Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-01 @ 9:34 PM
Study NCT ID:
NCT01621061
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Related Breathing Disturbances and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535833', 'term': 'Pulmonary edema of mountaineers'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-14', 'studyFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2012-06-13', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep related breathing disturbances', 'timeFrame': '4 months', 'description': 'Nocturnal oxygen saturation and apnea/hypopnea index'}], 'secondaryOutcomes': [{'measure': 'Pulmonary artery pressure', 'timeFrame': '4 months', 'description': 'Echocardiography'}, {'measure': 'Dyspnea', 'timeFrame': '4 months', 'description': 'NYHA functional class'}, {'measure': 'Vigilance', 'timeFrame': '4 months', 'description': 'Psychomotor vigilance'}, {'measure': 'Exercise performance', 'timeFrame': '4 months', 'description': '6 min walk test'}, {'measure': 'Pulmonary function', 'timeFrame': '4 months', 'description': 'Spirometry'}, {'measure': 'Cerebral oxygen saturation', 'timeFrame': '4 months', 'description': 'Near-infrared spectroscopy'}, {'measure': 'Mountain sickness', 'timeFrame': '4 months', 'description': 'Quinghai chronic mountain sickness score'}, {'measure': 'Generic quality of life', 'timeFrame': '4 months', 'description': 'SF-36 quality of life questionnaire'}, {'measure': 'Disease specific quality of life', 'timeFrame': '4 months', 'description': 'Kansas City Cardiomyopathy questionnaire'}, {'measure': 'Subjective sleepiness', 'timeFrame': '4 months', 'description': 'Epworth sleepiness scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['high altitude illness', 'pulmonary hypertension', 'sleep apnea', 'hypoxia'], 'conditions': ['High Altitude Pulmonary Hypertension', 'Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term residents at altitudes \\>2500 m, is characterized by dyspnea, hypoxemia, impaired exercise performance and hypertension in the pulmonary circulation. Whether sleep related breathing disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the current study will investigate whether highlanders with high altitude pulmonary hypertension have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Highlanders with high altitude pumonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of \\<1000 m.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high altitude pulmonary hypertension confirmed by clinical presentation and systolic pulmonary artery pressure \\>50 mmHg measured by echocardiography at altitude of residence.\n* healthy subjects (high altitude controls)\n* Both genders\n* Age \\>16 y\n* Kyrgyz ethnicity\n* born, raised and currently living at \\>2500 m\n* healthy subjects currently living at \\<1000 m (low altitude controls)\n\nExclusion criteria:\n\n* Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography\n* excessive erythrocytosis\n* other coexistent disorders that may interfere with the cardio-respiratory system and sleep\n* regular use of medication that affects control of breathing\n* heavy smoking'}, 'identificationModule': {'nctId': 'NCT01621061', 'briefTitle': 'Sleep Related Breathing Disturbances and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders', 'orgStudyIdInfo': {'id': '01-7/219'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High altitude pulmonary hypertension', 'description': 'Highlanders with high altitude pulmonary hypertension'}, {'label': 'High altitude control', 'description': 'Healthy highlanders'}, {'label': 'Low altitude control', 'description': 'Healthy lowlanders'}]}, 'contactsLocationsModule': {'locations': [{'zip': '720040', 'city': 'Bishkek', 'country': 'Kyrgyzstan', 'facility': 'National Center for Cardiology and Internal Medicine', 'geoPoint': {'lat': 42.87, 'lon': 74.59}}], 'overallOfficials': [{'name': 'Konrad E Bloch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich, Switzerland'}, {'name': 'Talant Sooronbaev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov'}]}, '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': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Konrad E. Bloch', 'investigatorAffiliation': 'University of Zurich'}}}}