Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-28 @ 10:40 AM
Study NCT ID:
NCT01365832
Status:
COMPLETED
Last Update Posted:
2011-06-06
First Post:
2011-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}, {'id': 'D011175', 'term': 'Positive-Pressure Respiration'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 436}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-03', 'studyFirstSubmitDate': '2011-05-17', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment.', 'timeFrame': 'Day 1, Month 3 and Month 6 post treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'C-reactive protein (CRP) is directly implicated in atherogenesis and associated cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and thus consequently improve disease-related cardiovascular morbidity. However, the influence of gender on the CRP evolution pattern has never been assessed before. The aim of our study was to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months after the start of effective CPAP treatment.', 'detailedDescription': 'OSA is an independent risk factor for a number of cardiovascular diseases. One important possible mechanism underlying cardiovascular disease in patients with OSA is systemic inflammation. CRP, an acute phase reactant secreted by the liver, is one of the most actively studied biomarkers of low-grade inflammation, and numerous studies have shown that higher CRP levels are associated with high mortality and morbidity due to cardiovascular disease in men and women. In patients with OSA, the question as to whether or not CRP levels are elevated is still under debate. Although continuous positive airway pressure (CPAP) is effective in the management of OSA, conflicting data also exist regarding the effects of CPAP on CRP levels. However, none of the existing studies assessed the influence of gender on the CRP evolution pattern. Therefore, the aim of this study was to investigate possible gender differences in CRP evolution in patients with moderate to severe OSA, free of medical comorbidities, 3 and 6 months after the start of effective CPAP treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with apnoea-hypopnoea index \\>15/h\n\nExclusion Criteria:\n\n* chronic obstructive pulmonary disease\n* diabetes mellitus\n* coronary artery disease\n* congestive heart failure\n* chronic renal failure\n* known dyslipidemia\n* smoking history\n* hypothyroidism\n* chronic or recent infectious or inflammatory disease\n* use of anti-inflammatory or antibiotic drugs, or statins.\n* postmenopausal females on estrogen replacement therapy.'}, 'identificationModule': {'nctId': 'NCT01365832', 'briefTitle': 'Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)', 'organization': {'class': 'OTHER', 'fullName': 'University of Crete'}, 'officialTitle': 'CRP Evolution Pattern in CPAP Treated Obstructive Sleep Apnea Patients. Does Gender Play a Role?', 'orgStudyIdInfo': {'id': 'OSACRP-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep apnea', 'description': 'Participants with Obstructive Sleep Apnea (OSA).This arm will undergo a pre-treatment blood draw, six months of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw 3 and 6 months later.\n\nIntervention: Procedure: Continuous Positive Airway Pressure (CPAP)', 'interventionNames': ['Procedure: Continuous Positive Airway Pressure (CPAP)']}], 'interventions': [{'name': 'Continuous Positive Airway Pressure (CPAP)', 'type': 'PROCEDURE', 'otherNames': ['positive pressure ventilation'], 'description': 'Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment blood draw 3 and 6 months after the start of effective CPAP treatment', 'armGroupLabels': ['Sleep apnea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71110', 'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}], 'overallOfficials': [{'name': 'Sophia E Schiza, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Crete'}, {'name': 'Charalampos Mermigkis, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece'}, {'name': 'Izolde Bouloukaki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Crete'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Crete', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sophia Schiza', 'oldOrganization': 'University of Crete'}}}}