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| Name | Class |
|---|---|
| KlinEra Global Services | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA | Suspected of obstructive sleep apnea and about to undergo assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device A | Device | A finger worn OSA home sleep test (HST) diagnostic device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity is defined as the device's ability to correctly diagnose patients with OSA, relative to AHI 5 | Single night PSG |
| Specificity | Specificity is defined as the device's ability to correctly identify patients without OSA, relative to AHI 5. | A single night PSG |
| Measure | Description | Time Frame |
|---|---|---|
| Severity Categorisation | Ability to correctly identify OSA severity category, based on AHI threshold values (normal, mild, moderate, severe). | A single night PSG |
| Total Sleep Time | Total portion of the recording identified as sleep time |
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Inclusion Criteria:
Exclusion Criteria:
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Patient suspected or known to have OSA
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison Wimms, PhD | Contact | 02 8884 2203 | Alison.Wimms@resmed.com.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula Sleep Clinic | Sydney | New South Wales | Australia |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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 |
|
| A single night PSG |
| 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 | A single night PSG |
| 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. | A single night PSG |
| Adelaide Institute for Sleep Health (FHMRI Sleep Health), Flinders University | Adelaide | South Australia | Australia |
|
| Flinders Health and Medical Research Institute | Adelaide | South Australia | Australia |
|
| Centre for Sleep Science, The University of Western Australia. | Perth | UWA | Australia |
|
| Box Hill Hospital | Box Hill | Victoria | Australia |
|
| Victorian Respiratory Support Service (VRSS) | Heidelberg | Victoria | Australia |
|
| School of Psychological Science | Perth | Australia |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |