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Recruiting NCT06110962

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

Observational OSA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleeptracker-AI.
Who it may be relevant to
Registry conditions: OSA. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Apnea Hypopnea Index [Time frame: One night]
Secondary outcome measures (3)
  • Total Sleep Time [Time frame: One night]
  • NREM Sleep Time [Time frame: One night]
  • REM Sleep Time [Time frame: One night]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Australia · 1 center
  • Woolcock Institute of Medical Research — Macquarie Park

Identifiers

NCT: NCT06110962 · X23-0255

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