Evaluation of Compumedics Somfit Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Performance Evaluation of the Compumedics Somfit Sleep Monitoring Device

Conditions
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Sleep Apnea

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals age between 18 to 75 Be able to give informed consent Individuals with diagnosed Obstructive Sleep Apnoea (OSA) Exclusion Criteria: Less than 18 years of age Greater than 75 years of age Unable or not willing to provide informed consent Need for nursing care Currently working nightshift

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>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)<br>* Data were recorded overnight by both devices simultaneously<br>|
| Case<br>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)<br>* Data were recorded overnight by both devices simultaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |