Validation of a single-use and reusable home sleep apnea test based on peripheral arterial tonometry compared to laboratory polysomnography for the diagnosis of obstructive sleep apnea

Study Objectives: The objective of this study was to independently validate a disposable and a reusable home sleep apnea test (HSAT) recording on peripheral arterial tonometry, compared to laboratory polysomnography (PSG), for the diagnosis of obstructive sleep apnea (OSA).Methods: 115 participants undergoing PSG for suspected OSA were recruited and fitted with the two study devices (NightOwl, Ectosense, Belgium). After exclusions were applied and device failures were removed, data from 100 participants were analyzed. HSAT-derived apnea-hypopnea index (AHI), OSA severity category, total sleep time, and oxygen desaturation index 3% were compared to PSG.Results: Both study devices demonstrated satisfactory levels of agreement with minimal mean bias for determination of AHI and oxygen desaturation index 3% (disposable: AHI mean bias 2.04 events/h [95% limits of agreement-20.9 to 25.0], oxygen desaturation index 3% mean bias-0.21/h [-18.1 to 17.7]; reusable: AHI mean bias 2.91 events/h [-16.9 to 22.7], oxygen desaturation index 3% mean bias 0.77/h [-15.7 to 17.3]). Level of agreement diminished at higher AHI levels although misclassification for severe OSA occurred infrequently. Total sleep time level of agreement for the reusable HSAT was also satisfactory with minimal mean bias (4.18 minutes,-125.1 to 112.4), but the disposable HSAT was impacted by studies with high signal rejection (23.7 minutes,-132.7 to 180.1). Categorization of OSA severity demonstrated moderate agreement with laboratory PSG, with a kappa of 0.52 and 0.57 for the disposable and reusable HSATs respectively.Conclusions: The two HSAT devices were comparable and performed well compared to laboratory PSG for the diagnosis of OSA.Clinical Trial Registration: Registry: Australian New Zealand Clinical Trials Registry; Identifier: ANZCTR12621000444886.