CLINICAL TRIAL
JOURNAL ARTICLE
VALIDATION STUDIES
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Validation of the Apnea Risk Evaluation System (ARES) device against laboratory polysomnography in pregnant women at risk for obstructive sleep apnea syndrome.

STUDY OBJECTIVE: To assess the validity of using the Apnea Risk Evaluation System (ARES) Unicorder for detecting obstructive sleep apnea (OSA) in pregnant women.

METHODS: Sixteen pregnant women, mean age (SD) = 29.8 (5.4) years, average gestational age (SD) = 28.6 (6.3) weeks, mean body mass index (SD) = 44.7 (6.9) kg/m(2) with signs and symptoms of OSA wore the ARES Unicorder during one night of laboratory polysomnography (PSG). PSG was scored according to AASM 2007 criteria, and PSG AHI and RDI were compared to the ARES 1%, 3%, and 4% AHIs calculated with the ARES propriety software.

RESULTS: Median PSG AHI and PSG RDI were 3.1 and 10.3 events/h of sleep, respectively. Six women had a PSG AHI ≥ 5 events/h of sleep and 11 had a PSG RDI ≥ 5 events/h of sleep. PSG AHI and RDI were strongly correlated with the ARES AHI measures. When compared with polysomnographic diagnosis of OSA, the ARES 3% algorithm provided the best balance between sensitivity (1.0 for PSG AHI, 0.91 for PSG RDI) and specificity (0.5 for PSG AHI, 0.8 for PSG RDI) for detecting sleep disordered breathing in our sample.

CONCLUSIONS: The ARES Unicorder demonstrated reasonable consistency with PSG for diagnosing OSA in this small, heterogeneous sample of obese pregnant women.

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