Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
Study NCT ID:
NCT06557928
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-08-16
First Post:
2024-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'help understand the physiological mechanisms and psychological changes of hypoxic adaptation', 'timeFrame': '2024-5-27~2026-12-1', 'description': 'This study is expected to increase our understanding of the physiological mechanisms and psychological changes of hypoxic adaptation mainly through analysis of multi-omics.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high altitude', 'adaptation', 'acclimatization'], 'conditions': ['High Altitude']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Doctors in Tibet from Peking Union Medical College Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals aged 20-65 years\n* They can sign a written informed consent and is willing to cooperate\n* They have the qualification to aid Tibet and meet the basic requirements of physical examination for aid to Tibet\n\nExclusion Criteria:\n\n* Age less than 20 years or more than 65 years\n* Unable to sign a written informed consent or unwilling to cooperate\n* They do not have the qualification for supporting Tibet or do not meet the basic requirements of medical examination for supporting Tibet'}, 'identificationModule': {'nctId': 'NCT06557928', 'briefTitle': 'Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments: A Clinical Study of Doctors From Peking Union Medical College Hospital', 'orgStudyIdInfo': {'id': '2022-I2M-1-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Doctors to Tibet from Peking Union Medical College Hospital in 2024', 'interventionNames': ['Other: measurement']}, {'label': 'Doctors to Tibet from Peking Union Medical College Hospital in 2025', 'interventionNames': ['Other: measurement']}], 'interventions': [{'name': 'measurement', 'type': 'OTHER', 'description': 'Measurement of multiple physiological indicators and psychological status and multi-omics study', 'armGroupLabels': ['Doctors to Tibet from Peking Union Medical College Hospital in 2024', 'Doctors to Tibet from Peking Union Medical College Hospital in 2025']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Gastroenterology', 'investigatorFullName': 'DONG WU', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}