INSOMNIA IN ELDERLY--PASSIVE BODY HEATING VS ZOLPIDEM

老年人失眠——被动发热VS唑吡坦

• 批准号: 2517058
• 负责人: CYNTHIA M DORSEY
• 金额: $ 9.81万
• 依托单位: MCLEAN HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-01 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2517058
• 关键词: body temperature; circadian rhythms; clinical research; drug administration rate /duration; drug adverse effect; drug screening /evaluation; electrocardiography; electroencephalography; electromyography; electrophysiology; female; heat; human old age (65+); human subject; human therapy evaluation; memory; patient monitoring device; performance; questionnaires; respiratory airflow measurement; sedative /hypnotic; sleep disorders; somatotropin; statistics /biometry; wakefulness

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.

描述（改编自研究者摘要）：本申请将 研究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10天/夜的方案中， 身体加热（PBH）和常用的催眠药（唑吡坦）对睡眠， 体温、生长激素分泌、主观嗜睡，以及 性能 将收集基线活动记录和睡眠日记数据 在研究前10天，以评估在家的睡眠，并确认 失眠 受试者将被随机分配至四种治疗之一 条件：PBH/安慰剂、PBH/唑吡坦、PBH对照/安慰剂、PBH对照 唑吡坦。 PBH干预将涉及让受试者坐在一个 在装有40 ℃（活性）或37 ℃（对照）水的桶中浸泡30分钟。 唑吡坦将以5 mg剂量给药。 睡眠的客观衡量标准将是 使用标准睡眠评分标准进行量化。 睡眠的变化 效率和架构将被测量， 将使用功率谱分析来量化慢波睡眠。 将使用睡眠后问卷对睡眠进行主观测量 和视觉模拟量表。 核心体温和运动活动将 使用流动监测系统连续记录。 生长激素 将在一个基线和一个治疗夜期间每30分钟采样一次 并使用标准方法测定。 记忆力反应时间 白天要保持警惕 PBH技术可以实现 与唑吡坦对睡眠有相同的有益作用， 催眠药的副作用 调查人员打算 以确定PBH手术是否是一种有用的非药物治疗方法， 一种治疗老年人失眠的方法。