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To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
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 "gold standard" technology is expensive and therefore does not allow to meet public health demand for diagnosis of sleep disorders, especially obstructive sleep apnea (OSA) and also can be uncomfortable for the patients and distort their natural sleep architecture. To solve this problem, Compumedics has recently developed a miniaturized, portable, automated and affordable sleep monitoring system with code name of "Somfit" which is attached to patients' forehead and can be used in the comfort of patients' home. While Somfit has already gained TGA approval, the aim of this study is to compare Somfit with the "gold standard" PSG and another approved portable sleep testing device, Itamar WatchPAT One, in terms of accuracy of characterising sleep neurological architecture and diagnosing OSA, with the objective of applying for the international regulatory approvals.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system | Device | Each intervention is a separate diagnostic device. They will all be operating at the same time |
| Measure | Description | Time Frame |
|---|---|---|
| The AHI difference between the test device (Somfit) and gold standard (PSG) | AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG | Data required for the primary outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings |
| The AHI difference between the test device (Somfit) and predicate device (WatchPAT) | AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG | Data required for this primary outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and PSG | It will test the null hypothesis that the accuracy of sleep staging performed by the test device (Somfit) is inferior to that of the predicate device (WatchPAT) | Data required for this outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Event Index (REI) for Somfit | Additional outcome for sleep quality | The measure will be calculated for every participant following a single night sleep recording |
| Oxygen Desaturation Index (ODI) for Somfit |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SleepMetrics Pty Ltd | Heidelberg | VUC | 3084 | 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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As the study investigate performances of the diagnostic equipment, the three diagnostic devices can be applied to the single group of patients at the same time
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The sleep technologists who assess the sleep study outcomes will be blinded to the device generating the diagnostic data
| Hypnogram percent agreement between Somfit and PSG | It will test the null hypothesis that the accuracy of sleep staging performed by the test device (Somfit) is inferior to that demonstrated by the accredited sleep technologists | Data required for this outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings |
Additional outcome for sleep quality
| The measure will be calculated for every participant following a single night sleep recording |
| Average pulse rate (PR) for Somfit | Additional outcome for sleep quality | The measure will be calculated for every participant following a single night sleep recording |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |