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

Recruiting

• Conditions: OSA
• Interventions: Device: Sleeptracker-AI

• Registration Number: NCT06110962
• Lead Sponsor: Woolcock Institute of Medical Research

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-29
• Study First Posted: 2023-11-01
• Study Start: 2024-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-11-01
• Study Completion: 2028-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Sleeptracker-AI	Sleep clinic patients undergoing polysomnography sleep studies for diagnosis of sleep apnea

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	One night	AHI (events per hour of sleep)

Secondary Outcome Measures

Name	Time	Method
Total Sleep Time	One night	Total Sleep Time (minutes)
NREM Sleep Time	One night	Non-REM sleep time (minutes)
REM Sleep Time	One night	REM sleep time (minutes)

Trial Locations

Locations (1)

Woolcock Institute of Medical Research; 🇦🇺 Macquarie Park, New South Wales, Australia