莫达非尼改善未使用标准治疗的轻至中度阻塞性睡眠呼吸暂停患者的日间嗜睡：一项随机安慰剂对照交叉试验。
Modafinil improves daytime sleepiness in patients with mild to moderate obstructive sleep apnoea not using standard treatments: a randomised placebo-controlled crossover trial.
机构信息
The NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS), The University of Sydney, , Sydney, New South Wales, Australia.
出版信息
Thorax. 2014 Mar;69(3):274-9. doi: 10.1136/thoraxjnl-2013-203796. Epub 2013 Nov 28.
INTRODUCTION
Patients with mild to moderate obstructive sleep apnoea (OSA) commonly suffer excessive daytime sleepiness. Continuous positive airway pressure (CPAP) has limited effectiveness in reducing sleepiness in milder OSA. Modafinil is a wake-promoting drug licensed to treat residual sleepiness in CPAP-treated OSA. We hypothesised that modafinil may effectively treat sleepiness in untreated mild to moderate OSA.
METHODS
Untreated sleepy men with mild to moderate OSA (age 18-70, apnoea-hypopnoea index (AHI) 5-30/h, Epworth Sleepiness Scale (ESS) ≥10) were randomised to receive 200 mg modafinil or matching placebo daily for 2 weeks before crossing over to the alternative treatment after a minimum 2-week washout. Mixed model analysis of variance was used to compare the changes on modafinil to placebo while classifying all randomised patients as random factors.
RESULTS
32 patients were randomised (mean (SD) AHI 13 (6.4)/h, age 47 (10.7) years, ESS 13.6 (3.3), body mass index 28.2 (3.6) kg/m(2)), 29 of whom (91%) completed the trial. The primary outcome (ESS) improved more on modafinil than placebo (3.6 points, 95% CI 1.3 to 5.8, p=0.003) and the secondary outcome (40-min driving simulator performance) also improved more on modafinil than placebo (steering deviation 4.7 cm, 95% CI 0.8 to 8.5, p=0.018). Psychomotor Vigilance Task reciprocal reaction time improved significantly over placebo (0.15 (1/ms), 95% CI 0.03 to 0.27, p=0.016). Improvements on the Functional Outcomes of Sleep Questionnaire were not significant (5.3 points over placebo, 95% CI -1 to 11.6, p=0.093).
CONCLUSIONS
Modafinil significantly improved subjective sleepiness in patients with untreated mild to moderate OSA. The size of this effect is clinically relevant at 3-4 ESS points of improvement compared with only 1-2 points in CPAP clinical trials. Driving simulator performance and reaction time also improved on modafinil.
CLINICAL TRIAL REGISTRATION
ACTRN#12608000128392.
简介
患有轻度至中度阻塞性睡眠呼吸暂停（OSA）的患者通常会经历过度的日间嗜睡。持续气道正压通气（CPAP）在减轻轻度 OSA 患者的嗜睡方面效果有限。莫达非尼是一种促醒药物，被批准用于治疗 CPAP 治疗后的 OSA 患者的残余嗜睡。我们假设莫达非尼可能有效治疗未经治疗的轻度至中度 OSA 患者的嗜睡。
方法
未接受治疗的、有轻度至中度 OSA（年龄 18-70 岁，呼吸暂停-低通气指数（AHI）5-30/小时，Epworth 嗜睡量表（ESS）≥10）的男性嗜睡患者被随机分配接受莫达非尼 200mg 或匹配的安慰剂，每日一次，持续 2 周，然后在最低 2 周洗脱期后交叉接受替代治疗。混合模型方差分析用于比较莫达非尼与安慰剂的变化，同时将所有随机患者分类为随机因素。
结果
32 名患者（平均（SD）AHI 13（6.4）/小时，年龄 47（10.7）岁，ESS 13.6（3.3），体重指数 28.2（3.6）kg/m2），其中 29 名（91%）完成了试验。主要结局（ESS）在莫达非尼治疗后比安慰剂改善更多（3.6 分，95%CI 1.3 至 5.8，p=0.003），次要结局（40 分钟驾驶模拟器性能）在莫达非尼治疗后也比安慰剂改善更多（转向偏差 4.7cm，95%CI 0.8 至 8.5，p=0.018）。精神运动警觉任务的反应时间较安慰剂显著改善（0.15（1/ms），95%CI 0.03 至 0.27，p=0.016）。睡眠问卷的功能结局改善不显著（比安慰剂改善 5.3 分，95%CI 1 至 11.6，p=0.093）。
结论
莫达非尼显著改善了未经治疗的轻度至中度 OSA 患者的主观嗜睡。与 CPAP 临床试验中仅改善 1-2 分相比，这种改善效果在 ESS 上改善 3-4 分具有临床意义。驾驶模拟器性能和反应时间也在莫达非尼治疗后改善。
临床试验注册
ACTRN#12608000128392。
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