Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-24 @ 5:07 AM
Study NCT ID:
NCT03070769
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2017-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1053}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls.', 'timeFrame': '4 years', 'description': 'Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls,as assessed by high sensitive -C-reactive protein (hs-CRP), Fibrinogen, Erythrocyte sedimentation rate (ESR) and uric acid (UA).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea of Adult']}, 'referencesModule': {'references': [{'pmid': '28831208', 'type': 'DERIVED', 'citation': 'Bouloukaki I, Mermigkis C, Tzanakis N, Kallergis E, Moniaki V, Mauroudi E, Schiza SE. Evaluation of Inflammatory Markers in a Large Sample of Obstructive Sleep Apnea Patients without Comorbidities. Mediators Inflamm. 2017;2017:4573756. doi: 10.1155/2017/4573756. Epub 2017 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of OSA patients and to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters.\n\nSubjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI \\< 5 served as control group. Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between groups.', 'detailedDescription': 'Systemic inflammation is important in obstructive sleep apnea (OSA) pathophysiology and its comorbidity. The objective of this study was to investigate how early biomarkers of inflammation may be altered in OSA patients. To complete this goal the investigators assessed the circulating levels of four inflammatory markers, hs-C-reactive protein (hs-CRP), Fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) in a representative population of consecutively enrolled, untreated and otherwise healthy subjects with a clinical suspicion of obstructive sleep apnea. A secondary objective was to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters of these subjects.Subjects who had undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI \\< 5 served as control group. Demographic, PSG data, serum levels of hs-CRP, fibrinogen, ESR and UA were measured and compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients, who were admitted to the Sleep Disorders Center, Department of Thoracic Medicine, University of Crete Medical School, for evaluation of suspected sleep-disordered breathing, were considered as potential recruits for this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed, untreated, and otherwise healthy obstructive sleep apnea (OSA) patients\n* healthy subjects (without OSA)\n\nExclusion Criteria:\n\n* refusal to participate,\n* previous OSA diagnosis and treatment\n* known comorbidities,\n* pregnancy,\n* history of narcolepsy or restless leg syndrome.\n* Subjects younger than 18 years,\n* Central sleep apnea syndrome (CSAS) diagnosed with PSG,'}, 'identificationModule': {'nctId': 'NCT03070769', 'briefTitle': 'Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Crete'}, 'officialTitle': 'Evaluation of Inflammatory Markers in a Large Sample of Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': 'OSAINFL1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Subjects without Obstructive sleep apnea (Apnea-hypopnea index-AHI\\<5). Venous blood collection for biomarkers measurements.', 'interventionNames': ['Procedure: Venous blood collection for biomarkers measurements']}, {'label': 'Obstructive sleep apnea (OSA) patients', 'description': 'Patients with Obstructive sleep apnea (AHI\\> or =5). Venous blood collection for biomarkers measurements.', 'interventionNames': ['Procedure: Venous blood collection for biomarkers measurements']}], 'interventions': [{'name': 'Venous blood collection for biomarkers measurements', 'type': 'PROCEDURE', 'description': 'Venous blood was collected in all subjects for measurements of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) between 8:00 and 9:00 AM, following an overnight fast, shortly after the conclusion of the overnight polysomnography (PSG).', 'armGroupLabels': ['Control', 'Obstructive sleep apnea (OSA) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71110', 'city': 'Heraklion', 'country': 'Greece', 'facility': 'Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}], 'overallOfficials': [{'name': 'Sophia Schiza, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Crete'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Crete', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Izolde Bouloukaki', 'investigatorAffiliation': 'University of Crete'}}}}