Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02133859
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2014-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive Servo-ventilation Monitoring Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2014-05-01', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of hypoxemia, as measured by overnight pulse oximetery, with worsening heart failure', 'timeFrame': '12 months', 'description': 'Hypoxemia, as measured by pulse oximetery will be compared with heart failure status to measure if a correlation exists between hypoxemia and deterioration of heart failure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'Sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat sleep apnea in these patients. This is an observational study to document changes in respiratory parameters in HF patients using ASV for a period of 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic Heart Failure patients using adaptive servo ventilation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMore than 18 years old Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines NYHA Class III or IV at the time of inclusion with at least one hospitalization for heart failure in the last 12 months Moderate to severe sleep apnea (AHI ≥ 15/hour). Already using or willing to use ASV-therapy and able to tolerate the mask treatment\n\nExclusion Criteria:\n\nPlanned or scheduled heart valve interventions and/or CABG Untreated or therapy refractory Restless Leg Syndrome Patients for whom the use of positive airway pressure therapy may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum Pregnancy'}, 'identificationModule': {'nctId': 'NCT02133859', 'briefTitle': 'Adaptive Servo-ventilation Monitoring Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Feasibilty of Respiratory Monitoring With Adaptive Servoventilation (PaceWave™) to Predict Worsening of Heart Failure in Patients With Severe Heart Failure and Sleep-disordered Breathing', 'orgStudyIdInfo': {'id': 'MA220414'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Heart Failure patients using ASV', 'description': 'Patients with chronic heart failure who are using or willing to use adaptive servo ventilation (ASV) therapy will be enrolled. Respiratory data will be collected from this group every 3 months over a 12 month period'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-32545', 'city': 'Bad Oeynhausen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Sleep Laboratory, Ruhr University of Bochum', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}], 'overallOfficials': [{'name': 'Olaf Oldenburg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruhr University of Bochum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}