Clinical trial NCT05411185: The Study on Effects of Acute Exposure to High Altitude Hypoxia on Cognitive Function in Lowlanders
Official title: The Study on Effects of Acute Exposure to High Altitude Hypoxia on Cognitive Function in Lowlanders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognition
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive impairment after an altitude of 3,800 meters
timeFrame: 7 days
Secondary outcomes:
measure: The changing trend of cognitive function in plateau environment
timeFrame: 7 days
measure: Changes of the relative power values of five different EEG band
timeFrame: 7 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Fourth Military Medical University
state: Shaanxi
Study officials:
References:
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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.