CLINICAL TRIAL/MELATONIN AS HYPNOTIC FOR NEUROLAB CREW

描述：（改编自申请人摘要）睡眠中断是 在太空飞行中很常见。对来自9架航天飞机的58名机组人员的调查 调查显示，大多数人都患有睡眠中断， 飞行期间每天睡眠时间不超过6小时， 每天在地面上。19%的船员单身 轮班任务和50%的机组人员在两班制 运营商报告在其运营期间使用安眠药（苯二氮卓类） 任务。虽然苯二氮卓类药物作为催眠药是有效的，但它们的 不利的次日副作用包括镇静，性能下降， 健忘症和睡眠脑电图的扭曲。 我们的初步数据表明，松果体激素褪黑激素， 据报道可以调节人类昼夜节律起搏器的输出， 也可能有急性催眠性质需要治疗 睡眠中断的航天飞行，而不会产生不利的一面 与苯二氮卓类药物相关的影响。申请人假设 睡前服用褪黑激素会降低 睡眠延迟，减少夜间睡眠中断，改善睡眠 效率和增强的第二天警觉性和认知表现 无论是在地面模拟还是在神经实验室的使命中。 建议进行双盲安慰剂对照试验，其中：（1） 褪黑激素作为催眠药的有效性是独立于其 对内源性昼夜节律起搏器相位的影响， 基于研究，使用一个强大的实验模型， （2）褪黑激素作为催眠药的有效性是 在神经实验室的使命中进行了评估在这两个实验中， 褪黑激素对睡眠阶段和脑电图频谱组成的影响 睡眠将被确定，以及它对白天警觉性的影响， 性能 这项拟议中的研究可能对睡眠和睡眠质量都有重要意义。 疾病医学和航空航天医学。建议的结果 研究可能会导致开发一种新的治疗方案， 睡眠障碍的各种病因在太空飞行，这可能 使机组成员避免警觉性和性能的下降， 与睡眠剥夺有关。因此，这项工作可以有一个 对健康、生产力和安全的深远影响， 宇航员在太空飞行期间，而且其他群体的高 失眠的患病者，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.