Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00607893
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2008-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mehrar@ccf.org', 'phone': '216-445-1698', 'title': 'Reena Mehra', 'organization': 'Case Western Reserve University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SHAM CPAP', 'description': 'Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.\n\nSham CPAP: Participants will use the lower pressure CPAP every night for 8 weeks.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 27, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Treatment CPAP', 'description': 'Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.\n\nContinuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 32, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Run-in/Washout Treatment CPAP', 'description': 'The initial run-in and washout period for study qualification to document CPAP adherence on treatment CPAP.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 23, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Run-in/Washout Sham CPAP', 'description': 'The initial run-in and washout period for study qualification to document CPAP adherence on Sham CPAP (negligible pressure).', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 8, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Bruise from venipucture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart monitor for irregular heartbeat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Run of nonsustained ventricular tachycardia on PSG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye infection/injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated glucose level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Developed sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fell and bruised rib', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General pain (leg, back, muscle)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'auto accident / physical therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breathing problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold/congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-productive cough/post nasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spot on lung (possible cancer)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Strep throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abrasion on bridge of nose from CPAP mask', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cysts on chin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flare up of eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness on external nares from nasal pillow mask marks on face from maks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tumor removed from finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcer on foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'scabs on head from electrodes from psg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth extracted/root canal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest Pain (went to ER)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enlarged coronary artieries/chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irregular heartbeat (went to ER)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New onset atrial flutter (shown on psg)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ER with swollen Knee (hospitalized)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration and possible kidney failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia/Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spot on lung - biopsy for cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot ulcer amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ruptured appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'F2-isoprostanes/Cr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.10'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.18', 'upperLimit': '0.03'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.071', 'ciLowerLimit': '-0.090', 'ciUpperLimit': '0.23', 'estimateComment': 'F2-isoprostanes/Cr was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'ng/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Myeloperoxidase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.33', 'groupId': 'OG000', 'lowerLimit': '-17.02', 'upperLimit': '10.37'}, {'value': '-5.15', 'groupId': 'OG001', 'lowerLimit': '-18.65', 'upperLimit': '8.35'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '-17.42', 'ciUpperLimit': '21.07', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'pmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Arterial BP, Evening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.59', 'groupId': 'OG000', 'lowerLimit': '-2.53', 'upperLimit': '1.35'}, {'value': '-0.72', 'groupId': 'OG001', 'lowerLimit': '-2.65', 'upperLimit': '1.20'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-2.60', 'ciUpperLimit': '2.87', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulse Wave Velocity, Evening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.57', 