Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 6:57 PM
Study NCT ID:
NCT01801761
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2012-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Simplified Questionnaire to Detect OSA in COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-28', 'studyFirstSubmitDate': '2012-12-28', 'studyFirstSubmitQcDate': '2013-02-28', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of simple questionnaire to detect severe OSA in COPD patients', 'timeFrame': 'since Dec 1, 2012 to Dec 1, 2014 (up to 2 years)', 'description': 'The main outcome of this study : calculate the sensitivity, specificity, positive predictive value, negative predictive value, ROC curve Time frame: enroll 5 patients in 1 month and complete 4 patients at least we need 24 months to complete 120 patients PSG is standard diagnostic tool and it is no safety issue in this study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['OSA', 'COPD']}, 'descriptionModule': {'briefSummary': 'To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a simplified questionnaire was developed for identifying those COPD patients with severe OSA.', 'detailedDescription': "To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a simplified questionnaire was developed for identifying those COPD patients with severe OSA.\n\nWith patient's BMI, neck and waist circumference, snores, witnessed apnea...\n\nTime frame suspect to enroll 5 patients in 1 month and complete 4 patients at least we need 24 months to complete 120 patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'develop group : previous COPD cohort study validation group : consecutive COPD patient from outpatients clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable COPD patients\n\nExclusion Criteria:\n\n* cancer exacerbation in recent 2 months pregnancy central type sleep apnea claustrophobia chronic respiratory failure'}, 'identificationModule': {'nctId': 'NCT01801761', 'briefTitle': 'A Simplified Questionnaire to Detect OSA in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'A Simplified Screening Questionnaire to Detect the Existence of Severe Obstructive Sleep Apnea in Chronic Obstructive Pulmonary Disease Patients', 'orgStudyIdInfo': {'id': '101-3555b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'develop group', 'description': 'previous COPD study'}, {'label': 'validation group', 'description': 'consecutive COPD patients from outpatient clinics'}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Thoracic Medicine, Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Tsai-Yu Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Thoracic Medicine, Chang Gung Memorial Hospital 199 Tun-Hwa N. Rd., Taipei, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}