The Impact of Air Travel on Passenger Cognitive Functions

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.

Study Overview

• Status: Unknown
• Conditions: Air Travel
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Arman Lurye; Phone Number: +7 701 765 2196; Email: arman@lurye.clinic
• Study Contact Backup: Name: Dinara Dzhumanbayeva; Phone Number: +7 701 765 2196; Email: dinara@lurye.clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The study Group; 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; Citicoline 500 mg (Vitaae®) per os; Other Names: Citicoline (Vitaae®); Drug: Cytochrome C6; Cytochrome10 mg per os; Other Names: (Cytochrome C®); Drug: Sodium Chloride Oral Product; Sodium Chloride (NaCl) 2.6 g. per os; Drug: Potassium Chloride Oral Product; Potassium Chloride 1.5 g per os; Other Names: Potassium Chloride; Drug: Sodium Citrate Oral Product; Sodium Citrate 2.90 g per os; Other Names: Sodium Citrate; Drug: Dextrose Oral Tablet, Chewable; Dextrose 13.5 g per os; Other Names: Dextrose; Drug: Domperidone Oral Product; Domperidone 1 tablet per os; Other Names: Motilium ®; Drug: Simethicone; 3-4 capsules per os; Other Names: Gas-X®; Drug: Acetylsalicylic acid; Acetylsalicylic acid 150 mg per os; Drug: Magnesium hydroxide; magnesium hydroxide 30 mg per os; Drug: Probiotic Formula; 1 capsule per os.; Other Names: Bactistatin®
Active Comparator: Control group; Melatonin® 5 mg per os 2 hours before bedtime on the day of arrival for 3-4 days.	Drug: Melatonin 5 mg; Melatonin 5 mg per os.; Other Names: Natrol Melatonin
No Intervention: Explanatory group: 12 participants without any intervention.

What is the study measuring?

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
SpO2 level	Pulse oximetry	24 hours before the flight
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

Collaborators and Investigators

• Sponsor: Dinara Zhumanbayeva

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: health; Air Travel
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Antiemetics; Gastrointestinal Agents; Protective Agents; Dermatologic Agents; Dopamine Agents; Dopamine Antagonists; Anticoagulants; Antioxidants; Antifoaming Agents; Emollients; Chelating Agents; Sequestering Agents; Nootropic Agents; Calcium Chelating Agents; Antacids; Aspirin; Melatonin; Simethicone; Magnesium Hydroxide; Domperidone; Citric Acid; Sodium Citrate; Cytidine Diphosphate Choline
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No