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Exploration of Current and New Technologies for Accuracy of Diagnosing OSA

ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResMed

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patient suspected or known to have OSA

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: OSA6 interventions

Trial outcomes

Primary outcomes

1

Sensitivity

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

Time frame
Single night PSG
2

Specificity

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

Time frame
A single night PSG

Secondary outcomes

1

Severity Categorisation

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

Time frame
A single night PSG
2

Total Sleep Time

Total portion of the recording identified as sleep time

Time frame
A single night PSG
3

ODI

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

Time frame
A single night PSG
4

Sleep Staging

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

Time frame
A single night PSG

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ResMed

Lead sponsor

KlinEra Global Services

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: