CLINICAL TRIAL/MELATONIN AS HYPNOTIC FOR NEUROLAB CREW

描述：(改编自申请者摘要)睡眠障碍是 在航天飞行中很常见。对9架航天飞机58名机组人员的调查 任务显示，大多数人都受到睡眠障碍的困扰， 每天的睡眠时间不能超过6小时，相比之下，每天的睡眠时间为7.9小时 每天在地面上工作几个小时。19%的船员单身 轮班任务和50%的双班船员 手术报告使用安眠药(苯二氮卓类) 任务。虽然苯二氮卓类药物是有效的催眠药，但他们的 第二天的副作用包括镇静，表现减退， 睡眠脑电中的健忘症和扭曲。 我们的初步数据表明松果体激素褪黑素，它有 据报道可以调节人体昼夜节律起搏器的输出， 也可能具有急性催眠特性，用于治疗 航天睡眠中断，不产生不良副作用 与苯二氮类药物相关的影响。申请者的假设 睡前服用褪黑激素会导致 睡眠延迟，减少夜间睡眠干扰，改善睡眠 效率和增强的第二天警觉性和认知表现 无论是在地面模拟中还是在神经实验室任务中。 建议进行双盲安慰剂对照试验：(1) 褪黑素作为催眠药的有效性是独立于其 对地面内源性昼夜节律起搏器时相的影响 基于研究，使用了一个强大的睡眠障碍的实验模型 以及(2)褪黑素作为催眠剂的有效性 在神经实验室任务期间进行了评估。在这两个实验中， 褪黑素对睡眠分期和脑电频谱组成的影响 将确定睡眠及其对白天警觉性和 性能。 这项拟议的研究可能会对这两种睡眠产生重大影响 疾病医学和航空航天医学。建议的研究结果 研究可能导致开发一种新的治疗方案 航天期间各种原因引起的睡眠障碍，这可能 使船员避免警觉性和表现的降低 与睡眠不足有关。因此，这项工作可能会有一个 对健康、生产力和安全产生深远影响的不仅是 航天员在太空飞行时，也对其他群体有很高的 失眠的流行，如倒班工人和老年人。

DESCRIPTION: (Adapted from applicant's abstract) Sleep disruption is common during spaceflight. A survey of 58 crew members from 9 shuttle missions revealed that most suffered from sleep disruption and were unable to sleep more than six hours per day of flight as compared to 7.9 hours per day on the ground. Nineteen percent of crew members on single shift missions and 50 percent of the crew members in dual shift operations reported sleeping pill usage (benzodiazepines) during their missions. Although benzodiazepines are effective as hypnotics, their adverse next-day side effects include sedation, performance decrements, amnesia and distortions in the sleep EEG. Our preliminary data suggest that the pineal hormone melatonin, which has been reported to modulate the output of the human circadian pacemaker, may also have the acute hypnotic properties needed for treating the sleep disruption of spaceflight, without producing the adverse side effects associated with benzodiazepines. The applicants hypothesize that pre-sleep administration of melatonin will result in decreased sleep latency, reduced nocturnal sleep disruption, improved sleep efficiency and enhanced next-day alertness and cognitive performance both in ground-based simulations and during the Neurolab mission. Double-blind placebo-controlled trials are proposed in which: (1) the effectiveness of melatonin as a hypnotic is assessed independent of its effects on the phase of the endogenous circadian pacemaker in ground- based studies, using a powerful experimental model of the dyssomnia of spaceflight; and (2) the effectiveness of melatonin as a hypnotic is assessed during the Neurolab mission. In both experiments the effects of melatonin on sleep stages and spectral composition of the EEG during sleep will be determined as well as its effects on daytime alertness and performance. The proposed research could have significant implications for both sleep disorders medicine and aerospace medicine. The results of the proposed research could lead to the development of a new treatment regimen for sleep disturbances of various etiologies during spaceflight, which could enable crew members to avoid the decrements in alertness and performance associated with sleep deprivation. This work could therefore have a profound impact on the health, productivity and safety not only of astronauts during space flight, but also of other groups with a high prevalence of insomnia, such as shift workers and the elderly.