Trial Review

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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
Scientific title
Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor
Secondary ID [1] 0 0
X23-0255
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
OSA 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea Hypopnea Index
Timepoint [1] 0 0
One night
Secondary outcome [1] 0 0
Total Sleep Time
Timepoint [1] 0 0
One night
Secondary outcome [2] 0 0
NREM Sleep Time
Timepoint [2] 0 0
One night
Secondary outcome [3] 0 0
REM Sleep Time
Timepoint [3] 0 0
One night

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.
Minimum age
20 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Unable to understand study procedure.

- Unable to sign informed consent form.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
20/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/10/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Macquarie Park
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Fullpower Technologies, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06110962
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig Phillips, PhD
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Camillah Hoyos, PhD
Address 0 0
Country 0 0
Phone 0 0
+61298053229
Fax 0 0
Email 0 0
camilla.hoyos@mq.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06110962