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Clinical Trials/NCT06110962
NCT06110962
Recruiting
Not Applicable

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

Woolcock Institute of Medical Research1 site in 1 country100 target enrollmentJuly 10, 2024
ConditionsOSA

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
OSA
Sponsor
Woolcock Institute of Medical Research
Enrollment
100
Locations
1
Primary Endpoint
Apnea Hypopnea Index
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2024
End Date
October 10, 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Apnea Hypopnea Index

Time Frame: One night

AHI (events per hour of sleep)

Secondary Outcomes

  • Total Sleep Time(One night)
  • NREM Sleep Time(One night)
  • REM Sleep Time(One night)

Study Sites (1)

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