1187 A Real-World Analysis of Patient-Applied, Home Polysomnography Use Across US and European Settings

Abstract Introduction While home polysomnography shows promise for expanding access to comprehensive sleep diagnostics, real-world data on technical performance and usage patterns is limited. This study analyzed outcomes from patient-applied home PSG (hPSG) studies conducted across US and European (EU) healthcare settings using the Onera Sleep Test System (patch-based PSG). Methods A total of 4,683 (3,817 EU, 866 US) sleep studies were performed across 30 sleep clinics (15 EU, 15 US) between January 2025 -December 2025 using a patient-applied, patch-based hPSG system. The patch-based device was shipped to the patient’s home with a return label and was sent for scoring as part of a “PSG as a Service” pipeline. Studies were conducted exclusively at patients' homes, self-applied without technician intervention, and were manually scored according to AASM criteria. Data collection included technical performance metrics such as scorer-reported signal quality assessments and study completion times. Results The clinician reported sleep study acceptance rate was 86.0% (85.8% EU, 86.6% US). A patient success rate of 94% (94.2% EU, 93.3% US) was reported. Average time from study request to report completion was 11.0 ± 5.76 days (11.3 ± 6.6 days EU, 11.2 ± 3.7 days US) with an average device shipping turnaround time of 10.0 ± 5.6 days ( 10.5 ± 6.3 days EU, 8.6 ± 3.4 days US) and scoring completed within 0.75 ± 1.6 days (0.4 ± 1.4 days EU, 2.1 ± 1.9 days US) providing insight into clinical workflows with the patch-based device and scoring. Among the studies assessed by sleep scorers, >80% quality was achieved for almost all essential signals—body position (98.5% of studies), nasal pressure (94.6%), respiratory effort or flow (94.0%), EMG (90.7%), EEG (88.4%), EOG (89.0%) and SpO2 (76.6%). Conclusion This first real-world analysis demonstrates that patient-applied hPSG achieves consistent technical success rates across different regions with high signal quality. The results of this research provides evidence in support of home diagnostics and could address the significant challenge of limited access to in-lab PSG facing sleep medicine practices today. Support (if any)