Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 3:18 PM
Study NCT ID:
NCT01096433
Status:
COMPLETED
Last Update Posted:
2012-01-26
First Post:
2010-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circadian Variations of Prostaglandin in Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-24', 'studyFirstSubmitDate': '2010-03-29', 'studyFirstSubmitQcDate': '2010-03-30', 'lastUpdatePostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostaglandins in the urine and blood', 'timeFrame': 'baseline, and 2days, 3 months after CPAP'}], 'secondaryOutcomes': [{'measure': 'polysomnography measurements', 'timeFrame': 'baseline, and 2days, 3 months after CPAP'}, {'measure': 'sleepiness and health-related quality of life', 'timeFrame': 'baseline, and 2days, 3 months after CPAP'}, {'measure': 'Clinical measurements (blood pressure, heart rate, sympathetic activity etc)', 'timeFrame': 'baseline, and 2days, 3 months after CPAP'}, {'measure': 'serum and urinary biomarker (inflammation, oxidative stress etc.)', 'timeFrame': 'baseline, and 2days, 3 months after CPAP'}, {'measure': 'endothelial function', 'timeFrame': 'baseline, and 2days, 3 months after CPAP'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep apnea', 'CPAP', 'Prostaglandins', 'Circadian variations'], 'conditions': ['Sleep Apnea', 'Continuous Positive Airway Pressure', 'Prostaglandins', 'Circadian Variations']}, 'referencesModule': {'references': [{'pmid': '23222881', 'type': 'DERIVED', 'citation': 'Chihara Y, Chin K, Aritake K, Harada Y, Toyama Y, Murase K, Yoshimura C, Hitomi T, Oga T, Mishima M, Urade Y. A urine biomarker for severe obstructive sleep apnoea patients: lipocalin-type prostaglandin D synthase. Eur Respir J. 2013 Dec;42(6):1563-74. doi: 10.1183/09031936.00133512. Epub 2012 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the associations of circadian variations, sleep architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.', 'detailedDescription': 'Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction during sleep that provoke frequents arousals, sleep fragmentation, oxygen desaturation, and excessive daytime sleepiness. OSA may contribute to the development of systemic hypertension, cardiovascular disease. Many studies has reported a crucial role for the prostaglandin D system in sleep regulation. In addition, it has been described urinary or blood levels of prostaglandins was higher in the patients with hypertension, diabetes mellitus, and these values were associated with the severity of coronary artery disease. However, the relation between alterations of prostaglandin D system and sleep architecture, sleepiness, and clinical outcomes such as hypertension, arteriosclerosis in the patients with OSA are not known. Additionally, after CPAP treatment, we will investigate the association between change of prostaglandin system and sleep architecture, sleepiness, clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.\n* Subjects diagnosed with OSA (apnea hypopnea index \\>=5/hour) by overnight polysomnography.\n\nExclusion Criteria:\n\n* Subjects treating for acute infections or malignancy.\n* Subjects with severe cardiovascular disease, diabetes,and renal failure.\n* Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.'}, 'identificationModule': {'nctId': 'NCT01096433', 'briefTitle': 'Circadian Variations of Prostaglandin in Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Kyoto University Hospital'}, 'officialTitle': 'Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea', 'orgStudyIdInfo': {'id': 'C-411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP', 'description': 'The subjects introduced with CPAP treatment', 'interventionNames': ['Device: CPAP treatment']}], 'interventions': [{'name': 'CPAP treatment', 'type': 'DEVICE', 'otherNames': ['REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)'], 'description': 'maintains upper airway patency and minimizes the obstructive events', 'armGroupLabels': ['CPAP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Graduate School of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Kazuo Chin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyoto University, Graduate School of Medicine'}, {'name': 'Yuichi Chihara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyoto University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoto University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Yuichi Chihara', 'investigatorAffiliation': 'Kyoto University'}}}}