MANAGEMENT OF EXCESSIVE DAYTIME SLEEPINESS IN NARCOLEPSY

描述：(改编自调查人员摘要)许多 发作性睡病的心理和经济后果可以直接 归因于睡眠发作和白天过度困倦。 白天失控的睡眠会使驾驶变得困难或 危险，影响个人继续教育的能力和 追求事业，经常干扰人际关系。 尽管发作性睡病的治疗可以显著改善某些患者的症状 发作性睡病患者中，多达三分之一的患者几乎没有得到任何帮助。 受益于当前的治疗方法。研究表明，广泛的 对目前的药物治疗不满意；一些患者报告 用药不足，他们的症状没有得到充分的控制 刺激性药物，他们对治疗不满意 要求白天小睡和/或毒品假期的政权。两者之间的差异 应答者和非应答者以及这些差异的基础是 未知。此外，识别不太可能发生癌症的患者 对刺激性药物的反应，将使临床医生更专注 努力改善这些患者的治疗制度。这个 鉴定对治疗敏感、可靠的器械 效果，且易于管理，对于评估将具有很大价值 患者对治疗的反应。因此，这项提议的目的是 多中心研究的目的是：1)建立有反应的患者的档案 刺激性药物和那些没有反应的药物；以及2)评估两种 简明问卷(发作性睡病症状状况问卷和Epworth 嗜睡量表)，看看它们是否可以用来评估治疗效果 一种临床环境。两组发作性睡病受试者(135例确诊 患者和85名新诊断的患者)将从5名 经认可的睡眠障碍中心。回答以下问题的受试者简介 兴奋剂药物和那些不起作用的药物将从 人口统计数据、症状严重程度测量和24小时不间断检查 在受试者的日常环境中进行的多导睡眠监测记录。 对兴奋剂药物的依从性也将进行评估。为了 评估NSSQ和ESS对治疗效果是否敏感， 新诊断的受试者将在开始服用兴奋剂之前进行测试 治疗3个月后和治疗1年后进行药物治疗。

DESCRIPTION: (Adapted from investigator's abstract) Many of the psychological and economic consequences of narcolepsy can be directly attributed to sleep attacks and excessive daytime sleepiness. Uncontrollable episodes of daytime sleep make driving difficult or hazardous, affect the individual's ability to continue an education and pursue a career, and often interfere with interpersonal relationships. Although treatment of narcolepsy can improve symptoms dramatically in some patients, up to a third of patients with narcolepsy obtain little or no benefit from current therapies. Studies have shown widespread dissatisfaction with current pharmacologic treatments; some patients report being undermedicated, that their symptoms are not adequately controlled with stimulant medications, and that they are not satisfied by with treatment regimes that require daytime naps and/or drug holidays. Differences between responders and non-responders and the bases for those differences are unknown. In addition, the identification of patients who are less likely to respond to stimulant medications, will allow clinicians to concentrate more efforts on improving treatment regimes for these patients. The identification of an instrument that is reliable, sensitive to treatment effects, and easy to administer would be of great value for assessing patient's responses to treatment. Thus, the aims of this proposed multicenter study are to: 1) Develop profiles of those patients who respond to stimulant medications and those who do not respond; and 2) evaluate two brief questionnaires (Narcolepsy Symptom Status Questionnaire and Epworth Sleepiness Scale) to see if they can be used to assess treatment efficacy in a clinical setting. Two groups of narcoleptic subjects (135 established patients and 85 newly diagnosed patients) will be recruited from 5 accredited sleep disorders centers. A profile of subjects who respond to stimulant medications and those who do not will be developed from demographic data, symptom severity measures, and 24-hr ambulatory polysomnographic recordings made in the subject's usual environment. Compliance with stimulant medications will also be evaluated. In order to evaluate whether or not the NSSQ and ESS are sensitive to treatment effects, newly diagnosed subjects will be tested prior to starting stimulant medications, after 3 months of treatment and after one year of treatment.