INSOMNIA IN ELDERLY--PASSIVE BODY HEATING VS ZOLPIDEM

描述(改编自《调查者摘要》)：此应用程序将 检查老年人的睡眠和睡眠障碍，寻求发展一种 改善老年人睡眠质量的替代方法。四十 患有睡眠维持性失眠的老年女性志愿者将参加 在一项为期10天/夜间的方案中，包括比较被动的影响 体温(PBH)和一种常用的催眠药(唑吡坦)， 体温，生长激素分泌，主观嗜睡，以及 性能。将收集基线活动和睡眠日记数据 在研究前十天评估在家睡眠并确认 失眠。受试者将被随机分配到四种治疗中的一种 条件：PBH/安慰剂、PBH/唑吡坦、PBH控制/安慰剂、PBH控制 唑吡坦。PBH干预将包括让受试者坐在 浴缸中装满40摄氏度(活动)或37摄氏度(对照)的水30分钟。 唑吡坦的剂量为5毫克。客观的睡眠衡量标准将是 使用标准睡眠评分标准进行量化。睡眠的变化 将测量效率和架构，以及 慢波睡眠将使用功率谱分析进行量化。 对睡眠的主观测量将使用睡眠后问卷进行 和可视模拟天平。核心体温和运动活动量将 使用动态监测系统连续记录。生长激素 将在一个基线和一个治疗之夜每30分钟采样一次 并使用标准程序进行检测。记忆力、反应时间的测量 白天会保持警惕。PBH技术可以实现 与唑吡坦对睡眠的有益影响相同，但存在以下风险 与催眠药物有关的副作用。调查人员打算 确定PBH手术是否将是一种有用的非药理学方法 治疗老年人失眠的方法。

DESCRIPTION (Adapted from Investigator's Abstract): This application will examine sleep and sleep disturbance in the elderly, seeking to develop an alternative method for improving sleep quality in the elderly. Forty elderly female volunteers with sleep maintenance insomnia will participate in a 10-day/night protocol involving a comparison of the effects of Passive Body Heating (PBH) and a commonly used hypnotic (zolpidem) on sleep, temperature, growth hormone secretion, subjective sleepiness, and performance. Baseline actigraphic and sleep diary data will be collected for ten days prior to the study to evaluate sleep at home and to confirm insomnia. Subjects will be randomly assigned to one of four treatment conditions: PBH/placebo, PBH/zolpidem, PBH control/placebo, PBH control zolpidem. The PBH intervention will involve having the subjects sit in a tub filled with 40 C (active) or 37 C (control) water for 30 minutes. Zolpidem will be administered at 5mg. Objective measures of sleep will be quantified using standard sleep scoring criteria. Changes in sleep efficiency and architecture will be measured and amplitude and density of slow wave sleep will be quantified using power spectral analysis. Subjective measures of sleep will be taken using a post-sleep questionnaire and a visual analog scale. Core body temperature and motor activity will be recorded continuously using ambulatory monitoring systems. Growth hormone will be sampled every 30 minutes during one baseline and one treatment night and assayed using standard procedures. Measures of memory, reaction time and vigilance will be made during the day. The PBH technique may achieve the same beneficial effects on sleep as zolpidem, with the risk of side-effects associated with hypnotic medication. The investigators intend to determine whether the PBH procedure will be a useful non-pharmacologic method for treating insomnia in the elderly.