Trial Review

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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
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
Secondary ID [1] 253111 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodic leg movement syndrome 258670 0
Obstructive sleep apnoes 258671 0
insomnia 258672 0
parasomnia 258673 0
Condition category
Condition code
Neurological 258817 258817 0 0
Other neurological disorders
Respiratory 258818 258818 0 0
Sleep apnoea
Mental Health 258819 258819 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 257703 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259681 0
Correlation between amplitude of movement detected using accelerometry with amplitude of movement using tibialis anterior EMG
Timepoint [1] 259681 0
At time of PSG (T=0)
Primary outcome [2] 259682 0
Correlation between amplitude of movement detected using accelerometry with amplitude of movement using piezo electric movement sensors
Timepoint [2] 259682 0
At time of PSG (T=0)
Primary outcome [3] 259685 0
Area under ROC curve for predicting arousal based on movement observed using accelerometry, compared to clinician scored arousal based on full PSG
Timepoint [3] 259685 0
At time of PSG (T=0)
Secondary outcome [1] 266381 0
Area under ROC curve for predicting periodic leg movement based on movement observed using accelerometry, compared to clinician scored using EMG and piezo gauges
Timepoint [1] 266381 0
At the time of PSG (T=0)
Secondary outcome [2] 268596 0
- Clinician identification of movement artefact in PSG channels will be compared with prediction of movement artefact using accelerometry data alone
Timepoint [2] 268596 0
At the time of PSG (T=0)
Secondary outcome [3] 268597 0
- Indicies derived from accelerometry will be compared to standardised surveys and PSG based measures (sleep efficiency) in their ability to estimate quality of sleep
Timepoint [3] 268597 0
At the time of PSG (T=0)

Eligibility
Key inclusion criteria
Patients referred to The Prince Charles Hospital Sleep Service for an overnight diagnostic polysomnogram for any reason
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3466 0
4032

Funding & Sponsors
Funding source category [1] 258091 0
University
Name [1] 258091 0
The University of Queensland New Staff Research Grant
Country [1] 258091 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane, Queensland, 4072
Australia
Country
Australia
Secondary sponsor category [1] 257271 0
Hospital
Name [1] 257271 0
The Prince Charles Hospital
Address [1] 257271 0
The Prince Charles Hospital
Rode Road, Chermside, Queensland, 4032
Country [1] 257271 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260083 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 260083 0
The Prince Charles Hospital
Rode Rd., Chermside, Queensland, 4032
Ethics committee country [1] 260083 0
Australia
Date submitted for ethics approval [1] 260083 0
01/03/2010
Approval date [1] 260083 0
25/06/2010
Ethics approval number [1] 260083 0
HREC/10/QPCH/27
Ethics committee name [2] 260100 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 260100 0
The University of Queensland
Brisbane, Queensland, 4072
Ethics committee country [2] 260100 0
Australia
Date submitted for ethics approval [2] 260100 0
Approval date [2] 260100 0
31/07/2010
Ethics approval number [2] 260100 0
2010000961

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31927 0
Address 31927 0
Country 31927 0
Phone 31927 0
Fax 31927 0
Email 31927 0
Contact person for public queries
Name 15174 0
Philip Terrill
Address 15174 0
The School of IT and Electrical Engineering
The University of Queensland
Brisbane, Queensland, 4077
Country 15174 0
Australia
Phone 15174 0
+61 7 3365 8328
Fax 15174 0
+61 7 33654 999
Email 15174 0
[email protected]
Contact person for scientific queries
Name 6102 0
Philip Terrill
Address 6102 0
The School of IT and Electrical Engineering
The University of Queensland
Brisbane, Queensland, 4077
Country 6102 0
Australia
Phone 6102 0
+61 7 3365 8328
Fax 6102 0
+61 7 33654 999
Email 6102 0
[email protected]

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
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