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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: OSA
• Intervention / Treatment: Device: Sleeptracker-AI

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Samran Sheriff, PhD; Phone Number: +61298053248; Email: Samran.Sheriff@mq.edu.au
• Study Contact Backup: Name: Craig L Phillips, PhD; Phone Number: +61298053248; Email: c.phillips@mq.edu.au

Study Locations

• Australia
  • New South Wales
    • Glebe, New South Wales, Australia, 2095
      • Woolcock Institute of Medical Research
      • Principal Investigator: Craig Phillips, PhD
      • Contact: Grigori Kaplan, PhD; Phone Number: +61 98053232; Email: grigori.kaplan@woolcock.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Woolcock Institute for a diagnostic sleep study for possible sleep apnea.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients; Sleep clinic patients undergoing polysomnography sleep studies for diagnosis of sleep apnea

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Hypopnea Index	AHI (events per hour of sleep)	One night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time	Total Sleep Time (minutes)	One night
NREM Sleep Time	Non-REM sleep time (minutes)	One night
REM Sleep Time	REM sleep time (minutes)	One night

Collaborators and Investigators

• Sponsor: Woolcock Institute of Medical Research
• Collaborators: Fullpower Technologies, Inc.
• Investigators: Principal Investigator: Craig Phillips, PhD, Woolcock Institute of Medical Research

Study record dates

Study Major Dates

• Study Start (Estimated): January 18, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): October 10, 2028

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: polysomnography; validation study; Sleeptracker-AI
• Other Study ID Numbers: X23-0255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No