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Not yet recruiting NCT07485582

Exploration of Current and New Technologies for Accuracy of Diagnosing OSA

— Observational Obstructive Sleep Apnea

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: Device A, Device B, Device C, Device D.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea. Basic parameters: from 18 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 →

Unsure about the terms? Read our patient guide →

Overview

Resmed is the manufacturer of medical devices which screen, diagnose, treat and monitor people with sleeping and respiratory disorders, such as obstructive sleep apnea (OSA). From time to time, for regulatory, quality, and marketing purposes, there may be a need to test the various products performance against PSG (gold standard technology), and other products. The purpose of this study is: 1. Products performance against PSG 2. comparison against other products, and 3. Assessments of potential new technologies

Interventions

  • Device Device A
    A finger worn OSA home sleep test (HST) diagnostic device
  • Device Device B
    A wrist worn OSA home sleep test (HST) diagnostic device
  • Device Device C
    Ring: wellness device
  • Device Device D
    Torso and limb worn patches
  • Device Device E
    An eye mask
  • Diagnostic test Screener A
    A mobile app screener

Primary outcome measures

  • Sensitivity [Time frame: Single night PSG]
  • Specificity [Time frame: A single night PSG]
Secondary outcome measures (4)
  • Severity Categorisation [Time frame: A single night PSG]
  • Total Sleep Time [Time frame: A single night PSG]
  • ODI [Time frame: A single night PSG]
  • Sleep Staging [Time frame: A single night PSG]

Eligibility criteria

Inclusion criteria

  • Participant is 18 years of age or older
  • Participant is willing to provide informed consent
  • Participant is willing to participate in all study related procedures

Exclusion criteria

  • Unable to cease PAP therapy during PSG (if currently using)
  • Requires use of oxygen therapy during sleep
  • Diagnosis of untreated clinically relevant sleep disorder (other than SDB, e.g. severe insomnia)
  • Who are or may be pregnant
  • Participants are unsuitable to participate in the study in the opinion of the investigator
  • Participant has a permanent pacemaker, sustained non-sinus cardiac arrhythmias, and/or takes alpha blocker or short acting nitrate medication.
  • Shift workers who worked an overnight shift in the past 3 days
  • Participant who are contraindicated to use the NightOwl sensor

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 · 7 centers
  • Peninsula Sleep Clinic — Sydney
  • Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University — Adelaide
  • Flinders Health and Medical Research Institute — Adelaide
  • Centre for Sleep Science, The University of Western Australia. — Perth
  • Box Hill Hospital — Box Hill
  • Victorian Respiratory Support Service (VRSS) — Heidelberg
  • School of Psychological Science — Perth

Identifiers

NCT: NCT07485582 · MA280126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