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% O2 desaturation (PSG-AHI3%) and ≥4% O2 desaturation (PSG-AHI4%), respectively. The results of PSG and ODM were compared by drawing parallels between the PSG-AHI3% and PSG-AHI4% 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/m2; PSG-AHI3%: 35.3±30.1/h, ODM-ODI3%: 30.3±25.9/h). The variability in the AASM scoring bias (PSG-AHI3%vs PSG-AHI4%) was significantly higher than that for PSG-AHI3%vs ODM-ODI3% (3%) and PSG-AHI4%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.