Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-03 @ 11:13 AM
Study NCT ID:
NCT04093102
Status:
UNKNOWN
Last Update Posted:
2019-09-17
First Post:
2019-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Biomarkers to Screen for Obstructive Sleep Apnea
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': 'D000074062', 'term': 'Environmental Biomarkers'}], 'ancestors': [{'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004784', 'term': 'Environmental Monitoring'}, {'id': 'D004781', 'term': 'Environmental Exposure'}, {'id': 'D004787', 'term': 'Environmental Pollution'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-14', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-09-14', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of biomarkers to screen for obstructive sleep apnea', 'timeFrame': 'baseline', 'description': 'analysis of biomarkers results (which include Pentraxin 3, HbA1C,Uric acid,CRP,ESR,Plasma fibrinogen) will be assessed and compared to the results of polysymnography'}], 'secondaryOutcomes': [{'measure': 'Inflammatory biomarker level in OSA patients compared to controls', 'timeFrame': 'baseline', 'description': 'Inflammatory biomarkers which include ESR , CRP and pentraxin 3 will be measured and compared in both cases and controls.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '27448424', 'type': 'BACKGROUND', 'citation': 'Watson NF. Health Care Savings: The Economic Value of Diagnostic and Therapeutic Care for Obstructive Sleep Apnea. J Clin Sleep Med. 2016 Aug 15;12(8):1075-7. doi: 10.5664/jcsm.6034.'}, {'pmid': '10505820', 'type': 'BACKGROUND', 'citation': 'Kapur V, Blough DK, Sandblom RE, Hert R, de Maine JB, Sullivan SD, Psaty BM. The medical cost of undiagnosed sleep apnea. Sleep. 1999 Sep 15;22(6):749-55. doi: 10.1093/sleep/22.6.749.'}, {'pmid': '27380998', 'type': 'BACKGROUND', 'citation': 'Maeder MT, Mueller C, Schoch OD, Ammann P, Rickli H. Biomarkers of cardiovascular stress in obstructive sleep apnea. Clin Chim Acta. 2016 Sep 1;460:152-63. doi: 10.1016/j.cca.2016.06.046. Epub 2016 Jul 2.'}, {'pmid': '22796846', 'type': 'BACKGROUND', 'citation': 'Montesi SB, Bajwa EK, Malhotra A. Biomarkers of sleep apnea. Chest. 2012 Jul;142(1):239-245. doi: 10.1378/chest.11-2322.'}]}, 'descriptionModule': {'briefSummary': 'assess the relationship between obstructive sleep apnea and endocrine, inflammatory, and metabolic bio-markers in consecutively enrolled adult male patients with a clinical suspicion of obstructive sleep apnea.', 'detailedDescription': 'Obstructive sleep apnea (OSA) is a disorder with high prevalence, estimated to occur in 34% of men and 17% of women , afflicting more than 100 million adults worldwide.\n\nOSA is the third most common serious respiratory condition after Asthma and COPD.\n\nPatients with untreated OSA are at increased risk for hypertension, cardiovascular disease, heart failure, stroke, obesity, metabolic dysregulation, diabetes mellitus, daytime sleepiness, depression, accidents and are a significant burden on the healthcare system.\n\nUnfortunately, up to 90% of individuals with OSA remain without a diagnosis or therapy.\n\nThe association between OSA and adverse health consequences has led the American Heart Association and others to suggest that OSA screening be integrated into routine clinical care.\n\nCurrent tools for OSA screening rely on questionnaires with low diagnostic accuracy from low-quality studies, as reported in meta-analyses, OSA screening measures that are frequently used include the Epworth Sleepiness Scale (ESS) and STOP-Bang questionnaires.\n\nThe ESS assesses subjective daytime sleepiness but is nonspecific for OSA, was not designed nor validated for OSA screening.\n\nThe recent American Academy of Sleep Medicine (AASM) clinical practice guidelines report that more accurate and user-friendly screening tools, such as blood bio-markers, are needed to better predict OSA diagnosis and severity, a recent review of potential OSA bio-markers concludes that an optimal screening test should be clinically sensitive, specific, simple, timely, inexpensive, and correlate to disease severity.\n\nFurthermore, bio-markers should make pathophysiological sense, reflecting functional changes that accompany OSA.\n\nNumerous individual OSA blood bio-markers have been studied previously dysfunctions in metabolic and endocrine systems induced by OSA, chronic inflammation, hypoxemia, sleep fragmentation, and stress are associated with alterations in bio-markers. These bio-markers include glycated hemoglobin (HbA1c), C-reactive protein (CRP), erythropoietin (EPO), and uric acid,Unfortunately, the diagnostic utility of individual bio-markers or combinations of markers is inconclusive in identifying OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'it will be patients with suspected OSA , bio-markers testing and polysomnography will be done for all participants.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients with a clinical suspicion of obstructive sleep apnea enrolled to the investigator's chest department.\n\nExclusion Criteria:\n\n* Patients who previously treated as obstructive sleep apnea, or receiving opioid pain medications."}, 'identificationModule': {'nctId': 'NCT04093102', 'briefTitle': 'Role of Biomarkers to Screen for Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Biomarkers to Screen for Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'obstructive sleep apnea'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases', 'description': 'cases with obsrtuctive sleep apnea', 'interventionNames': ['Diagnostic Test: biomarkers']}, {'label': 'control', 'description': 'cases without obstructive sleep apnea.', 'interventionNames': ['Diagnostic Test: biomarkers']}], 'interventions': [{'name': 'biomarkers', 'type': 'DIAGNOSTIC_TEST', 'description': 'bio-markers testing will be made to all suspected OSA patients(CRP, Hba1C,uric acid, ESR, plasma fibrinogen, pentraxin3), and to control cases.', 'armGroupLabels': ['cases', 'control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abuzaid', 'role': 'CONTACT', 'email': 'anaover32@yahoo.com', 'phone': '01064756136'}, {'name': 'doaa magdy, lecturer', 'role': 'CONTACT', 'email': 'doaa_magy2020@yahoo.com', 'phone': '01006261010'}], 'overallOfficials': [{'name': 'suzan salama, professor', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ali Abuzaid Ali', 'investigatorAffiliation': 'Assiut University'}}}}