NCT05411185

Brief Summary

The purpose of this study is to investigate the impact of rapid elevation to 3,800 meters on the cognitive function of low-altitude residents through a plateau field and plain control study, and explore the objective indicators related to the impaired cognitive function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

May 26, 2022

Last Update Submit

October 8, 2024

Conditions

Cognition

Outcome Measures

Primary Outcomes (1)

  • Cognitive impairment after an altitude of 3,800 meters

    To assess cognitive function, we used CNS Vital Signs Neurocognitive test. The core CNS Vital Signs "BRIEF-CORE" neurocognitive assessment battery consists of seven subtests: Verbal Memory (VBM), Visual Memory (VIM), Finger Tapping (FTT), Symbol Digit Coding (SDC), Stroop Test (ST), Rat Attention Test (SAT) and the Continuous Performance Test (CPT). Based on the above 7 test results, the quantitative evaluation results of 11 cognitive functions, including complex memory, graphic memory, vocabulary memory, psychomotor speed, motor speed, processing speed, reaction time, cognitive flexibility, executive function, complex attention and simple attention, were generated. By comparing the cognitive function at different stages before and after entering the plateau, we will find out the impaired cognitive function.

    7 days

Secondary Outcomes (2)

  • The changing trend of cognitive function in plateau environment

    7 days

  • Changes of the relative power values of five different EEG band

    7 days

Study Arms (2)

the plateau group

People travelling from the plains to areas at altitudes of 3800 meters

the plain group

People staying in the plains throughout the whole test

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

According to the inclusion and exclusion criteria, this study intends to recruit 60 subjects from the healthy young and middle-aged people who live in the plain for the first time, such as students for internship in Tibet for the first time, cadres for aid to Tibet for the first time, and tourists for the first time.

You may qualify if:

  • Lived in plain, never entered the plateau

You may not qualify if:

  • patients with epilepsy, migraine, brain injury, stroke and other neuropsychiatric diseases;
  • central nervous system drugs;
  • history of heart or head surgery;
  • MMSE score \< 25;
  • patients suffering from pulmonary heart disease, chronic obstructive pulmonary disease, emphysema, pulmonary embolism and other serious respiratory diseases;
  • patients with negative resistance to the study and poor compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (5)

  • Eide RP 3rd, Asplund CA. Altitude illness: update on prevention and treatment. Curr Sports Med Rep. 2012 May-Jun;11(3):124-30. doi: 10.1249/JSR.0b013e3182563e7a.

    PMID: 22580489BACKGROUND

  • Ciarlone GE, Dean JB. Acute hypercapnic hyperoxia stimulates reactive species production in the caudal solitary complex of rat brain slices but does not induce oxidative stress. Am J Physiol Cell Physiol. 2016 Dec 1;311(6):C1027-C1039. doi: 10.1152/ajpcell.00161.2016. Epub 2016 Oct 12.

    PMID: 27733363BACKGROUND

  • Davranche K, Casini L, Arnal PJ, Rupp T, Perrey S, Verges S. Cognitive functions and cerebral oxygenation changes during acute and prolonged hypoxic exposure. Physiol Behav. 2016 Oct 1;164(Pt A):189-97. doi: 10.1016/j.physbeh.2016.06.001. Epub 2016 Jun 2.

    PMID: 27262217BACKGROUND

  • Turner CE, Barker-Collo SL, Connell CJ, Gant N. Acute hypoxic gas breathing severely impairs cognition and task learning in humans. Physiol Behav. 2015 Apr 1;142:104-10. doi: 10.1016/j.physbeh.2015.02.006. Epub 2015 Feb 4.

    PMID: 25660759BACKGROUND

  • Falla M, Papagno C, Dal Cappello T, Vogele A, Hufner K, Kim J, Weiss EM, Weber B, Palma M, Mrakic-Sposta S, Brugger H, Strapazzon G. A Prospective Evaluation of the Acute Effects of High Altitude on Cognitive and Physiological Functions in Lowlanders. Front Physiol. 2021 Apr 28;12:670278. doi: 10.3389/fphys.2021.670278. eCollection 2021.

    PMID: 33995130BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 9, 2022

Study Start

January 1, 2022

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

October 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)