- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04802785
The Impact of Air Travel on Passenger Cognitive Functions
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Medicin: Citicoline
- Medicin: Cytochrome C6
- Medicin: Sodium Chloride Oral Product
- Medicin: Potassium Chloride Oral Product
- Medicin: Sodium Citrate Oral Product
- Medicin: Dextrose Oral Tablet, Chewable
- Medicin: Domperidone Oral Product
- Medicin: Simethicone
- Medicin: Acetylsalicylic acid
- Medicin: Magnesium hydroxide
- Medicin: Probiotic Formula
- Medicin: Melatonin 5 mg
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: The study Group
|
Citicoline 500 mg (Vitaae®) per os
Andre navne:
Cytochrome10 mg per os
Andre navne:
Sodium Chloride (NaCl) 2.6 g. per os
Potassium Chloride 1.5 g per os
Andre navne:
Sodium Citrate 2.90 g per os
Andre navne:
Dextrose 13.5 g per os
Andre navne:
Domperidone 1 tablet per os
Andre navne:
3-4 capsules per os
Andre navne:
Acetylsalicylic acid 150 mg per os
magnesium hydroxide 30 mg per os
1 capsule per os.
Andre navne:
|
|
Aktiv komparator: Control group
Melatonin® 5 mg per os 2 hours before bedtime on the day of arrival for 3-4 days.
|
Melatonin 5 mg per os.
Andre navne:
|
|
Ingen indgriben: Explanatory group:
12 participants without any intervention.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Autonome agenter
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodpladeaggregationshæmmere
- Cyclooxygenase-hæmmere
- Antipyretika
- Antiemetika
- Gastrointestinale midler
- Beskyttelsesagenter
- Dermatologiske midler
- Dopaminmidler
- Dopamin-antagonister
- Antikoagulanter
- Antioxidanter
- Skumdæmpende midler
- Blødgørende midler
- Chelaterende midler
- Sekvesteringsagenter
- Nootropiske midler
- Calciumchelateringsmidler
- Antacida
- Aspirin
- Melatonin
- Simeticon
- Magnesiumhydroxid
- Domperidon
- Citronsyre
- Natriumcitrat
- Cytidin Diphosphat Cholin
Andre undersøgelses-id-numre
- 1 (Mobile Health and Wellness Program)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Air Travel
-
Cairo UniversityAfsluttetFekry VS Air-Q Intubating AirwaysEgypten
-
Dr.Mahak MehtaAfsluttetProseal LMA vs Air-Q LMA vs Ambu AurGain LMA
-
University Hospital, MontpellierAix Marseille Université; LBM- Nanosecurity platform - CEA Grenoble; LR2N...AfsluttetAir France Companys medarbejdere, der arbejder i lufthavnene i Marseilles og Paris (Flyline og administrative medarbejdere)Frankrig
-
Dartmouth-Hitchcock Medical CenterRekruttering
Kliniske forsøg med Citicoline
-
Mclean HospitalNational Institute on Drug Abuse (NIDA)AfsluttetMisbrug af marihuanaForenede Stater
-
Armed Forces Hospital, PakistanUkendtHypoksisk-iskæmisk encefalopatiPakistan
-
Clinical Institute of the Brain, RussiaEver Neuro Pharma GmbH; Nycomed; VeropharmAfsluttet
-
University of OttawaThe Ottawa HospitalUkendtFørste episode skizofreniCanada
-
Eunice Kennedy Shriver National Institute of Child...AfsluttetTraumatisk hjerneskadeForenede Stater
-
Medical University of South CarolinaAktiv, ikke rekrutterende