- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05411185
The Study on Effects of Acute Exposure to High Altitude Hypoxia on Cognitive Function in Lowlanders
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Fourth Military Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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the plateau group
People travelling from the plains to areas at altitudes of 3800 meters
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the plain group
People staying in the plains throughout the whole test
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cognitive impairment after an altitude of 3,800 meters
Time Frame: 7 days
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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 |
|---|---|---|
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Changes of the relative power values of five different EEG band
Time Frame: 7 days
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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
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The changing trend of cognitive function in plateau environment
Time Frame: 7 days
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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.
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7 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20222059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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