0317 Advancing Home Sleep Testing: A Comparative Analysis of Type 2 New HST Technology vs. In-Lab PSG Validation Study

Abstract Introduction Currently, a typical home sleep test only measures respiratory signals, not actual sleep. Therefore, results may be inconclusive or false. Current practice also allows for one-night sleep study at home, that may also affect the results and render them inconclusive. Given these limitations, there is a growing need for a more convenient, accurate, and cost-effective method to diagnose sleep disorders at home. The method should allow patients to connect by themselves to the device at home and allow remote real-time monitoring. It should also provide the possibility for a study that spans over several nights. Methods Forty seven adults (mean ± SD age 52.2 ± 12.8 years, 19% females, body mass index 29.4 ± 5.3 kg/m2) used the DormoTech V-lab and simultaneously underwent a full PSG test using the Nox A1 system (K192469). Quantitative methods such as Bland–Altman plots, correlation analysis, and Passing-Bablok regression analysis were used to assess the extent of agreement between the Nox device and the Vlab device. The tests were manually scored based on recommended guidelines. Results The mean ± standard deviation apnea-hypopnea index (AHI) was 21.72 ± 24.17 events/h on the Vlab device, 21.50 ±23.86 events/h on in-laboratory PSG NoxA1 system with a p-value of 0.732. Bland-Altman analysis of AHI showed a mean difference of −0.193; the limits of agreement were −7.209 to 6.823 events/h. High agreements across the AHI severity levels. Precision, recall (equivalent to sensitivity), and F1-scores ranged from 0.88 to 1.00, indicating high accuracy and reliability. The correlation coefficients are predominantly above 0.9. Similar results were obtained for the secondary endpoints, with no statistically significant differences and high correlation. no safety event occurred. Conclusion There is a substantial consistency across the Vlab, and the selected PSG device in capturing various sleep metrics. This consistency is substantiated by robust statistical analyses. In essence, the high level of agreement between these devices sets a strong foundation for their reliability and consistency in sleep diagnostics. The Vlab is deemed substantially equivalent to the reference device NOX in terms of safety, usability, and efficacy. Support (if any)