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Trial registered on ANZCTR


Registration number
ACTRN12622000648729
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
3/05/2022
Date last updated
20/07/2023
Date data sharing statement initially provided
3/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of therapeutic acute intermittent hypoxia on upper limb and respiratory function in people more than one year post spinal cord injury: The AERO-SCI trial
Scientific title
Assessing the effect of therapeutic acute intermittent hypoxia protocols on upper limb and respiratory function in people with chronic spinal cord injury: a Bayesian Optimal Phase II Design trial
Secondary ID [1] 306327 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AERO-SCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury (chronic: > 1-year post impairment) with incomplete paralysis in target muscle groups 325109 0
Condition category
Condition code
Neurological 322525 322525 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve the implementation of therapeutic acute intermittent hypoxia (AIH) alone or AIH in combination with task-specific training.
Participants will be randomly allocated to one of two intervention arms in this Bayesian Optimal Phase II design. These will comprise either:
• Acute intermittent hypoxia
• Acute intermittent hypoxia + task-specific training (upper limb and respiratory muscle training)

Participants will be asked to undertake 10 intervention sessions over a 2-week period, in the presence of an experienced physiotherapist (5 consecutive days x 2 consecutive weeks). Sessions will be conducted on-site (hospital, university or research institute location), or in the participant's home if feasible.

In both trial arms, acute intermittent hypoxia will be generated via a Hypoxico-123 air generator device (Hypoxico Altitude Training Systems Inc, New York, USA, 10001). The AIH protocol for each intervention session will comprise 15 periods (repetitions) of: 60 seconds in which participants breathe air with ~9% fraction of inspired oxygen (FiO2) (equivalent to low 80%’s oxygen saturation (SpO2)), followed by 60 seconds of breathing medical-grade room air (~21% FiO2). This AIH protocol is estimated to take a total of 30 minutes per session.

In the acute intermittent hypoxia + task-specific training arm, the upper limb and respiratory training will be standardised and delivered by the same experienced physiotherapist, following each AIH component. Tasks will include 3 sets of 8-10 handgrips, wrist contractions and breaths through an inspiratory muscle training device (such as a Philips Threshold IMT or similar) at 70% of the maximal voluntary contraction each session. A dexterity task using pegs and holes will also be practiced each session for 15 minutes. Total duration of the task-specific training component is approximately 30 minutes per session.

Adherence to the intervention will be recorded by the supervising clinician during each session (session attendance checklists)
Intervention code [1] 322759 0
Treatment: Other
Intervention code [2] 322760 0
Rehabilitation
Comparator / control treatment
In this Bayesian Optimal Phase II design study, there is no control group. The study has two different models of AIH therapy (AIH alone or AIH plus task-specific training), in order to identify which therapeutic strategies are futile or not. This trial will not determine which treatment is `'better`'.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330316 0
This Bayesian Optimal Phase II Design trial has a single binary composite primary outcome, where good outcome (or "signal of benefit”) is defined by achieving BOTH:

A) Binary outcome: Improvement (increase) above baseline value that is equal or more than the predefined outcome-specific stated threshold (below), on at least ONE priority outcome
B) Binary outcome: No deterioration (decline) below baseline value that is equal or more than the predefined outcome-specific stated threshold (below), on ANY of the priority outcomes

