TY - JOUR
T1 - Belun Ring (Belun Sleep System BLS-100)
T2 - Deep learning-facilitated wearable enables obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification in patients suspected of obstructive sleep apnea
AU - Strumpf, Zachary
AU - Gu, Wenbo
AU - Tsai, Chih Wei
AU - Chen, Pai Lien
AU - Yeh, Eric
AU - Leung, Lydia
AU - Cheung, Cynthia
AU - Wu, I. Chen
AU - Strohl, Kingman P.
AU - Tsai, Tiffany
AU - Folz, Rodney J.
AU - Chiang, Ambrose A.
N1 - Funding Information:
This work was performed at the University Hospitals Cleveland Medical Center Sleep Lab and the University Hospitals Beachwood Sleep Lab. We acknowledge Subhra Chakrabarti, the University Hospitals Sleep Labs manager, and the sleep lab technicians for their expertise and assistance in data collection. This work was financially supported by the Belun Technology Company Limited under Grant UHCMC-2021-1.
Funding Information:
This clinical research was supported by grant UHCMC-2021–1 from Belun Technology Limited, Hong Kong. The Belun Rings used in this study were provided by the company. Belun Technology agreed with the design of the study and has no role in the data collection. The sponsor did contribute to the data analysis, decision to publish, and manuscript preparation.
Publisher Copyright:
© 2023
PY - 2023/8
Y1 - 2023/8
N2 - Goal and aims: Our objective was to evaluate the performance of Belun Ring with second-generation deep learning algorithms in obstructive sleep apnea (OSA) detection, OSA severity categorization, and sleep stage classification. Focus technology: Belun Ring with second-generation deep learning algorithms Reference technology: In-lab polysomnography (PSG) Sample: Eighty-four subjects (M: F = 1:1) referred for an overnight sleep study were eligible. Of these, 26% had PSG-AHI<5; 24% had PSG-AHI 5–15; 23% had PSG-AHI 15–30; 27% had PSG-AHI ≥ 30. Design: Rigorous performance evaluation by comparing Belun Ring to concurrent in-lab PSG using the 4% rule. Core analytics: Pearson's correlation coefficient, Student's paired t-test, diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, Cohen's kappa coefficient (kappa), Bland-Altman plots with bias and limits of agreement, receiver operating characteristics curves with area under the curve, and confusion matrix. Core outcomes: The accuracy, sensitivity, specificity, and kappa in categorizing AHI ≥ 5 were 0.85, 0.92, 0.64, and 0.58, respectively. The accuracy, sensitivity, specificity, and Kappa in categorizing AHI ≥ 15 were 0.89, 0.91, 0.88, and 0.79, respectively. The accuracy, sensitivity, specificity, and Kappa in categorizing AHI ≥ 30 were 0.91, 0.83, 0.93, and 0.76, respectively. BSP2 also achieved an accuracy of 0.88 in detecting wake, 0.82 in detecting NREM, and 0.90 in detecting REM sleep. Core conclusion: Belun Ring with second-generation algorithms detected OSA with good accuracy and demonstrated a moderate-to-substantial agreement in categorizing OSA severity and classifying sleep stages.
AB - Goal and aims: Our objective was to evaluate the performance of Belun Ring with second-generation deep learning algorithms in obstructive sleep apnea (OSA) detection, OSA severity categorization, and sleep stage classification. Focus technology: Belun Ring with second-generation deep learning algorithms Reference technology: In-lab polysomnography (PSG) Sample: Eighty-four subjects (M: F = 1:1) referred for an overnight sleep study were eligible. Of these, 26% had PSG-AHI<5; 24% had PSG-AHI 5–15; 23% had PSG-AHI 15–30; 27% had PSG-AHI ≥ 30. Design: Rigorous performance evaluation by comparing Belun Ring to concurrent in-lab PSG using the 4% rule. Core analytics: Pearson's correlation coefficient, Student's paired t-test, diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, Cohen's kappa coefficient (kappa), Bland-Altman plots with bias and limits of agreement, receiver operating characteristics curves with area under the curve, and confusion matrix. Core outcomes: The accuracy, sensitivity, specificity, and kappa in categorizing AHI ≥ 5 were 0.85, 0.92, 0.64, and 0.58, respectively. The accuracy, sensitivity, specificity, and Kappa in categorizing AHI ≥ 15 were 0.89, 0.91, 0.88, and 0.79, respectively. The accuracy, sensitivity, specificity, and Kappa in categorizing AHI ≥ 30 were 0.91, 0.83, 0.93, and 0.76, respectively. BSP2 also achieved an accuracy of 0.88 in detecting wake, 0.82 in detecting NREM, and 0.90 in detecting REM sleep. Core conclusion: Belun Ring with second-generation algorithms detected OSA with good accuracy and demonstrated a moderate-to-substantial agreement in categorizing OSA severity and classifying sleep stages.
KW - Apnea-hypopnea index
KW - Artificial intelligence
KW - Digital health
KW - Home sleep apnea testing
KW - Obstructive sleep apnea
KW - Peripheral arterial tonometry
KW - Photoplethysmography
KW - Sleep technology
KW - Validation
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U2 - 10.1016/j.sleh.2023.05.001
DO - 10.1016/j.sleh.2023.05.001
M3 - Article
AN - SCOPUS:85163142207
VL - 9
SP - 430
EP - 440
JO - Sleep Health
JF - Sleep Health
SN - 2352-7218
IS - 4
ER -