Silverberg Jonathan I, Rodriguez Danielle N, Dias-Barbosa Carla, Filipenko Dina, Ulianov Liliana, Piketty Christophe, Puelles Jorge
George Washington University School of Medicine and Health Sciences, Suite 2B-425, 2150 Pennsylvania Avenue NW, Washington, DC, 20037, USA.
Evidera, Seattle, WA, USA.
Dermatol Ther (Heidelb). 2025 Apr;15(4):963-995. doi: 10.1007/s13555-025-01385-3. Epub 2025 Mar 21.
A subject sleep diary (SSD) capturing 14 sleep parameters was developed to assess daily fluctuations in atopic dermatitis (AD)-associated sleep disturbance. This study aimed to evaluate the psychometric properties of the SSD using data including all randomized patients from the phase 3 ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) trials of nemolizumab in adults and adolescents (age ≥ 12 years) with moderate-to-severe AD.
Reliability, validity, and responsiveness of the SSD were evaluated, and its relationship with the single-item Sleep Disturbance Numerical Rating Scale (SD NRS) was examined using the equipercentile linking method.
In ARCADIA 1 (N = 941), most SSD parameters showed good test-retest reliability (intraclass correlations ≥ 0.70) in patients with stable scores over 1 week on sleep disturbance or itch measures. The SSD parameters of wakefulness after sleep onset (WASO), total awake time (TWT), sleep efficiency (SE), number of times (NWASO-AD) and duration (WASO-AD) of AD-related WASO, and sleep quality/refresh (SQR) showed moderate or strong correlations (r = 0.30-0.66) at baseline, in the expected direction; with the SD NRS and at least one of the measures assessing itch and skin disease-related quality of life (Pruritus Categorical Scale, Peak Pruritus NRS, Average Pruritus NRS, and Dermatology Life Quality Index). Correlations with measures assessing distal concepts were weak for most sleep parameters. Sleep onset latency (SOL), WASO, TWT, SE, NWASO-AD, WASO-AD, and SQR demonstrated good known-groups validity at baseline and week 16, and showed responsiveness based on most anchors used in the analysis. Values of the same percentile rankings for the SD NRS and each SSD parameter were identified. Comparable results were obtained using ARCADIA 2 data (N = 787).
The results provided evidence that the SSD, particularly its SOL, WASO, TWASO, TWT, SE, NWASO-AD, WASO-AD, and SQR parameters, is reliable and valid to measure multidimensional concepts of sleep disturbance in clinical studies.
NCT03985943, NCT03989349.
开发了一种记录14项睡眠参数的受试者睡眠日记（SSD），以评估特应性皮炎（AD）相关睡眠障碍的每日波动情况。本研究旨在利用来自成人和青少年（年龄≥12岁）中重度AD的那莫利单抗3期ARCADIA 1（NCT03985943）和ARCADIA 2（NCT03989349）试验的所有随机分组患者的数据，评估SSD的心理测量特性。
评估了SSD的信度、效度和反应度，并使用等百分位链接法检验了其与单项睡眠障碍数字评定量表（SD NRS）的关系。
在ARCADIA 1（N = 941）中，对于睡眠障碍或瘙痒测量指标在1周内得分稳定的患者，大多数SSD参数显示出良好的重测信度（组内相关系数≥0.70）。睡眠起始后觉醒时间（WASO）、总觉醒时间（TWT）、睡眠效率（SE）、AD相关WASO的次数（NWASO-AD）和持续时间（WASO-AD）以及睡眠质量/恢复程度（SQR）等SSD参数在基线时呈中度或强相关性（r = 0.30 - 0.66），且方向符合预期；与SD NRS以及评估瘙痒和皮肤病相关生活质量的至少一项指标（瘙痒分类量表、瘙痒峰值NRS、瘙痒平均NRS和皮肤病生活质量指数）相关。大多数睡眠参数与评估远端概念的指标相关性较弱。睡眠起始潜伏期（SOL）、WASO、TWT、SE、NWASO-AD、WASO-AD和SQR在基线和第16周显示出良好的已知组效度，并基于分析中使用的大多数锚定指标表现出反应度。确定了SD NRS和每个SSD参数相同百分位排名的值。使用ARCADIA 2数据（N = 787）获得了可比结果。
结果表明，SSD，尤其是其SOL、WASO、TWASO、TWT、SE、NWASO-AD、WASO-AD和SQR参数，在临床研究中测量睡眠障碍的多维概念是可靠且有效的。
NCT03985943，NCT03989349。
