Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT04363333
Status:
UNKNOWN
Last Update Posted:
2021-02-17
First Post:
2020-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnea & Covid-19 Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D011014', 'term': 'Pneumonia'}], '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': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2020-04-19', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Long-term outcomes', 'timeFrame': '4-6 months after the initial hospital admission', 'description': 'Re-analysis of the correlation of obstructive sleep apnea (objectively verified) severity in terms of apnea-hypopnea index and oxygenation levels with the primary and secondary outcomes as described above (the rate of clinical improvement defined as a decline of 2 categories from admission on a 7-category ordinal scale; time to hospital discharge, ICU discharge, weaning from intubation, weaning from supplemental oxygen, incident pneumonia, ARDS, in-hospital mortality as well as with the lung function, CO-diffusion capacity, cardiac function, CT thorax pathologies, biomarkers (cytokines, polymorphisms) and IgG-antibodies after 4 months.'}], 'primaryOutcomes': [{'measure': 'The rate of clinical improvement', 'timeFrame': '7 days', 'description': 'Defined as a decline of 2 categories from admission on a 7-category ordinal scale'}, {'measure': 'The rate of clinical improvement', 'timeFrame': '14 days', 'description': 'Defined as a decline of 2 categories from admission on a 7-category ordinal scale'}, {'measure': 'The rate of clinical improvement', 'timeFrame': '21 days', 'description': 'Defined as a decline of 2 categories from admission on a 7-category ordinal scale'}, {'measure': 'The rate of clinical improvement', 'timeFrame': '28 days', 'description': 'Defined as a decline of 2 categories from admission on a 7-category ordinal scale'}], 'secondaryOutcomes': [{'measure': 'Clinical status - improvement', 'timeFrame': '7, 14, 21, 28 days', 'description': 'Time to hospital discharge, ICU discharge, weaning from intubation, weaning from supplemental oxygen, incident pneumonia, ARDS, in-hospital mortality'}, {'measure': 'Clinical status - worsening', 'timeFrame': '7, 14, 21, 28 days', 'description': 'Defined as an increase in category on a 7-category ordinal scale from admission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID', 'Obstructive Sleep Apnea', 'Pneumonia'], 'conditions': ['COVID', 'Obstructive Sleep Apnea', 'Pneumonia']}, 'referencesModule': {'references': [{'pmid': '33596161', 'type': 'DERIVED', 'citation': 'Peker Y, Celik Y, Arbatli S, Isik SR, Balcan B, Karatas F, Uzel FI, Tabak L, Cetin B, Baygul A, Ozturk AB, Altug E, Iliaz S, Atasoy C, Kapmaz M, Yazici D, Bayram H, Cetin BD, Caglayan B; OSACOVID-19 Study Collaborators. Effect of High-Risk Obstructive Sleep Apnea on Clinical Outcomes in Adults with Coronavirus Disease 2019: A Multicenter, Prospective, Observational Clinical Trial. Ann Am Thorac Soc. 2021 Sep;18(9):1548-1559. doi: 10.1513/AnnalsATS.202011-1409OC.'}]}, 'descriptionModule': {'briefSummary': 'Covid-19 infection is an on-going pandemic with worse diagnosis in adults with comorbid conditions such as hypertension and cardiopulmonary diseases. Obstructive sleep apnea (OSA) is common in those comorbidities and may contribute to worse prognosis for the Covid-19 cases.', 'detailedDescription': "The investigators' primary aim is to address the association between the high probability of having OSA and Covid-19 outcomes within 28 days of the hospitalization.\n\nSecondary outcomes will be conducting a polysomnography in cases with high probability of having OSA compared to those with low probability, approx. 4 months after the Covid-19 diagnosis, and re-evaluate the association of the verified OSA diagnosis and severity with the outcomes in the first 4 weeks as well as with the outcomes after 4 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with Covid-19 diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with Covid 19 diagnosis\n* Ability to read and speak\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies\n* Subjects with alcohol dependency'}, 'identificationModule': {'nctId': 'NCT04363333', 'acronym': 'OSACOVID-19', 'briefTitle': 'Obstructive Sleep Apnea & Covid-19 Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Koç University'}, 'officialTitle': 'Impact of Obstructive Sleep Apnea on Covid-19 Outcomes (OSACOVID-19 Study): A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '2020.140.IRB1.030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High Probability of OSA', 'description': 'Based on a sleep questionnaire', 'interventionNames': ['Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography']}, {'label': 'Low Probability of OSA', 'description': 'Based on a sleep questionnaire', 'interventionNames': ['Diagnostic Test: Home Sleep Apnea Testing or In-hospital Polysomnography']}], 'interventions': [{'name': 'Home Sleep Apnea Testing or In-hospital Polysomnography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis', 'armGroupLabels': ['High Probability of OSA', 'Low Probability of OSA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Basibuyuk', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': 'TR34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Koc University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Koc Healthcare Istanbul American Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yuksel Peker, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Koc University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within 6 months after the publications, respectively', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results that will be reported in articles would be available to other researchers by contacting the corresponding authors', 'accessCriteria': 'Within 6 months after the publications, respectively, for 5 years'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koç University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Koc Healthcare Istanbul American Hospital, Marmara University Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}