Objective: To investigate the role of a portable screening device (SleepStrip) in the diagnosis of obstructive sleep apnea (OSA).
Methods and materials: Prospective, nonrandomized double-blinded single cohort study at an academic health center. Patients with suspected OSA scheduled for an attended overnight Level I polysomnogram (PSG) and who consented to participate in the study wore the SleepStrip device at home the night after the PSG. The apnea-hypopnea index (AHI) determined by PSG was compared with the results of the SleepStrip recording.
Results: Thirty-seven patients with a mean age of 52.1 +/- 12.2 years and mean body mass index of 35.7 +/- 5.2 participated in the study. The overall agreement between the AHI and the SleepStrip results using Cohen's Kappa value was 0.139 (P = 0.19). The sensitivity and specificity of the SleepStrip for diagnosing severe OSA when the AHI was >40 were 33.3% and 95% (P = 0.05). When the AHI was >25, the SleepStrip sensitivity and specificity were 43.8% and 81.3% (P = 0.26). The sensitivity and specificity of the SleepStrip for diagnosing OSA in patients with an AHI >15 were 54.6% and 70%, respectively (P = 0.26).
Conclusion: The SleepStrip has a low correlation with the AHI as measured by PSG. Further studies are needed before this device can be recommended as a screening tool for the diagnosis of OSA.
Ebm rating: B-2b.