Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-03-01 @ 7:59 AM
Study NCT ID:
NCT03637192
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2018-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Exposure of High Altitude on Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Including a baseline assessment and assessments at Low altitude and High altitude'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Function test', 'timeFrame': '1 day at altitude', 'description': 'Change in cognitive function test time during the exposure to High altitude (Säntis ; 2500m above sea level) compared to low altitude (Zurich)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Altitude', 'cognitive function'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Randomized crossover Trial in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to High Altitude (2500m above sea level) on cognitive functions', 'detailedDescription': 'Low altitude baseline measurements will be performed in Zurich (460m) including Echocardiography, Right heart catheterization, 6 Minute walk test, pulmonary function test, clinical assessment and blood gas analysis.\n\nRandomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).\n\nDuring the exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hour, the participants will perform cognitive function test .\n\nThe results will be compared to low altitude in Zurich (470m).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis\n* PH class 1 (PAH) or 4 (CTEPH)\n* Stable condition, on the same medication for \\> 4 weeks\n* Patient live permanently at an altitude \\< 1000m asl.\n\nExclusion Criteria:\n\n* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \\> 16hour daily (nocturnal oxygen therapy alone is allowed)\n* Severe daytime hypercapnia (pCO2 \\> 6.5 kPa)\n* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.\n* Exposure to an altitude \\>1500m for ≥3 nights during the last 4 weeks before the study participation\n* Residence \\> 1000m above sea level\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability\n* Women who are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT03637192', 'briefTitle': 'Acute Exposure of High Altitude on Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise', 'orgStudyIdInfo': {'id': '2018-00455_B6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Order A', 'description': 'The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)', 'interventionNames': ['Other: Low altitude: 470m above sea level']}, {'type': 'EXPERIMENTAL', 'label': 'Order B', 'description': 'The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).', 'interventionNames': ['Other: Low altitude: 470m above sea level', 'Other: Säntis; 2500m above sea Level']}], 'interventions': [{'name': 'Low altitude: 470m above sea level', 'type': 'OTHER', 'description': 'Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure', 'armGroupLabels': ['Order A', 'Order B']}, {'name': 'Säntis; 2500m above sea Level', 'type': 'OTHER', 'description': 'Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours', 'armGroupLabels': ['Order B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Respiratory Clinic, University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Silvia Ulrich, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}