Obstructive Sleep Apnea
Conditions
Brief summary
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
Sponsors
ResMed
KlinEra Global Services
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Single night PSG | Sensitivity is defined as the device's ability to correctly diagnose patients with OSA, relative to AHI 5 |
| Specificity | A single night PSG | Specificity is defined as the device's ability to correctly identify patients without OSA, relative to AHI 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity Categorisation | A single night PSG | Ability to correctly identify OSA severity category, based on AHI threshold values (normal, mild, moderate, severe). |
| Total Sleep Time | A single night PSG | Total portion of the recording identified as sleep time |
| ODI | 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 |
| Sleep Staging | 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. |
Countries
Australia
Contacts
CONTACTAlison Wimms, PhD
Outcome results
None listed