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Completed

NCT Number: NCT05411185

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2022
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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