Contact-free Monitoring Technology for Screening of sleep Tal A, Goldbart A, Yizraeli-Davidovich M, Shinar Z Soroka University Medical Center Faculty of Health Sciences, Ben-Gurion University of the Negev Earlysense, Ramat Gan חיפ"פ 30-11-16 באר שבע
Background Moderate-Severe OSA affects between 13% of men and 6% of women ( Peppard PE et al, Am J Epidemiol 2013;177:1006-1014) to 49.7% in men and 23% in women (Lancet Respir Med. 2015 April)
OSA: Under-Diagnosis Sleep Apnea is highly prevalent, yet under-diagnosed Experts estimate that only ~20% of prevalent cases are diagnosed, with studies ranging from 1. 7-30% 3
Effect of Sleep-Disordered Breathing on the hospitalized patient
OSA Diagnosis: PSG and AHI The Apnea-Hypopnea Index (AHI) is the most commonly used criteria to establish a diagnosis of OSA and quantify its severity. The AHI is a PSG assessment of the total number of apneas plus hypopneas per hour of sleep. 5
Polysomnography
EarlySense piezo-electric (PE) system Contact free under-the-mattress measurement Based on a piezo-electric (PE) transducer Records a combination of gross body motion, rib cage movements, and the cardioballistic effect Validated RR, HR, movement detection Using Heart Rate Variability, and respiration variability together with movement analysis to have an accurate sleep/wake detection
Flow diagram Tal A, Shinar Z, et al JCSM, in press
Patients Demographics
Heart rate from the ES sensor compared to heart rate from gold standard ECG
Data from a single night, with ES sensor
Total sleep time (TST) ES sensor vs. PSG
Sleep pattern PE sensor vs. PSG Tal A, Shinar Z, et al JCSM, in press
Conclusion TST estimates with the contact-free sleep monitoring system were closely correlated with the gold-standard reference. This system shows good sleep staging capability with improved performance over accelerometer-based apps, and collects additional physiological information on heart rate and respiratory rate.
Validation of contact-free sleep monitoring device comparison to polysomnography Purpose to evaluate the performance of the PE contact-free system for its capability to detect moderate to severe OSA Methods Simultaneous recording of full-night PSG and PE system Comparison of AHI as determined by both methods
Study population 117 subjects (one night each) 96 subjects who were referred to a sleep lab to R/O OSA 21 healthy subjects tested at home. Age: 23-88 years (46.7 ± 14.8) BMI: 15-62 (31.1 ± 9.6) 89 (76%) males and 28 (24%) females
AHI: PE vs. Reference (PSG) Bland Altman 0.33 ± 6.97 (Mean ± SD) Bias not dependent on AHI value
PE system Apnea classification moderate/severe apnea detected moderate/severe apnea NOT detect Gold standard AHI > 15 AHI < 15 31 7 PPV 81.6% 4 75 NPV 94.9% Sensitivity Specificity Accuracy 88.6% 91.5% 90.6% Severe apnea (AHI=>30): 16 Moderate apnea (15<=AHI<30): 19 Mild apnea (5<=AHI<15): 32 No OSA (AHI<5): 50 100% of severe apnea detected 79% of moderate apnea detected 5/7 FP with AHI 9-14 2/7 FP with AHI 2.5-5 (Periodic Leg Movement) 2/4 FN with AHI 15-18 (borderline) 2/4 FN with AHI 22-24 according to reference.
Conclusions The PE contact-free sensor shows high sensitivity and PPV. This contact-free system enables us to evaluate patients for moderate severe OSA at home, in their own bed. The PE contact-free system can be used to screen hospitalized patients in general and surgical wards, to minimize adverse safety conditions
Children: Apnea and sleep staging Preliminary results Nov 2016
subjects 9 children were tested full PSG Ages: 1-13 All referred to R/O SDB
ES TST Reference TST ES AHI Reference AHI Age # 6.83 6.75 0.49 0 7 1206 5.38 6.23 1.86 1.93 10 1212 5.07 6.99 0.88 1.86 1.2 1213 5.60 7.14 0.56 1.12 3.6 1214 6.42 7.22 2.83 2.91 4 1215 6.32 6.93 2.84 2.16 5 1217 3.42 3.63 2.94 1.10 7 1218 6.47 6.81 0 1.03 13 1220 4.77 5.67 2.10 1.06 3 1222
3 2.5 2 AHI ES 1.5 1 0.5 0-0.5 0 0.5 1 1.5 2 2.5 3 3.5 AHI ref
10 9 8 7 TST ES 6 5 4 3 2 1 0 2 4 6 8 10 TST ref
25 20 ES events 15 10 5 0-5 -10-5 0 5 10 15 20 25 30 35 #events ref
Thank you for the attention