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

George do Lago Pinheiro, Andrea Fonseca Cruz, Diego Munduruca Domingues, Pedro Rodrigues Genta, Luciano F Drager, Patrick J Strollo, Geraldo Lorenzi-Filho, George do Lago Pinheiro, Andrea Fonseca Cruz, Diego Munduruca Domingues, Pedro Rodrigues Genta, Luciano F Drager, Patrick J Strollo, Geraldo Lorenzi-Filho

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.

Conflict of interest statement

No potential conflict of interest was reported.

Figures

Figure 1. Flow diagram of the participant…
Figure 1. Flow diagram of the participant recruitment process. ODM=overnight digital monitoring.
Figure 2. Scatter plots and Spearman’s correlation…
Figure 2. Scatter plots and Spearman’s correlation (r) and Bland-Altman plots comparing A) PSG-AHI3% and PSG-AHI4%, B) PSG-AHI3% and ODM-ODI3%, and C) PSG-AHI4% and ODM-ODI4%.PSG=polysomnography; AHI=apnea-hypopnea index; ODM=overnight digital monitoring; ODI=oxygen desaturation index.
Figure 3. Receiver-operator characteristic curves of PSG-AHI3%…
Figure 3. Receiver-operator characteristic curves of PSG-AHI3% vs PSG-AHI4% (light gray line), PSG-AHI3% vs ODM-ODI3% (medium gray line), and PSG-AHI4% vs ODM-ODI4% (black line) PSG=polysomnography; AHI=apnea-hypopnea index; ODM=overnight digital monitoring; ODI=oxygen desaturation index; vs=versus.

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