The set of priority outcomes and corresponding, predefined outcome-specific thresholds are:
1) Box and block test (BBT): The Box and Block test is a measure of gross unilateral upper limb dexterity and function. This test will be completed using the dominant hand. Predefined threshold is 5.5 blocks
2) Hand grip dynamometer: Grip strength, measured using a hand-held dynamometer, is a quantitative and objective measure of isometric muscular strength of the hand. This test will be performed according to a standardised procedure. Predefined threshold is 5.0 kg
3) Maximal inspiratory pressure (MIP): Maximal inspiratory pressure sustained at the mouth for 1 second is a standard test of respiratory muscle strength. This test will be performed according to a standardised procedure. Predefined threshold is 10 cmH2O
Timepoint [1] 330316 0
Each priority outcome will be assessed at Baseline and the Follow-up Assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [1] 405769 0
Feasibility of the intervention will be assessed based on the proportion of the sample that could complete the intervention period. In participants who are not able to complete the intervention in its entirety, reasons and supporting information will be collected (i.e. from therapy logs and research notes after each session).
Timepoint [1] 405769 0
Study conclusion
Secondary outcome [2] 405770 0
Safety of the AIH intervention will be determined by recording the incidence of adverse events throughout the intervention sessions, assessed by participant self-report and/or physical examination by supervising clinician. Adverse events include but are not limited to: light-headedness, dizziness, headaches, altered vision, respiratory distress, cyanosis, spasticity, autonomic dysreflexia, cardiopulmonary instability or worsening sensory or motor function i.e. below the baseline level.
Timepoint [2] 405770 0
Collected during each intervention session and collated at Study completion
Secondary outcome [3] 405771 0
Upper limb dexterity and function measure: 9 Hole peg test
The 9-hole peg test is a test of upper limb dexterity and function. This test will be undertaken using the dominant hand. This test involves a participant taking pegs from a container, one by one, and placing them into holes on a board as quickly as possible. The pegs are then transferred back to the container one by one. Shorter time required to complete the task indicates better dexterity. If a participant is unable to complete the test, the score will be recorded as 120 seconds.
Timepoint [3] 405771 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [4] 405772 0
Upper limb dexterity and function measure: Action research arm test (ARAT)
The ARAT is a comprehensive test of upper limb function. The test involves 19 tasks used to assess grasp, grip, pinch and gross movement. Equipment such as wood blocks, a cricket ball, a stone, a jug, a glass, a tube, a washer and bolt, a ball bearing, a marble, a chair with no arm rests, a table, a plant and tin lid are required. The participant is asked to complete the first (and most complex) task of each domain. If they are able to complete the task in its’ entirety, they are scored top marks (i.e. ‘performs test normally’) and they move onto the next section. If the participant is not able to undertake the first task, they are scored according to the following criteria: ‘completes test but takes abnormally long or has great difficulty’, ‘performs test partially', ‘can perform no part of the test’. The second task of each section is the easiest. If the participant is unable to complete this task, they are given a score of zero for the whole section. Participants are given a final score between 0 and 57. The test takes 5 to 15 minutes to complete.
Timepoint [4] 405772 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [5] 405773 0
Upper limb strength: pinch grip dynamometer
Pinch grip strength, measured using a dynamometer, is a quantitative and objective measure of isometric muscular strength of the hand. This test will be performed according to a standardised procedure for key (lateral) pinch test, using the dominant hand
Timepoint [5] 405773 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [6] 405774 0
Forced vital capacity (FVC):
Measured by spirometry, according to standardised respiratory function testing published guidelines.
Timepoint [6] 405774 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [7] 408376 0
Forced expiratory volume in 1 second (FEV1):
Measured by spirometry, according to standardised respiratory function testing published guidelines.
Timepoint [7] 408376 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [8] 408377 0
Peak expiratory flow (PEF):
Measured by spirometry, according to standardised respiratory function testing published guidelines.
Timepoint [8] 408377 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [9] 408378 0
Maximal expiratory pressure (MEP):
Maximal expiratory pressure sustained at the mouth for 1 second is a standard test of respiratory muscle strength. This test will be performed according to standardised respiratory function testing published guidelines.
Timepoint [9] 408378 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [10] 408379 0
Sniff nasal inspiratory pressure (SNIP):
SNIP is a standard test of respiratory muscle strength. This test will be performed according to standardised respiratory function testing published guidelines.
Timepoint [10] 408379 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [11] 408380 0
Peak cough flow (PCF):
Measured using a pneumotachograph. The participant will be asked to take a deep breath in and cough as forcibly as possible into a facemask (i.e., cough from the maximum, unassisted inspiratory volume)
Timepoint [11] 408380 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [12] 408381 0
Fraction of inspired oxygen (FiO2):
Measured using an oxygen analyser in the AIH breathing circuit
Timepoint [12] 408381 0
Monitored continuously during each AIH intervention session conducted in the laboratory.
Secondary outcome [13] 408382 0
Inspired flow
Measured using a pneumotachograph in the AIH breathing circuit
Timepoint [13] 408382 0
Monitored continuously during each AIH intervention session conducted in the laboratory.
Secondary outcome [14] 408383 0
Oxygen saturation levels (SpO2):
Measured via pulse oximeter
Timepoint [14] 408383 0
Monitored continuously during each AIH intervention session
Secondary outcome [15] 408384 0
Heart rate:
Measured via pulse oximeter
Timepoint [15] 408384 0
Monitored continuously during each AIH intervention session
Secondary outcome [16] 408385 0
Blood pressure:
Measured using a sphygmomanometer
Timepoint [16] 408385 0
Measured on a single occasion prior to and following each AIH intervention session
Secondary outcome [17] 408386 0
Brain-derived neurotrophic factor (BDNF) via salivary sample.
A buccal swab (salivary) sample will be taken from participants. Participants will be instructed to wash their mouths out with a standardised solution prior to the swab being taken. Samples will be stored appropriately at each laboratory. Analysis will be performed at the Australian Genetics once all swabs are collected. These samples will be analysed for BDNF levels.
Timepoint [17] 408386 0
Baseline and Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [18] 408387 0
Participant satisfaction:
Participants will be asked to rate their level of satisfaction with the intervention from a function and time-burden perspective on a 5-point Likert scale from ‘very satisfied’ to ‘very dissatisfied’.
Timepoint [18] 408387 0
Follow-up (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [19] 408388 0
Participant perceived benefit - box and block test: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [19] 408388 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [20] 409152 0
Participant perceived benefit - hand grip strength: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [20] 409152 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [21] 409153 0
Participant perceived benefit - MIP: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [21] 409153 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [22] 409154 0
Participant perceived benefit - 9-hole peg test: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [22] 409154 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [23] 409155 0
Participant perceived benefit - ARAT: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [23] 409155 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [24] 409156 0
Participant perceived benefit - pinch strength: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [24] 409156 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [25] 409157 0
Participant perceived benefit - FVC: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [25] 409157 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [26] 409158 0
Participant perceived benefit - MEP: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [26] 409158 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [27] 409159 0
Participant perceived benefit - SNIP: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [27] 409159 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).
Secondary outcome [28] 409160 0
Participant perceived benefit - PCF: Assessed using an "anchor-based method". At the time of the follow-up assessment (immediately after performing the test), participants will be asked to estimate a global rating of change. Participants will be asked, “Has there been any change in your test since you started the research trial?” Responses will be made on a Likert scale, with a score of 0 indicating no change, positive scores indicating improvement, and negative scores indicating worsening. Change will be scored as follows: 1—almost the same, hardly any better at all; 2—a little better; 3—somewhat better; 4—moderately better; 5—a good deal better; 6—a great deal better; and 7—a very great deal better. Similar assessments were made for deterioration, substituting “worse” for “better.”
Timepoint [28] 409160 0
Immediately after performing the test at the follow-up assessment (conducted at the completion of the 2-week intervention period, within 5 days of the final intervention session).

