Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2025
A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03533114 (A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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 Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Who cites it
1 citing paper in PubMed.
- Idiopathic hypersomnia is a 24-hour disorder.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesMeasurement 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.
methodsData 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.
resultsOf 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;
conclusionsEstablishing 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 registrationRegistry: 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.
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