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Trial registered on ANZCTR


Registration number
ACTRN12623001234606
Ethics application status
Approved
Date submitted
30/10/2023
Date registered
30/11/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study comparing home-based and in-hospital methods of adjusting non-invasive ventilator settings for people with long-term breathing failure
Scientific title
A single-centre randomised controlled trial of the feasibility and impact on adherence of laboratory or home non-invasive ventilation (NIV) adjustment for adults with chronic respiratory failure: Synchronise NIV@Home
Secondary ID [1] 310859 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Synchronise NIV@Home
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hypercapnic respiratory failure 331895 0
Neuromuscular disease 331896 0
Chronic obstructive lung disease (COPD) 331897 0
Restrictive thoracic disease 331898 0
Obesity hyperventilation syndrome 331899 0
Condition category
Condition code
Respiratory 328629 328629 0 0
Other respiratory disorders / diseases
Neurological 328630 328630 0 0
Neurodegenerative diseases
Public Health 328760 328760 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to one of three arms prior to NIV implementation, and will remain in the study arm they were allocated to for the duration of the trial. There is a four-week acclimatisation period (Time 0 to Week 4), a four-week intervention period (Week 4 to Week 8), and an eight-week follow-up period (Week 8 to Week 16). NIV usage is recorded by the NIV device. After an acclimatisation period (4 weeks), only participants who are not successfully using NIV will be provided with the once off overnight sleep study assessment and NIV adjustments corresponding to their study arm. Participants will be asked to continue to use NIV as prescribed for the subsequent follow up period. Participants may undergo their NIV monitoring more than once, if deemed necessary by the clinician, to improve NIV treatment.

Experimental 1: Intervention
In the ‘Experimental 1’ arm participants will receive adjustments to NIV settings based off ‘Breath by breath’ analysis of a polygraphy conducted at home. This arm involves a physiotherapist or sleep scientist setting up the sleep study equipment in the participant's home, for the participant to wear and sleep with overnight. The sleep study will measure: thoracic and abdominal respibands (respiratory effort); oxygen saturation measured continuously with the use of a pulse oximeter and a finger probe; transcutaneous carbon dioxide (PtcCO2) and ventilator data incorporated into the recording including mask pressure, total flow, tidal volume and leak. The equipment will then be collected by a physiotherapist or sleep scientist the following day. The study will be reviewed by unblinded clinicians to determine optimal NIV settings based on breath by breath analysis, within 72 hours of the monitoring.

Experimental 2: Intervention
In the ‘Experimental 2’ arm participants will receive adjustments to NIV settings based off 'Summarised' analysis of a polygraphy conducted at home. The participant will be guided to apply the oximeter probe via telehealth. There are no other differences in input for participants. This arm involves a physiotherapist or sleep scientist accessing a single-night's ventilator data remotely from a participants NIV device. This data will include mask pressure, total flow, tidal volume and leak with oxygen saturation measured continuously with the use of a pulse oximeter and a finger probe The study will be reviewed by unblinded clinicians to determine optimal NIV settings based on viewing summarised whole of night data, within 72 hours of the monitoring.
Intervention code [1] 327277 0
Treatment: Other
Comparator / control treatment
Comparator: Control
The participants allocated to the control group will be asked to attend an overnight in-laboratory sleep study Polysomnography (PSG), and will receive NIV adjustments based off ‘breath by breath’ analysis of the sleep study PSG conducted in a laboratory. Other NIV monitoring (Usage) will be at home.
Control group
Active

Outcomes
Primary outcome [1] 336426 0
NIV usage.
Timepoint [1] 336426 0
Prior to NIV implementation, and post NIV implementation at Week 4, Week 8, Week 12, Week 16 (primary endpoint).
Secondary outcome [1] 428335 0
Composite outcome of Treatment failure.
Timepoint [1] 428335 0
Post NIV implementation at Week 4, Week 16.
Secondary outcome [2] 428336 0
Control of Respiratory Failure On Therapy.
Timepoint [2] 428336 0
Post NIV implementation at Week 16.
Secondary outcome [3] 428337 0
Patient reported outcome: Dyspnoea.
Timepoint [3] 428337 0
Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.
Secondary outcome [4] 428344 0
Patient reported outcome: Dyspnoea.
Timepoint [4] 428344 0
Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.
Secondary outcome [5] 428345 0
Patient reported outcome: Health-related quality of life.
Timepoint [5] 428345 0
Prior to NIV implementation, and post NIV implementation at Week 16.
Secondary outcome [6] 428346 0
Patient reported outcome: Health-related quality of life.
Timepoint [6] 428346 0
Prior to NIV implementation, and post NIV implementation at Week 16.
Secondary outcome [7] 428347 0
Patient reported outcome: Health-related quality of life.
Timepoint [7] 428347 0
Prior to NIV implementation, and post NIV implementation at Week 16.
Secondary outcome [8] 428348 0
Patient reported outcome: Sleep quality.
Timepoint [8] 428348 0
Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.
Secondary outcome [9] 428349 0
Patient reported outcome: Daytime somnolence.
Timepoint [9] 428349 0
Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.
Secondary outcome [10] 428350 0
Patient reported outcome: Daytime somnolence.
Timepoint [10] 428350 0
Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.
Secondary outcome [11] 428351 0
Patient reported outcome: Comfort on ventilator.
Timepoint [11] 428351 0
Post NIV implementation at Week 4, Week 8, Week 12, Week 16.
Secondary outcome [12] 428858 0
Control of Respiratory Failure On Therapy
Timepoint [12] 428858 0
Post NIV implementation at Week 16.
Secondary outcome [13] 428859 0
Healthcare utilisation.
Timepoint [13] 428859 0
Post NIV implementation at Week 4, Week 8, Week 12, Week 16.
Secondary outcome [14] 428860 0
Safety.
Timepoint [14] 428860 0
Throughout trial period.
Secondary outcome [15] 428861 0
Feasibility.
Timepoint [15] 428861 0
Throughout trial period.
Secondary outcome [16] 428862 0
Feasibility.
Timepoint [16] 428862 0
Throughout trial period.
Secondary outcome [17] 428863 0
Feasibility
Timepoint [17] 428863 0
Throughout trial period.
Secondary outcome [18] 428864 0
Feasibility.
Timepoint [18] 428864 0
Throughout trial period.
Secondary outcome [19] 428865 0
Measures of C02 off ventilation.
Timepoint [19] 428865 0
Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.