Eligibility
Key inclusion criteria
- Young adults (aged 18 to 50 years)
- Independently ventilating with a history of chronic SCI (>1 year post-injury or impairment onset. American Spinal Injury Association Impairment Scale [ASIA] A to D; with incomplete paralysis in target muscle groups)
- Able to perform one block on the Box and Block Test
- Medically stable
- Ability to follow verbal and visual commands
- Ability to provide informed consent
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Medically unstable, including current or recent infection or inflammation
- Current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions
- Poorly controlled diabetes
- An episode of autonomic dysreflexia in the previous 6 months
- Significant other neurological, psychiatric, pulmonary, cardiovascular, orthopedic (including osteoporosis and/or previous post-SCI fracture) or oncological conditions
- Severe untreated obstructive sleep apnoea
- Recent change in medication prescription
- Not proficient in English
- Pregnancy

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)
The computer-generated randomisation list will be generated by an independent person who is not otherwise involved with the assessment or intervention of the study. Allocation will be concealed by the use of sealed opaque envelopes. The researcher administering the AIH intervention will receive the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to either the AIH alone or AIH plus task-specific training groups will be via a computer-generated randomisation list allocated on a 1:1 basis.
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
Umbrella design with two independent single arm Bayesian Optimal Phase IIa trials.
This design controls for type I and II errors while maintaining power, and minimises participant exposure to a treatment that may be futile.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study is a Bayesian Optimal Phase IIa umbrella trial of therapeutic acute intermittent hypoxia therapy in people more than one year post spinal cord injury.

