Air TravelPhase 2/3NCT04802785
The Impact of Air Travel on Passenger Cognitive Functions
A Phase 2/3 study testing Citicoline, Cytochrome C6 and Sodium Chloride Oral Product in people with Air Travel, run by Dinara Zhumanbayeva.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Air Travel
- What is being tested?
- Citicoline, Cytochrome C6 and Sodium Chloride Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to May 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Citicoline, Cytochrome C6, Sodium Chloride Oral Product, Potassium Chloride Oral Product, Sodium Citrate Oral Product
- Keywords
- Air Travel, health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDrug
Also called Citicoline (Vitaae®)
Citicoline 500 mg (Vitaae®) per os
Cytochrome C6Drug
Also called (Cytochrome C®)
Cytochrome10 mg per os
Sodium Chloride Oral ProductDrug
Sodium Chloride (NaCl) 2.6 g. per os
Potassium Chloride Oral ProductDrug
Also called Potassium Chloride
Potassium Chloride 1.5 g per os
Sodium Citrate Oral ProductDrug
Also called Sodium Citrate
Sodium Citrate 2.90 g per os
Dextrose Oral Tablet, ChewableDrug
Also called Dextrose
Dextrose 13.5 g per os
Domperidone Oral ProductDrug
Also called Motilium ®
Domperidone 1 tablet per os
SimethiconeDrug
Also called Gas-X®
3-4 capsules per os
Acetylsalicylic acidDrug
Acetylsalicylic acid 150 mg per os
Magnesium hydroxideDrug
magnesium hydroxide 30 mg per os
Probiotic FormulaDrug
Also called Bactistatin®
1 capsule per os.
Melatonin 5 mgDrug
Also called Natrol Melatonin
Melatonin 5 mg per os.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Melatonin 5 mg |
| Explanatory group: | No intervention | 12 participants without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Specific Gravity
Urine Specific Gravity test
Measured: 24 hours before the flight
SpO2 level
Pulse oximetry
Measured: 24 hours before the flight
Ultrasound examination
Ultrasound examination of the veins of the lower limbs
Measured: 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
Measured: 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
Measured: 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.
Measured: 24 hours after the flight
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 24 hours after the flight
Urine Specific Gravity
Urine Specific Gravity test
Measured: 24 hours after the flight
SpO2 level
Pulse oximetry
Measured: 24 hours before the flight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air TravelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dinara Zhumanbayeva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dinara Zhumanbayeva, lurye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802785
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2021
- First submitted
- 17 Feb 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Air Travel on Passenger Cognitive Functions
- ClinicalTrials.gov ID
- NCT04802785
- Acronym / sponsor ID
- 1
- Conditions
- Air Travel
- Keywords
- Air Travel, health
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dinara ZhumanbayevaUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The study Group | Experimental | 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 Formula1. 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. |
| Control group | Active comparator | Drug: Melatonin 5 mgMelatonin® 5 mg per os 2 hours before bedtime on the day of arrival for 3-4 days. |
| Explanatory group: | No intervention | –12 participants without any intervention. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiticolineAlso: Citicoline (Vitaae®)Citicoline 500 mg (Vitaae®) per os | Drug | The study Group |
| Cytochrome C6Also: (Cytochrome C®)Cytochrome10 mg per os | Drug | The study Group |
| Sodium Chloride Oral ProductSodium Chloride (NaCl) 2.6 g. per os | Drug | The study Group |
| Potassium Chloride Oral ProductAlso: Potassium ChloridePotassium Chloride 1.5 g per os | Drug | The study Group |
| Sodium Citrate Oral ProductAlso: Sodium CitrateSodium Citrate 2.90 g per os | Drug | The study Group |
| Dextrose Oral Tablet, ChewableAlso: DextroseDextrose 13.5 g per os | Drug | The study Group |
| Domperidone Oral ProductAlso: Motilium ®Domperidone 1 tablet per os | Drug | The study Group |
| SimethiconeAlso: Gas-X®3-4 capsules per os | Drug | The study Group |
| Acetylsalicylic acidAcetylsalicylic acid 150 mg per os | Drug | The study Group |
| Magnesium hydroxidemagnesium hydroxide 30 mg per os | Drug | The study Group |
| Probiotic FormulaAlso: Bactistatin®1 capsule per os. | Drug | The study Group |
| Melatonin 5 mgAlso: Natrol MelatoninMelatonin 5 mg per os. | Drug | Control group |
Primary outcome
Urine Specific Gravity
Time frame: 24 hours before the flight
Urine Specific Gravity test
SpO2 level
Time frame: 24 hours before the flight
Pulse oximetry
Ultrasound examination
Time frame: 24 hours before the flight
Ultrasound examination of the veins of the lower limbs
The Liverpool Jet Lag questionnaire
Time frame: 24 hours before the flight
Changes 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 System
Time frame: 24 hours before the flight
Mild acute mountain sicknessas 3-5 points, moderate acute mountain sickness as 6-9 points, and severe acute mountain sickness as 10-12 points
Neuropsychological tests (Trail Making Test, Wechsler Memory Scale - IV, Free recall
Time frame: 24 hours after the flight
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.
5 secondary outcomes
The Liverpool Jet Lag questionnaire (LJLQ)
Time frame: 24 hours after the flight
Lake Louise Acute Mountain Sickness Assessment System
Time frame: 24 hours after the flight
The Stroop Test
Time frame: 24 hours after the flight
Urine Specific Gravity
Time frame: 24 hours after the flight
SpO2 level
Time frame: 24 hours before the flight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Citicoline, Cytochrome C6 and Sodium Chloride Oral Product in people with Air Travel, run by Dinara Zhumanbayeva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arman Lurye (+7 701 765 2196, arman@lurye.clinic), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Specific Gravity (time frame: 24 hours before the flight). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.