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

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411185
• Other study ID #: KY20222059
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• Cognition
• Hypoxia

Locations

Country	Name	City	State
China	Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The changing trend of cognitive function in plateau environment	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
Secondary	Changes of the relative power values of five different EEG band	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 (d wave, ? wave, a wave, ß wave and ? 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