Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-04-19 @ 5:24 AM
Study NCT ID:
NCT01979120
Status:
UNKNOWN
Last Update Posted:
2013-11-08
First Post:
2013-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-11-03', 'studyFirstSubmitDate': '2013-11-03', 'studyFirstSubmitQcDate': '2013-11-03', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': '2 years'}, {'measure': 'Hospitalization', 'timeFrame': '2 years'}, {'measure': 'ICD therapies (i.e. shock or anti-tachycardia pacing)', 'timeFrame': '2 years'}, {'measure': 'atrial fibrillation', 'timeFrame': '2 years'}, {'measure': 'routine B-type natriuretic peptide', 'timeFrame': '1 night', 'description': 'only if applicable!'}], 'primaryOutcomes': [{'measure': 'Apnea-Hypopnea-Index', 'timeFrame': '1 night'}], 'secondaryOutcomes': [{'measure': 'Apnea-Hypopnea-Index >/= 30 (in-laboratory polysomnography)', 'timeFrame': '1 night'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep-disordered breathing', 'Chronic heart failure', 'Implantable cardioverter-defibrillator', 'Apnea-Hypopnea-Index', 'Portable Polygraphy Monitoring', 'Polysomnography'], 'conditions': ['Sleep-disordered Breathing', 'Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'A prospective observational multi-centre study for the validation of the ApneaScan algorithm (integrated in ICD devices (with or without cardiac resynchronization therapy function) of the "Incepta" series for the screening of sleep disordered breathing in patients with stable symptomatic chronic heart failure, using portable polygraphy monitoring device ("Embletta Gold") as reference for the Apnea-Hypopnea-Index (AHI).\n\nSecondary objectives are the detection of severe sleep disordered breathing in patients with clinically indicated in-laboratory polysomnography, as well as correlations of the AHI detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial fibrillation and ventricular arrhythmia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stable symptomatic chronic heart failure and implanted ICD/CRT-D of the "INCEPTA" series', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Patient´s written informed consent\n* Patients with a cardiac rhythm management device (ICD with or without cardiac resynchronization therapy function) of the "Incepta" series (including the ApneaScan algorithm) already implanted for at least 8 weeks (corresponding to the duration of the leads´ healing process); in order to standardize the enrollment period, inclusion should be effected between the first (the earliest 8 weeks after implantation) and the second routine control of ICD-function (the latest 9 months after implantation)\n* Stable symptomatic chronic heart failure for either ischemic or non-ischemic reason (moderately to severely impaired systolic left ventricular function with NYHA-class II to III) under optimal pharmacological treatment (according to guidelines 2012 of the European Society of Cardiology)\n\nExclusion Criteria:\n\n* Unstable heart failure (NYHA-class IV) or asymptomatic chronic heart failure (including patients with very mild exercise induced dyspnea, i.e. NYHA-class I)\n* Patients already treated for sleep apnea syndrome (i.e. continuous positive airway pressure mask) or chronic obstructive pulmonary disease with GOLD-class IV (i.e. long-term oxygen therapy)\n* A limited AHI detection by the ApneaScan algorithm until the planned inclusion (randomly defined by \\<50% of countable AHI detection-points within the last 2 weeks).\n* Patients with limited mobility due to orthopedic, neurologic or oncologic diseases (because of restricted assessment of exercise induced dyspnea)\n* Patients on dialysis (either acute or chronic)\n* Alcoholism or regular intake of hypnotics\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT01979120', 'acronym': 'VASA', 'briefTitle': 'Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Patients With Stable Symptomatic Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'ISROTH20033'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'only 1 cohort!', 'description': 'All patients already got an ICD implanted which includes an algorithm for screening of sleep-disordered breathing and will be examined by an portable polygraphy monitor in order to compare the Apnea-Hypopnea-Index.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Reinhard Achleitner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hietzing Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christoph Schukro, MD, PhD', 'role': 'CONTACT', 'email': 'christoph.schukro@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '4614'}, {'name': 'Christoph Schukro, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Wolfgang Cozzarini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SMZO', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gabriele Jakl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wilhelminenspital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Wiener Neustadt', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Alexander Teubl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wiener Neustadt Hospital', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}, {'city': 'Bad Oeynhausen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Heart and Diabetes centre NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Coburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Johannes Brachmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'city': 'Leipzig', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Reinbek', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Herbert Nägele, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reinbek Hospital', 'geoPoint': {'lat': 53.51703, 'lon': 10.2488}}, {'city': 'Kyushu', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shin-Ichi Ando, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyushu University'}, {'city': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshifumi Takata, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tokyo Medical University', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tottori', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masahiko Kato, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tottori University', 'geoPoint': {'lat': 34.24877, 'lon': 134.67796}}, {'city': 'Urayasu', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takatoshi Kasai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juntendo University School of Medicine', 'geoPoint': {'lat': 35.65879, 'lon': 139.90055}}, {'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Haran Burri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Christoph Schukro, MD, PhD', 'role': 'CONTACT', 'email': 'christoph.schukro@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '4614'}], 'overallOfficials': [{'name': 'Christoph Schukro, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Christoph Schukro', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Dr. Christoph Schukro', 'investigatorAffiliation': 'Medical University of Vienna'}}}}