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Trial registered on ANZCTR
Registration number
ACTRN12612000699864
Ethics application status
Approved
Date submitted
27/06/2012
Date registered
29/06/2012
Date last updated
10/08/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Treatment effectiveness, compliance and cardiovascular outcomes with a new supine avoidance therapy for supine-predominant snoring.
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Scientific title
In snorers with supine-predominant snoring, is supine avoidance therapy an effective treatment with high patient compliance, and does the therapy improve cardiovascular outcomes?
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Secondary ID [1]
280745
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Nil
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Universal Trial Number (UTN)
Nil
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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:
Snoring
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Condition category
Condition code
Respiratory
287106
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Supine avoidance therapy using a body position monitoring and supine alarm device (BuzzPOD, Gorman ProMed Pty Ltd, VIC Australia).
The study intervention is a small battery operated device worn on the chest each night. It records body position continuously and uses a vibration alarm activated after 5-sec in the supine position to discourage supine sleep. The device can be configured to record body position with or without supine alarm active, allowing long-term posture recordings with or without active therapy. An event button on the device is used to record bed-time and wake-up time to define periods of time in bed.
Participants will be randomised to 2 weeks of inactive or alarm active therapy before crossing over to 2 weeks of the other condition (no washout). Posture recordings over the full trial period will be used to assess supine-avoidance effectiveness and device usage. In-home sleep studies and questionnaires at the end of each 2 week period will be used to assess other outcomes.
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Intervention code [1]
285173
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Treatment: Devices
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Comparator / control treatment
This is a relatively short-term cross-over trial for which participants will serve as their own control. The comparator / control is the 2-week period of posture recording alone with a completely inactive supine alarm.
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Control group
Active
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Outcomes
Primary outcome [1]
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Study device measured average nightly supine time with active versus inactive supine alarm.
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Assessment method [1]
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Timepoint [1]
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Supine time will be measured from study device posture recordings over every night of the trial, downloaded from the study device at the end of each 2 week period. Independent posture measurements will also be collected during overnight full-sleep studies conducted at the end of each 2 week period.
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Primary outcome [2]
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Snoring frequency and intensity, quantified using a portable unattended type III monitor (Visi-lab GreyFlash, Stowood Scientific Instruments Ltd, UK).
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Assessment method [2]
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Timepoint [2]
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At baseline, and at the end of both 2-weeks treatment arms.
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Primary outcome [3]
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Sleep efficiency and quality (total sleep time, arousal indicies) measured from full polysomnography in the home setting (Somte, Compumedics, Australia).
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Assessment method [3]
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Timepoint [3]
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At the end of both 2-weeks treatment arms.
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Secondary outcome [1]
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Average nightly study device usage assessed from overnight posture changes and participant button responses marking bedtime and wakeup times.
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Assessment method [1]
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Timepoint [1]
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Posture recordings are continuous such that overnight position changes and button push responses will be assessed every night of the trial, downloaded from the study device at the end of each 2 week period.
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Secondary outcome [2]
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Reduced frequency and intensity of overnight cardiovascular system disturbances quantified from ECG measured tachycardia and finger photoplethysmogram measured vasoconstriction responses during home polysomnography (Somte, Compumedics, Australia).
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Assessment method [2]
298125
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Timepoint [2]
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At the end of both 2-weeks treatment arms.
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Secondary outcome [3]
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Reduced daytime blood pressure measured in clinic (auscultatory method).
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Assessment method [3]
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Timepoint [3]
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At baseline, and at the end of both 2-weeks treatment arms.
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Secondary outcome [4]
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Questionnaire measured participant and where applicable bed-partner sleep quality and snoring (Functional Outcomes of Sleep Questionnaire, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index and Sleep Apnea Symptoms Questionnaire), and Assessment of Quality of Life (AQoL-8D).
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Assessment method [4]
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Timepoint [4]
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Baseline and at the end of both 2-weeks treatment arms.
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Eligibility
Key inclusion criteria
Snorer:
- Age > or = 18 years
- History of disruptive supine-mainly or supine-only snoring
- Home sleep study confirmed supine-predominant snoring (supine > or = twice non-supine snoring frequency measured from at least 4 hours of recording with at least 30 min in each posture condition)
- AHI < 15 /hr from a home screening study (i.e. to rule out clinically significant OSA).
