CognitionNCT05411185
The Study on Effects of Acute Exposure to High Altitude Hypoxia on Cognitive Function in Lowlanders
An observational study of Cognition, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Lived in plain, never entered the plateau
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the plateau group | People travelling from the plains to areas at altitudes of 3800 meters | |
| the plain group | People staying in the plains throughout the whole test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (2)
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.
Measured: 7 days
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 (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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DongHailong, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411185
- Sponsor's protocol ID
- KY20222059
- Status last verified
- Feb 2024
- First submitted
- 26 May 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22580489Ciarlone 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.
PubMed 27733363Davranche 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.
PubMed 27262217Turner 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.
PubMed 25660759Falla 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.
PubMed 33995130
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on Effects of Acute Exposure to High Altitude Hypoxia on Cognitive Function in Lowlanders
- ClinicalTrials.gov ID
- NCT05411185
- Acronym / sponsor ID
- KY20222059
- Conditions
- Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the plateau group | – | –People travelling from the plains to areas at altitudes of 3800 meters |
| the plain group | – | –People staying in the plains throughout the whole test |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Lived in plain, never entered the plateau
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
The changing trend of cognitive function in plateau environment
Time frame: 7 days
Changes of the relative power values of five different EEG band
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 22580489Eide 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.
- Background: PubMed 27733363Ciarlone 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.
- Background: PubMed 27262217Davranche 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.
- Background: PubMed 25660759Turner 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.
- Background: PubMed 33995130Falla 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment after an altitude of 3,800 meters (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05411185, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.