medications Procedures) (e.g. unanticipated severe hypoventilation [PtcCO2 >55mmHg], unanticipated severe hyperventilation [PtcCO2 <30mmHg], unanticipated severe hypoxaemia [SpO2 persistently < 88% on room air]).
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Timepoint [5]
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Recorded monthly from enrolment until Week 16 post-randomisation and when sleep studies are analysed.
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Secondary outcome [6]
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Dyspnoea
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Assessment method [6]
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Modified Medical Research Council dyspnoea scale (mMRC)
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Timepoint [6]
446666
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Week 0, Week 4 and Week 16 post-initial daytime titration of NIV.
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Secondary outcome [7]
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Health-related quality of life
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Assessment method [7]
446668
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Euroqol five-dimension five-level (EQ-5D-5L) questionnaire
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Timepoint [7]
446668
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Week 0 and Week 16 post-initial daytime titration of NIV.
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Secondary outcome [8]
446688
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Resource usage costs
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Assessment method [8]
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Inpatient admission costs will be collected from medical records and measured using admission duration and diagnosis code. Staff time for providing intervention (including any travel time) will be collected from medical and study records. Direct and indirect costs related to the set up of participants on NIV, monitoring equipment and analysis of data will be recorded.
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Timepoint [8]
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [9]
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Dyspnoea
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Assessment method [9]
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Modified Borg Scale (MBS) completed at rest and off NIV
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Timepoint [9]
446667
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Week 0, Week 4 and Week 16 post-initial daytime titration of NIV.
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Secondary outcome [10]
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Time to analysis method
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Assessment method [10]
446678
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Time in days from randomisation to sleep study analysis method. Data will be collected from medical and study records.
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Timepoint [10]
446678
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [11]
448143
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Control of Respiratory Failure on therapy
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Assessment method [11]
448143
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Nocturnal SpO2 whilst on NIV in the home using pulse oximeter with finger probe: 3% SpO2 dips
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Timepoint [11]
448143
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Week 16 post-initial daytime titration of NIV
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Secondary outcome [12]
446664
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NIV treatment failure
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Assessment method [12]
446664
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Composite outcome for NIV treatment failure: Average NIV usage < 4 hours in previous 4 weeks (as described above), or Daytime partial pressure of carbon dioxide (PaCO2) > 45 mmHg (seated position off ventilation using arterial blood gas (ABG) or capillary blood gas sampling (CAPGas) if ABG is unobtainable), or Admission to hospital for respiratory or cardiac cause (from local hospital records or self-reported by participant), or Death (from local hospital records or reported by participant carer/family member)
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Timepoint [12]
446664
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Week 4 and Week 16 post initial daytime titration of NIV.
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Secondary outcome [13]
448163
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Control of Respiratory Failure on therapy
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Assessment method [13]
448163
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Nocturnal SpO2 whilst on NIV in the home using pulse oximeter with finger probe: percent of time with SpO2 <90%
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Timepoint [13]
448163
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Week 16 post-initial daytime titration of NIV
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Secondary outcome [14]
448167
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Successful recording of ventilator and monitoring data.
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Assessment method [14]
448167
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Proportion of sleep studies from which setting recommendations were made.
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Timepoint [14]
448167
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [15]
446671
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Health-related quality of life
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Assessment method [15]
446671
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The Severe Respiratory Insufficiency questionnaire (SRI)
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Timepoint [15]
446671
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Week 0 and Week 16 post-initial daytime titration of NIV.
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Secondary outcome [16]
446677
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Comfort on ventilator
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Assessment method [16]
446677
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The S3-NIV questionnaire
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Timepoint [16]
446677
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Week 4, Week 8, Week 12 and Week 16 post-initial daytime titration of NIV.
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Secondary outcome [17]
446679
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Time to setting adjustment
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Assessment method [17]
446679
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Time in days from sleep study analysis method to setting adjustments being made. Data will be collected from medical and study records.
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Timepoint [17]
446679
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [18]
448168
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To understand the feasibility of the interventions and the implementation of the interventions from the perspective of patient participants
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Assessment method [18]
448168
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A semi-structured interview and questionnaire with purposively recruited patient participants to explore the feasibility and acceptability of the models of care, including identification of barriers and facilitators to implementation, using the Theoretical Framework of Acceptability (TFA) and COM-B behaviour change framework.
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Timepoint [18]
448168
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Once only between week 16-20 post-initial daytime titration of NIV.
