Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT02356367
Status:
WITHDRAWN
Last Update Posted:
2017-04-12
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020182', 'term': 'Sleep Apnea, Central'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'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'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography', 'timeFrame': '12 months', 'description': 'Autonomic nervous system balance measure by microneurography'}], 'secondaryOutcomes': [{'measure': 'anxiety and nervous depression', 'timeFrame': '12 months', 'description': "using Spielberger questionnaire and Beck's Depression Inventory"}, {'measure': 'sleep disordered breathing symptomatology', 'timeFrame': '12 months', 'description': 'using Epworth sleepiness scale and Oxford Sleep Resistance Test'}, {'measure': 'Nocturia', 'timeFrame': '24 months', 'description': 'evaluated by number of urination per night, diuresis, plasmatic dosage of Atrial Natriuretic peptide, Brain natriuretic peptide, Antidiuretic hormone'}, {'measure': 'sleep quality', 'timeFrame': '24 months', 'description': 'evaluated by Pittsburgh Sleep Quality Index; minnesota living with heart failure questionnaire; actimetry; home polysomnography'}, {'measure': 'Heart Failure status', 'timeFrame': '24 months', 'description': 'evaluated by echocardiography, New York Heart Association functional classification; Electrocardiography'}, {'measure': 'therapy compliance', 'timeFrame': '24 months', 'description': 'evaluated by Morisky Medication Adherence Scale and with telemonitoring data'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['telemonitoring', 'Adaptive servo-ventilation'], 'conditions': ['Central Sleep Apnea', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart Failure patient eligible for adaptative servo-ventilation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Patient with Chronic Heart Failure\n* Central Sleep Apnea requiring Adaptative Servo-Ventilation therapy\n* Patient is able to fully understand study information and signed informed consent\n\nExclusion Criteria:\n\n* Contra-indications to Adaptative Servo-Ventilation therapy\n* Respiratory Failure or Hypercapnia inconsistent with Adaptative Servo-Ventilation therapy'}, 'identificationModule': {'nctId': 'NCT02356367', 'acronym': 'FACE', 'briefTitle': 'French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10 CS): Predictive Factors of Poor Compliance', 'orgStudyIdInfo': {'id': 'Face Pilot Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'telemonitoring', 'type': 'OTHER', 'otherNames': ['Airview']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'CHU Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}