Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT00559832
Status:
COMPLETED
Last Update Posted:
2007-11-16
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Acute Mountain Sickness by Intermittent Hypoxia
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-15', 'studyFirstSubmitDate': '2007-11-15', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of acute mountain sickness', 'timeFrame': 'during one night at 4500 m'}], 'secondaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'during one night at altitude'}, {'measure': 'ventilatory acclimatization', 'timeFrame': 'during one night at altitude'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute mountain sickness', 'intermittent hypoxia', 'acclimatization'], 'conditions': ['Acute Mountain Sickness']}, 'descriptionModule': {'briefSummary': 'Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective in prevention of acute mountain sickness (AMS).\n\nThe aim of this study is to investigate whether intermittent exposure to normobaric hypoxia during sleep is also effective to prevent AMS.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n\nExclusion Criteria:\n\n* Altitude exposure above 2000 m 8 weeks prior or during the study'}, 'identificationModule': {'nctId': 'NCT00559832', 'briefTitle': 'Prevention of Acute Mountain Sickness by Intermittent Hypoxia', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Prevention of Acute Mountain Sickness by Sleeping at Simulated Altitude (Normobaric Hypoxia)', 'orgStudyIdInfo': {'id': '039/2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Normoxia', 'description': 'Sleeping in normoxia for 14 nights prior to one night at 4500 m'}, {'type': 'EXPERIMENTAL', 'label': 'Hypoxia', 'description': 'Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m', 'interventionNames': ['Other: Hypoxic Exposure']}], 'interventions': [{'name': 'Hypoxic Exposure', 'type': 'OTHER', 'description': 'Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m', 'armGroupLabels': ['Hypoxia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Sports Medicine, University Hospital', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Christoph Dehnert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}}}}