Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT00863135
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2009-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hours blood pressure monitoring', 'timeFrame': 'basal and after three months of CPAP treatment'}], 'secondaryOutcomes': [{'measure': 'oxidative stress and inflammatory mediators', 'timeFrame': 'basal and after three months of CPAP treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'refractory arterial hypertension', 'continuous positive airways pressure'], 'conditions': ['Obstructive Sleep Apnea', 'Refractory Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of CPAP treatment on blood pressure in patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH).\n\nAlso, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress, sympathetic hyperactivity) will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15\n\nExclusion Criteria:\n\n* excessive sleepiness\n* professional drivers\n* secondary arterial hypertension'}, 'identificationModule': {'nctId': 'NCT00863135', 'briefTitle': 'Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension', 'orgStudyIdInfo': {'id': 'FIS PI070219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous Positive Airway Pressure', 'description': 'nocturnal continuous positive airways pressure', 'interventionNames': ['Device: CPAP']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time', 'interventionNames': ['Device: Control']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'continuous positive airways pressure', 'armGroupLabels': ['Continuous Positive Airway Pressure']}, {'name': 'Control', 'type': 'DEVICE', 'description': 'Patients are 3 months without any change in their treatment, and are in the waiting list to come into the CPAP procedure after that time', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporacio Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Jaume Almirall, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporació Parc Taulí'}, {'name': 'Juan-Carlos Martinez-Ocaña, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Corporació Parc Tauli'}, {'name': 'Antonio Ferrer, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Corporacio Parc Tauli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carlos III Health Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Jaume Almirall', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}