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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06110962
Registration number
NCT06110962
Ethics application status
Date submitted
24/10/2023
Date registered
1/11/2023
Date last updated
30/04/2024
Titles & IDs
Public title
Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor
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Scientific title
Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor
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Secondary ID [1]
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X23-0255
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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:
OSA
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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 - Sleeptracker-AI
Patients - Sleep clinic patients undergoing polysomnography sleep studies for diagnosis of sleep apnea
Treatment: Devices: Sleeptracker-AI
The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) is a commercially available, unobtrusive, and non-wearable home sleep monitoring device. It is either pre-installed in a mattress or can be purchased separately by consumers where it is placed under the mattress. The device uses piezo-electric sensors that register the forces exerted through the mattress by features such as the subject's motion, respiration, heartbeats, and snoring vibrations.
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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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Apnea Hypopnea Index
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Assessment method [1]
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AHI (events per hour of sleep)
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Timepoint [1]
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One night
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Secondary outcome [1]
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Total Sleep Time
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Assessment method [1]
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Total Sleep Time (minutes)
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Timepoint [1]
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One night
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Secondary outcome [2]
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NREM Sleep Time
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Assessment method [2]
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Non-REM sleep time (minutes)
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Timepoint [2]
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One night
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Secondary outcome [3]
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REM Sleep Time
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Assessment method [3]
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REM sleep time (minutes)
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Timepoint [3]
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One night
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Eligibility
Key inclusion criteria
- Adults aged 20-90 years old at time of assessment.
- Attending the Woolcock Institute for an overnight sleep study for investigation of
sleep apnoea.
- Able to give informed consent.
- Fluent in English.
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Minimum age
20
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
- Unable to understand study procedure.
- Unable to sign informed consent form.
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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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
20/05/2024
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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
10/10/2028
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Macquarie Park
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Recruitment postcode(s) [1]
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2113 - Macquarie Park
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Funding & Sponsors
Primary sponsor type
Other
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Name
Woolcock Institute of Medical Research
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Fullpower Technologies, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to simultaneously acquire sleep and breathing data using the
under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California,
USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing
investigation for possible obstructive sleep apnoea (OSA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06110962
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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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Craig Phillips, PhD
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Address
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Woolcock Institute of Medical Research
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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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Camillah Hoyos, PhD
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Address
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Country
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Phone
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+61298053229
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06110962
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