Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-02-21 @ 10:47 AM
Study NCT ID:
NCT02059993
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2014-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'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': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zhihongliufuwai@163.com', 'phone': '+86-01088398196', 'title': 'Zhihong Liu', 'organization': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'First, the sample size was relatively small. Second, this was a nondouble-blind study. Third, we did not use 24-hour ambulatory BP to monitor changes in BP and could not evaluate the nighttime BP.'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'description': 'SCCEs included new-onset acute myocardial infarction (AMI), hospitalization for heart failure, need for repeated coronary revascularization, stroke, and death associated with cardiovascular and cerebrovascular disease.', 'eventGroups': [{'id': 'EG000', 'title': 'Continuous Positive Airway Pressure(CPAP) Group', 'description': 'The CPAP group received fixed-level CPAP titration using an automated pressure setting device for 1 night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control', 'description': 'The control subjects received standardised anti-hypertension medications according to the current guildline.', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'severe cardiovascula'}, {'term': 'heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'severe cardiovascula'}, {'term': 'stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'severe cardiovascula'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Positive Airway Pressure(CPAP) Group', 'description': 'The subjects who received CPAP treatment and standardized medicine.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The patients who use standardized drugs without CPAP machine.'}], 'classes': [{'title': 'Change of SBP', 'categories': [{'measurements': [{'value': '-8', 'spread': '11', 'groupId': 'OG000'}, {'value': '-3', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'Change of DBP', 'categories': [{'measurements': [{'value': '-4', 'spread': '11', 'groupId': 'OG000'}, {'value': '-3', 'spread': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'groupDescription': 'The sample size was calculated to assess a minimum reduction of 5 ± 5 mm Hg in systolic BPafter CPAP treatment, assuming an alpha error of 5% and a statistical power of 80%.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and follow-up at 36 months', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 participants withdrew before the end of study. Two subjects were lost to follow-up in the control group, and 4 patients (all of them had no SCCE) with very poor CPAP compliance were also excluded.'}, {'type': 'SECONDARY', 'title': 'Change in Epworth Sleepiness Scale (ESS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Positive Airway Pressure(CPAP) Group', 'description': 'The subjects who received CPAP treatment and standardized medicine.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The patients who use standardized drugs without CPAP machine.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline，end of study ( up to 54 months)', 'description': "The epworth sleepiness scale（ESS） measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP). It is a simple questionnaire based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations. The ESS is the most commonly used method for measuring a person's ASP.The ESS ranges from 0-24, higher scores indicate more severe daytime sleepiness.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cardiovascular and Cerebrovascular Events', 'timeFrame': 'Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuous Positive Airway Pressure(CPAP) Group', 'description': 'The continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure and the the cardiovascular drugs based on the guidelines.'}, {'id': 'FG001', 'title': 'Control', 'description': 'The controls only received the cardiovascular drugs based on the guidelines but without continuous positive airway pressure machine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'We recruited consecutive patients from outpatient and inpatient departments of Fuwai Hospital from January 2009 to June 2012. Patients were randomly assigned to either continuous positive airway pressure (CPAP) group or no CPAP therapy (control).', 'preAssignmentDetails': 'A total of 243 patients were screened between January 2009 and June 2012. Out of 97 (39.9%) patients diagnosed with obstructive sleep apnea (OSA), 5 subjects declined to participate in the study, and 9 subjects were excluded because of the following: apnea-hypopnea index (AHI) \\<15 (n = 8 patients) and severe heart failure (n = 1 patient).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Continuous Positive Airway Pressure(CPAP) Group', 'description': 'The CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.'}, {'id': 'BG001', 'title': 'Control', 'description': 'The control group received the standardized antihypertensive medications but without receiving CPAP machine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '62.7', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '62.4', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'morning systolic and diastolic BP (mmHg)', 'classes': [{'title': 'systolic BP', 'categories': [{'measurements': [{'value': '146', 'spread': '8', 'groupId': 'BG000'}, {'value': '148', 'spread': '11', 'groupId': 'BG001'}, {'value': '147', 'spread': '9', 'groupId': 'BG002'}]}]}, {'title': 'diastolic BP', 'categories': [{'measurements': [{'value': '83', 'spread': '7', 'groupId': 'BG000'}, {'value': '83', 'spread': '8', 'groupId': 'BG001'}, {'value': '83', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The morning BP was measured with a mercury sphygmomanometer by an experienced physician unaware of the patient's group assignment,which was the main end point.", 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'A total of 243 patients were screened between January 2009 and June 2012. Out of 97 (39.9%) patients diagnosed with OSA, 5 subjects declined to participate in the study, and 9 subjects were excluded because of the following: AHI \\<15 (n = 8 patients) and severe heart failure (n = 1 patient).