Sodium Oxybate for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson Disease

作者：Fabian Büchele, Marc Hackius, Sebastian R. Schreglmann, Wolfgang Omlor, Esther Werth, Angelina Maric, Lukas Imbach, Stefan Hägele-Link, Daniel Waldvogel, Christian Rainer Baumann · 发表于：JAMA Neurology · 年份：2017 · DOI：10.1001/jamaneurol.2017.3171 · 被引用次数：100 · 研究领域：Sleep and Wakefulness Research、Parkinson's Disease Mechanisms and Treatments、Sleep and related disorders

Importance: Sleep-wake disorders are a common and debilitating nonmotor manifestation of Parkinson disease (PD), but treatment options are scarce. Objective: To determine whether nocturnal administration of sodium oxybate, a first-line treatment in narcolepsy, is effective and safe for excessive daytime sleepiness (EDS) and disturbed nighttime sleep in patients with PD. Design, Setting, and Participants: Randomized, double-blind, placebo-controlled, crossover phase 2a study carried out between January 9, 2015, and February 24, 2017. In a single-center study in the sleep laboratory at the University Hospital Zurich, Zurich, Switzerland, 18 patients with PD and EDS (Epworth Sleepiness Scale [ESS] score >10) were screened in the sleep laboratory. Five patients were excluded owing to the polysomnographic diagnosis of sleep apnea and 1 patient withdrew consent. Thus, 12 patients were randomized to a treatment sequence (sodium oxybate followed by placebo or placebo followed by sodium oxybate, ratio 1:1) and, after dropout of 1 patient owing to an unrelated adverse event during the washout period, 11 patients completed the study. Two patients developed obstructive sleep apnea during sodium oxybate treatment (1 was the dropout) and were excluded from the per-protocol analysis (n = 10) but included in the intention-to-treat analysis (n = 12). Interventions: Nocturnal sodium oxybate and placebo taken at bedtime and 2.5 to 4.0 hours later with an individually titrated dose between 3.0 a...