0042 PERFORMANCE OF ADHESIVE WIRELESS PATCH SENSOR FOR SCREENING OF SLEEP ARCHITECTURE IN NORMAL AND APNEA

Abstract

Introduction: Sleep is a renowned marker of health. One in three adults endure sleep disorders with out diagnosis due to lack of effective sleep screening technology. The study presents clinical validation of VitalPatch, a wireless adhesive medical device for screening of sleep architecture in normal and apnea compared to the Polysomnography (PSG). Method(s): 45 volunteers (male/female: 24/21; 42 +/- 13 years) were recruited for an overnight PSG study, and attached to 22-channel PSG and a VitalPatch sensor on chest. Simultaneous PSG and patch data were acquired wirelessly during overnight. PSG recordings were scored to obtain 5-stage sleep architecture and apnea-hypopnea index (AHI) per AASM guidelines. Based on PSG's AHI values, the study population was grouped into normal (28), mild apnea (10) and moderate apnea (7). The statistical differences in sleep patterns among 3 groups were assessed using PSG sleep metrics. 3-class hypnograms with wake, non-rapid eye movement (NREM) and REM stages were further derived using VitalPatch recordings and calculated their respective sleep metrics. Performance analyses of VitalPatch's sleep assessment were carried out compared to the PSG. Result(s): PSG revealed significant decrease in total REM time (P=0.032) and increase in latency to REM (P=0.005) in apnea than normal. Latency to NREM and wake after sleep onset (WASO) were increased in apnea (P=0.063 and P=0.072, respectively). The accuracy and Cohen's kappa of sleep stage prediction using VitalPatch compared to the PSG were (82.4 +/- 8.2, 79.2 +/- 4.3 and 72.2 +/- 10.0 in %) and (0.57 +/- 0.16, 0.54 +/- 0.09 and 0.39 +/- 0.25), respectively in normal, mild apnea and moderate apnea groups. VitalPatch's total sleep time, total NREM time and total REM time had highest correlation (R) of 0.93, 0.86 and 0.72 with PSG respectively in normal and relatively lower in apnea groups. WASO was highly correlated to PSG in moderate apnea (0.67) compared to normal (0.47), as the number awakenings and wake duration after sleep onset were higher in apnea than normal. Conclusion(s): The study validates good performance of adhesive wireless VitalPatch sensor for sleep staging in normal and apnea compared to the PSG. The unobtrusive disposable patch sensor can be valuable for widespread clinical screening of sleep architecture.