Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02731456
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2016-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-23', 'studyFirstSubmitDate': '2016-04-03', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained attention measured by a visual pychomotor vigilance test (PVT)', 'timeFrame': 'Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7', 'description': 'Change in psychomotor response speed across two cycles of altitude exposure, comparing 5050m to 520m.'}], 'secondaryOutcomes': [{'measure': 'Indices of sleep quality measured by actigraphy (total sleep time, sleep efficiency, sleep latency', 'timeFrame': 'Low altitude dojourn at 520m; forst sojourn at 5050m Day 2, 7; second sojourn at 5050m Day 2, 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['high altitude', 'cognition', 'sleep'], 'conditions': ['Effect of High Altitude']}, 'descriptionModule': {'briefSummary': 'Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on psychomotor vigilance to measure sustained attention.', 'detailedDescription': 'Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* born, raised and currently living \\<1300m\n* No overnight stays at altitudes \\>1500m 4 weeks before the study\n\nExclusion Criteria:\n\n* previous altitude intolerance \\<3000m\n* pregnancy\n* health impairment, which requires regular treatment'}, 'identificationModule': {'nctId': 'NCT02731456', 'briefTitle': 'Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance and Sleep Quality in Lowlanders', 'orgStudyIdInfo': {'id': 'REB15 - 2709_MOD1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Altitude exposure', 'description': 'Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude.', 'interventionNames': ['Other: altitude exposure']}], 'interventions': [{'name': 'altitude exposure', 'type': 'OTHER', 'description': 'altitude exposure', 'armGroupLabels': ['Altitude exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Marc J Poulin, PhD, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marc Poulin', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marc Poulin', 'investigatorAffiliation': 'University of Calgary'}}}}