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Trial registered on ANZCTR
Registration number
ACTRN12611000119998
Ethics application status
Approved
Date submitted
22/11/2010
Date registered
2/02/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Characterising the nature, and clinical significance of body and limb movements during adult sleep using multi-site accelerometry
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Scientific title
Characterising the nature, and clinical significance of body and limb movements during adult sleep using a continuous multisite accelerometry system (CMAS) versus standard polysomnogram indices in patients undergoing diagnostic polysomnograms
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Secondary ID [1]
253111
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N/A
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Universal Trial Number (UTN)
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Trial acronym
N/A
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Periodic leg movement syndrome
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Obstructive sleep apnoes
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insomnia
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parasomnia
258673
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Condition category
Condition code
Neurological
258817
258817
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0
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Other neurological disorders
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Respiratory
258818
258818
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0
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Sleep apnoea
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Mental Health
258819
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0
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Other mental health disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
A continuous multisite accelerometry system will be applied in addition to conventional polysomnogram channels, for the duration of a overnight polysomnogram (typically 6-9 hours).
Each of the 50 participants will be studied for the duration of a single overnight polysomnogram.
The duration to complete all 50 studies is anticipated to be approximately 12 months.
The continuous multisite accelerometry system consists of 3 separate units, each containing a digital triaxial accelerometer:
- One located on the patients wrist. This unit also has a lead with an additional accelerometer which will be taped to the participants middle finger
- One located on the participants ankle. This unit also has a lead with an additional accelerometer which will be taped to the participants middle finger
- One located on the participants chest (just below sternal notch)
Each unit continuously measures acceleration, and transmits data via a low power radio link to a logging PC.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Correlation between amplitude of movement detected using accelerometry with amplitude of movement using tibialis anterior EMG
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Assessment method [1]
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Timepoint [1]
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At time of PSG (T=0)
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Primary outcome [2]
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Correlation between amplitude of movement detected using accelerometry with amplitude of movement using piezo electric movement sensors
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Assessment method [2]
259682
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Timepoint [2]
259682
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At time of PSG (T=0)
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Primary outcome [3]
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Area under ROC curve for predicting arousal based on movement observed using accelerometry, compared to clinician scored arousal based on full PSG
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Assessment method [3]
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Timepoint [3]
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At time of PSG (T=0)
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Secondary outcome [1]
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Area under ROC curve for predicting periodic leg movement based on movement observed using accelerometry, compared to clinician scored using EMG and piezo gauges
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Assessment method [1]
266381
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Timepoint [1]
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At the time of PSG (T=0)
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Secondary outcome [2]
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- Clinician identification of movement artefact in PSG channels will be compared with prediction of movement artefact using accelerometry data alone
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Assessment method [2]
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Timepoint [2]
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At the time of PSG (T=0)
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Secondary outcome [3]
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- Indicies derived from accelerometry will be compared to standardised surveys and PSG based measures (sleep efficiency) in their ability to estimate quality of sleep
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Assessment method [3]
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Timepoint [3]
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At the time of PSG (T=0)
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Eligibility
Key inclusion criteria
Patients referred to The Prince Charles Hospital Sleep Service for an overnight diagnostic polysomnogram for any reason
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Minimum age
18
Years
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Maximum age
85
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
- Women who are pregnant
- People who are highly dependant on medical care
- Perople with degenerative neuromuscular disorders such as Parkinson's hisease and Huntington's chorea where a resting involuntary tremor is present
-People, who as observed on the PSG, have an uninterpretable EEG
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2011
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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
50
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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]
3466
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4032
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Queensland New Staff Research Grant
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Address [1]
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The University of Queensland
Brisbane, Queensland, 4072
Australia
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
The University of Queensland
Brisbane, Queensland, 4072
Australia
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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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The Prince Charles Hospital
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Address [1]
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The Prince Charles Hospital
Rode Road, Chermside, Queensland, 4032
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Prince Charles Hospital Human Research Ethics Committee
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Ethics committee address [1]
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The Prince Charles Hospital
Rode Rd., Chermside, Queensland, 4032
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Ethics committee country [1]
260083
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Australia
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Date submitted for ethics approval [1]
260083
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01/03/2010
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Approval date [1]
260083
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25/06/2010
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Ethics approval number [1]
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HREC/10/QPCH/27
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Ethics committee name [2]
260100
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The University of Queensland Human Research Ethics Committee
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Ethics committee address [2]
260100
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The University of Queensland
Brisbane, Queensland, 4072
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Ethics committee country [2]
260100
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Australia
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Date submitted for ethics approval [2]
260100
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Approval date [2]
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31/07/2010
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Ethics approval number [2]
260100
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2010000961
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Summary
Brief summary
The general aim of this research is to investigate whether continuous tri-axial accelerometry is a usfull tool for the qunatification, and characterisation of movements during sleep in a clinical diagnosis setting. This research targets:
- Movements as a consequence of movement disorders (Such as Periodic Leg Movements During Sleep),
- Movements as a consequence of arousals during the night
- Movements as a conqequence of respiratory events during the night
50 adults attending The Princel Charles Hospital Sleep Service for a Diagnostic Polysomnogram (sleep study) will be recruited. In addition to the standard physiological channels recorded in a sleep study, Multiple accelerometers will be strategically placed on each subject (ankle and big toe, wrist and middle finger and central thorax).
Data will be analysed to determine whether:
- The amplitude of movements observed using accelerometry predict cortical arousal
- Continuous triaxial accelerometry may be used to automatically classify sleep from wake more accurately than commercial actigraphs
- Multisite accelerometry allows primary limb movements to be distinguished from gross body movements as a consequence of arousal or other events
- Indices of movement events correlate with qualtiy of life measures
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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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Philip Terrill
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Address
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The School of IT and Electrical Engineering
The University of Queensland
Brisbane, Queensland, 4077
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Country
15174
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Australia
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Phone
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+61 7 3365 8328
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Fax
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+61 7 33654 999
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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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Philip Terrill
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Address
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The School of IT and Electrical Engineering
The University of Queensland
Brisbane, Queensland, 4077
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Country
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Australia
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Phone
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+61 7 3365 8328
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Fax
6102
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+61 7 33654 999
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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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