'upperLimit': '0.40'}, {'value': '-0.30', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '0.20'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.91', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'cm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.68'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.46', 'upperLimit': '0.29'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.92', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Measures of inflammation outcome, analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Arterial BP, Morning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '-1.64', 'upperLimit': '2.12'}, {'value': '-2.17', 'groupId': 'OG001', 'lowerLimit': '-4.03', 'upperLimit': '-0.30'}]}]}], 'analyses': [{'pValue': '0.076', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.40', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '5.07', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'sIL-6R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.06'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '-0.01'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.062', 'ciLowerLimit': '0.010', 'ciUpperLimit': '0.11', 'estimateComment': 'sIL-6R was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Measures of inflammation outcome, logarithm transformed before analysis due to skewed distribution, analyzed change of from baseline with adjustment of baseline. The least squares mean is transformed back to present the percent change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulse Wave Velocity, Morning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'groupId': 'OG000', 'lowerLimit': '-0.82', 'upperLimit': '0.32'}, {'value': '-0.42', 'groupId': 'OG001', 'lowerLimit': '-1.01', 'upperLimit': '0.16'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.99', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between Months 2 and 3 of treatment', 'description': 'Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'cm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Augmentation Index, Evening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000', 'lowerLimit': '-3.87', 'upperLimit': '3.00'}, {'value': '-1.79', 'groupId': 'OG001', 'lowerLimit': '-5.36', 'upperLimit': '1.78'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '-3.60', 'ciUpperLimit': '6.31', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between Months 2 and 3 of treatment', 'description': 'Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Augmentation Index, Morning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham CPAP', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'OG001', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG000', 'lowerLimit': '-2.22', 'upperLimit': '3.10'}, {'value': '-6.49', 'groupId': 'OG001', 'lowerLimit': '-9.32', 'upperLimit': '-3.65'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.93', 'ciLowerLimit': '3.04', 'ciUpperLimit': '10.81', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measured between Months 2 and 3 of treatment', 'description': 'Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham CPAP', 'description': 'Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.\n\nSham treatment: Participants will use the lower pressure CPAP every night for 8 weeks.'}, {'id': 'FG001', 'title': 'Treatment CPAP', 'description': 'Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.\n\nContinuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Underwent Randomization', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Completed Baseline Visit', 'comment': 'Completed Baseline Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'Completed 8 Week Visit', 'comment': 'Completed 8 Week Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'Completed 12 Week Visit', 'achievements': [{'comment': '12 Week Visit only offered to participants on actual CPAP Treatment', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '12 Week Visit only offered to participants on actual CPAP Treatment', 'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'withdrew due to loss of interest', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew due to osteomyelitis surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'withdrew could not tolerate CPAP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Declined to be treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew due to hypertensive urgency', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment CPAP', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.'}, {'id': 'BG001', 'title': 'Sham CPAP', 'description': 'Participants used the Sham CPAP every night for 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '51.0', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2008-01-25', 'resultsFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2008-01-25', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-17', 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'F2-isoprostanes/Cr', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline'}, {'measure': 'Myeloperoxidase', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline'}], 'secondaryOutcomes': [{'measure': 'Mean Arterial BP, Evening', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline'}, {'measure': 'Pulse Wave Velocity, Evening', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline'}, {'measure': 'IL-6', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Measures of inflammation outcome, analyzed absolute change from baseline, with adjustment of baseline'}, {'measure': 'Mean Arterial BP, Morning', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline'}, {'measure': 'sIL-6R', 'timeFrame': 'Measured between baseline and after treatment', 'description': 'Measures of inflammation outcome, logarithm transformed before analysis due to skewed distribution, analyzed change of from baseline with adjustment of baseline. The least squares mean is transformed back to present the percent change from baseline.'