Evaluation of Compumedics "Somfit" Device
Study Details
Study Description
Brief Summary
To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Control Healthy volunteers |
Device: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
Data were recorded overnight by both devices simultaneously
|
| Case Volunteers with diagnosed sleep apnea |
Device: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
Data were recorded overnight by both devices simultaneously
|
Outcome Measures
Primary Outcome Measures
- Comparison between raw EEG signals [single night recording for each subject]
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.
Secondary Outcome Measures
- Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram [single night recording for each subject]
Epoch-by-epoch comparison between manual and automatic scoring of sleep data recorded by Somfit and Grael devices
Other Outcome Measures
- Validation of the new device for detection of sleep apnea [single night recording for each subject]
Differentiation between case and control groups
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Individuals age between 18 to 75
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Be able to give informed consent
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Individuals with diagnosed Obstructive Sleep Apnoea (OSA)
Exclusion Criteria:
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Less than 18 years of age
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Greater than 75 years of age
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Unable or not willing to provide informed consent
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Need for nursing care
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Currently working nightshift
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SleepMetrics Pty Ltd | Melbourne | Victoria | Australia | 3752 |
Sponsors and Collaborators
- Compumedics Limited
Investigators
- Principal Investigator: Elizabeth Kealy, Sleepmetrics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SOMFIT02