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Trial registered on ANZCTR
Registration number
ACTRN12624000313538p
Ethics application status
Submitted, not yet approved
Date submitted
31/01/2024
Date registered
22/03/2024
Date last updated
22/03/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Brain stimulation to target slow brain waves and cognition in obstructive sleep apnea
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Scientific title
Slow oscillation transcranial direct current stimulation in adults with obstructive sleep apnea: a proof-of-concept study
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Secondary ID [1]
311394
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea
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Condition category
Condition code
Respiratory
329372
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0
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Proof of concept/ Feasibility study.
We aim to compare if two configurations (frontal vs parietal vs sham) of slow oscillation-transcranial direct current stimulation are effective at boosting sleep markers in middle to late age people with obstructive sleep apnea. We will recruit 5 participants for this proof of concept, feasibility study. Participants will complete 3 daytime nap studies at the Woolcock Institute, with at least 1 week washout between sessions. At the visits they will complete a memory and a cognition task before and after a 90-minute nap with each condition of slow-oscillation transcranial direct current stimulation (so-tDCS) applied at each visit (2 active stimulation montages and sham). Participants will be fitted with a high-density electroencephalography (EEG) net with the stimulation electrodes nested between the cap. Stimulation will be applied using the Soterix M×N 33/65 High Definition-transcranial Electrical Stimulator using sintered HD electrodes. Active stimulation will consist of an anodal current sinusoidally oscillating at a frequency of 0.75 Hz between zero and 260 µA. The maximum current density will be 0.522 mA/cm2. Channel impedance will be <2 kO. The low level so-tDCS stimulation will be applied in 5 x 5-minute stimulation blocks by trained researchers. Following each nap participants will complete a perceived effects and tolerability questionnaire which probes blinding, tolerability and acceptability of the intervention. Researchers will also monitor recruitment statistics and data completion throughout the study.
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Intervention code [1]
327832
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Treatment: Devices
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Comparator / control treatment
The sham condition will be identical to the stimulation conditions however the stimulation intensity will not be high enough to generate meaningful cortical excitability (>0.1mA).
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Control group
Active
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Outcomes
Primary outcome [1]
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Global slow oscillation densities (slow oscillation power 0.5-1Hz and delta/slow wave activity 1-4.5Hz) averaged across measurement blocks.
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Assessment method [1]
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Electroencephalography will be measured for 60 seconds after each stimulation block. Fast fourier transformation methods will be used to extract EEG spectral densities.
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Timepoint [1]
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The primary outcome will be assessed across 3 study visits. Electroencephalography will be measured in NREM (N2 and N3 slee0) for 60 seconds after each stimulation block for 5 blocks.
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Primary outcome [2]
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Regional slow oscillation densities (slow oscillation power 0.5-1Hz and delta/slow wave activity 1-4.5Hz) averaged across measurement blocks.
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Assessment method [2]
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Electroencephalography will be measured for 60 seconds after each stimulation block. Fast fourier transformation methods will be used to extract EEG spectral densities.
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Timepoint [2]
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The primary outcome will be assessed across 3 study visits. Electroencephalography will be measured in NREM (N2 and N3 slee0) for 60 seconds after each stimulation block for 5 blocks.
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Secondary outcome [1]
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Recruitment statistics will be assessed across 3 study visits.
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Assessment method [1]
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Recruitment success will be calculated using the number of successfully and unsuccessfully recruited participants based on study recruitment tracking database.
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Timepoint [1]
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Recruitment success will be assessed for all participants contacted for screening.
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Secondary outcome [2]
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Data completion
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Assessment method [2]
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Data completion will be measured by count of how many people successfully completed all data points based on study recruitment tracking database.
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Timepoint [2]
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Data completion outcome will be assessed at the end of each visit and calculated at the end of the study.
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Secondary outcome [3]
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Blinding success
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Assessment method [3]
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Blinding will be measured using the perceived effects and tolerability questionnaire a questionnaire designed specifically for this study.
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Timepoint [3]
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Blinding outcome will be assessed once at the end of each visit.
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Secondary outcome [4]
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Acceptability of intervention (Descriptive composite of perceived effectiveness, burden rating, willingness to participate)
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Assessment method [4]
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Acceptability will be measured using the perceived effects and tolerability questionnaire a questionnaire designed specifically for this study.
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Timepoint [4]
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The acceptability of intervention outcome will be collected once at the end of each visit.
