The Impact of Air Travel on Passenger Cognitive Functions

NCT04802785 | Unknown Phase 2

• 1 other identifier: 1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Air Travel

Keywords

Air Travel; health

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• The Liverpool Jet Lag questionnaire (LJLQ)

  24 hours after the flight

• Lake Louise Acute Mountain Sickness Assessment System

  24 hours after the flight

• The Stroop Test

  24 hours after the flight

• Urine Specific Gravity

  24 hours after the flight

• SpO2 level

  24 hours before the flight

Study Arms (3)

The study Group

EXPERIMENTAL

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.

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

Control group

ACTIVE COMPARATOR

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

Drug: Melatonin 5 mg

Explanatory group:

NO INTERVENTION

12 participants without any intervention.

Interventions

Citicoline DRUG

Citicoline 500 mg (Vitaae®) per os

Also known as: Citicoline (Vitaae®)

The study Group

Cytochrome C6 DRUG

Cytochrome10 mg per os

Also known as: (Cytochrome C®)

The study Group

Sodium Chloride Oral Product DRUG

Sodium Chloride (NaCl) 2.6 g. per os

The study Group

Potassium Chloride Oral Product DRUG

Potassium Chloride 1.5 g per os

Also known as: Potassium Chloride

The study Group

Sodium Citrate Oral Product DRUG

Sodium Citrate 2.90 g per os

Also known as: Sodium Citrate

The study Group

Dextrose Oral Tablet, Chewable DRUG

Dextrose 13.5 g per os

Also known as: Dextrose

The study Group

Domperidone Oral Product DRUG

Domperidone 1 tablet per os

Also known as: Motilium ®

The study Group

Simethicone DRUG

3-4 capsules per os

Also known as: Gas-X®

The study Group

Acetylsalicylic acid DRUG

Acetylsalicylic acid 150 mg per os

The study Group

Magnesium hydroxide DRUG

magnesium hydroxide 30 mg per os

The study Group

Probiotic Formula DRUG

1 capsule per os.

Also known as: Bactistatin®

The study Group

Melatonin 5 mg DRUG

Melatonin 5 mg per os.

Also known as: Natrol Melatonin

Control group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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. \-

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dinara Zhumanbayeva: lead

MeSH Terms

Interventions

Cytidine Diphosphate Choline; Cytochromes c6; Cytochromes c; Potassium Chloride; Sodium Citrate; Glucose; Domperidone; Simethicone; Aspirin; Magnesium Hydroxide; Melatonin

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Cytochrome c Group; Cytochromes; Enzymes and Coenzymes; Hemeproteins; Proteins; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Potassium Compounds; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Hexoses; Monosaccharides; Sugars; Carbohydrates; Piperidines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Magnesium Compounds; Tryptamines; Indoles; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Arman Lurye

CONTACT

+7 701 765 2196; arman@lurye.clinic

Dinara Dzhumanbayeva

CONTACT

+7 701 765 2196; dinara@lurye.clinic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: head of laboratory

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 17, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: May 1, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share