}, {'measure': 'Pulse Wave Velocity, Morning', 'timeFrame': 'Measured between Months 2 and 3 of treatment', 'description': 'Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline'}, {'measure': 'Augmentation Index, Evening', 'timeFrame': 'Measured between Months 2 and 3 of treatment', 'description': 'Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline'}, {'measure': 'Augmentation Index, Morning', 'timeFrame': 'Measured between Months 2 and 3 of treatment', 'description': 'Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep-Disordered Breathing'], 'conditions': ['Sleep Apnea Syndromes', 'Oxidative Stress', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '16983050', 'type': 'BACKGROUND', 'citation': 'Mehra R, Storfer-Isser A, Kirchner HL, Johnson N, Jenny N, Tracy RP, Redline S. Soluble interleukin 6 receptor: A novel marker of moderate to severe sleep-related breathing disorder. Arch Intern Med. 2006 Sep 18;166(16):1725-31. doi: 10.1001/archinte.166.16.1725.'}, {'pmid': '16931151', 'type': 'BACKGROUND', 'citation': 'Mehra R, Principe-Rodriguez K, Kirchner HL, Strohl KP. Sleep apnea in acute coronary syndrome: high prevalence but low impact on 6-month outcome. Sleep Med. 2006 Sep;7(6):521-8. doi: 10.1016/j.sleep.2006.03.012. Epub 2006 Aug 23.'}, {'pmid': '16424443', 'type': 'BACKGROUND', 'citation': 'Mehra R, Benjamin EJ, Shahar E, Gottlieb DJ, Nawabit R, Kirchner HL, Sahadevan J, Redline S; Sleep Heart Health Study. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2006 Apr 15;173(8):910-6. doi: 10.1164/rccm.200509-1442OC. Epub 2006 Jan 19.'}, {'pmid': '31860326', 'type': 'DERIVED', 'citation': 'May AM, Wang L, Strohl KP, Walia H, Hazen SL, Mehra R. Sex-Specific Differential Responses of Circulating Biomarkers in Obstructive Sleep Apnea Treatment. A Post Hoc Analysis of a Randomized Controlled Trial. Ann Am Thorac Soc. 2020 May;17(5):605-613. doi: 10.1513/AnnalsATS.201908-593OC.'}, {'pmid': '29684316', 'type': 'DERIVED', 'citation': 'May AM, Gharibeh T, Wang L, Hurley A, Walia H, Strohl KP, Mehra R. CPAP Adherence Predictors in a Randomized Trial of Moderate-to-Severe OSA Enriched With Women and Minorities. Chest. 2018 Sep;154(3):567-578. doi: 10.1016/j.chest.2018.04.010. Epub 2018 Apr 21.'}, {'pmid': '27091532', 'type': 'DERIVED', 'citation': 'DeMartino T, Ghoul RE, Wang L, Bena J, Hazen SL, Tracy R, Patel SR, Auckley D, Mehra R. Oxidative Stress and Inflammation Differentially Elevated in Objective Versus Habitual Subjective Reduced Sleep Duration in Obstructive Sleep Apnea. Sleep. 2016 Jul 1;39(7):1361-9. doi: 10.5665/sleep.5964.'}, {'pmid': '26997243', 'type': 'DERIVED', 'citation': 'Paz Y Mar HL, Hazen SL, Tracy RP, Strohl KP, Auckley D, Bena J, Wang L, Walia HK, Patel SR, Mehra R. Effect of Continuous Positive Airway Pressure on Cardiovascular Biomarkers: The Sleep Apnea Stress Randomized Controlled Trial. Chest. 2016 Jul;150(1):80-90. doi: 10.1016/j.chest.2016.03.002. Epub 2016 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'Sleep-disordered breathing (SDB) is a condition in which a person experiences frequent breathing pauses during sleep, also known as sleep apnea. There is evidence that the recurrent sleep arousal and associated shortage of oxygen in the body may increase risk for cardiovascular disease (CVD). It is believed that treatment with continuous positive airway pressure (CPAP) may reduce certain risk factors for heart disease, including markers of inflammation and oxidative stress. This study will evaluate the effectiveness of CPAP in reducing CVD risk factors in people with SDB.', 'detailedDescription': 'It is estimated that 18 million Americans are affected by SDB. SDB involves repeated sleep arousal caused by breathing difficulties. These frequent sleep disruptions may cause a person to experience daytime drowsiness, impaired mental functioning, and trouble concentrating or staying alert. SDB is also associated with an increased risk of certain cardiovascular diseases, such as high blood pressure and heart disease. Researchers believe that increased oxidative stress and inflammation associated with SDB may play a role in the physiologic pathway linking SDB and CVD. However, more information on the SDB-CVD relationship is needed to be able to identify risk factors for CVD and to discover the best means of treatment. CPAP, a current treatment for SDB, acts by delivering air through a mask during sleep. CPAP helps improve overnight breathing and quality of sleep and may, in turn, decrease oxidative stress and associated CVD risks. This study will compare the effectiveness of CPAP versus placebo CPAP in reducing CVD risk factors, such as oxidative stress markers, in people with SDB.