Validation a portable monitoring device for sleep apnea diagnosis in a population based cohort using synchronized home polysomnography

Subject Objective: To assess the accuracy of a portable monitoring device based on peripheral arterial tonometry to diagnose obstructive sleep apnea (OSA). To propose a new standard for limited-channel device validation using synchronized polysomnography (PSG) home recordings and a population-based cohort. Design: Single-night, unattended PSG and Watch_PAT 100 (WP_100). Setting: Home environment. Participants: Ninety-eight subjects (55 men; age, 60 7 year; body mass index, 28 +/- 4 kg/m(2)) consecutively recruited from the Skaraborg Hypertension and Diabetes Project. Measurements and Results: The WP_100 records peripheral arterial tone, heart rate, oxygen saturation and actigraphy for automatic analysis of respiratory disturbance index (RDI), apnea-hypopnea index (AHI), oxygen desaturation index (ODI), and sleep-wake state. The accuracy of WP_100 in RDI, AHI, ODI, and sleep-wake detection was assessed by comparison with data from simultaneous PSG recordings. The mean PSG-AHl in this population was 25.5 +/- 22.9 events per hour. The WP_100 RDI, AHI, and ODI correlated closely (0.88, 0.90, and 0.92; p < .0001, respectively) with the corresponding indexes obtained by PSG. The areas under the curve for the receiver-operator characteristic curves for WP_100 AHI and RDI were 0.93 and 0.90 for the PSG-AHl and RDI thresholds 10 and 20 (p < .0001, respectively). The agreement of the sleep-wake assessment based on 30-second bins between the 2 systems was 82 +/- 7%. Conclusions: The WP_100 was reasonably accurate for unattended home diagnosis of OSA in a population sample not preselected for OSA symptoms. The current design, including simultaneous home PSG recordings in population-based cohorts, is proposed as a reasonable validation standard for assessment of simplified recording tools for OSA diagnosis.