Sleep disorders affect millions worldwide, yet accurate diagnosis remains challenging due to limited access to gold-standard polysomnography and the need for specialized sleep labs. Before new sleep diagnostic technologies can be adopted in clinical practice, they must undergo rigorous validation to prove they match the accuracy of traditional methods.
In a landmark multicenter study with 206 participants across seven clinical sites, the patch-based Onera STS home polysomnography system demonstrated comparable performance to traditional in-lab sleep recording for both sleep staging and respiratory event detection, with high concordance across key sleep variables and substantial epoch-by-epoch agreement. This robust validation provides evidence that innovative sleep diagnostic solutions can maintain clinical accuracy while increasing accessibility to sleep disorder diagnosis. https://jcsm.aasm.org/doi/10.5664/jcsm.11524
Agreement in Total Sleep Time Onera STS & in-lab PSG
Agreement in Apnea-Hypopnea Index Onera STS & in-lab PSG
Inter-scorer reliability between Onera STS & in-lab PSG
Fig. 1 caption: Concordance correlation plot showing good agreement between Onera STS and in-lab PSG (Concordance correlation coefficient = 0.88)
Fig. 2 caption: Concordance correlation plot showing excellent agreement between Onera STS and in-lab PSG (Concordance correlation coefficient = 0.93)
Fig. 3 caption: Interclass Correlation Coefficients showing good agreement between scorers for sleep staging and Total Sleep Time
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