Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Bogan Richard K, Fuller Douglas S, Whalen Marisa, Casstevens Cristina, Schneider Logan D
Аннотация
STUDY OBJECTIVES: Measurement tools for sleep inertia, a common and important idiopathic hypersomnia symptom, are limited. For individuals with idiopathic hypersomnia, this post hoc analysis proposes a minimal clinically important difference (MCID) for the Sleep Inertia Visual Analog Scale (SI-VAS), which assesses difficulty waking up.
METHODS: Data from the pivotal phase 3, double-blind, placebo-controlled, randomized withdrawal study (NCT03533114) of low-sodium oxybate in adults with idiopathic hypersomnia were used to estimate an SI-VAS MCID anchored to the Patient Global Impression of Change, Idiopathic Hypersomnia Severity Scale, and Functional Outcomes of Sleep Questionnaire.
RESULTS: Of 109 participants included, the majority female (69.7%) and White (81.7%), most were at least moderately ill (95%) per baseline Clinical Global Impression of Severity. SI-VAS score changes were strongly associated with Patient Global Impression of Change levels (Kruskal-Wallis test statistic, 110.2; P < .0001). Estimated mean (standard error) difference in SI-VAS scores between consecutive Patient Global Impression of Change levels was 10.9 (0.8) mm, suggesting an MCID estimate of 10-12 mm. SI-VAS was also highly correlated with Idiopathic Hypersomnia Severity Scale (Pearson r, 0.79; P < .0001) and Functional Outcomes of Sleep Questionnaire (Pearson r, -0.74; P < .0001). Mean (standard error) SI-VAS change per 4-unit Idiopathic Hypersomnia Severity Scale change (MCID) was 6.0 (0.3) mm and per 2-unit Functional Outcomes of Sleep Questionnaire change (cutpoint) was 8.5 (0.5) mm.
CONCLUSIONS: Establishing an MCID strengthens the SI-VAS value, adds context for findings related to sleep inertia in individuals with idiopathic hypersomnia from the phase 3 study, and aids clinicians in identifying clinically meaningful changes in sleep inertia to improve patient outcomes.
CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension; URL: https://www.clinicaltrials.gov/study/NCT03533114; Identifier: NCT03533114.
CITATION: Bogan RK, Fuller DS, Whalen M, Casstevens C, Schneider LD. A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia. J Clin Sleep Med. 2025;21(7):1209-1216.
METHODS: Data from the pivotal phase 3, double-blind, placebo-controlled, randomized withdrawal study (NCT03533114) of low-sodium oxybate in adults with idiopathic hypersomnia were used to estimate an SI-VAS MCID anchored to the Patient Global Impression of Change, Idiopathic Hypersomnia Severity Scale, and Functional Outcomes of Sleep Questionnaire.
RESULTS: Of 109 participants included, the majority female (69.7%) and White (81.7%), most were at least moderately ill (95%) per baseline Clinical Global Impression of Severity. SI-VAS score changes were strongly associated with Patient Global Impression of Change levels (Kruskal-Wallis test statistic, 110.2; P < .0001). Estimated mean (standard error) difference in SI-VAS scores between consecutive Patient Global Impression of Change levels was 10.9 (0.8) mm, suggesting an MCID estimate of 10-12 mm. SI-VAS was also highly correlated with Idiopathic Hypersomnia Severity Scale (Pearson r, 0.79; P < .0001) and Functional Outcomes of Sleep Questionnaire (Pearson r, -0.74; P < .0001). Mean (standard error) SI-VAS change per 4-unit Idiopathic Hypersomnia Severity Scale change (MCID) was 6.0 (0.3) mm and per 2-unit Functional Outcomes of Sleep Questionnaire change (cutpoint) was 8.5 (0.5) mm.
CONCLUSIONS: Establishing an MCID strengthens the SI-VAS value, adds context for findings related to sleep inertia in individuals with idiopathic hypersomnia from the phase 3 study, and aids clinicians in identifying clinically meaningful changes in sleep inertia to improve patient outcomes.
CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension; URL: https://www.clinicaltrials.gov/study/NCT03533114; Identifier: NCT03533114.
CITATION: Bogan RK, Fuller DS, Whalen M, Casstevens C, Schneider LD. A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia. J Clin Sleep Med. 2025;21(7):1209-1216.