Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Neurocognitive function
研究概览
简要总结
Low oxygen at altitude causes pauses in breathing during sleep, called central sleep apnea. Central sleep apnea causes repeated awakenings and poor sleep. Low oxygen itself and the induced oxidative stress can damage mental function which is likely worsened by poor sleep. Reduced mental function due to low oxygen can pose a serious danger to mountain climbers. However there is also mounting evidence that even in populations of people that live at high altitudes and are considered adapted, low oxygen contributes to reductions in learning and memory. Therefore there is a serious need for treatments which may improve sleep, control of breathing and mental function during low oxygen. Melatonin is a hormone produced in the brain during the night which regulates sleep patterns with strong antioxidant and anti-inflammatory properties. A study previously reported that melatonin taken 90 mins before bed at 4,300 m (14,200 ft) induced sleep earlier, reduced awakenings and improved mental performance the following day. However how melatonin caused these effects was not determined. Therefore this study aims to determine how melatonin effects control of breathing, sleep and mental performance during exposure to low oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Sleep disorders
- •Pregnant females
- •Smokers (quit ≥ 1 year ago acceptable)
- •Any known cardiac (apart from treated hypertension with acceptable drugs, see below), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, hepatic disease, or patients with diabetes.
- •Prior or current use of melatonin.
- •Use of any medications that may affect sleep or breathing, blood-thinning medications (anticoagulants), antioxidants, anti-inflammatories, medications that suppress the immune system (immunosuppressants), diabetes medications and birth control pills.
- •A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- •Substantial alcohol (>3oz/day) or use of illicit drugs.
- •Previous occurrence of high altitude pulmonary or cerebral edema.
- •Recent exposure to altitude (>8000ft) in the last month or having slept at an altitude >6000ft in the last month.
- •Inability to provide written informed consent or able to complete the experiment.
- •Non-English speakers (necessary to complete neurocognitive testing).
- •More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
研究组 & 干预措施
Hypoxia with Melatonin
Sleep in hypoxic tent after taking 5 mg Melatonin before bed.
干预措施: Melatonin (Dietary Supplement)
Hypoxia with Placebo
Sleep in hypoxic tent after taking Placebo 1 hour before bed.
干预措施: Hypoxia (Other)
Normoxia
Sleep in normal room air with no drug
结局指标
主要结局
Neurocognitive function
时间窗: 30 minutes after arousal from sleep
Stroop-color word test median number of errors. Higher numbers indicate worse performance.
Endothelial function
时间窗: 5 minutes after arousal from sleep
Reactive hypermedia index via EndoPat
Lipid peroxidation in serum
时间窗: immediately after arousal from sleep
Concentration of Malondialdehyde in serum samples
Hypercapnic hypoxic ventilatory sensitivity
时间窗: 1 hour after arousal from sleep
This is the one outcome. It is the gain of the ventilatory response to changes in CO2, during sustained hypoxia. Delta minute ventilation / delta mmHg CO2 during sustained hypoxia
次要结局
未报告次要终点
研究者
Naomi Deacon
Research Scholar
University of California, San Diego