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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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OSA

Intervention / Treatment
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* Device: Sleeptracker-AI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Sleep clinic patients undergoing polysomnography sleep studies for diagnosis of sleep apnea | Device: Sleeptracker-AI<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polysomnography, validation study, Sleeptracker-AI