Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor

OSA Clinical Trial

Official title:

Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06110962
• Other study ID #: X23-0255
• Status: Not yet recruiting
• Start date: May 20, 2024
• Est. completion date: October 10, 2028

Study information

• Verified date: December 2023
• Source: Woolcock Institute of Medical Research
• Contact: Camillah Hoyos, PhD
• Phone: +61298053229
• Email: camilla.hoyos[@]mq.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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). The de-identified Sleeptracker and PSG data will then be used by Fullpower Technologies to improve the accuracy of their current algorithm for detecting sleep and breathing disorders using the Sleeptracker device.

De-identified data recorded from the Sleeptracker device and PSG data from the Compumedics Grael system will be manually uploaded to a secure commercial server maintained by Fullpower Technologies.

Fullpower Technologies will use the de-identified data to refine their algorithms for detecting sleep and breathing disturbances.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 10, 2028
• Est. primary completion date: November 1, 2025
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Exclusion Criteria:

• Unable to understand study procedure.

• Unable to sign informed consent form.

Related Conditions & MeSH terms

• OSA

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Woolcock Institute of Medical Research	Macquarie Park	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Woolcock Institute of Medical Research	Fullpower Technologies, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index	AHI (events per hour of sleep)	One night
Secondary	Total Sleep Time	Total Sleep Time (minutes)	One night
Secondary	NREM Sleep Time	Non-REM sleep time (minutes)	One night
Secondary	REM Sleep Time	REM sleep time (minutes)	One night