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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01925430
Registration number
NCT01925430
Ethics application status
Date submitted
15/08/2013
Date registered
19/08/2013
Date last updated
2/05/2014
Titles & IDs
Public title
The Evaluation of a New Sleep Algorithm
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Scientific title
The Evaluation of a New Sleep/Wake State Algorithm
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Secondary ID [1]
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MA06082013
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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:
Healthy
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Condition category
Condition code
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
Treatment: Devices - Screening device
Treatment: Devices - Comparative product
Comparative product - A device which monitors sleep/wake states
Screening device - This device will screen for sleep-breathing disorders
Treatment: Devices: Screening device
Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions.
Treatment: Devices: Comparative product
A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total sleep time
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Assessment method [1]
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To measure the total sleep time recorded and analysed on the device using the new algorithm
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Timepoint [1]
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12 hrs
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Secondary outcome [1]
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Frequency of arousals during sleep
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Assessment method [1]
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To compare the data acquired of the new device's algorithm against a pre-existing device detailing the frequency of sleep and wake periods
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Timepoint [1]
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12 hrs
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Secondary outcome [2]
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Duration of arousals during sleep
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Assessment method [2]
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To compare the data acquired of the new device's algorithm against a pre-existing device detailing the duration of sleep and wake
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Timepoint [2]
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12 hrs
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Secondary outcome [3]
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Occurrence of arousals during sleep
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Assessment method [3]
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To compare the data acquired of the new device's algorithm against a pre-existing device detailing when sleep and wake periods occurred
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Timepoint [3]
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12 hrs
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Eligibility
Key inclusion criteria
* => 18yrs old
* can read and write English
* Provide informed written consent
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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
* Unable to participate for the full duration of the study
* An individual who is deemed unsuitable to participate in the opinion of the investigator
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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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
1/02/2014
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Sample size
Target
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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RedMed Ltd - Sydney
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Recruitment postcode(s) [1]
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2153 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ResMed
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.
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Trial website
https://clinicaltrials.gov/study/NCT01925430
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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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Klaus Schindhelm, BE PhD
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Address
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The University of New South Wales, Australia & ResMed Ltd
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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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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 scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01925430
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