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NCT Number: NCT07485582

Exploration of Current and New Technologies for Accuracy of Diagnosing OSA

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peninsula Sleep Clinic, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device A

Device

A finger worn OSA home sleep test (HST) diagnostic device

Device B

Device

A wrist worn OSA home sleep test (HST) diagnostic device

Device C

Device

Ring: wellness device

Device D

Device

Torso and limb worn patches

Device E

Device

An eye mask

Screener A

Diagnostic Test

A mobile app screener

Primary outcomes

  1. Sensitivity

    Time frame: Single night PSG

    Sensitivity is defined as the device's ability to correctly diagnose patients with OSA, relative to AHI 5

  2. Specificity

    Time frame: A single night PSG

    Specificity is defined as the device's ability to correctly identify patients without OSA, relative to AHI 5.

Secondary outcomes

  1. Severity Categorisation

    Time frame: A single night PSG

    Ability to correctly identify OSA severity category, based on AHI threshold values (normal, mild, moderate, severe).

  2. Total Sleep Time

    Time frame: A single night PSG

    Total portion of the recording identified as sleep time

  3. ODI

    Time frame: A single night PSG

    The Oxygen Desaturation Index (ODI) measures the number of times per hour of sleep that blood oxygen levels drop by a specific percentage from baseline

  4. Sleep Staging

    Time frame: A single night PSG

    Time in the various sleep stages, Stage 1 (light sleep), Stage 2 (deeper, intermediate), Stage 3 (deep, slow-wave sleep/restorative) and REM.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Wimms, PhD

CONTACT

[email protected]

02 8884 2203

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Collaborators

  • KlinEra Global Services

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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