Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 5:39 PM
Study NCT ID:
NCT01201200
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2010-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right Ventricular Function in Patients With Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-07', 'studyFirstSubmitDate': '2010-09-13', 'studyFirstSubmitQcDate': '2010-09-13', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Right Ventricular Function', 'Pulmonary Hypertension'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in right ventricular function evaluated by three dimensional echocardiography.', 'detailedDescription': 'Several studies have reported the association between sleep disorders to an increased risk to the development of cardiac disease. However, there is no substantial that about the influence of Obstructive Sleep Apnea on the right ventricular function. Objective: to analyse the right ventricular function in patients with Obstructive Sleep Apnea by means of Real-Time Three dimensional Echocardiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Initially, 56 patients with obstructive sleep apnea (OSA) and 50 non-OSA controls underwent real-time three-dimensional echocardiography. 30 Patients with moderate and severe OSA underwent to continuous positive airway pressure treatment over 6 months. Echocardiogram will be repeated on the third and sixth months from the treatment onset.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals \\> 18 years old and \\< 70.\n\nExclusion Criteria:\n\n* Body mass index greater than 35\n* Past of clinically significant cardiac conditions'}, 'identificationModule': {'nctId': 'NCT01201200', 'briefTitle': 'Right Ventricular Function in Patients With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Associação Fundo de Incentivo à Pesquisa'}, 'officialTitle': 'Right Ventricular Function in Patients With Obstructive Sleep Apnea Assessed by Real-time Three-dimensional Echocardiography', 'orgStudyIdInfo': {'id': 'Eco2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 - Obstructive Sleep Apnea (OSA)', 'description': 'Fifty-six patients with Obstructive Sleep Apnea'}, {'label': 'Group 2 - Non-OSA Controls', 'description': 'Fifty individuals without OSA with similar age, gender and body mass index (BMI)'}, {'label': 'Group 3 - Treatment', 'description': 'Fifteen patients with moderate and severe sleep apnea from group 1 underwent treatment with continuous positive airway pressure'}, {'label': 'Group 4 - Placebo', 'description': 'Fifteen patients with moderate/severe sleep apnea underwent to placebo'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04516001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Escola Paulista de Medicina', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Orlando Campos, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Escola Paulista de Medicina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associação Fundo de Incentivo à Pesquisa', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wercules Oliveira', 'oldOrganization': 'AFIP/Escola Paulista de Medicina'}}}}