Division of Sleep Medicine, Stanford University, Stanford, CA, USA.
Fullpower Technologies Inc, Santa Cruz, CA, USA.
Sleep Med. 2022 Aug;96:20-27. doi: 10.1016/j.sleep.2022.04.010. Epub 2022 Apr 22.
The objective of this study is to evaluate the validity of an under-mattress monitoring device (Fullpower Technologies) in estimating sleep continuity and architecture, as well as estimating obstructive sleep apnea in an adult population.
Adult volunteers (n=102, 55% male and 45% female, aged 40.6 ± 13.7 years with a mean body mass index of 26.8 ± 5.8 kg/m) each participated in a one-night unattended in-lab study conducted by Fullpower Technologies. Each participant slept on a queen-sized bed with Sleeptracker-AI Monitor sensors placed underneath the mattress. Standard polysomnography (PSG) was simultaneously recorded on the same night. Researchers (FD and CK) were provided de-identified sleep studies and datasets by Fullpower Technologies for analysis. Sleep continuity measures, 30-s epoch-by-epoch sleep stages, and apnea and hypopnea events estimated by an automated algorithm from the Sleeptracker-AI Monitor were compared with the PSG recordings, with the PSG recordings serving as the reference.
Overall, the Sleeptracker-AI Monitor estimated similar sleep continuity measures compared with PSG. The Sleeptracker-AI Monitor overestimated total sleep time (TST) by an average of 6.3 min and underestimated wake after sleep onset (WASO) by 10.2 min. Sleep efficiency (SE) was similar between the Sleeptracker-AI Monitor and PSG (87.6% and 86.3%, respectively). The epoch-by-epoch accuracy of Sleeptracker-AI Monitor to distinguish 4-stage sleep (wake, light, deep, and REM sleep) was 79.0% (95% CI: 77.8%, 80.2%) with a Cohen's kappa of 0.676 (95% CI: 0.656, 0.697). Thirty-five participants (34.3%) were diagnosed with obstructive sleep apnea (OSA) with an apnea-hypopnea index (AHI) ≥ 5 based on PSG. Accuracy, sensitivity, and specificity for the Sleeptracker-AI Monitor to estimate OSA (an AHI ≥5) were 87.3% (95% CI: 80.8%, 93.7%), 85.7% (95% CI: 74.1%, 97.3%), and 88.1% (95% CI: 80.3%, 95.8%) respectively. The positive likelihood ratio (LR+) for AHI ≥5 was 7.18 (95% CI: 3.69, 14.0), and the negative likelihood ratio (LR-) for AHI ≥5 was 0.16 (95% CI: 0.072, 0.368).
The Sleeptracker-AI Monitor had high accuracy, sensitivity, and specificity in estimating sleep continuity measures and sleep architecture, as well as in estimating apnea and hypopnea events. These findings indicate that Sleeptracker-AI Monitor is a valid device to monitor sleep quantity and quality among adults. Sleeptracker-AI Monitor may also be a reliable complementary tool to PSG for OSA screening in clinical practice.
本研究旨在评估一款床垫下监测设备(Fullpower Technologies)在评估成年人睡眠连续性和结构以及估计阻塞性睡眠呼吸暂停方面的有效性。
102 名成年志愿者(55%为男性,45%为女性;年龄 40.6±13.7 岁,平均 BMI 为 26.8±5.8kg/m²)参与了 Fullpower Technologies 进行的一项无人值守的实验室夜间研究。每位参与者均睡在配有 Sleeptracker-AI Monitor 传感器的加大号床上。同时在同一晚进行标准多导睡眠图(PSG)记录。Fullpower Technologies 为研究人员(FD 和 CK)提供了去识别睡眠研究和数据集进行分析。使用自动化算法从 Sleeptracker-AI Monitor 估算的睡眠连续性指标、30 秒epoch-by-epoch 睡眠分期以及呼吸暂停和低通气事件与 PSG 记录进行了比较,PSG 记录作为参考。
总体而言,Sleeptracker-AI Monitor 与 PSG 相比,估计的睡眠连续性指标相似。Sleeptracker-AI Monitor 平均高估总睡眠时间(TST)6.3 分钟,低估睡眠后清醒时间(WASO)10.2 分钟。Sleeptracker-AI Monitor 的睡眠效率(SE)与 PSG 相似(分别为 87.6%和 86.3%)。Sleeptracker-AI Monitor 区分 4 期睡眠(清醒、浅睡、深睡和 REM 睡眠)的每 epoch 准确性为 79.0%(95%CI:77.8%,80.2%),Cohen's kappa 为 0.676(95%CI:0.656,0.697)。根据 PSG,35 名参与者(34.3%)被诊断为阻塞性睡眠呼吸暂停(OSA),呼吸暂停低通气指数(AHI)≥5。Sleeptracker-AI Monitor 估计 OSA(AHI≥5)的准确性、敏感度和特异性分别为 87.3%(95%CI:80.8%,93.7%)、85.7%(95%CI:74.1%,97.3%)和 88.1%(95%CI:80.3%,95.8%)。AHI≥5 的阳性似然比(LR+)为 7.18(95%CI:3.69,14.0),AHI≥5 的阴性似然比(LR-)为 0.16(95%CI:0.072,0.368)。
Sleeptracker-AI Monitor 在评估睡眠连续性指标和睡眠结构以及估计呼吸暂停和低通气事件方面具有较高的准确性、敏感度和特异性。这些发现表明 Sleeptracker-AI Monitor 是一种监测成年人睡眠量和质量的有效设备。Sleeptracker-AI Monitor 也可能是 PSG 在临床实践中用于 OSA 筛查的可靠补充工具。