Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT00725595
Status:
UNKNOWN
Last Update Posted:
2008-08-26
First Post:
2008-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-08-25', 'studyFirstSubmitDate': '2008-07-28', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Both ASV and Bilevel ventilation are effective in clinical treatment of CSR', 'timeFrame': 'three months'}], 'secondaryOutcomes': [{'measure': 'ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cheyne Stocks respiration', 'heart failure', 'sleep apnea', 'ventilator'], 'conditions': ['Heart Failure', 'Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '16854301', 'type': 'RESULT', 'citation': 'Zhang XL, Yin KS, Jiang SS, Li XL, Jia EZ, Su M. [Efficacy of adaptive pressure support servo-ventilation in patients with congestive heart failure and Cheyne-Stokes respiration]. Zhonghua Yi Xue Za Zhi. 2006 Jun 20;86(23):1620-3. Chinese.'}]}, 'descriptionModule': {'briefSummary': 'The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with both CSR and heart failure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States\n2. Subject is \\> 18 years old\n3. Patients with known history of CSR. CSR symptoms may include the following:\n\n * sleep fragmentation as reported by patient or as witnessed by another person\n * night arousal after apneic episodes\n * reduced exercise capacity\n * daytime sleepiness\n4. Expected to tolerate the ventilator therapy\n\nExclusion Criteria:\n\n1. Baseline oxygen saturation \\< 90% on a stable FIO2)\n2. Patient is currently enrolled in another clinical study which may confound the results of this study\n3. Patient for whom informed consent cannot be obtained\n4. Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure\n5. Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)\n6. Patients with severe COPD (per GOLD scale)\n7. Patients with a history of myocardial infarction within the 6 months prior to the study\n8. Patients with unstable angina'}, 'identificationModule': {'nctId': 'NCT00725595', 'briefTitle': 'Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'orgStudyIdInfo': {'id': '092801'}, 'secondaryIdInfos': [{'id': '20070928'}, {'id': 'No 092801'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'E, 2, III', 'description': 'To treat CSR with ASV and Bilevel ventilators'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Hong, PhD', 'role': 'CONTACT', 'email': 'zhsj_wh@hotmail.com', 'phone': '86-83714511', 'phoneExt': '6705'}, {'name': 'Zhang Shijiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhang Xilong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wang Hong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The 1st Affiliated Hospitak of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Zhang Xilong, PhD', 'role': 'CONTACT', 'email': 'zhangxilong1952@yahoo.com.cn', 'phone': '96-25-83714511', 'phoneExt': '6723'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Glenn Richard', 'oldOrganization': 'ResMed Inc. of Australia'}}}}