Eligibility
Key inclusion criteria
Medically stable

With or at risk of chronic hypercapnic respiratory failure

Diagnosis of slowly progressive neuromuscular disease, chronic obstructive lung disease, chest wall disease, COPD/OSA overlap syndrome or obesity hypoventilation syndrome.

Clinical indication to commence long term NIV

Suitable for short admission to hospital for NIV implementation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypoventilation attributable to medications with sedative/respiratory depressant side-effects

Regular use of NIV (> 6 hours/day on average AND usage on >50% of days) over the previous 3 months

Geographical – 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

No mobile network coverage

Home visit safety risk

Pregnancy

Non English speaking participant

Inability to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation and allocation concealment will be ensured through the REDCap trial database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following informed consent participants will undergo Baseline data collection, be randomised 1:1:1 to either control or intervention arms and be implemented on NIV (Time 0). All participants will be reviewed and assessed at Week 4: Those participants who have NOT achieved successful implementation according to a defined criteria will be provided a sleep study and NIV adjustments according to their study arm.

Blocked randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generation with randomly generated block sizes).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
27/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
171
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25788 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 41614 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 315115 0
Other
Name [1] 315115 0
Institute for Breathing and Sleep, Australia
Country [1] 315115 0
Australia
Funding source category [2] 315118 0
Charities/Societies/Foundations
Name [2] 315118 0
Avant Foundation
Country [2] 315118 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep, Australia
Address
Level 5, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 317132 0
Hospital
Name [1] 317132 0
Austin Health, Melbourne Australia
Address [1] 317132 0
145 Studley Road Heidelberg, Victoria, 3084
Country [1] 317132 0
Australia
Other collaborator category [1] 282860 0
University
Name [1] 282860 0
University of Melbourne
Address [1] 282860 0
University of Melbourne Office, School of Health Sciences , Level 5, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
Country [1] 282860 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314053 0
Austin Health HReC
Ethics committee address [1] 314053 0
Level 8, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
Ethics committee country [1] 314053 0
Australia
Date submitted for ethics approval [1] 314053 0
26/09/2023
Approval date [1] 314053 0
09/10/2023
Ethics approval number [1] 314053 0
92767

Summary
Brief summary
Non-invasive ventilation (NIV) is a treatment that uses positive pressure delivered via a face or mouthpiece to assist a person to breathe. It can be used as a long-term treatment for people whose breathing has failed – usually due to chronic conditions that produce weakness of the respiratory muscles (i.e. motor neurone disease [MND] or muscular dystrophy), restriction of chest wall movement (i.e. severe obesity or kyphoscoliosis) or in those with severe loss of lung function (i.e. from emphysema or cystic fibrosis). Most people use this treatment at night to improve their breathing during sleep. If a person is unable to use NIV they can be admitted to hospital overnight to undergo a polysomnography (PSG, “sleep study”) in order to adjust ventilator settings and use NIV more effectively. Previous studies have shown that home-based sleep studies or polygraphies, are both safe and feasible, however it is not known whether patient ventilator synchrony can be optimized similarly to a hospital-based PSG. This study will compare the current hospital admission-based model for adjustment of NIV, with two different home-based models for adjusting NIV therapy, with the goals to improve usage and access to this life sustaining treatment for a vulnerable population. Successful model development will likely also reduce use of acute hospital beds and thus costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130250 0
A/Prof Mark Howard
Address 130250 0
Victorian Respiratory Support Service (VRSS), Level 5, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
Country 130250 0
Australia
Phone 130250 0
+61 03 9496 3663
Fax 130250 0
Email 130250 0
mark.howard@austin.org.au
Contact person for public queries
Name 130251 0
Miss Kayla Bruzzese
Address 130251 0
Institute for Breathing and Sleep (IBAS), Level 5, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
Country 130251 0
Australia
Phone 130251 0
+61 03 9496 5000
Fax 130251 0
Email 130251 0
vrssresearch@austin.org.au
Contact person for scientific queries
Name 130252 0
A/Prof Mark Howard
Address 130252 0
Victorian Respiratory Support Service (VRSS), Level 5, Harold Stokes Building, Austin Health 145 Studley Road Heidelberg, Victoria, 3084
Country 130252 0
Australia
Phone 130252 0
+61 03 9496 5000
Fax 130252 0
Email 130252 0
mark.howard@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified, anonymised individual data (including individual participant data collected during the trial), will be available to investigators whose proposed use of the individual participant data has been approved by an independent review committee.
When will data be available (start and end dates)?
Data will be available beginning 18 months following publication with no end date.
Available to whom?
Investigators whose proposed use of the individual participant data has been approved by an independent review committee. Data requesters will need to sign a data access agreement.
Available for what types of analyses?
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.
How or where can data be obtained?
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.


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.