The Impact of Air Travel on Passenger Cognitive Functions
研究概览
地位
条件
研究类型
注册 (预期的)
阶段
- 阶段2
- 第三阶段
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Study participants (Volunteers) will be recruited through media, advertisements and announcements. Prior to the study, study participants will receive written and oral explanations of the study protocols, and written informed consent will be obtained from each study participant. All potential research participants will undergo medical and psychological selection. The components, stages of selection are almost the same as those of general professional selection: the first stage is professiography / psychogram, the second stage is psychodiagnostics, the third stage is assessment and forecasting, and the fourth stage is decision making. Selection will assess the ability of participants to perform complex sequential actions.
Inclusion criterion:
- Age from 22 to 30 years old;
- at least 15 years of education, including secondary education;
- understand and speak Russian (Due to the valid Russian-language questionnaire and methodology).
In addition, study participants will be asked not to limit their caffeine intake from their daily intake, but only water is allowed 4 hours before the neuropsychological testing. Participants in the study should not hmedical/medicallane in the last two weeks prior to the start of the study, nor should they consume alcohol during the study.
Exclusion criterion:
- A member taking melatonin (affects circadian rhythm);
- Participant with comorbidities that affect cognitive function and sleep (eg, stroke, TIA, concussion with loss of consciousness, hearing problems, chronic fatigue syndrome, depression, seasonal affective disorder, anorexia);
- A participant with another ongoing sleep disorder.
All participants must be free of a history of venous thrombosis, antithrombotic or anticoagulant medications and oral contraceptives and / or any other drugs that interfere with blood coagulation (i.e. warfarin, coumadin) for at least 2 months prior to study initiation, and sign a consent to refrain from taking medications that may affect coagulation, such as aspirin or non-steroidal anti-inflammatory drugs, within 3 days after the flight, unless there is a medical / medical need.
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学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：The study Group
|
Citicoline 500 mg (Vitaae®) per os
其他名称：
Cytochrome10 mg per os
其他名称：
Sodium Chloride (NaCl) 2.6 g. per os
Potassium Chloride 1.5 g per os
其他名称：
Sodium Citrate 2.90 g per os
其他名称：
Dextrose 13.5 g per os
其他名称：
Domperidone 1 tablet per os
其他名称：
3-4 capsules per os
其他名称：
Acetylsalicylic acid 150 mg per os
magnesium hydroxide 30 mg per os
1 capsule per os.
其他名称：
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有源比较器：Control group
Melatonin® 5 mg per os 2 hours before bedtime on the day of arrival for 3-4 days.
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Melatonin 5 mg per os.
其他名称：
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无干预：Explanatory group:
12 participants without any intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Urine Specific Gravity
大体时间：24 hours before the flight
|
Urine Specific Gravity test
|
24 hours before the flight
|
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SpO2 level
大体时间：24 hours before the flight
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Pulse oximetry
|
24 hours before the flight
|
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Ultrasound examination
大体时间：24 hours before the flight
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Ultrasound examination of the veins of the lower limbs
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24 hours before the flight
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The Liverpool Jet Lag questionnaire
大体时间：24 hours before the flight
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Changes from normal (0 to 5) while jetlag rating was recorded on a scale from 0 = insignificant jetlag to 10 = severe jetlag
|
24 hours before the flight
|
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Lake Louise Acute Mountain Sickness Assessment System
大体时间：24 hours before the flight
|
Mild acute mountain sicknessas 3-5 points, moderate acute mountain sickness as 6-9 points, and severe acute mountain sickness as 10-12 points
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24 hours before the flight
|
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Neuropsychological tests (Trail Making Test, Wechsler Memory Scale - IV, Free recall
大体时间：24 hours after the flight
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Word, color, and color-word T-Scores of 40 or less are considered "low."
Word, color, and color-word T-Scores above 40 or are considered "normal."
In order for one score to be considered "higher" or "lower" than another, a 10 point or greater T score difference is required.
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24 hours after the flight
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SpO2 level
大体时间：24 hours before the flight
|
Pulse oximetry
|
24 hours before the flight
|
|
The Liverpool Jet Lag questionnaire (LJLQ)
大体时间：24 hours after the flight
|
Changes from normal (0 to 5) while jetlag rating was recorded on a scale from 0 = insignificant jetlag to 10 = severe jetlag
|
24 hours after the flight
|
|
Lake Louise Acute Mountain Sickness Assessment System
大体时间：24 hours after the flight
|
Mild acute mountain sicknessas 3-5 points, moderate acute mountain sickness as 6-9 points, and severe acute mountain sickness as 10-12 points
|
24 hours after the flight
|
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The Stroop Test
大体时间：24 hours after the flight
|
Word, color, and color-word T-Scores of 40 or less are considered "low."
Word, color, and color-word T-Scores above 40 or are considered "normal."
In order for one score to be considered "higher" or "lower" than another, a 10 point or greater T score difference is required.
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24 hours after the flight
|
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Urine Specific Gravity
大体时间：24 hours after the flight
|
Urine Specific Gravity test
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24 hours after the flight
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Air Travel的临床试验
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Dr.Mahak Mehta完全的Proseal LMA 对比 Air-Q LMA 对比 Ambu AurGain LMA