The Effectiveness of a Novel Sleep Test Based on Cardiopulmonary Coupling to Detect Obstructive Sleep Apnea: A Multicenter Prospective Study.

Abstract

Purpose: Obstructive sleep apnea (OSA) is common and requires early detection and timely management to relieve symptoms and lower the risk of long-term complications. Although established home sleep apnea testing systems are available, many require multiple sensors, and simplified ECG-based approaches may reduce setup burden and improve ease of use. This study aimed to evaluate the diagnostic performance of a cardiopulmonary coupling-based sleep test against polysomnography-derived apnea-hypopnea index (AHI) in adults with clinically suspected OSA.

Patients and methods: In this prospective study at three tertiary medical centers in Taiwan, adults with suspected OSA received simultaneous in-laboratory polysomnography and a novel home sleep apnea test (Largan Health AI-Tech). The wearable device used a wireless electrocardiogram Holter monitor placed on the left anterior chest to record electrocardiogram signals during sleep. Signals were processed with cardiopulmonary coupling analysis to derive a respiratory event index, which was compared with the AHI from polysomnography.

Results: Among 479 participants, 200 were enrolled from CMUH, 193 from TVGH, and 86 from HTCH. The respiratory event index correlated strongly with the AHI (ρ = 0.889, p < 0.001), with high cohort-level consistency by intraclass correlation coefficient (ICC = 0.955). For identifying OSA, the area under the receiver operating characteristic curve was 0.923 (95% confidence interval 0.91-0.95) at an AHI of at least 5 events per hour, 0.929 (95% confidence interval 0.90-0.95) at least 15 events per hour, and 0.967 (95% confidence interval 0.95-0.98) at least 30 events per hour. In the subgroup with supplemental pulse oximetry, the combined approach showed higher areas under the receiver operating characteristic curve of 0.981, 0.984, and 0.992 at the corresponding thresholds.

Conclusion: CPC-derived REI showed good diagnostic performance against PSG-derived AHI in adults with clinically suspected OSA referred to tertiary sleep centers in Taiwan, supporting its potential role as a simplified adjunctive tool for OSA evaluation in this referred clinical setting.