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Secondary outcome [5]
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Tolerability
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Assessment method [5]
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Tolerability will be measured using the perceived effects and tolerability questionnaire a questionnaire designed specifically for this study.
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Timepoint [5]
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Tolerability will be collected once at the end of each visit.
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Eligibility
Key inclusion criteria
Moderate to severe OSA (polysomnography (PSG) within 1 year with AHI equal to 15 or any night oximetry 3% ODI equal to 15), are fluent in English, are able to perform cognitive tasks are willing to provide informed consent and willingness to participate and comply with the study requirements.
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Minimum age
40
Years
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Maximum age
65
Years
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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
Participants will be excluded if they;
• Have a history of head injury with associated loss of consciousness equal to or greater than 30 minutes;
• Have any current or previous diagnosis of psychiatric conditions (other than well managed affective disorders - beck depression inventory 2 score equal to 19 and no current feelings of suicidality as determined by item 9, beck anxiety inventory score equal to 15 severity);
• Have any diagnosis of a neurological disorder (e.g. Parkinson’s disease, epilepsy, multiple sclerosis);
• Have a diagnosis of cognitive impairment or dementia or a Mini-Mental State Examination Score less than 24
• Have a history of cerebrovascular events (e.g. stroke, TIA);
• Have any clinically significant comorbidity which will impede participation (as decided by the study doctor);
• Currently regularly use central nervous system active agents (e.g. cholinergic, anticonvulsant);
• Have a history of substance abuse or heavy alcohol use (greater than 10 standard drinks a week and greater than 4 standard drinks on any one day.);
• Are a current shift-worker or travel overseas within the last 2 weeks;
• Have previously used treatment for obstructive sleep apnea (e.g. CPAP) in the last 2 months;
• Are currently pregnant;
• Have a history of migraine;
• Have metallic implants including intracranial electrodes, surgical clips, shrapnel or a pacemaker;
• Have history of seizure;
• Have had adverse effects to previous brain stimulation methods;
• Previous adverse reaction to topical anaesthetic;
• Have a diagnosis of another primary sleep disorder (determined via medical screening or Insomnia Severity Index score equal to 12);
• Are unable to easily nap in the afternoon (determined by questionnaire).
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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)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Linear mixed effects model will be performed to compare global and regional frequencies across conditions. The conditions will be assigned as a fixed factor and participant ID will be assigned as a random factor (i.e. random intercept).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
8/04/2024
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Actual
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Date of last participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last data collection
Anticipated
31/08/2024
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Actual
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Sample size
Target
5
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Glebe
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Recruitment postcode(s) [1]
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2037 - Glebe
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Centre for Chronic Diseases of Ageing
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Address [1]
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Sydney NSW, 2000, Australia
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Country [1]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Woolcock Institute of Medical Research
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Address
1 Innovation RdMacquarie Park NSW 2113
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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none
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Sydney Local Health District Ethics Review Committee RPAH
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Ethics committee address [1]
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Level 11, King George V Building, Missenden Road, Camperdown NSW 2050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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29/01/2024
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Approval date [1]
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Ethics approval number [1]
314537
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Summary
Brief summary
People with obstructive sleep apnea show impairments in cognition and are at risk for developing dementia. Slow wave brain waves, occuring during “deep sleep”, have been associated with cognition are less prominent in people with sleep apnea. This research study aims to understand whether low current brain stimulation applied on different areas can boost slow brain waves during sleep in people with obstructive sleep apnea. This study involves 3 in-person daytime visits to the Woolcock Institute of Medical Research where participants will undergo cognitive testing before and after a nap with low intensity brain stimulation applied during sleep.
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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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Dr Angela D'Rozario
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Address
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Dr. Angela D'Rozario, Woolcock Institute of Medical Research, 2 Innovation rd, Macquarie Park NSW 2113
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Country
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Australia
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Phone
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+610298053289
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Andrea Ricciardiello
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Address
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Dr. Angela D'Rozario, Woolcock Institute of Medical Research, 2 Innovation rd, Macquarie Park NSW 2113
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Country
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Australia
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Phone
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+610298053289
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Andrea Ricciardiello
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Address
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Dr. Angela D'Rozario, Woolcock Institute of Medical Research, 2 Innovation rd, Macquarie Park NSW 2113
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Country
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Australia
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Phone
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+610298053289
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Only de-identified processed data will be shared.
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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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