The Study on Effects of Acute Exposure to High Altitude Hypoxia on Cognitive Function in Lowlanders

October 8, 2024 updated by: DongHailong, Xijing Hospital
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.

Study Overview

Status

Completed

Conditions

Detailed Description

This study intends to recruit 60 healthy young people residing in plain area to 3000 m. Participants were divided into two groups: the plateau group (N=30) and the plain group (N=30).

Firstly, we collected baseline data one week before the plateau group rushed to the plateau, and then repeated the above data collection at the same time on day 1 (3-5 hours after arrival), day 2, day 3, day 5, and day 7 after entering the plateau. The plain group was studied in the plain according to the same test plan.

Finally, analyze and find out the main types of cognitive impairment, and explore the physiological prediction index, including exploring the characteristics of EEG changes before and after entering the plateau.

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Fourth Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • Lived in plain, never entered the plateau

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive impairment after an altitude of 3,800 meters
Time Frame: 7 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the relative power values of five different EEG band
Time Frame: 7 days

To collect the EEG data, we used the ZhenTec's 32-conductivity EEG monitoring device. 32 electrodes ( Fp1、Fp2、F3、F4、Fz、FT7、FT8、FC3、FC4、FCz、Cz、TP7、TP8、CP3、CP4、Pz、Oz、C3、C4、P3、P4、O1、O2、 F7、F8、T3、T4、T5、T6) were placed according to the international 10/20 system electrode placement method, and EEG data of the subjects were collected in the quiet state for 20 min. By analyzing the collected EEG data, we can calculate the relative power values of five different EEG band (δ wave, θ wave, α wave, β wave and γ wave) under different leads.

By comparing the relative power values at different stages before and after entering the plateau, we tried to look for significantly altered EEG signatures, to find its association with the impaired cognitive function.

7 days
The changing trend of cognitive function in plateau environment
Time Frame: 7 days
For the above 12 cognitive functions, the values in plain and plateau were counted respectively, and then make a line chart to observe the change trend of different cognitive function.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

June 5, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KY20222059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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