University of California San Francisco, Department of Neurology, USA.
University of Nebraska Medical Center, Nebraska Medicine Sleep Center, Internal Medicine, Division of Pulmonary, Critical Care & Sleep Medicine, USA.
Sleep Med. 2023 Jul;107:236-242. doi: 10.1016/j.sleep.2023.04.031. Epub 2023 May 18.
Sleep dysregulation in Parkinson's disease (PD) has been hypothesized to occur, in part, from dysfunction in the basal ganglia-cortical circuit. Assessment of this relationship requires accurate sleep stage determination, a known challenge in this clinical population. Our objective was to optimize the consensus on the sleep staging process and reduce interrater variability in a cohort of advanced PD subjects.
Fifteen PD subjects were enrolled from three sites in a clinical trial that involved recordings from subthalamic nucleus (STN) deep brain stimulation (DBS) leads (NCT04620551). Video polysomnography (vPSG) data for a total of 45 nights were analyzed. Four experienced scorers independently scored data on initial review. Epochs with less than 75% consensus were flagged for secondary review. In secondary review of discordant epochs, two of the original scorers re-assessed epochs, from which the final consensus stage was derived.
Sleep stage classification agreement averaged 83.10% across all sleep stages on initial scoring (IS), and on secondary consensus scoring (CS) review, agreement reached 96.58%. Greatest disagreement was noted in determination of awake epochs (33.6% of discordant epochs) and non-rapid-eye-movement stage 2 (N2) epochs (31.8% of discordant epochs). Scoring discrepancy was resolved with direct measurement of cortical frequency and amplitudes, physiologic context of the epoch, and video review.
Our method of multi-level initial and then secondary consensus review scoring resulted in consensus scoring agreement superior to conventional standards. This work features a custom-engineered vPSG software and review platform for integration of consensus sleep stage scoring in a multi-site clinical trial.
帕金森病(PD)的睡眠失调被假设部分源于基底节-皮质回路的功能障碍。评估这种关系需要准确的睡眠分期,这在这一临床人群中是一个已知的挑战。我们的目的是优化睡眠分期过程的共识,并减少高级 PD 受试者队列中的评分者间变异性。
从一项涉及丘脑底核(STN)深部脑刺激(DBS)导联记录的临床试验的三个地点招募了 15 名 PD 受试者(NCT04620551)。共分析了 45 个晚上的视频多导睡眠图(vPSG)数据。四名经验丰富的评分者在初次审查时独立评分数据。少于 75%一致性的时段被标记为二次审查。在对不一致时段的二次审查中,两名原始评分者重新评估了时段,最终的共识阶段由此得出。
初始评分(IS)时,所有睡眠阶段的睡眠分期分类一致性平均为 83.10%,而在二次共识评分(CS)审查时,一致性达到 96.58%。在确定清醒时段(33.6%的不一致时段)和非快速眼动睡眠阶段 2(N2)时段(31.8%的不一致时段)时,分歧最大。通过直接测量皮质频率和幅度、时段的生理背景和视频审查解决了评分差异。
我们的多级初始和二次共识审查评分方法得出的共识评分一致性优于传统标准。这项工作采用了定制的 vPSG 软件和审查平台,用于在多站点临床试验中整合共识睡眠分期。