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To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. Given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. However, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (PSG) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. This will cause discomfort for the patients in a long run. To solve this problem, Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "Somfit" which can be used in the comfort of patients' home. The aim of this study is to validate Somfit for home based sleep studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Healthy volunteers |
| |
| Case | Volunteers with diagnosed sleep apnea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system) | Device | Data were recorded overnight by both devices simultaneously |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between raw EEG signals | Direct comparison of Raw EEG data between Somfit and Grael system on an epoch by epoch basis (with each epoch being equivalent to 30 secs) to test and validate Somfit for data acquisition, display and record of Raw EEG data. | single night recording for each subject |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram | Epoch-by-epoch comparison between manual and automatic scoring of sleep data recorded by Somfit and Grael devices | single night recording for each subject |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of the new device for detection of sleep apnea | Differentiation between case and control groups | single night recording for each subject |
Inclusion Criteria:
Exclusion Criteria:
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30 volunteers were invited to participate in this study. 15 participants will be selected among healthy volunteers, by advertising to the general public. The remaining 15 will be among patients with diagnosed sleep apnea who visit SleepMetrics clinic as part of their routine treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Kealy | Sleepmetrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SleepMetrics Pty Ltd | Melbourne | Victoria | 3752 | Australia |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |