NCT07018193

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jun 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jun 2025Dec 2028

First Submitted

Initial submission to the registry

May 12, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 12, 2025

Status Verified

May 1, 2025

Enrollment Period

3.5 years

First QC Date

May 12, 2025

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 3 years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Recruit those who live in plains and prepare to move to the plateau in the short term or medium term.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2025

First Posted

June 12, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 12, 2025

Record last verified: 2025-05