- Willing to cease any current anti-snoring treatment (e.g. over the counter anti-snoring sprays, nasal dilator strips, tennis ball or other discomfort based supine avoidance treatments etc).
Bed-Partner:
- Regular bed partner (defined as present > or = 5 nights/week) of the snorer participant
- Age > or = 18 years
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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?
Yes
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Key exclusion criteria
- Obstructive Sleep Apnoea (Apnoea Hypopnoea Index > or = 15 /hr)
- Co-morbidities that may preclude supine-avoidance treatment (e.g. arthritis, mobility problems preventing non-supine sleep, or a pacemaker given unknown effects of an electronic device in close proximity on the chest)
- Severe oxygen desaturation in sleep (minimum blood oxygen saturation less than 75% during home screening sleep study)
- Sleepiness potentially dangerous and requiring urgent treatment (e.g. history of falling asleep while driving, or Epworth Sleepiness Scale >16) or commercial drivers
- Already on treatment for hypertension
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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)
Subjects will be recruited via advertising and randomised to active versus inactive therapy first, followed by cross-over to the other condition after 2 weeks. Treatment allocation will not be disclosed to participants, but effective participant blinding and allocation concealment is not possible with this treatment.
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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 (i.e. computerised sequence generation).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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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
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/07/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
5451
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5000-5121
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Recruitment postcode(s) [2]
5452
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5125-5174
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Recruitment postcode(s) [3]
5453
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5950
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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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NHMRC project grant 1020892
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Address [1]
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National Health and Medical Research Council
Level 1, 16 Marcus Clarke St
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
A/Prof Peter Catcheside
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Address
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Miss Biyou Yeo (Jamie)
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Address [1]
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Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country [1]
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Dr Daniel Stadler
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Address [1]
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Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country [1]
276884
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Australia
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Other collaborator category [2]
276885
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Individual
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Name [2]
276885
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A/Prof Nick Antic
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Address [2]
276885
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Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country [2]
276885
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Australia
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Other collaborator category [3]
276886
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Individual
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Name [3]
276886
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Prof Doug McEvoy
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Address [3]
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Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country [3]
276886
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Australia
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Other collaborator category [4]
276887
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Individual
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Name [4]
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Dr Maree Barnes
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Address [4]
276887
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Institute for Breathing and Sleep
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg VIC 3084
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Country [4]
276887
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Australia
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Other collaborator category [5]
276888
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Individual
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Name [5]
276888
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Dr Steve Quinn
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Address [5]
276888
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Flinders Clinical Effectiveness
Flinders University
Sturt Road
Bedford Park SA 5042
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Country [5]
276888
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Australia
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Other collaborator category [6]
276889
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Individual
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Name [6]
276889
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Dr Jeremy Mercer
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Address [6]
276889
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Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country [6]
276889
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
287551
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
287551
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Southern Adelaide Clinical
Human Research Ethics Committee
The Flats G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
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Ethics committee country [1]
287551
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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25/05/2012
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Ethics approval number [1]
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SAC HREC: 129.12
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Ethics committee name [2]
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The University of Adelaide Human Research Ethics Committee
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Ethics committee address [2]
287552
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Human Research Ethics Committee
Research Ethics and Compliance Unit, Research Branch
Level 7, 115 Grenfell St
The University of Adelaide
Adelaide SA 5005
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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21/06/2012
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Ethics approval number [2]
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UoA HREC: H-2012-084
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Summary
Brief summary
This is a research study of a new treatment device designed to discourage snorers from sleeping on their back, when snoring is mainly a problem when asleep on the back.
The hypotheses of this project are that by avoiding sleeping on their back, snorers would have (1) reduced frequency and intensity of snoring episodes, (2) reduced overnight cardiovascular system disturbances, and (3) lower daytime blood pressure.
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Miss Biyou Yeo (Jamie)
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Address
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Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country
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Australia
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Phone
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+61 8 82751022
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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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A/Prof Peter Catcheside
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Address
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Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country
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Australia
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Phone
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+61 8 82751309
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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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