High AltitudeNCT07018193
The Study of Personalized Health Check-up Programs and Standards for High-altitude Migrant Populations
An observational study of High Altitude, run by Capital Medical University.
Trial summary
By using wearable devices to monitor and record the physiological data changes and health outcomes (incidence and severity of high-altitude illnesses) of high-altitude migrants at different stages (pre-entry, acute/chronic high-altitude phases, and de-acclimatization phase), and referencing previous cohort studies on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Altitude
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 31 Dec 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruit those who live in plains and prepare to move to the plateau in the short term or medium term.
Who may be able to join
- Men and women aged ≥18;
- Those living in plains and preparing to move to the plateau for a short-term or medium-term period;
- Can understand the research requirements and be willing to sign a written informed consent form (ICF).
Who cannot join
- Past history of contraindicated plateau travel: such as advanced COPD (FEV₁<30% of the expected value or requires continuous oxygen therapy), advanced cystic fibrosis (FEV₁<30% of the expected value or requires continuous oxygen therapy), advanced restricted pulmonary disease (FEV₁<50% of the expected value or requires continuous oxygen therapy), decompensated heart failure, high-risk pregnancy, myocardial infarction or stroke occurred within 90 days, poorly controlled epilepsy, pulmonary hypertension (PASP>90mmHg), sickle cell anemia, unstable angina pectoris, high-risk cerebrovascular abnormalities that have not been treated, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
By using wearable devices to monitor and record the physiological data changes and health outcomes (incidence and severity of high-altitude illnesses) of high-altitude migrants at different stages (pre-entry, acute/chronic high-altitude phases, and de-acclimatization phase), and referencing previous cohort studies on high-altitude populations, the study aims to provide a basis for developing personalized health assessment protocols for high-altitude migrants. The formulated assessment protocols and standards will then be validated.
- Conditions
- High Altitude
- Medical subject headings
- Altitude Sickness
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 |
|---|---|---|
| Exploration group | 200 participants, to explore and formulate and optimize personalized plans and standards for health examinations for people living in plateaus. | |
| Verification group | 100 participants, to verify the feasibility of the physical examination plan and its effectiveness in the early diagnosis of altitude sickness and plateau environment-related comorbidities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of high altitude sickness and related diseases.
Early diagnosis rates of acute and chronic altitude sickness and related diseases induced or aggravated by the plateau population in migrant plateau populations.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 Capital Medical UniversityThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018193
- Sponsor's protocol ID
- PHC-high
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Personalized Health Check-up Programs and Standards for High-altitude Migrant Populations
- ClinicalTrials.gov ID
- NCT07018193
- Acronym / sponsor ID
- PHC-high
- Conditions
- High Altitude
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jun 2025 (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.
By using wearable devices to monitor and record the physiological data changes and health outcomes (incidence and severity of high-altitude illnesses) of high-altitude migrants at different stages (pre-entry, acute/chronic high-altitude phases, and de-acclimatization phase), and referencing previous cohort studies on high-altitude populations, the study aims to provide a basis for developing personalized health assessment protocols for high-altitude migrants. The formulated assessment protocols and standards will then be validated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exploration group | – | –200 participants, to explore and formulate and optimize personalized plans and standards for health examinations for people living in plateaus. |
| Verification group | – | –100 participants, to verify the feasibility of the physical examination plan and its effectiveness in the early diagnosis of altitude sickness and plateau environment-related comorbidities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruit those who live in plains and prepare to move to the plateau in the short term or medium term.
Key inclusion criteria (3 listed)
- Men and women aged ≥18;
- Those living in plains and preparing to move to the plateau for a short-term or medium-term period;
- Can understand the research requirements and be willing to sign a written informed consent form (ICF).
Key exclusion criteria (1 listed)
- Past history of contraindicated plateau travel: such as advanced COPD (FEV₁<30% of the expected value or requires continuous oxygen therapy), advanced cystic fibrosis (FEV₁<30% of the expected value or requires continuous oxygen therapy), advanced restricted pulmonary disease (FEV₁<50% of the expected value or requires continuous oxygen therapy), decompensated heart failure, high-risk pregnancy, myocardial infarction or stroke occurred within 90 days, poorly controlled epilepsy, pulmonary hypertension (PASP>90mmHg), sickle cell anemia, unstable angina pectoris, high-risk cerebrovascular abnormalities that have not been treated, etc.
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
Rates of high altitude sickness and related diseases.
Time frame: through study completion, an average of 3 years
Early diagnosis rates of acute and chronic altitude sickness and related diseases induced or aggravated by the plateau population in migrant plateau populations.
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 12 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of High Altitude, run by Capital Medical University.
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 1 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: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yuan Wang, MD (+86-13581567815, wilma0106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of high altitude sickness and related diseases. (time frame: through study completion, an average of 3 years). 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 12 Jun 2025.