Clinical validation of a wireless patch-based polysomnography system: a pilot study

BackgroundPolysomnography (PSG) is the gold standard for diagnosing and monitoring sleep disorders, however, it is time-consuming and costly, as the application of the equipment can only be done by trained sleep technicians and the test must be conducted within a sleep laboratory. In this study we assessed the performance of the first wireless patch-based PSG system, the Onera Sleep Test System (STS), which can be applied by the patient and performed outside of the sleep laboratory in settings such as the home. To achieve this, sleep stage and physiological data from the Onera STS were compared to gold standard in-lab PSG. Materials and methodsThe recordings were unsupervised to simulate a home-use environment. Epoch-by-epoch agreement was assessed by calculating sensitivity, specificity, accuracy, and Cohens kappa coefficient. Pearsons correlation coefficients were calculated for multiple sleep parameters to measure the level of entire night agreement. ResultsSubstantial agreement with a Cohens kappa of 0.69 across all sleep stages was determined, which reached 0.81 when Stage N1 was removed from the analysis. A high accuracy, specificity, and sensitivity were found for wake N2, N3 and REM. Although specificity (95.25%) and accuracy (89.62%) were high for N1, sensitivity was low (27.19%). Sleep parameters calculated by sleep stage transitions, apnea hypopnea index and oxygen desaturation index, showed strong correlations. ConclusionsThe Onera STS provides comparable clinical information to traditional PSG. Moreover, the application time was reduced by 77% which reduces the overall costs of PSG. These results open the possibility for PSG studies to be performed efficiently outside of the sleep laboratory at a larger scale, thus improving access for patients.