推进儿童睡眠检测：一种专为家庭儿童评估设计的2型睡眠监测系统的实验室验证

文献信息

中文摘要

背景： 旨在支持家庭评估的综合2型睡眠监测系统可能改善儿童睡眠评估的可及性，同时保留对睡眠结构和呼吸事件的评估。本研究评估了一种可穿戴2型睡眠监测系统与标准实验室多导睡眠监测在儿童中的临床性能。
方法： 因夜间睡眠评估转诊的儿童同时使用Dormotech可穿戴2型系统和实验室多导睡眠监测（Nox A1）进行记录。记录按照美国睡眠医学会指南进行人工判读。主要结局为呼吸暂停低通气指数（AHI）和严重程度分类；次要结局包括整体睡眠-觉醒和呼吸参数、可用性和安全性。
结果： 24名儿童完成了监督下的实验室记录并纳入分析（中位年龄10.5岁；第25-75百分位数，8.8-13.3；50.0%女性）。Dormotech的中位AHI为2.2（第25-75百分位数，0.9-3.4）事件/小时，多导睡眠监测为1.3（0.6-3.6）事件/小时（p = 0.808）。AHI严重程度分类显示高度一致（κ = 0.896），Bland-Altman配对差异（Nox - Dormotech）中位数为-0.2事件/小时，经验95%一致性界限为-1.9至6.7事件/小时。次要睡眠或呼吸参数未观察到显著差异。用户体验良好，无设备相关不良事件。
结论： 该综合2型系统在儿童呼吸和整体睡眠-觉醒指标方面与实验室多导睡眠监测显示出强一致性。这些发现证明了在监督实验室条件下的一致性，并为未来评估该系统在无监督使用环境中性能的研究提供了基础。

英文摘要

BACKGROUND: Comprehensive Type 2 sleep-monitoring systems designed to support home-based assessment may improve access to pediatric sleep assessment while preserving evaluation of sleep architecture and respiratory events. This study evaluated the clinical performance of a wearable Type 2 sleep monitoring system compared with standard in-laboratory polysomnography in children.
METHODS: Children referred for overnight sleep evaluation underwent simultaneous recordings using the Dormotech wearable Type 2 system and in-laboratory polysomnography (Nox A1). Recordings were manually scored according to American Academy of Sleep Medicine guidelines. Primary outcomes were apnea-hypopnea index (AHI) and severity classification; secondary outcomes included global sleep-wake and respiratory parameters, usability, and safety.
RESULTS: Twenty-four children completed supervised in-laboratory recordings and were included in the analysis (median age, 10.5 years; 25th-3.6) events/h with polysomnography (p = 0.808). AHI severity classification showed high agreement (κ = 0.896), with a med75th percentiles, 8.8-13.3; 50.0% female). Median AHI was 2.2 (25th-75th percentiles, 0.9-3.4) events/h with Dormotech and 1.3 (0.6-3.6) events/h with polysomnography (p = 0.808). AHI severity classification showed high agreement (κ = 0.896), with a median Bland-Altman paired difference (Nox - Dormotech) of -0.2 events/h and empirical 95% limits of agreement of -1.9 to 6.7 events/h. No significant differences were observed across secondary sleep or respiratory parameters. User experience was favorable, with no device-related adverse events.
CONCLUSIONS: The comprehensive Type 2 system demonstrated strong agreement with in-laboratory polysomnography across respiratory and global sleep-wake measures in children. These findings demonstrate agreement under supervised laboratory conditions and provide a foundation for future studies evaluating the system's performance in unsupervised use settings.