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2014-02-09', 'resultsFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-07', 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiovascular and Cerebrovascular Events', 'timeFrame': 'Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month'}], 'primaryOutcomes': [{'measure': 'Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment', 'timeFrame': 'baseline and follow-up at 36 months'}], 'secondaryOutcomes': [{'measure': 'Change in Epworth Sleepiness Scale (ESS)', 'timeFrame': 'baseline，end of study ( up to 54 months)', 'description': "The epworth sleepiness scale（ESS） measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP). It is a simple questionnaire based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations. The ESS is the most commonly used method for measuring a person's ASP.The ESS ranges from 0-24, higher scores indicate more severe daytime sleepiness."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['continuous positive airway pressure', 'hypertension', 'coronary heart disease', 'metabolic disorder', 'obstructive sleep apnea'], 'conditions': ['Hypertension', 'Metabolic Disorder']}, 'referencesModule': {'references': [{'pmid': '25125635', 'type': 'DERIVED', 'citation': 'Huang Z, Liu Z, Luo Q, Zhao Q, Zhao Z, Ma X, Liu W, Yang D. Long-term effects of continuous positive airway pressure on blood pressure and prognosis in hypertensive patients with coronary heart disease and obstructive sleep apnea: a randomized controlled trial. Am J Hypertens. 2015 Mar;28(3):300-6. doi: 10.1093/ajh/hpu147. Epub 2014 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea(OSA) is an important identifiable cause of hypertension. Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease.The standardized treatment of moderate/severe OSA is continuous positive airway pressure (CPAP). Most of short-term trials indicated that CPAP treatment reduced BP in patients with OSA. But relevant studies have a relative short duration with only but few more than one year. In our opinion, they are not sufficient to detect the real effect of CPAP on reduction in BP. Besides, the impact of OSA on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment could reduce blood pressure and improve metabolic disorder in patients with coronary heart disease (CHD)and OSA.', 'detailedDescription': "Obstructive sleep apnea (OSA) is a common disorder characterized by repetitive partial (hypopnea) or complete (apnea) occlusion of the upper airway during sleep caused by collapse of the pharyngeal airway, resulting in sleep fragmentation and oxyhemoglobin desaturation. Kiely and colleague's study showed that over 20% of hypertensive patients exhibit OSA, whereas prevalence of hypertension in the setting of OSA exceeds 50%. One study confirmed that OSA is an important identifiable cause of hypertension. OSA is considered as one of the most common risk factors of resistant hypertension. Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease. Several studies confirmed that CPAP reduced systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with OSA. Additionally, some papers reported that there was a protective effect of CPAP therapy against death from cardiovascular disease in patients with severe OSA. Other researches regarding the antihypertensive effect of CPAP therapy, however, showed that CPAP had no antihypertensive effect. But relevant studies have a relative short duration with only but few more than one year. In our opinion, they are not sufficient to detect the real effect of CPAP on reduction in BP. According to our knowledge, there is no report about long-term effect of CPAP on BP in hypertensive patients with coronary revascularization (CRV) and OSA under conventional antihypertensive medications. Therefore, we conducted a long-term, prospective controlled study to investigate the effects of CPAP on BP, metabolic disorder, clinical symptoms, cardiovascular and cerebrovascular events in patients with CHD and OSA on conventional treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women, aged 45 to 75 years old\n* verified diagnosis of hypertension by medical history or receiving antihypertensive drugs\n* established diagnosis of CHD\n* at least 3-month optimal treatment for hypertension\n* moderate or severe OSA\n\nExclusion Criteria:\n\n* if they had secondary hypertension\n* central sleep apneas\n* history of significant chronic renal, or hepatic failure or severe pulmonary disease\n* diagnosed with malignant cancer with a life expectancy of less than 2years\n* regular use of medications that can affect BP(including corticosteroids or sedative drugs)\n* severe psychiatric disease\n* sustained excessive alcohol use\n* current use of CPAP treatment for OSA or pharyngeal surgery for OSA\n* New York Heart Association Class III-IV degree\n* declined to participate or were unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT02059993', 'briefTitle': 'The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Pulmonary Vascular Disease Research Group'}, 'officialTitle': 'The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease', 'orgStudyIdInfo': {'id': 'SF2009-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'continuous positive airway pressure', 'description': 'mean continuous positive airway pressure use was at least 4 hours per night; continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure', 'interventionNames': ['Device: continuous positive airway pressure']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control subjects received standardised anti-hypertension medications according to the current guildline.'}], 'interventions': [{'name': 'continuous positive airway pressure', 'type': 'DEVICE', 'description': 'mean continuous positive airway pressure use was at least 4 hours per night;continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure', 'armGroupLabels': ['continuous positive airway pressure']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhihong Liu, MD，PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuwai Hospital, National Center for Cardiovascular Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Pulmonary Vascular Disease Research Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}