Massie Frederik, Vits Steven, Verbraecken Johan, Bergmann Jeroen
Natural Interaction Lab, Thom Building, Department of Engineering, University of Oxford, Oxford, UK.
Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Sleep. 2025 Apr 11;48(4). doi: 10.1093/sleep/zsae248.
This paper reports on the clinical evaluation of the sleep staging performance of a novel single-lead biopotential device.
One hundred and thirty-three patients suspected of obstructive sleep apnea were included in a multi-site cohort. All patients underwent polysomnography and received the study device, a single-lead biopotential measurement device attached to the forehead. Clinical endpoint parameters were selected to evaluate the device's ability to determine sleep stages. Finally, the device's performance was compared to the clinical study results of comparable devices.
Concurrent PSG and study device data were successfully acquired for 106 of the 133 included patients. The results of this study demonstrated significant similarity in overall sleep staging performance (five-stage Cohen's Kappa of 0.70) to the best-performing reduced-lead biopotential device to which it was compared (five-stage Cohen's Kappa of 0.73). Contrary to the comparator devices, the study device reported a higher Cohen's Kappa for rapid eye movement (REM) (0.78) compared to N3 (0.61), which can be explained by its particular measuring electrode placement (diagonally across the lateral cross-section of the eye). This placement was optimized to ensure the polarity of rapid eye movements could be adequately captured, enhancing the capacity to discriminate between N3 and REM sleep when using only a single-lead setup.
The results of this study demonstrate the feasibility of incorporating a single-lead biopotential extension in a reduced-channel home sleep apnea testing setup. Such incorporation could narrow the gap in the functionality of reduced-channel home sleep testing and in-lab polysomnography without compromising the patient's ease of use and comfort.
NCT05035992, A Validation Study of the NightOwl Head Sensor https://clinicaltrials.gov/ct2/show/NCT05035992.
本文报告了一种新型单导联生物电位设备睡眠分期性能的临床评估结果。
133例疑似阻塞性睡眠呼吸暂停患者纳入多中心队列研究。所有患者均接受多导睡眠图检查，并使用研究设备，即一种贴于前额的单导联生物电位测量设备。选择临床终点参数来评估该设备确定睡眠阶段的能力。最后，将该设备的性能与类似设备的临床研究结果进行比较。
133例纳入患者中的106例成功获取了同步的多导睡眠图和研究设备数据。本研究结果表明，其总体睡眠分期性能（五阶段Cohen's Kappa系数为0.70）与所比较的性能最佳的简化导联生物电位设备（五阶段Cohen's Kappa系数为0.73）具有显著相似性。与对照设备不同的是，研究设备报告的快速眼动（REM）睡眠阶段的Cohen's Kappa系数（0.78）高于N3睡眠阶段（0.61），这可以通过其特殊的测量电极放置方式（对角穿过眼睛的横向截面）来解释。这种放置方式经过优化，以确保能够充分捕捉快速眼动的极性，从而增强在仅使用单导联设置时区分N3和REM睡眠的能力。
本研究结果证明了在简化通道的家庭睡眠呼吸暂停测试设置中加入单导联生物电位扩展的可行性。这种加入可以缩小简化通道家庭睡眠测试与实验室多导睡眠图在功能上的差距，同时不影响患者的易用性和舒适度。
NCT05035992，NightOwl头部传感器验证研究https://clinicaltrials.gov/ct2/show/NCT05035992