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Secondary outcome [19]
446676
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Daytime somnolence
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Assessment method [19]
446676
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The Karolinska Sleepiness Scale (KSS)
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Timepoint [19]
446676
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Week 0, Week 4 and Week 16 post-initial daytime titration of NIV.
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Secondary outcome [20]
446686
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Contact between staff and participants
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Assessment method [20]
446686
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Number of contacts between participant and staff will be accessed from medical records.
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Timepoint [20]
446686
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [21]
446675
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Daytime somnolence
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Assessment method [21]
446675
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The Epworth Sleepiness Scale-Alternative Version (ESS-ALT)
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Timepoint [21]
446675
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Week 0, Week 4 and Week 16 post-initial daytime titration of NIV.
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Secondary outcome [22]
446689
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Healthcare utilisation
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Assessment method [22]
446689
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Self-reported health-care utilisation and hospital admissions through custom-designed questionnaire. Measurements will include medication use, oxygen use, outpatient and general practitioner attendances, hospital admissions and medical investigations. This will include participant and carer travel time to attend appointments. Self-reported hospital admission and outpatient appointment attendance will be verified against medical records where possible.
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Timepoint [22]
446689
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Week 4, Week 8, Week 12, Week 16 post-initial daytime titration of NIV.
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Secondary outcome [23]
448164
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Successful recording of ventilator and monitoring data
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Assessment method [23]
448164
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Proportion of sleep studies able to be partly analysed.
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Timepoint [23]
448164
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [24]
446684
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Successful recording of ventilator and monitoring data.
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Assessment method [24]
446684
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Proportion of sleep studies able to be analysed in full
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Timepoint [24]
446684
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [25]
447487
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To understand the acceptability of the interventions and the implementation of the interventions from the perspective of clinicians who delivered the interventions.
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Assessment method [25]
447487
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A semi-structured interview and questionnaire with all clinicians who delivered the interventions to explore the feasibility and acceptability of the models of care, including identification of barriers and facilitators to implementation, using the Theoretical Framework of Acceptability (TFA) and COM-B behaviour change framework.
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Timepoint [25]
447487
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End of trial or cessation of employment in the trial
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Secondary outcome [26]
448169
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To understand the feasibility of the interventions and the implementation of the interventions from the perspective of clinicians who delivered the interventions.
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Assessment method [26]
448169
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A semi-structured interview and questionnaire with all clinicians who delivered the interventions to explore the feasibility and acceptability of the models of care, including identification of barriers and facilitators to implementation, using the Theoretical Framework of Acceptability (TFA) and COM-B behaviour change framework.
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Timepoint [26]
448169
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End of trial or cessation of employment in the trial
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Secondary outcome [27]
448165
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Successful recording of ventilator and monitoring data.
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Assessment method [27]
448165
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Proportion of sleep studies completed but no data available for analysis.
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Timepoint [27]
448165
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Cumulative data will be assessed at the conclusion of the trial.
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Secondary outcome [28]
448166
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Successful recording of ventilator and monitoring data.
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Assessment method [28]
448166
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Proportion of sleep studies not completed.
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Timepoint [28]
448166
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Cumulative data will be assessed at the conclusion of the trial.
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Eligibility
Key inclusion criteria
Age > 18 years,
Medically stable,
With or at risk of chronic hypercapnic respiratory failure,
Referred to the Victorian Respiratory Support Service (Victoria, Australia),
Clinical indication to commence long term NIV according to local protocols, published guidelines, and/or specialist opinion, AND
Either suitable for day admission or short stay (<2 nights) for NIV implementation, with support to enable travel and utilise NIV in the home OR commencing long term NIV at the end of an acute admission with respiratory failure and clinically stable prior to discharge
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Medically unstable,
Hypoventilation attributable to medications with sedative/respiratory depressant side-effects,
Diagnosis of motor neurone disease,
Regular use of NIV (> 6 hours/day on average AND usage on > 50% of days) over the previous 3 months,
Geographically lives more than 2 hours from Austin Health via road,
No or inadequate support to manage home monitoring equipment or instructions to adjust therapy at home, including carer support,
No mobile network coverage,
Home visit safety risk,
Pregnancy,
Limited English language skills, OR
Inability to provide informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation and allocation concealment will be ensured through a computer-generated algorithm (REDCap database). Allocation will be concealed from the research staff members recruiting participants as participants will be randomised four weeks (Week 4) following study recruitment (Week 0). Allocation will be concealed from the respiratory doctor who determines whether a participant requires a sleep study (Week 4, post acclimatisation period), as participants are randomised following this review by an independent research staff member.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation list will be provided by an independent statistician, using randomly permuted blocks. Participants will be randomised in a 1:1:1 ratio.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Assuming a SD of 132 minutes for NIV usage and to determine non-inferiority between interventions, 117 participants (39 per study group) are required to be 80% sure that the lower limit of a one-sided 95% confidence interval will be above the non-inferiority limit of -75 minutes in average daily NIV usage for the study arms (Arm 2 and 3 compared to Arm 1) at Week 16. Allowing for a 10% drop out and for 25% of participants successfully using NIV at Week 4, 172 participants will be required to be recruited at Week 0. Participants will be randomised in a 1:1:1 ratio to either Arm 1, Arm 2 or Arm 3.