For each intervention (Acute intermittent hypoxia (AIH); Acute intermittent hypoxia plus task-specific training (AIH+Training)), the rate of promising response ("signal of benefit" assessed using the single binary composite primary outcome) will be monitored at predefined stopping points. Too few promising responses will mean an individual AIH intervention is stopped and future trial participants are directed into other intervention strata under investigation.

While this umbrella trial is Bayesian in nature, its design ensures appropriate frequentist characteristics, such as power of 0.87 and alpha of 0.05. The sample size was estimated using an online tool for Bayesian Optimal Phase II (BOP) design. Allowing for one interim stopping point (Stage 1, n=10 per arm) and a final decision point analysis (n=20 per arm), the sample size of 20 participants per strata was determined using the null hypothesis rate of upper limb and respiratory function recovery of 0.3 vs alternative hypothesis rate of recovery of 0.6.

For each arm, at the completion of Stage 1 (10 participants per arm accrued), the number of participants who meet the criteria for a "signal of benefit" is determined. If 2 or less participants demonstrate a "signal of benefit", recruitment to that arm will cease. If there are 3 or more responses among the 10 participants, the arm will continue to Stage 2 and an additional 10 participants will be enrolled into that same arm, resulting in a per arm sample size of 20. If both arms demonstrate a "signal of benefit", both arms will continue to Stage 2, with allocation being randomised and a total sample size of 40 reached. If an arm proceeds to Stage 2, a final decision point analysis is conducted at completion of Stage 2 (n=20 participants per arm): If there are 9 or more "signal of benefit" responses among these 20 participants, we reject the null hypothesis and claim that the treatment is promising.

The results of the study will be analysed in accordance with the intention to treat principle, in consultation with a biostatistician (e.g., through the Statistical Consulting Centre at the University of Melbourne).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The AERO-SCI study is being withdrawn - trial stopped prior to first participant being recruited - as the investigator team has successfully secured funding to conduct a study that incorporates elements of this AERO-SCI trial. The new study will comprise components of this trial in addition to other interventions and as such will be registered as a new trial.
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
1/05/2024
Actual
Date of last data collection
Anticipated
15/05/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21626 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 21627 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment postcode(s) [1] 36555 0
3084 - Heidelberg
Recruitment postcode(s) [2] 36556 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 310686 0
Government body
Name [1] 310686 0
NSW Health (NSW Spinal Cord Injury Research Grants)
Country [1] 310686 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health
PO Box 5555 Heidelberg Victoria, 3084
Country
Australia
Secondary sponsor category [1] 311939 0
None
Name [1] 311939 0
Address [1] 311939 0
Country [1] 311939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310265 0
Austin Health HREC
Ethics committee address [1] 310265 0
Ethics committee country [1] 310265 0
Australia
Date submitted for ethics approval [1] 310265 0
Approval date [1] 310265 0
17/01/2022
Ethics approval number [1] 310265 0
HREC/68036/Austin-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117054 0
Prof David Berlowitz
Address 117054 0
Austin Health
145 Studley Road, Heidelberg, Victoria 3084
Country 117054 0
Australia
Phone 117054 0
+61 3 94963871
Fax 117054 0
Email 117054 0
david.berlowitz@austin.org.au
Contact person for public queries
Name 117055 0
Nicole Sheers
Address 117055 0
Austin Health
145 Studley Road, Heidelberg, Victoria 3084
Country 117055 0
Australia
Phone 117055 0
+61 3 94963871
Fax 117055 0
Email 117055 0
nicole.sheers@austin.org.au
Contact person for scientific queries
Name 117056 0
Nicole Sheers
Address 117056 0
Austin Health
145 Studley Road, Heidelberg, Victoria 3084
Country 117056 0
Australia
Phone 117056 0
+61 3 94963871
Fax 117056 0
Email 117056 0
nicole.sheers@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. Data requesters will need to sign a data access agreement.
When will data be available (start and end dates)?
Data will be available beginning nine 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, Prof David Berlowitz, via email (david.berlowitz@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.