Clinical trial NCT04802785: The Impact of Air Travel on Passenger Cognitive Functions
Official title: The Impact of Air Travel on Passenger Cognitive Functions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Air Travel
Keywords: Air Travel
health
Lead sponsor: lurye Clinic
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

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Primary outcomes:
measure: Urine Specific Gravity
timeFrame: 24 hours before the flight
measure: SpO2 level
timeFrame: 24 hours before the flight
measure: Ultrasound examination
timeFrame: 24 hours before the flight
measure: The Liverpool Jet Lag questionnaire
timeFrame: 24 hours before the flight
measure: Lake Louise Acute Mountain Sickness Assessment System
timeFrame: 24 hours before the flight
measure: Neuropsychological tests (Trail Making Test, Wechsler Memory Scale - IV, Free recall
timeFrame: 24 hours after the flight
Secondary outcomes:
measure: The Liverpool Jet Lag questionnaire (LJLQ)
timeFrame: 24 hours after the flight
measure: Lake Louise Acute Mountain Sickness Assessment System
timeFrame: 24 hours after the flight
measure: The Stroop Test
timeFrame: 24 hours after the flight
measure: Urine Specific Gravity
timeFrame: 24 hours after the flight
measure: SpO2 level
timeFrame: 24 hours before the flight
Other outcomes:
Locations:
Study officials:
References: