Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-12 @ 10:04 PM
Study NCT ID:
NCT02451020
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2015-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acclimatization of Healthy Subjects During a Stay at 3200 m
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2015-05-18', 'studyFirstSubmitQcDate': '2015-05-20', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean nocturnal oxygen saturation measured by pulse oximetry', 'timeFrame': 'night 7 at 3200 m', 'description': 'Difference in mean nocturnal oxygen saturation between night 1 and night 7'}], 'secondaryOutcomes': [{'measure': 'Mean nocturnal oxygen saturation measured by pulse oximetry', 'timeFrame': 'night 1 at 3200 m', 'description': 'Difference in mean nocturnal oxygen saturation between night 1 at 3200 and night 1 at 700 m'}, {'measure': 'Mean nocturnal oxygen saturation measured by pulse oximetry', 'timeFrame': 'night 21 at 3200 m', 'description': 'Difference in mean nocturnal oxygen saturation between night 21 and night 1 at 3200 m'}, {'measure': 'Mean nocturnal oxygen saturation measured by pulse oximetry', 'timeFrame': 'night 1 at 700 m (low altitude baseline)', 'description': 'Mean nocturnal oxygen saturation during night 1 at 700 m'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy volunteers', 'acclimatization', 'sleep', 'hypoxia'], 'conditions': ['Effects of High Altitude']}, 'descriptionModule': {'briefSummary': 'The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.', 'detailedDescription': 'This study evaluates the effect of 3 weeks altitude acclimatization on sleep related breathing disturbances in healthy subjects staying at 3200 m. Participants living in Bishkek, Kyrgyzstan (700 m), will be transferred by car within 4 h to the Tuja Ashu high altitude clinic (3200 m). Outcomes will be assessed repeatedly during the stay at 3200 m.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Perfect health\n* Born, raised and currently living at low altitude (\\<800m)\n* Informed consent.\n\nExclusion Criteria:\n\n* Any acute or chronic disease\n* heavy smoking (\\>20 cigarettes per day).'}, 'identificationModule': {'nctId': 'NCT02451020', 'briefTitle': 'Acclimatization of Healthy Subjects During a Stay at 3200 m', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Acclimatization of Healthy Subjects During a Stay at 3200 m', 'orgStudyIdInfo': {'id': 'EK15-2015_V2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Altitude exposure', 'description': 'Stay at 3200 m for 3 weeks', 'interventionNames': ['Other: Altitude exposure']}], 'interventions': [{'name': 'Altitude exposure', 'type': 'OTHER', 'description': 'Participants will stay for 3 weeks at an altitude of 3200 m', 'armGroupLabels': ['Altitude exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '720040', 'city': 'Bishkek', 'country': 'Kyrgyzstan', 'facility': 'National Center of Cardiology and Internal Medicine', 'geoPoint': {'lat': 42.87, 'lon': 74.59}}], 'overallOfficials': [{'name': 'Konrad E Bloch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Zürich'}, {'name': 'Talant M Sooronbaev, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}