Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-28 @ 6:06 PM
Study NCT ID:
NCT01033266
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2009-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nasal CPAP on Cardiopulmonary Exercise Testing in Patients With Overlap Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic 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'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of nasal CPAP on CPET performance in patients with overlap syndrome', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Nasal CPAP will improve cardiopulmonary exercise test (CPET) performance in patients with overlap syndrome(COPD and OSA). Nasal CPAP is proven to improve cardiopulmonary exercise testing in patients with OSA. The investigators hypothesis is that patients with overlap syndrome will have a greater improvement in their cardiopulmonary exercise testing besides a possible improvement in their lung function test and airway resistance.', 'detailedDescription': 'Patients presenting to the Oklahoma City VA sleep clinic with obstructive sleep apnea syndrome and a desire to initiate CPAP treatment will be included if they have overlap syndrome. Patients will undergo a spirometry and CPET before being started on CPAP as part of standard clinical care. The CPET will be repeated after 8-12 weeks of CPAP use. Patients will be excluded if they have any contraindication to mild exercise or they cannot perform an exercise test due to limited mobility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with OSA and COPD will perform CPET before and after use of CPAP.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obstructive sleep apnea (OSA)\n* COPD\n\nExclusion Criteria:\n\n* Inability to perform exercise test due to musculoskeletal limitation\n* Cardiac condition preventing patient from mild exercise\n* Continuous oxygen supplement'}, 'identificationModule': {'nctId': 'NCT01033266', 'briefTitle': 'Effect of Nasal CPAP on Cardiopulmonary Exercise Testing in Patients With Overlap Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Effect of Continuous Positive Airway Pressure (CPAP) and Cardiopulmonary Exercise Testing(CPET) in Patient With Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '14587/2895'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CPET CPAP', 'interventionNames': ['Diagnostic Test: CPET']}], 'interventions': [{'name': 'CPET', 'type': 'DIAGNOSTIC_TEST', 'description': 'CPET will be done on patients with overlap syndrome before and after clinical CPAP treatment.', 'armGroupLabels': ['CPET CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OU Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Gary Kinasewitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}, {'name': 'Houssein Youness, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}