\n\nParticipation in this study will last between 2.5 and 4 months and will include four to five study visits. During the first study visit, participants will undergo a CPAP titration study, which will involve appropriate CPAP mask fitting and an overnight sleep test to determine the best CPAP pressure, as well as a lower placebo pressure, for each participant. Participants will also be provided educational information on diet, sleep, and the use of CPAP as a treatment for sleep apnea. After the titration study, participants will be asked to wear their fitted CPAP mask every night for the next 2 weeks, during which they will use the lower (placebo) pressure one week and use the higher pressure the other week. During this time, a technician will contact participants every 3 to 4 days to address any questions or problems with the CPAP equipment.\n\nOne month later, participants who were able to tolerate and use CPAP most nights will attend Visit 2. This second visit will include an overnight sleep study without wearing the CPAP mask; blood and saliva collection; cheek brushing for genetic material; tests on diabetes, artery stiffness, and circulation; body fat measurements; and questionnaires. Participants will then be randomly assigned to use either the higher pressure CPAP or the lower pressure CPAP for 8 weeks. Visit 3 will occur 1 week after beginning CPAP treatment and will include a fasting blood test. During treatment, participants will be periodically contacted by a technician to check on equipment status.\n\nUpon completing treatment, participants will undergo repeat tests from Visit 2, except that they will wear the CPAP mask in the overnight sleep test. This fourth study visit will mark the completion of treatment for participants assigned to the lower pressure CPAP. Participants assigned to the higher pressure CPAP will be asked to use CPAP for 4 more weeks. These participants will return at the end of the 4 weeks for a final visit, which will include a repeat sleep study and other testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe sleep disordered breathing (SDB) (Apnea Hypopnea Index \\[AHI\\] greater than or equal to 15) diagnosed within the 2 months before study entry\n* Able to participate in more than two overnight/daytime sleep and physiologic assessments over a 2.5-month period\n\nExclusion Criteria:\n\n* Current or planned use of specific sleep apnea treatments (e.g., CPAP, oral appliance) outside of the study\n* Anticipated upper airway surgery or gastric bypass surgery in the 4 months after study completion\n* Supplemental oxygen use\n* Primary sleep disorder other than sleep apnea (e.g., periodic limb movement disorder)\n* Severe chronic insomnia or circadian rhythm disorder with less than 4 hours of sleep per night, chronic problems falling asleep within 1 hour of bedtime, or chronic problems with early morning awakenings\n* Unstable medical conditions (e.g., new onset or changing angina; heart attack or congestive heart failure exacerbation documented within the 6 months before study entry; high grade cardiac dysrhythmia/heart block; known unaddressed coronary artery disease by history, angina, stroke, or uncontrolled hypertension or diabetes mellitus; thyroid disorder; cirrhosis; a non-skin cancer diagnosed within the 2 years before study entry)\n* Inadequately treated psychiatric disorders or compromised competence\n* Daytime sleepiness with reports of sleepiness while driving or during other situations that would present a risk for the subject or public (e.g., operating heavy equipment)\n* Alcohol abuse\n* Pregnancy\n* Use of oral corticosteroids'}, 'identificationModule': {'nctId': 'NCT00607893', 'acronym': 'SASS', 'briefTitle': 'Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Oxidative Stress in Sleep Apnea and Cardiac Disease', 'orgStudyIdInfo': {'id': '562'}, 'secondaryIdInfos': [{'id': 'K23HL079114', 'link': 'https://reporter.nih.gov/quickSearch/K23HL079114', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham CPAP', 'description': 'Participants will receive sham continuous positive airway pressure (CPAP) for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.', 'interventionNames': ['Device: Sham CPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment CPAP', 'description': 'Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.', 'interventionNames': ['Device: Continuous Positive Airway Pressure (CPAP)']}], 'interventions': [{'name': 'Continuous Positive Airway Pressure (CPAP)', 'type': 'DEVICE', 'description': 'Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.', 'armGroupLabels': ['Treatment CPAP']}, {'name': 'Sham CPAP', 'type': 'DEVICE', 'description': 'Participants will use the lower pressure CPAP every night for 8 weeks.', 'armGroupLabels': ['Sham CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Reena Mehra, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Reena Mehra', 'investigatorAffiliation': 'Case Western Reserve University'}}}}