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The Impact of Air Travel on Passenger Cognitive Functions

The Impact of Air Travel on Passenger Cognitive Functions

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04802785
Enrollment
50
Registered
2021-03-17
Start date
2021-06-30
Completion date
2022-05-31
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Air Travel

Keywords

Air Travel, health

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.

Interventions

DRUGCiticoline

Citicoline 500 mg (Vitaae®) per os

DRUGCytochrome C6

Cytochrome10 mg per os

DRUGSodium Chloride Oral Product

Sodium Chloride (NaCl) 2.6 g. per os

Potassium Chloride 1.5 g per os

DRUGSodium Citrate Oral Product

Sodium Citrate 2.90 g per os

DRUGDextrose Oral Tablet, Chewable

Dextrose 13.5 g per os

Domperidone 1 tablet per os

3-4 capsules per os

DRUGAcetylsalicylic acid

Acetylsalicylic acid 150 mg per os

DRUGMagnesium hydroxide

magnesium hydroxide 30 mg per os

1 capsule per os.

Melatonin 5 mg per os.

Sponsors

Dinara Zhumanbayeva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
Yes

Inclusion 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. \-

Design outcomes

Primary

MeasureTime frameDescription
Neuropsychological tests (Trail Making Test, Wechsler Memory Scale - IV, Free recall24 hours after the flightWord, 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.
Urine Specific Gravity24 hours before the flightUrine Specific Gravity test
SpO2 level24 hours before the flightPulse oximetry
Ultrasound examination24 hours before the flightUltrasound examination of the veins of the lower limbs
The Liverpool Jet Lag questionnaire24 hours before the flightChanges from normal (0 to 5) while jetlag rating was recorded on a scale from 0 = insignificant jetlag to 10 = severe jetlag
Lake Louise Acute Mountain Sickness Assessment System24 hours before the flightMild acute mountain sicknessas 3-5 points, moderate acute mountain sickness as 6-9 points, and severe acute mountain sickness as 10-12 points

Secondary

MeasureTime frameDescription
Lake Louise Acute Mountain Sickness Assessment System24 hours after the flightMild acute mountain sicknessas 3-5 points, moderate acute mountain sickness as 6-9 points, and severe acute mountain sickness as 10-12 points
The Stroop Test24 hours after the flightWord, 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.
Urine Specific Gravity24 hours after the flightUrine Specific Gravity test
SpO2 level24 hours before the flightPulse oximetry
The Liverpool Jet Lag questionnaire (LJLQ)24 hours after the flightChanges from normal (0 to 5) while jetlag rating was recorded on a scale from 0 = insignificant jetlag to 10 = severe jetlag

Contacts

Primary ContactArman Lurye
arman@lurye.clinic+7 701 765 2196
Backup ContactDinara Dzhumanbayeva
dinara@lurye.clinic+7 701 765 2196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026