Comparison of a simple obstructive sleep apnea screening device with standard in-laboratory polysomnography.
BACKGROUND
Obstructive sleep apnea (OSA) is a common underdiagnosed sleep disorder. Various strategies have been employed to easily screen for OSA. The ApneaStrip® (AS - S.L.P. Ltd, Tel Aviv, Israel) is an FDA approved OSA screening device applied to the upper lip at home. We evaluated the performance of this device against simultaneous in-laboratory polysomnography (PSG) in a group of well-characterized OSA patients.


METHODS
Diagnostic PSG was performed in 56 patients (29 M, 37 F; age 48.9 ± 14.6 years; body mass index [BMI] 37.5 ± 9.0 kg/m(2); apnea-hypopnea index-events/h-[AHI] 32.8 ± 22.9). The AS was applied and positioned to detect nasal and oral airflow. The AS gives a "positive" result for AHI ≥ 15. We examined the sensitivity and specificity of the AS against three thresholds derived from PSG: AHI ≥ 5, AHI ≥ 15 (company recommendation), and AHI ≥ 30.


RESULTS
For PSG AHI ≥ 15, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AS were 80, 54.5, 87.8, and 40 %, respectively. For PSG AHI ≥ 5, the values were 75.1, 66.7, 97.1, and 13.3 %, respectively. For PSG AHI ≥ 30, the values were 86.9, 36.2, 48.8, and 80 %, respectively. There were no significant modifying effects of age, BMI, gender, hypertension, diabetes, lung disease, and heart disease.


CONCLUSIONS
The AS has a high sensitivity for detection of OSA with AHI ≥ 15, but only modest specificity. The AS could be a useful component of an OSA screening program; however, negative results should be interpreted cautiously.
Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, 100 N. Greene St 2nd Floor, Baltimore, MD, 21201, USA. sassefa1@medicine.umaryland.edu.
Samson Z
SZ
Assefa
Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, 100 N. Greene St 2nd Floor, Baltimore, MD, 21201, USA.
Montserrat
M
Diaz-Abad
Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, 100 N. Greene St 2nd Floor, Baltimore, MD, 21201, USA.|Veterans Affairs Oxnard Clinic, Oxnard, CA, 93036, USA.
Arkady
A
Korotinsky
Pharmaceutical Health Services Research Department, University of Maryland School of Pharmacy, Baltimore, MD, 21201, USA.
Sarah E
SE
Tom
Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, 100 N. Greene St 2nd Floor, Baltimore, MD, 21201, USA.
Steven M
SM
Scharf
D000328:Adult; D000368:Aged; D015374:Biosensing Techniques / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000295:instrumentation*; D008875:Middle Aged; D017286:Polysomnography / Q000295:instrumentation*; D055656:Prescriptions; D012680:Sensitivity and Specificity; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis*
ApneaStrip; Home apnea screening; Home sleep testing; Obstructive sleep apnea; Sleep apnea screening