Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.
Department of Internal Medicine, Duke University School of Medicine, Durham, NC.
Sleep. 2017 Jan 1;40(1). doi: 10.1093/sleep/zsw020.
Nocturia, voids which disturb sleep, is the most common cause of awakenings and is associated with daytime sleepiness. Because the standard treatments for the most common causes of nocturia are relatively ineffective, many treated patients with nocturia are left with residual sleepiness. We carried out this pilot study to evaluate the potential of armodafinil to be an effective means of addressing the sleepiness that persists in many nocturia patients, despite their receiving standard therapy.
This was a double-blind, placebo-controlled, crossover study carried out in 28 patients with nocturia who were receiving standard clinical therapy for their nocturia and who had an Epworth Sleepiness Scale (ESS) score of at least 10. Subjects received 4 weeks of both armodafinil (150-250 mg) and placebo with order randomized.
Armodafinil led to statistically significant improvement in sleepiness compared to placebo as indicated by the ESS (the primary outcome; p < .002) as well as the Clinical Global Impression of Improvement in Sleepiness scale (key secondary outcome; p = .01). Armodafinil did not increase nocturic events or significantly increase adverse effects versus placebo.
This pilot study, the first double-blind, placebo-controlled trial assessing whether a wake-promoting therapy can improve residual daytime sleepiness in patients with treated nocturia, indicates the promise of armodafinil for addressing this residual sleepiness and provides impetus to carry out a large-scale study to definitively evaluate whether armodafinil is an effective therapy for the many patients with nocturia who experience daytime sleepiness that persists, despite their receiving standard therapy for this condition.
夜尿症（打断睡眠的排尿）是最常见的导致觉醒的原因，并与日间嗜睡有关。由于治疗夜尿症最常见病因的标准治疗方法相对无效，许多接受夜尿症治疗的患者仍存在残余的嗜睡。我们进行了这项初步研究，以评估阿莫达非尼作为治疗许多夜尿症患者持续嗜睡的有效方法的潜力，尽管他们接受了标准治疗。
这是一项双盲、安慰剂对照、交叉研究，纳入了 28 名接受标准临床治疗夜尿症且 Epworth 嗜睡量表（ESS）评分至少为 10 分的夜尿症患者。患者接受了 4 周的阿莫达非尼（150-250mg）和安慰剂治疗，随机分组。
与安慰剂相比，阿莫达非尼显著改善了患者的嗜睡，这一结果通过 ESS（主要结局；p<.002）以及临床嗜睡改善整体印象量表（关键次要结局；p=.01）得到证实。与安慰剂相比，阿莫达非尼并未增加夜间排尿次数或显著增加不良反应。
这项初步研究是第一项评估唤醒治疗是否能改善治疗后夜尿症患者残余日间嗜睡的双盲、安慰剂对照试验，表明阿莫达非尼在解决这种残余嗜睡方面具有潜力，并为开展大规模研究提供了动力，以明确评估阿莫达非尼是否是治疗许多经历持续性日间嗜睡的夜尿症患者的有效治疗方法，尽管他们接受了该疾病的标准治疗。
