Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06110962




Registration number
NCT06110962
Ethics application status
Date submitted
24/10/2023
Date registered
1/11/2023

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?
No
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected during the study are completed de-identifiable and will be sent to FullPower for algorithm training purposes. No identifiable data will be shared.


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/NCT06110962