Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02923505
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2016-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'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': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Healthcare Costs', 'timeFrame': '2 years'}, {'measure': 'Diagnosis-related Healthcare Costs', 'timeFrame': '2 years'}, {'measure': 'Adherence to PAP therapy, (% days with usage >=4h/night)', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Sleep-Disordered Breathing', 'Pulmonary Disease, Chronic Obstructive', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to test the hypothesis that treatment of sleep disordered breathing (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart failure (HF) with positive airway pressure (PAP) is associated with reduced risk for hospitalizations and death, lower health care utilization, and greater cost-effectiveness.', 'detailedDescription': 'In this retrospective analysis the health care utilization in patients with COPD and HF will be quantified. Data of patients who additionally underwent a polysomnography or polygraphy between 2012 and 2015 are taken into consideration. The data (risk for hospitalization and death, comorbidities, diagnosis and therapy of SDB, costs of health care utilization) will be collected 12 months before and 12 months after diagnosis of SDB.\n\nThe patients\' medical records will also be reviewed for compliance to treatment for SDB, and the patients will be classified as treated or untreated. The treated group will be divided into two subgroups: those with "good adherence" to PAP therapy (≥ 4 hours PAP use per night) and those with "poor adherence" to PAP therapy (\\< 4 hours PAP use per night). Healthcare Utilizations, HF or COPD exacerbations and mortality will be identified by reviewing medical records, National database when available, or self-reported by patient or patient\'s family through phone interview or questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient from primary care clinics and sleep medicine centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects between 21 to 75 years;\n* consecutive patients who underwent polysomnography or polygraphy during the period of 01/01/2012 to 31/12/2015.\n* diagnosis of COPD and/or HF\n\nExclusion Criteria:\n\n* age \\<21 or \\>75 years'}, 'identificationModule': {'nctId': 'NCT02923505', 'briefTitle': 'Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)', 'organization': {'class': 'OTHER', 'fullName': 'Wissenschaftliches Institut Bethanien e.V'}, 'officialTitle': 'Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)', 'orgStudyIdInfo': {'id': 'WI_COPD+HF+SDB_16-250'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SDB+COPD', 'description': 'Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease', 'interventionNames': ['Procedure: polygraphy or polysomnography']}, {'label': 'SDB+HF', 'description': 'Patients with sleep-disordered breathing and concomitant heart failure', 'interventionNames': ['Procedure: polygraphy or polysomnography']}, {'label': 'SDB+COPD+HF', 'description': 'Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease and heart failure', 'interventionNames': ['Procedure: polygraphy or polysomnography']}], 'interventions': [{'name': 'polygraphy or polysomnography', 'type': 'PROCEDURE', 'armGroupLabels': ['SDB+COPD', 'SDB+COPD+HF', 'SDB+HF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Center for Sleep Medicine', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Grenoble Alpes, Pole Thorax et Vaisseaux (PTV), Clinique de Physiologie Sommeil et Exercice', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '42699', 'city': 'Solingen', 'country': 'Germany', 'facility': 'Wissenschaftliches Institut Bethanien für Pneumologie e.V.', 'geoPoint': {'lat': 51.17343, 'lon': 7.0845}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wissenschaftliches Institut Bethanien e.V', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Respironics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}