High AltitudeNCT06557928
Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments
An observational study of High Altitude, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a single-center prospective observational study. It plans to use a series of physiological and medical instruments and international common physiological and psychological questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- High Altitude
- What is being tested?
- measurement
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Doctors in Tibet from Peking Union Medical College Hospital
Who may be able to join
- Healthy individuals aged 20-65 years
- They can sign a written informed consent and is willing to cooperate
- They have the qualification to aid Tibet and meet the basic requirements of physical examination for aid to Tibet
Who cannot join
- Age less than 20 years or more than 65 years
- Unable to sign a written informed consent or unwilling to cooperate
- They do not have the qualification for supporting Tibet or do not meet the basic requirements of medical examination for supporting Tibet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments: A Clinical Study of Doctors From Peking Union Medical College Hospital
This study is a single-center prospective observational study. It plans to use a series of physiological and medical instruments and international common physiological and psychological questionnaires. To dynamically detect the changes of physiological and psychological adaptability of doctors in Peking Union Medical College Hospital before leaving Beijing, 1-7 days after arriving at the plateau in Tibet during the acute phase of plateau hypoxic stress, 2 weeks, 3 months, 6 months, 12 months after staying in Tibet during the chronic phase of plateau hypoxic stress, and after returning to Beijing.
- Conditions
- High Altitude
- Being tested
- measurement
- Keywords
- high altitude, adaptation, acclimatization
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurementOther
Measurement of multiple physiological indicators and psychological status and multi-omics study
| Study group | Role | What they receive |
|---|---|---|
| Doctors to Tibet from Peking Union Medical College Hospital in 2024 | Not described Receives: Other: measurement | |
| Doctors to Tibet from Peking Union Medical College Hospital in 2025 | Not described Receives: Other: measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
help understand the physiological mechanisms and psychological changes of hypoxic adaptation
This study is expected to increase our understanding of the physiological mechanisms and psychological changes of hypoxic adaptation mainly through analysis of multi-omics.
Measured: 2024-5-27~2026-12-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start17 May 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High AltitudeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DONG WU, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557928
- Sponsor's protocol ID
- 2022-I2M-1-003
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments: A Clinical Study of Doctors From Peking Union Medical College Hospital
- ClinicalTrials.gov ID
- NCT06557928
- Acronym / sponsor ID
- 2022-I2M-1-003
- Conditions
- High Altitude
- Keywords
- high altitude, adaptation, acclimatization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Aug 2024 (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.
This study is a single-center prospective observational study. It plans to use a series of physiological and medical instruments and international common physiological and psychological questionnaires. To dynamically detect the changes of physiological and psychological adaptability of doctors in Peking Union Medical College Hospital before leaving Beijing, 1-7 days after arriving at the plateau in Tibet during the acute phase of plateau hypoxic stress, 2 weeks, 3 months, 6 months, 12 months after staying in Tibet during the chronic phase of plateau hypoxic stress, and after returning to Beijing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doctors to Tibet from Peking Union Medical College Hospital in 2024 | – | Other: measurement |
| Doctors to Tibet from Peking Union Medical College Hospital in 2025 | – | Other: measurement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Doctors in Tibet from Peking Union Medical College Hospital
Key inclusion criteria (3 listed)
- Healthy individuals aged 20-65 years
- They can sign a written informed consent and is willing to cooperate
- They have the qualification to aid Tibet and meet the basic requirements of physical examination for aid to Tibet
Key exclusion criteria (3 listed)
- Age less than 20 years or more than 65 years
- Unable to sign a written informed consent or unwilling to cooperate
- They do not have the qualification for supporting Tibet or do not meet the basic requirements of medical examination for supporting Tibet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurementMeasurement of multiple physiological indicators and psychological status and multi-omics study | Other | Doctors to Tibet from Peking Union Medical College Hospital in 2024, Doctors to Tibet from Peking Union Medical College Hospital in 2025 |
Primary outcome
help understand the physiological mechanisms and psychological changes of hypoxic adaptation
Time frame: 2024-5-27~2026-12-1
This study is expected to increase our understanding of the physiological mechanisms and psychological changes of hypoxic adaptation mainly through analysis of multi-omics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 High Altitude, run by Peking Union Medical College 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 16 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
help understand the physiological mechanisms and psychological changes of hypoxic adaptation (time frame: 2024-5-27~2026-12-1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.