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A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparative product | A device which monitors sleep/wake states |
| |
| Screening device | This device will screen for sleep-breathing disorders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening device | Device | Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time | To measure the total sleep time recorded and analysed on the device using the new algorithm | 12 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of arousals during sleep | To compare the data acquired of the new device's algorithm against a pre-existing device detailing the frequency of sleep and wake periods | 12 hrs |
| Duration of arousals during sleep |
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Inclusion Criteria:
Exclusion Criteria:
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Volunteers who are employees within a medical device company
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Schindhelm, BE PhD | The University of New South Wales, Australia & ResMed Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RedMed Ltd | Sydney | New South Wales | 2153 | Australia |
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| ID | Term |
|---|---|
| D056044 | Actigraphy |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061725 | Accelerometry |
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| Comparative product | Device | A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states |
|
|
To compare the data acquired of the new device's algorithm against a pre-existing device detailing the duration of sleep and wake
| 12 hrs |
| Occurrence of arousals during sleep | To compare the data acquired of the new device's algorithm against a pre-existing device detailing when sleep and wake periods occurred | 12 hrs |
| D008919 |
| Investigative Techniques |