MANAGEMENT OF EXCESSIVE DAYTIME SLEEPINESS IN NARCOLEPSY

发作性睡病患者白天过度嗜睡的治疗

• 批准号: 2655412
• 负责人: ANN E ROGERS
• 金额: $ 35.24万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-10 至 1998-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2655412
• 关键词: REM sleep; adult human (21+); cataplexy; central nervous system stimulants; clinical research; human subject; human therapy evaluation; longitudinal human study; narcolepsy; nervous system disorder chemotherapy; nursing research; outcomes research; polysomnography; questionnaires; sleep disorders; therapy compliance

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.

描述：（改编自研究者摘要）许多 嗜睡症的心理和经济后果可以直接 归因于睡眠发作和白天过度嗜睡。 无法控制的白天睡眠使驾驶困难， 危险，影响个人继续接受教育的能力， 追求事业，经常干扰人际关系。 虽然治疗嗜睡症可以显着改善症状，在一些 患者中，多达三分之一的嗜睡症患者很少或根本没有 受益于目前的治疗。 研究表明， 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控制， 兴奋剂药物，他们不满意的治疗 需要白天小睡和/或药物假期的制度。 差异 应答者和非应答者，这些差异的基础是 未知 此外，识别那些不太可能 对刺激性药物的反应，将使临床医生更集中精力 努力改善这些患者的治疗方案。 的 识别可靠、对治疗敏感的仪器 效果，易于管理，将具有很大的价值，评估 患者对治疗的反应。 因此，本建议的目的 多中心研究的目的是：1）开发响应的患者的概况 刺激性药物和那些没有反应的人; 2）评估两个 简要问卷（发作性睡病症状状态问卷和埃普沃思 嗜睡量表），看看它们是否可用于评估治疗效果， 临床环境。 两组发作性睡病受试者（135名建立了 患者和85名新诊断患者）将从5名 认可的睡眠障碍中心。 对以下问题作出反应的受试者的概况 刺激性药物和那些谁不将开发从 人口统计学数据、症状严重程度指标和24小时门诊 在受试者的通常环境中进行的多导睡眠图记录。 还将评估兴奋剂药物的依从性。 为了 评估NSSQ和ESS是否对治疗效果敏感， 新诊断的受试者将在开始使用兴奋剂之前进行测试 治疗3个月后和治疗1年后。