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

NCT ID: NCT06110962

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-10

Study Completion Date

2028-10-10

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.

Conditions

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OSA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

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

Sleeptracker-AI

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fullpower Technologies, Inc.

INDUSTRY

Sponsor Role collaborator

Woolcock Institute of Medical Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig Phillips, PhD

Role: PRINCIPAL_INVESTIGATOR

Woolcock Institute of Medical Research

Locations

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Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Camillah Hoyos, PhD

Role: CONTACT

+61298053229

Craig L Phillips, PhD

Role: CONTACT

+61298053017

Facility Contacts

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Grigori Kaplan, PhD

Role: primary

+61 98053232

Other Identifiers

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X23-0255

Identifier Type: -

Identifier Source: org_study_id

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