ArticleDermatology and therapy2025
Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis.
Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
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7 authors.
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Abstract
introductionA 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.
methodsReliability, 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.
resultsIn 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).
conclusionsThe 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. CLINICAL
trial registrationNCT03985943, NCT03989349.
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