Linear mixed models will be used to compare average daily usage of NIV between the study arms during the intervention, with treatment arm included as a fixed effect and participant as a random effect. Survival analysis will be used to analyse the time to achieve usage of at least 6 hour per night on average over the period of a week between each group. Generalised linear models will be used to compare the proportion of participants in each arm with treatment failure. Mixed models will be used to compare changes in other secondary outcomes between groups from weeks 5 to 16.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
23/06/2025
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Actual
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Date of last participant enrolment
Anticipated
24/04/2028
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Actual
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Date of last data collection
Anticipated
18/08/2028
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Actual
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Sample size
Target
172
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27803
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
43997
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF)- 2023 Clinician Researchers: Applied Research in Health
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Address [1]
318784
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Country [1]
318784
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Australia
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Primary sponsor type
Other
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Name
Institute for Breathing and Sleep
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Address
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Austin Health, Melbourne
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Address [1]
321223
0
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Country [1]
321223
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Australia
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Other collaborator category [1]
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University
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Name [1]
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The University of Melbourne
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Address [1]
283490
0
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Country [1]
283490
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317392
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
317392
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
317392
0
Australia
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Date submitted for ethics approval [1]
317392
0
18/12/2024
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Approval date [1]
317392
0
14/04/2025
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Ethics approval number [1]
317392
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HREC/115209/Austin-2024
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Summary
Brief summary
Non-invasive ventilation (NIV) uses a breathing machine and a mask to help people with sleeping and/or breathing problems. Using NIV at night can reduce tiredness, hospital visits, and improve quality of life. In this research study, people with sleep and breathing problems who are having difficulties with using their non-invasive ventilation (NIV) will be randomly allocated to one of three groups: 1) night time hospital stay to monitor sleep patterns while using NIV; 2) detailed virtual monitoring of sleep patterns while sleeping at home using NIV; 3) basic virtual monitoring of sleep patterns while sleeping at home using NIV. The aim of this research study is to determine if there is a difference between these three ways of monitoring sleep patterns and whether they improve the amount of time people use NIV while sleeping.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Mark Howard
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Address
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Victorian Respiratory Support Service (VRSS), Level 5, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
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Country
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Australia
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Phone
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+61 03 9496 3663
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Fax
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0
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Email
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mark.howard@austin.org.au
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Contact person for public queries
Name
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Sarah Brown
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Address
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Institute for Breathing and Sleep (IBAS), Level 5, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
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Country
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Australia
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Phone
140911
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+61 03 9496 3877
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Fax
140911
0
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Email
140911
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vrssresearch@austin.org.au
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Contact person for scientific queries
Name
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Mark Howard
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Address
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Victorian Respiratory Support Service (VRSS), Level 5, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
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Country
140912
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Australia
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Phone
140912
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+61 03 9496 3663
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Fax
140912
0
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Email
140912
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mark.howard@austin.org.au
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Investigators whose proposed use of the individual participant data has been approved by an independent review committee. Data requester will need to sign a data access agreement.
Conditions for requesting access:
•
Yes, conditions apply:
•
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
•
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
De-identified individual participant data:
What types of analyses could be done with individual participant data?
•
Sharing of de-identified individual participant data will be considered for individual patient data meta-analyses and other types of analyses on a case-by-case basis.
When can requests for individual participant data be made (start and end dates)?
From:
Data will be available beginning 18 months following publication with no end date.
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Data can be obtained via written request to the Principal Investigator, A/Prof Mark Howard, via email (mark.howard@austin.org.au). Approval will be granted by an independent review committee.
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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