Gu Wenbo, Leung Lydia, Kwok Ka Cheung, Wu I-Chen, Folz Rodney J, Chiang Ambrose A
Belun Technology Company Limited, Hong Kong, People's Republic of China.
Department of Computer Science, National Chiao Tung University, Hsinchu, Taiwan.
J Clin Sleep Med. 2020 Sep 15;16(9):1611-1617. doi: 10.5664/jcsm.8592.
The objective of the study is to validate the performance of Belun Ring Platform, a novel home sleep apnea testing system using a patented pulse oximeter sensor and a proprietary cloud-based neural networks algorithm.
The Belun Ring captures oxygen saturation, photoplethysmography, and accelerometer signals. The Belun Ring total sleep time is derived from features extracted from accelerometer, oxygen saturation, and photoplethysmography signals. The Belun Ring respiratory event index is derived from Belun Ring total sleep time and features extracted from heart rate variability and oxygen saturation changes. A total of 50 adults without significant cardiopulmonary or neuromuscular comorbidities and heart rate affecting medications were evaluated. In-lab sleep studies were performed simultaneously with the Ring and the studies were manually scored using the American Academy of Sleep Medicine Scoring Manual 4% desaturation criteria.
The Belun Ring respiratory event index correlated well with the polysomnography-apnea-hypopnea index (AHI; r = .894, P < .001). The sensitivity and specificity in categorizing AHI ≥ 15 events/h were 0.85 and 0.87, respectively, and the positive predictive value and negative predictive value were 0.88 and 0.83, respectively. The Belun Ring total sleep time also correlated well with the polysomnography-total sleep time (r = .945, P < .001). Although the Belun Ring Platform has a good overall performance, it tends to overestimate AHI in individuals with AHI under 15 events/h and underestimate AHI in those with AHI over 15 events/h. Conclusions: In this proof-of-concept study, the Belun Ring Platform demonstrated a reasonable accuracy in predicting AHI and total sleep time in patients without significant comorbidities and heart rate-affecting medications.
Registry: ClinicalTrials.gov; Name: Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT04121923; Identifier: NCT04121923.
本研究的目的是验证贝伦环平台（Belun Ring Platform）的性能，这是一种新型的家庭睡眠呼吸暂停检测系统，它使用了专利脉搏血氧仪传感器和基于云的专有神经网络算法。
贝伦环可采集血氧饱和度、光电容积脉搏波描记图（PPG）和加速度计信号。贝伦环的总睡眠时间由从加速度计、血氧饱和度和PPG信号中提取的特征得出。贝伦环呼吸事件指数由贝伦环总睡眠时间以及从心率变异性和血氧饱和度变化中提取的特征得出。总共对50名无显著心肺或神经肌肉合并症且未服用影响心率药物的成年人进行了评估。在使用贝伦环的同时进行了实验室睡眠研究，并根据美国睡眠医学会评分手册4%血氧饱和度下降标准进行人工评分。
贝伦环呼吸事件指数与多导睡眠图呼吸暂停低通气指数（AHI；r = 0.894，P < 0.001）相关性良好。将AHI≥15次/小时进行分类时的敏感性和特异性分别为0.85和0.87，阳性预测值和阴性预测值分别为0.88和0.83。贝伦环总睡眠时间与多导睡眠图总睡眠时间也具有良好的相关性（r = 0.945，P < 0.001）。尽管贝伦环平台总体性能良好，但对于AHI低于15次/小时的个体，它往往会高估AHI；而对于AHI高于15次/小时的个体，它往往会低估AHI。结论：在这项概念验证研究中，贝伦环平台在预测无显著合并症且未服用影响心率药物患者的AHI和总睡眠时间方面显示出合理的准确性。
注册机构：ClinicalTrials.gov；名称：一种用于筛查阻塞性睡眠呼吸暂停症状患者的新型设备的验证；网址：https://clinicaltrials.gov/ct2/show/NCT04121923；标识符：NCT04121923。
