Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT03621566
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2018-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Belgian Central Sleep Apnea REgistry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020182', 'term': 'Sleep Apnea, Central'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2028-06-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment choice', 'timeFrame': '5 years', 'description': 'Proportion of patients treated with the different treatment modalities'}], 'secondaryOutcomes': [{'measure': 'Factors determining treatment choice', 'timeFrame': '5 years', 'description': 'Relation between patient and CSA characteristics and the treatment choice'}, {'measure': 'Treatment compliance', 'timeFrame': '5 years', 'description': 'Compliance to the different treatment modalities'}, {'measure': 'Short Form 36 Health Survey', 'timeFrame': '5 years', 'description': 'To measure eight domains of health\n\nContent:\n\n* physical functioning\n* role limitations due to physical health\n* bodily pain\n* general health perceptions\n* vitality\n* social functioning\n* role limitations due to emotional problems\n* mental health\n\nNumber of items: 36 items are included in scoring\n\nScore interpretation: each item scored on a 0 to 100 range so that the lower and highest possible scores are set at 0 and 100. Scores represent the percentage of total possible score achieved.'}, {'measure': 'Pitssburgh Sleep Quality index', 'timeFrame': '5 years', 'description': 'To measure sleep quality and disturbances. Score range: 0-21 points, with lower scores indicating better sleep quality.'}, {'measure': 'Mortality', 'timeFrame': '5 years', 'description': 'Proportion of subjects alive with different treatment modalities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This study evaluates different factors that determine the treatment choice and treatment compliance in patients with central sleep apnea. All patients will receive routine care (registry).', 'detailedDescription': 'Central sleep apnea (CSA) is characterized by intermittent cessation or decrease of airflow and effort of breathing during sleep. The diagnostic criteria for CSA varies according to the type of CSA (e.g. CSA due to cardiac failure, due to a medication, ...).\n\nCSA is defined as: (1) an apnea/hypopnea index ≥ 15 per hour of sleep and (2) the number of central apneas and/or hypopneas is \\> 50% of the total number of apneas and hypopneas.\n\nPresence of CSA is associated with excessive daytime sleepiness and poor sleep quality. Furthermore, in patients with heart failure, presence of CSA was found to be related to mortality. As yet, however, there is insufficient knowledge on the clinical features, pathophysiological background and consecutive algorithms for treatment. Currently, it is not fully clear whether CSA or the treatment of CSA is related to disease progress.\n\nThe aim of this trial is to evaluate the current treatment choices for CSA in Belgium and compliance with and effects of these treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with an apnea/hypopnea index ≥ 15/h of sleep and proportion of non-obstructive events \\> 50%, derived from polysomnography (diagnostic or during positive airway pressure treatment)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* An apnea/hypopnea index ≥ 15/h of sleep and proportion of non-obstructive events \\> 50%, derived from polysomnography (diagnostic or during (PAP) treatment)\n* Written informed consent provided\n\nExclusion Criteria:\n\n\\- Patients with mental disability making it impossible to understand the study protocol'}, 'identificationModule': {'nctId': 'NCT03621566', 'acronym': 'B-CARE', 'briefTitle': 'Belgian Central Sleep Apnea REgistry', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Belgian Central Sleep Apnea REgistry (B-CARE)', 'orgStudyIdInfo': {'id': 'B322201835950'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Central Sleep Apnea', 'description': 'Subjects with an apnea/hypopnea index ≥ 15/h of sleep and proportion of non-obstructive events \\> 50%, derived from polysomnography (diagnostic or during positive airway pressure treatment)', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Routine care (registry)', 'armGroupLabels': ['Central Sleep Apnea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Berend-Jan Berendes, MD', 'role': 'CONTACT'}], 'facility': 'OLV Ziekenhuis', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2020', 'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Lieven Bedert, MD', 'role': 'CONTACT'}], 'facility': 'ZNA Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2650', 'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Johan Verbraecken, MD, PhD', 'role': 'CONTACT'}], 'facility': 'UZA', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '8000', 'city': 'Bruges', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Veerle Ringoet, MD', 'role': 'CONTACT'}], 'facility': 'AZ Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Marie Bruyneel, MD, PhD', 'role': 'CONTACT'}], 'facility': 'CHU Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Katrien Hertegonne, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Karolien Weytjens, MD', 'role': 'CONTACT'}], 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '8500', 'city': 'Kortrijk', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sofie Maddens, MD', 'role': 'CONTACT'}], 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '7100', 'city': 'La Louvière', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Alain Volckaert, MD', 'role': 'CONTACT'}], 'facility': 'CH Jolimont', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dries Testelmans, MD, PhD', 'role': 'CONTACT'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Farhad Baharloo, MD', 'role': 'CONTACT'}], 'facility': 'CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5530', 'city': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Thibaut Vandenhove, MD', 'role': 'CONTACT'}], 'facility': 'CHU UCL Namur', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '9600', 'city': 'Ronse', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Edwin Hill, MD', 'role': 'CONTACT'}], 'facility': 'AZ Glorieux', 'geoPoint': {'lat': 50.74574, 'lon': 3.6005}}, {'zip': '2300', 'city': 'Turnhout', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Maryse Van den Heuvel, MD', 'role': 'CONTACT'}], 'facility': 'AZ Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}], 'centralContacts': [{'name': 'Dries Testelmans, MD, PhD', 'role': 'CONTACT', 'email': 'dries.testelmans@uzleuven.be', 'phone': '16 342522', 'phoneExt': '+32'}], 'overallOfficials': [{'name': 'Dries Testelmans, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Respironics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}