睡眠障碍主要表现为入睡相关障碍，以及诸如磨牙症、睡行症、睡惊症、鼾症、梦语症、肢体运动障碍等在内的睡眠行为异常，显著影响儿童的体格发育、情绪调节、注意力、行为、代谢和免疫功能及生活质量等。近年来，国内外儿童睡眠障碍临床试验逐渐增多，但受临床定位及终点指标不明确所限，制约了高质量循证医学证据的产生。采用叙述性综述方法系统梳理近10年国内外儿童睡眠障碍临床试验疗效评价指标，明确当前疗效评价指标主要可归于睡眠质量、生活质量、临床疗效、中医证候等4个指标域，具体到睡眠质量又可进一步划分为综合睡眠质量、入睡及睡眠维持、睡眠呼吸、日间嗜睡、睡眠质量受损程度等5个指标域，并对各域指标的应用现状、适用人群、优势与局限进行分析，进而就其临床合理选择提出具体建议，以期为临床及科研工作者开展儿童睡眠障碍临床研究时选择合适的疗效评价指标提供指导，也为构建儿童睡眠障碍临床试验核心指标集（COS）提供一定参考。

Sleep disorder mainly manifest as falling asleep disorder, as well as sleep behavioral abnormalities such as bruxism, sleep walking, sleep startle, snoring, dream speech disorder, and limb movement disorder, which significantly affect children's physical development, emotional regulation, attention, behavior, metabolism, immune function, and quality of life. In recent years, there has been a gradual increase in clinical trials of sleep disorder in children both domestically and internationally. However, the lack of clear clinical positioning and endpoint indicators has limited the production of high-quality evidence-based medicine evidence. Therefore, a narrative review method was adopted to systematically sort out the efficacy evaluation indicators for clinical trials of sleep disorder in children at home and abroad in the past decade. It was clarified that the current efficacy evaluation indicators can be mainly classified into four indicator domains: sleep quality, quality of life, clinical efficacy, and traditional Chinese medicine symptoms. Specifically, sleep quality can be further divided into five indicator domains: comprehensive sleep quality, falling asleep and sleep maintenance, sleep breathing, daytime somnolence, and degree of impaired sleep quality. The application status, applicable populations, advantages, and limitations of indicators in each domain were analyzed, and specific suggestions for their rational clinical selection were proposed. This aims to provide guidance for clinicians and researchers in selecting appropriate efficacy evaluation indicators when conducting clinical research on sleep disorder in children, and also to offer some reference for the future construction of a core outcome set(COS) for clinical trials of sleep disorder in children.

R971

国家中医针灸临床医学研究中心开放课题-揿针治疗孤独症谱系障碍儿童睡眠障碍的临床研究(NCRCOP2024016)