NCT06110962

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Jul 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Jul 2024Oct 2028

First Submitted

Initial submission to the registry

October 24, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

July 10, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2028

Expected
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

October 24, 2023

Last Update Submit

March 25, 2025

Conditions

Keywords

validation studySleeptracker-AIpolysomnography

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea Index

    AHI (events per hour of sleep)

    One night

Secondary Outcomes (3)

  • Total Sleep Time

    One night

  • NREM Sleep Time

    One night

  • REM Sleep Time

    One night

Study Arms (1)

Patients

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

Device: Sleeptracker-AI

Interventions

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.

Patients

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to understand study procedure.
  • Unable to sign informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

Study Officials

  • Craig Phillips, PhD

    Woolcock Institute of Medical Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camillah Hoyos, PhD

CONTACT

Craig L Phillips, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

November 1, 2023

Study Start

July 10, 2024

Primary Completion

November 1, 2025

Study Completion (Estimated)

October 10, 2028

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Locations