Biobehavioral and Health Sciences Division, School of Nursing, Center for Sleep and Respiratory Neurobiology, University of Pennsylvania, Philadelphia, PA 19104-6096, USA.
J Clin Sleep Med. 2009 Dec 15;5(6):499-505.
The objective of this secondary analysis was to examine the effects of modafinil on the Functional Outcomes of Sleep Questionnaire (FOSQ) in patients with obstructive sleep apnea and residual excessive sleepiness with continuous positive airway pressure (CPAP) use. We also explored the association of improvement of functional status with the presenting level of subjective sleepiness.
Data were pooled from 2 randomized placebo-controlled studies (4-week and 12-week interventions) of modafinil in patients with residual sleepiness (Epworth Sleepiness Scale score > or =10 on CPAP).
The analysis included 480 patients (FOSQ efficacy data n=442 patients), 292 in the modafinil group and 188 in the placebo group. The mean age (SD) of the analyzed sample was 49.7 (9.2) years; 76% were men. Following administration with modafinil, there were greater improvements from baseline in the Total score (p < 0.0001) as well as 4 of the 5 domains (p < 0.05), compared with placebo. A greater proportion of patients who received modafinil were considered responders, compared with patients who received placebo (45% vs. 25%; p < 0.001). Responder analysis based on the individual FOSQ domain items demonstrated that 18 of the 30 FOSQ items increased by at least 1 point for significantly more patients who received modafinil (p < 0.05). Improvements in functional status were not found to depend on patients' degree of subjective sleepiness at baseline.
In this secondary analysis of data from patients with OSA and excessive sleepiness despite CPAP use, modafinil was associated with improvements in patients' functional outcomes and their ability to engage in a broad array of everyday activities.
本二次分析旨在研究莫达非尼对使用持续气道正压通气（CPAP）治疗后仍存在阻塞性睡眠呼吸暂停和过度嗜睡的患者的睡眠功能问卷（FOSQ）的影响。我们还探讨了功能状态改善与主观嗜睡程度之间的关联。
数据来自 2 项莫达非尼治疗残余嗜睡（CPAP 时 Epworth 嗜睡量表评分≥10）患者的随机安慰剂对照研究（4 周和 12 周干预）。
该分析纳入了 480 例患者（FOSQ 疗效数据 n=442 例），莫达非尼组 292 例，安慰剂组 188 例。分析样本的平均年龄（SD）为 49.7（9.2）岁，76%为男性。与安慰剂相比，莫达非尼组治疗后总评分（p＜0.0001）和 5 个领域中的 4 个领域（p＜0.05）均有显著改善。与安慰剂组相比，接受莫达非尼治疗的患者中有更多的患者被认为是应答者（45% vs. 25%；p＜0.001）。基于个体 FOSQ 领域项目的应答者分析表明，莫达非尼治疗的患者中，有 18 项 FOSQ 项目中的 30 项至少增加了 1 分，明显更多（p＜0.05）。在功能状态改善方面，并未发现与患者基线时的主观嗜睡程度有关。
在对使用 CPAP 治疗后仍存在阻塞性睡眠呼吸暂停和过度嗜睡的患者数据进行二次分析时，莫达非尼与患者功能结局的改善以及他们参与广泛日常活动的能力有关。
