Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03637127
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2018-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Exposure of Simulated Hypoxia on Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The allocated gas mixture will not be disclosed to the patient since he will breath through a facemask during both interventions.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Including a baseline assessment and assessments under simulated altitude and normoxia.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-04-01', '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': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Function test', 'timeFrame': '2 hours', 'description': 'Change in cognitive function test time during the exposure to simulated altitude (FiO2: 15.1%) and normoxia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Simulated altitude', 'cognitive function'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on cognitive functions.', 'detailedDescription': 'Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.\n\nRandomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.\n\nDuring the exposure to simulated altitude (FiO2: 15.1%) of approximately 1 hour, the participants will perform cognitive function test .\n\nThe results will be compared under hypoxic and normal conditions.'}, '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: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (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 partial oxygen pressure (PaO2) ≤7.3 kilopascal (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, high-altitude pulmonary edema (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': 'NCT03637127', 'briefTitle': 'Acute Exposure of Simulated Hypoxia 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_A4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Order air-hypoxia', 'description': 'The participants will be exposed to shamed hypoxia (FiO2: 20.9% equivalent to sea level and consecutively to simulated altitude (FiO2: 15.1% equivalent to 2500m above sea level) administered by an altitude Simulator ("Altitrainer, SMTEC"), simulated altitude (FiO2: 15.1%), with a facemask.', 'interventionNames': ['Device: Simulated Altitude (FiO2: 15.1%)', 'Device: Shamed Hypoxia (FiO2: 20.9)']}, {'type': 'EXPERIMENTAL', 'label': 'Order hypoxia-air', 'description': 'The participant will be exposed to hypoxia (FiO2, 15.1% equivalent to 2500m above sea level), simulated altitude (FiO2: 15.1%), and consecutively to shamed hypoxia (FiO2, 20.9%) administered by an altitude simulator ("Altitrainer, SMTEC") with a facemask.', 'interventionNames': ['Device: Simulated Altitude (FiO2: 15.1%)', 'Device: Shamed Hypoxia (FiO2: 20.9)']}], 'interventions': [{'name': 'Simulated Altitude (FiO2: 15.1%)', 'type': 'DEVICE', 'description': 'Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 1 hour. given by a facemask.', 'armGroupLabels': ['Order air-hypoxia', 'Order hypoxia-air']}, {'name': 'Shamed Hypoxia (FiO2: 20.9)', 'type': 'DEVICE', 'description': 'Inhalation of unmodified air through an altitude Simulator ("Altitrainer") for approximately 1 hour given by a facemask', 'armGroupLabels': ['Order air-hypoxia', 'Order hypoxia-air']}]}, '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'}}}}