Detecting Heart Rate, Respiration, and Sleep With the Sle... | NCT06110962

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

NCT06110962

Sponsor

Woolcock Institute of Medical Research

Status

Recruiting

Last Update Posted

Mar 28, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Interventions

Sleeptracker-AI

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2024Actual

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Oct 10, 2028Estimated

First Submitted Date

Oct 24, 2023

First Submission Date that Met QC Criteria

Oct 29, 2023

First Posted Date

Nov 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2025

Last Update Posted Date

Mar 28, 2025Actual

Name	Class
Fullpower Technologies, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Sleep clinic patients undergoing polysomnography sleep studies for diagnosis of sleep apnea	Device: Sleeptracker-AI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleeptracker-AI	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Camillah Hoyos, PhD	Contact	+61298053229		camilla.hoyos@mq.edu.au
Craig L Phillips, PhD	Contact	+61298053017		c.phillips@mq.edu.au

Overall Officials

Name	Affiliation	Role
Craig Phillips, PhD	Woolcock Institute of Medical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Woolcock Institute of Medical Research	Recruiting	Macquarie Park	New South Wales	2113	Australia

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided