The Impact of Air Travel on Passenger Cognitive Functions

Study Overview
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Brief Summary
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In the period from June 2021 to June 2022, a prospective clinical study will be conducted in the Republic of Kazakhstan with economy class passengers traveling by plane with a minimum flight period of 5-7 flight hours in the territory of the Republic of Kazakhstan.

Official Title
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The Impact of Air Travel on Passenger Cognitive Functions

Conditions
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Air Travel

Intervention / Treatment
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* Drug: Citicoline
* Drug: Cytochrome C6
* Drug: Sodium Chloride Oral Product
* Drug: Potassium Chloride Oral Product
* Drug: Sodium Citrate Oral Product
* Drug: Dextrose Oral Tablet, Chewable
* Drug: Domperidone Oral Product
* Drug: Simethicone
* Drug: Acetylsalicylic acid
* Drug: Magnesium hydroxide
* Drug: Probiotic Formula
* Drug: Melatonin 5 mg


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study Group<br>Before the flight in the conditions of the clinic's medical treatment room: Citicoline 500 mg(Vitaae®) and Cytochrome10 mg (Cytochrome C®) per os. 30 minutes before the flight: dilute 1 sachet of ORS® (Sodium Chloride 2.6 g+Potassium Chloride 1.5 g+Sodium Citrate 2.90 g+Dextrose 13.5 g) in 1 liter of water. Drink half of the solution (0.5 l) 30 minutes before the flight (at the airport). Also, 0.5 L of the solution will be provided on the plane during landing. If the flight lasts more than 1.5 hours, then dilute the second sachet of ORS® with 0.5-1 liters of water. 30 minutes before the flight (per os): Domperidone (Motilium ®) (1 tablet), Simethicone (Gas-X®) (3-4 capsules), Acetylsalicylic acid 150 mg and magnesium hydroxide 30,39 mg (Cardiomagnyl®)(1 tablet), probiotic (Bactistatin®) (1 capsule) per os. | Drug: Citicoline<br>* Citicoline 500 mg (Vitaae®) per os<br>* Other names: Citicoline (Vitaae®);Drug: Cytochrome C6<br>* Cytochrome10 mg per os<br>* Other names: (Cytochrome C®);Drug: Sodium Chloride Oral Product<br>* Sodium Chloride (NaCl) 2.6 g. per os<br>Drug: Potassium Chloride Oral Product<br>* Potassium Chloride 1.5 g per os<br>* Other names: Potassium Chloride;Drug: Sodium Citrate Oral Product<br>* Sodium Citrate 2.90 g per os<br>* Other names: Sodium Citrate;Drug: Dextrose Oral Tablet, Chewable<br>* Dextrose 13.5 g per os<br>* Other names: Dextrose;Drug: Domperidone Oral Product<br>* Domperidone 1 tablet per os<br>* Other names: Motilium ®;Drug: Simethicone<br>* 3-4 capsules per os<br>* Other names: Gas-X®;Drug: Acetylsalicylic acid<br>* Acetylsalicylic acid 150 mg per os<br>Drug: Magnesium hydroxide<br>* magnesium hydroxide 30 mg per os<br>Drug: Probiotic Formula<br>* 1 capsule per os.<br>* Other names: Bactistatin®;|
| Active Comparator: Control group<br>Melatonin® 5 mg per os 2 hours before bedtime on the day of arrival for 3-4 days. | Drug: Melatonin 5 mg<br>* Melatonin 5 mg per os.<br>* Other names: Natrol Melatonin;|
| No Intervention: Explanatory group:<br>12 participants without any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Specific Gravity | Urine Specific Gravity test | 24 hours before the flight | 
| SpO2 level | Pulse oximetry | 24 hours before the flight | 
| Ultrasound examination | Ultrasound examination of the veins of the lower limbs | 24 hours before the flight | 
| The Liverpool Jet Lag questionnaire | 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 | 
| Lake Louise Acute Mountain Sickness Assessment System | 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 before the flight | 
| Neuropsychological tests (Trail Making Test, Wechsler Memory Scale - IV, Free recall | 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. | 24 hours after the flight | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Liverpool Jet Lag questionnaire (LJLQ) | 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 | 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 | 
| The Stroop Test | 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. | 24 hours after the flight | 
| Urine Specific Gravity | Urine Specific Gravity test | 24 hours after the flight | 
| SpO2 level | Pulse oximetry | 24 hours before the flight | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Air Travel, health