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Trial registered on ANZCTR
Registration number
ACTRN12606000066583
Ethics application status
Approved
Date submitted
14/02/2006
Date registered
16/02/2006
Date last updated
11/03/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
Power spectral analysis and inverse modeling of the electroencephalogram to monitor sleepiness on a driving simulator during sleep deprivation
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Scientific title
The effect of 40 hours sleep deprivation on sleepiness, driving simulator performance and electrographic power in healthy volunteers and patients with obstructive sleep apnea
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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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Healthy volunteers also studied.
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Condition category
Condition code
Respiratory
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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
Sleep deprivation 40 hours
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Intervention code [1]
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None
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Comparator / control treatment
non-sleep deprived state (measured at baseline before 40-hour sleep deprivation period, time = zero hours)
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Control group
Active
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Outcomes
Primary outcome [1]
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Subjective sleepiness.
Note that the key aim is to model the progression of the outcomes across the 40 hour intervention period.
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Assessment method [1]
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Timepoint [1]
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Measured every 2 hours during study.
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Secondary outcome [1]
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Driving simulator performance
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Assessment method [1]
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Timepoint [1]
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Measured every 2 hours.
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Secondary outcome [2]
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Quantitative electroencephalography measures
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Assessment method [2]
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Timepoint [2]
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Measured every 2 hours.
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Eligibility
Key inclusion criteria
Healthy group: n = 12 without sleep disorder.OSA group: n = 12.
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Minimum age
25
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
Use of hypnotics, head injury or neurological conditions, use of drugs known to affect central nervous system.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not 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
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
13/02/2006
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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
24
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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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Funding & Sponsors
Funding source category [1]
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Other Collaborative groups
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Name [1]
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RACP-CONROD Fellowship
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Address [1]
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x
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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NSW Biofirst Award
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Address [2]
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x
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Country [2]
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Australia
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Primary sponsor type
Individual
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Name
Naomi Rogers
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Address
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Country
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Secondary sponsor category [1]
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Individual
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Name [1]
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Delwyn Bartlett
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Address [1]
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x
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Country [1]
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Australia
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Secondary sponsor category [2]
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Individual
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Name [2]
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Keith Wong
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Address [2]
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x
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Country [2]
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Australia
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Secondary sponsor category [3]
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Individual
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Name [3]
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Nathaniel Marshall
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Address [3]
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x
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Country [3]
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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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Sydney South West Area Health Service (Eastern Zone)
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Ethics committee address [1]
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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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Approval date [1]
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01/08/2005
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Ethics approval number [1]
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X05-0165
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Ethics committee name [2]
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University of Sydney
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Ethics committee address [2]
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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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02/02/2006
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Ethics approval number [2]
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8609
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Summary
Brief summary
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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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Sarah Newton-John
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Address
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Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 2 95156578
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Fax
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+61 2 95505865
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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 Keith Wong
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Address
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PO Box M77
Missenden Road
Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 2 95158981
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Fax
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+61 2 9515 7070
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Email
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[email protected]
au
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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
Source
Title
Year of Publication
DOI
Embase
Performance of an automated algorithm to process artefacts for quantitative EEG analysis during a simultaneous driving simulator performance task.
2017
https://dx.doi.org/10.1016/j.ijpsycho.2017.08.004
Embase
Brain bioenergetics during resting wakefulness are related to neurobehavioral deficits in severe obstructive sleep apnea: A 31P magnetic resonance spectroscopy study.
2018
https://dx.doi.org/10.1093/sleep/zsy117
Embase
Sleep EEG microstructure is associated with neurobehavioural impairment after extended wakefulness in obstructive sleep apnea.
2021
https://dx.doi.org/10.1007/s11325-020-02066-5
N.B. These documents automatically identified may not have been verified by the study sponsor.
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