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The Impact of Air Travel on Passenger Cognitive Functions

15. mars 2021 oppdatert av: Dinara Zhumanbayeva
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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 30 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: The study Group
  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.
Legemiddel: Citicoline
Citicoline 500 mg (Vitaae®) per os
Andre navn:
  • Citicoline (Vitaae®)
Legemiddel: Cytochrome C6
Cytochrome10 mg per os
Andre navn:
  • (Cytochrome C®)
Legemiddel: Sodium Chloride Oral Product
Sodium Chloride (NaCl) 2.6 g. per os
Legemiddel: Potassium Chloride Oral Product
Potassium Chloride 1.5 g per os
Andre navn:
  • Kaliumklorid
Legemiddel: Sodium Citrate Oral Product
Sodium Citrate 2.90 g per os
Andre navn:
  • Sodium Citrate
Legemiddel: Dextrose Oral Tablet, Chewable
Dextrose 13.5 g per os
Andre navn:
  • Dekstrose
Legemiddel: Domperidone Oral Product
Domperidone 1 tablet per os
Andre navn:
  • Motilium ®
Legemiddel: Simethicone
3-4 capsules per os
Andre navn:
  • Gas-X®
Legemiddel: Acetylsalicylic acid
Acetylsalicylic acid 150 mg per os
Legemiddel: Magnesium hydroxide
magnesium hydroxide 30 mg per os
Legemiddel: Probiotic Formula
1 capsule per os.
Andre navn:
  • Bactistatin®
Aktiv komparator: Control group
Melatonin® 5 mg per os 2 hours before bedtime on the day of arrival for 3-4 days.
Legemiddel: Melatonin 5 mg
Melatonin 5 mg per os.
Andre navn:
  • Natrol Melatonin
Ingen inngripen: Explanatory group:
12 participants without any intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Urine Specific Gravity
Tidsramme: 24 hours before the flight
Urine Specific Gravity test
24 hours before the flight
SpO2 level
Tidsramme: 24 hours before the flight
Pulse oximetry
24 hours before the flight
Ultrasound examination
Tidsramme: 24 hours before the flight
Ultrasound examination of the veins of the lower limbs
24 hours before the flight
The Liverpool Jet Lag questionnaire
Tidsramme: 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
24 hours before the flight
Lake Louise Acute Mountain Sickness Assessment System
Tidsramme: 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
24 hours before the flight
Neuropsychological tests (Trail Making Test, Wechsler Memory Scale - IV, Free recall
Tidsramme: 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.
24 hours after the flight

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
SpO2 level
Tidsramme: 24 hours before the flight
Pulse oximetry
24 hours before the flight
The Liverpool Jet Lag questionnaire (LJLQ)
Tidsramme: 24 hours after the flight
Changes from normal (0 to 5) while jetlag rating was recorded on a scale from 0 = insignificant jetlag to 10 = severe jetlag
24 hours after the flight
Lake Louise Acute Mountain Sickness Assessment System
Tidsramme: 24 hours after 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
24 hours after the flight
The Stroop Test
Tidsramme: 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.
24 hours after the flight
Urine Specific Gravity
Tidsramme: 24 hours after the flight
Urine Specific Gravity test
24 hours after the flight

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dinara Zhumanbayeva

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. juni 2021

Primær fullføring (Forventet)

1. juli 2021

Studiet fullført (Forventet)

1. mai 2022

Datoer for studieregistrering

Først innsendt

17. februar 2021

Først innsendt som oppfylte QC-kriteriene

15. mars 2021

Først lagt ut (Faktiske)

17. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1 (Mobile Health and Wellness Program)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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