Boice Matthew, Bryant Svetlana, Klein Matthew, Meyer Martine, Bangerter Abi, Vairavan Srinivasan, Pandina Gahan
Neuroscience, Janssen Research and Development, Titusville, NJ, United States.
Department of Psychology, Barker Lab, Rutgers, The State University of New Jersey, Piscataway, NJ, United States.
Front Psychiatry. 2025 May 23;16:1570611. doi: 10.3389/fpsyt.2025.1570611. eCollection 2025.
The use of actigraphy as a continuous experimental measure of clinical change was explored through a comparison of two clinical studies in autism spectrum disorder (ASD). The data quality, implementation ease, wear compliance, and clinical outcome correlation of actigraphy as a measure were assessed.
Two clinical studies were conducted and used as a basis of comparison: (1) AUT2001, a Phase 2A interventional study in ASD (N=63), and (2) AUT0002, a Phase 0 non-interventional study in typically-developing (TD) participants (N=53). Participants in both studies wore a wrist-based actigraph throughout enrollment. Actigraphy features were identified based on potential clinical relevance and calculated as weekly averages for each participant's study timepoints. Expert review was used to confirm validity of automated sleep/wake period detection. Feature differences were then assessed using tests/ANCOVA. Spearman rank correlations between actigraphy features and caregiver reported outcome measures were also examined.
Results from both clinical studies were combined during analysis. Actigraphy was shown to be feasible as a measure of longitudinal change in ASD, but with notable challenges in adherence: participant exclusions due to poor wear compliance substantially reduced the size of the final dataset. Despite this limitation, several findings were noted. Significant differences in sleep disturbance were observed at baseline between the ASD and TD populations as measured by physical activity occurring within the defined sleep period. No significant between-group differences were noted in changes from baseline to endpoint in key sleep variables. Caregiver reported sleep quality significantly correlated with actigraphy measures of sleep disturbance. Additional significant correlations were observed between caregiver reported outcomes of self-regulation and actigraphy features measuring daytime physical activity. Finally, potentially relevant correlations with anxiety, social responsiveness, and restricted and repetitive behaviors are reported.
The observed correlations suggest there may be alignment between some generalized features of actigraphy and core and associated domains of ASD. The clinical utility of actigraphy as a biomarker of clinically relevant outcomes in ASD requires further study. Actigraphy may provide supportive evidence of treatment outcome, providing clinical context, or as a objective behavioral measure (e.g., of sleep or activity level) when combined with more traditional clinical outcome measures.
通过比较两项针对自闭症谱系障碍（ASD）的临床研究，探讨使用活动记录仪作为临床变化的连续实验测量方法。评估了活动记录仪作为一种测量方法的数据质量、实施便利性、佩戴依从性以及与临床结果的相关性。
进行了两项临床研究并将其作为比较基础：（1）AUT2001，一项针对ASD的2A期干预性研究（N = 63）；（2）AUT0002，一项针对典型发育（TD）参与者的0期非干预性研究（N = 53）。两项研究的参与者在整个入组期间都佩戴基于手腕的活动记录仪。根据潜在的临床相关性确定活动记录仪特征，并计算为每个参与者研究时间点的每周平均值。采用专家评审来确认自动睡眠/清醒时段检测的有效性。然后使用检验/协方差分析评估特征差异。还检查了活动记录仪特征与照顾者报告的结果测量之间的Spearman等级相关性。
在分析过程中将两项临床研究的结果合并。活动记录仪被证明作为ASD纵向变化的一种测量方法是可行的，但在依从性方面存在显著挑战：由于佩戴依从性差导致参与者被排除，大大减少了最终数据集的规模。尽管有此限制，但仍有一些发现。通过在定义的睡眠时段内发生的身体活动测量，在基线时观察到ASD和TD人群之间睡眠障碍存在显著差异。在关键睡眠变量从基线到终点的变化方面，未观察到组间显著差异。照顾者报告的睡眠质量与活动记录仪测量的睡眠障碍显著相关。在照顾者报告的自我调节结果与测量白天身体活动的活动记录仪特征之间还观察到其他显著相关性。最后，报告了与焦虑、社交反应性以及受限和重复行为的潜在相关关系。
观察到的相关性表明，活动记录仪的一些一般特征与ASD的核心及相关领域之间可能存在一致性。活动记录仪作为ASD临床相关结果生物标志物的临床效用需要进一步研究。当与更传统的临床结果测量相结合时，活动记录仪可能为治疗结果提供支持性证据、提供临床背景或作为一种客观行为测量方法（例如睡眠或活动水平）。
