Department of Pulmonary and Critical Care Medicine, Peking University People's Hospital, Beijing, China.
Contributed equally as first authors.
J Clin Sleep Med. 2021 May 1;17(5):1075-1082. doi: 10.5664/jcsm.9138.
To evaluate the utility of a contact-free device in screening for obstructive sleep apnea.
Three hundred fifty-nine participants (mean age 46 ± 13 years, body mass index 26.1 ± 4.2 kg/m², 67.7% male) underwent overnight monitoring using a contact-free device, the OrbSense, and polysomnography (PSG) in the sleep laboratory simultaneously. The OrbSense recordings were analyzed automatically, and PSG was scored based on recommended guidelines.
The respiratory event index from the OrbSense was lower than the apnea-hypopnea index (AHI) from PSG (25.5 ± 20.7 vs 27.0 ± 25.2 events/h; P = .007) and was significantly correlated with AHI (Pearson coefficient, 0.92; P < .0001). Bland-Altman analysis showed a mean difference of 1.5 events/h, and the limit of agreement was -18.6 to 21.5 events/h. Use of the OrbSense resulted in larger underestimates of AHI and lower negative predictive values at higher AHI values (especially when AHI ≥ 30 events/h). When we used a PSG diagnostic criterion of AHI > 5 events/h, the optimal diagnostic cutoff value from the OrbSense was 8 events/h, with a sensitivity of 90.4%, a specificity of 77.6%, a 94.6% positive predictive value, and a 65% negative predictive value. For patients with moderate to severe obstructive sleep apnea whose AHI was > 15 events/h, the OrbSense cutoff was 16.6 events/h, with a sensitivity of 87.1% and a specificity of 89.7%. Among the 359 participants, 250 patients (69.6%) had the same obstructive sleep apnea severity division classified by both PSG and the OrbSense.
The contact-free device OrbSense can detect respiratory events during sleep and has close agreement with in-laboratory PSG in screening for obstructive sleep apnea. Further studies are warranted to test its utility in community-based settings and at home.
评估一种无接触设备在筛查阻塞性睡眠呼吸暂停中的效用。
359 名参与者(平均年龄 46 ± 13 岁,体重指数 26.1 ± 4.2kg/m²,67.7%为男性)同时在睡眠实验室中使用无接触设备 OrbSense 和多导睡眠图(PSG)进行整夜监测。OrbSense 记录自动分析,PSG 根据推荐指南进行评分。
OrbSense 的呼吸事件指数低于 PSG 的呼吸暂停低通气指数(AHI)(25.5 ± 20.7 与 27.0 ± 25.2 事件/小时;P =.007),并且与 AHI 呈显著相关(Pearson 系数为 0.92;P <.0001)。Bland-Altman 分析显示平均差异为 1.5 个事件/小时,一致性界限为-18.6 至 21.5 个事件/小时。当使用 OrbSense 时,在 AHI 值较高时,对 AHI 的估计值会明显偏低,阴性预测值也会降低(尤其是当 AHI ≥ 30 个事件/小时时)。当我们使用 PSG 的 AHI > 5 个事件/小时的诊断标准时,OrbSense 的最佳诊断截止值为 8 个事件/小时,其灵敏度为 90.4%,特异性为 77.6%,阳性预测值为 94.6%,阴性预测值为 65%。对于 AHI > 15 个事件/小时的中重度阻塞性睡眠呼吸暂停患者,OrbSense 的截止值为 16.6 个事件/小时,其灵敏度为 87.1%,特异性为 89.7%。在 359 名参与者中,250 名患者(69.6%)的 PSG 和 OrbSense 分类的阻塞性睡眠呼吸暂停严重程度相同。
无接触设备 OrbSense 可以在睡眠期间检测呼吸事件,并且在筛查阻塞性睡眠呼吸暂停方面与实验室 PSG 具有密切的一致性。需要进一步的研究来测试其在社区和家庭环境中的效用。