Validation of an Overnight Wireless High-Resolution Oximeter plus Cloud-Based Algorithm for the Diagnosis of Obstructive Sleep Apnea

Abstract

OBJECTIVES: Obstructive sleep apnea (OSA) is a common but largely underdiagnosed condition. This study aimed to test the hypothesis that the oxygen desaturation index (ODI) obtained using a wireless high-resolution oximeter with a built-in accelerometer linked to a smartphone with automated cloud analysis, Overnight Digital Monitoring (ODM), is a reliable method for the diagnosis of OSA. METHODS: Consecutive patients referred to the sleep laboratory with suspected OSA underwent in-laboratory polysomnography (PSG) and simultaneous ODM. The PSG apnea-hypopnea index (AHI) was analyzed using the criteria recommended and accepted by the American Academy of Sleep Medicine (AASM) for the definition of hypopnea: arousal or >= 3% O-2 desaturation (PSG-AHI(3%)) and >= 4% O-2 desaturation (PSG-AHI(4%)), respectively. The results of PSG and ODM were compared by drawing parallels between the PSG-AHI(3%) and PSG-AHI(4%) with ODM-ODI3% and ODM-ODI4%, respectively. Bland-Altman plots, intraclass correlation, receiver operating characteristics (ROC) and area under the curve (AUC) analyses were conducted for statistical evaluation. ClinicalTrial.gov: NCT03526133. RESULTS: This study included 304 participants (men: 55%; age: 55 +/- 14 years; body mass index: 30.9 +/- 5.7 kg/m(2); PSG-AHI(3%): 35.3 +/- 30.1/h, ODM-ODI3%: 30.3 +/- 25.9/h). The variability in the AASM scoring bias (PSG-AHI(3%) vs PSG-AHI(4%)) was significantly higher than that for PSG-AHI(3%) vs ODM-ODI3% (3%) and PSG-AHI(4%) vs ODM-ODI4% (4%) (9.7, 5.0, and 2.9/h, respectively; p < 0.001). The limits of agreement (2 +/- SD, derived from the Bland-Altman plot) of AASM scoring variability were also within the same range for (PSG vs ODM) 3% and 4% variability: 18.9, 21.6, and 16.5/h, respectively. The intraclass correlation/AUC for AASM scoring variability and PSG vs ODM 3% or 4% variability were also within the same range (0.944/0.977 and 0.953/0.955 or 0.971/0.964, respectively). CONCLUSION: Our results showed that ODM is a simple and accurate method for the diagnosis of OSA.