Effects of Altitude Hypoxia and Hypoxia on Cognitive Function in Acute Patients

Sponsor
Xijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05411185
Collaborator
(none)
80
1
12
6.7

Study Details

Study Description

Brief Summary

By observing the changes of cognitive function of subjects after moving from plain to plateau, this study aims to find out the main types of impaired cognitive function and explore the indicators related to impaired cognitive function in the EEG.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study intends to recruit healthy subjects from plain area to 3000 m altitude group (N=40) and 4000 m altitude group (N=40).

    First, subjects completed baseline cognitive function tests and information collection in the plain area.

    Second, the tests were repeated on day 1, day 3 and day 7 after the two groups of subjects entered the area at different altitudes.

    Finally, analyze and find out the main types of cognitive impairment, and explore the related indicators of cognitive impairment in EEG.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Effects of Altitude Hypoxia and Hypoxia on Cognitive Function in Acute Patients
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Group A

    People travelling from the plains to areas at altitudes of 3000-3500 meters

    Group B

    People travelling from the plains to areas at altitudes of 4000-4500 meters

    Outcome Measures

    Primary Outcome Measures

    1. Major impairment of cognitive function types [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 Outcome Measures

    1. Changes of the relative power values of five different EEG band [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.

    2. Changes of the percentage of each EEG band in the total monitoring time [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 percentage of each EEG band (δ wave, θ wave, α wave, β wave and γ wave) in the total monitoring time. By comparing the percentage of each EEG band in the total monitoring time 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fourth Military Medical University Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT05411185
    Other Study ID Numbers:
    • KY20222059
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2022