The Impact of Air Travel on Passenger Cognitive Functions

Dinara Zhumanbayeva

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Air Travel

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04802785

1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

The study Group

Experimental group

Description:

1. Before the flight in the conditions of the clinic's medical treatment room: Citicoline 500 mg(Vitaae®) and Cytochrome10 mg (Cytochrome C®) per os. 2. 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. 3. 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.

Treatment:

Drug: Probiotic Formula

Drug: Acetylsalicylic acid

Drug: Cytochrome C6

Drug: Magnesium hydroxide

Drug: Simethicone

Drug: Potassium Chloride Oral Product

Drug: Dextrose Oral Tablet, Chewable

Drug: Sodium Citrate Oral Product

Drug: Sodium Chloride Oral Product

Drug: Citicoline

Drug: Domperidone Oral Product

Control group

Active Comparator group

Description:

Melatonin® 5 mg per os 2 hours before bedtime on the day of arrival for 3-4 days.

Treatment:

Drug: Melatonin 5 mg

Explanatory group:

No Intervention group

Description:

12 participants without any intervention.